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t33 | t33_26 | no | The only side effects attributed to antibiotics were rare nausea and temporary elevation of liver enzymes. | Clostridium difficile ( C. difficile ) is recognized as a frequent cause of antibiotic‐associated diarrhoea and colitis. This review is an update of a previously published Cochrane review. Objectives The aim of this review is to investigate the efficacy and safety of antibiotic therapy for C. difficile‐ associated diarrhoea (CDAD), or C. difficile infection (CDI), being synonymous terms. Search methods We searched MEDLINE, EMBASE, CENTRAL and the Cochrane IBD Group Specialized Trials Register from inception to 26 January 2017. We also searched clinicaltrials.gov and clinicaltrialsregister.eu for ongoing trials. Selection criteria Only randomised controlled trials assessing antibiotic treatment for CDI were included in the review. Data collection and analysis Three authors independently assessed abstracts and full text articles for inclusion and extracted data. The risk of bias was independently rated by two authors. For dichotomous outcomes, we calculated the risk ratio (RR) and corresponding 95% confidence interval (95% CI). We pooled data using a fixed‐effect model, except where significant heterogeneity was detected, at which time a random‐effects model was used. The following outcomes were sought: sustained symptomatic cure (defined as initial symptomatic response and no recurrence of CDI), sustained bacteriologic cure, adverse reactions to the intervention, death and cost. Twenty‐two studies (3215 participants) were included. The majority of studies enrolled patients with mild to moderate CDI who could tolerate oral antibiotics. Sixteen of the included studies excluded patients with severe CDI and few patients with severe CDI were included in the other six studies. Twelve different antibiotics were investigated: vancomycin, metronidazole, fusidic acid, nitazoxanide, teicoplanin, rifampin, rifaximin, bacitracin, cadazolid, LFF517, surotomycin and fidaxomicin. Most of the studies were active comparator studies comparing vancomycin with other antibiotics. One small study compared vancomycin to placebo. There were no other studies that compared antibiotic treatment to a placebo or a 'no treatment' control group. The risk of bias was rated as high for 17 of 22 included studies. Vancomycin was found to be more effective than metronidazole for achieving symptomatic cure. Seventy‐two per cent (318/444) of metronidazole patients achieved symptomatic cure compared to 79% (339/428) of vancomycin patients (RR 0.90, 95% CI 0.84 to 0.97; moderate quality evidence). Fidaxomicin was found to be more effective than vancomycin for achieving symptomatic cure. Seventy‐one per cent (407/572) of fidaxomicin patients achieved symptomatic cure compared to 61% (361/592) of vancomycin patients (RR 1.17, 95% CI 1.04 to 1.31; moderate quality evidence). Teicoplanin may be more effective than vancomycin for achieving a symptomatic cure. Eightly‐seven per cent (48/55) of teicoplanin patients achieved symptomatic cure compared to 73% (40/55) of vancomycin patients (RR 1.21, 95% CI 1.00 to 1.46; very low quality evidence). For other comparisons including the one placebo‐controlled study the quality of evidence was low or very low due to imprecision and in many cases high risk of bias because of attrition and lack of blinding. One hundred and forty deaths were reported in the studies, all of which were attributed by study authors to the co‐morbidities of the participants that lead to acquiring CDI. Although many other adverse events were reported during therapy, these were attributed to the participants' co‐morbidities. The only adverse events directly attributed to study medication were rare nausea and transient elevation of liver enzymes. Recent cost data (July 2016) for a 10 day course of treatment shows that metronidazole 500 mg is the least expensive antibiotic with a cost of USD 13 (Health Warehouse). Vancomycin 125 mg costs USD 1779 (Walgreens for 56 tablets) compared to fidaxomicin 200 mg at USD 3453.83 or more (Optimer Pharmaceuticals) and teicoplanin at approximately USD 83.67 (GBP 71.40, British National Formulary). No firm conclusions can be drawn regarding the efficacy of antibiotic treatment in severe CDI as most studies excluded patients with severe disease. The lack of any 'no treatment' control studies does not allow for any conclusions regarding the need for antibiotic treatment in patients with mild CDI beyond withdrawal of the initiating antibiotic. Nonetheless, moderate quality evidence suggests that vancomycin is superior to metronidazole and fidaxomicin is superior to vancomycin. The differences in effectiveness between these antibiotics were not too large and the advantage of metronidazole is its far lower cost compared to the other two antibiotics. The quality of evidence for teicoplanin is very low. Adequately powered studies are needed to determine if teicoplanin performs as well as the other antibiotics. A trial comparing the two cheapest antibiotics, metronidazole and teicoplanin, would be of interest. |
t33 | t33_27 | no | Recent cost data (July 2016) for a 10 day course of treatment shows that metronidazole 500 mg is the least expensive antibiotic with a cost of USD 13. | Clostridium difficile ( C. difficile ) is recognized as a frequent cause of antibiotic‐associated diarrhoea and colitis. This review is an update of a previously published Cochrane review. Objectives The aim of this review is to investigate the efficacy and safety of antibiotic therapy for C. difficile‐ associated diarrhoea (CDAD), or C. difficile infection (CDI), being synonymous terms. Search methods We searched MEDLINE, EMBASE, CENTRAL and the Cochrane IBD Group Specialized Trials Register from inception to 26 January 2017. We also searched clinicaltrials.gov and clinicaltrialsregister.eu for ongoing trials. Selection criteria Only randomised controlled trials assessing antibiotic treatment for CDI were included in the review. Data collection and analysis Three authors independently assessed abstracts and full text articles for inclusion and extracted data. The risk of bias was independently rated by two authors. For dichotomous outcomes, we calculated the risk ratio (RR) and corresponding 95% confidence interval (95% CI). We pooled data using a fixed‐effect model, except where significant heterogeneity was detected, at which time a random‐effects model was used. The following outcomes were sought: sustained symptomatic cure (defined as initial symptomatic response and no recurrence of CDI), sustained bacteriologic cure, adverse reactions to the intervention, death and cost. Twenty‐two studies (3215 participants) were included. The majority of studies enrolled patients with mild to moderate CDI who could tolerate oral antibiotics. Sixteen of the included studies excluded patients with severe CDI and few patients with severe CDI were included in the other six studies. Twelve different antibiotics were investigated: vancomycin, metronidazole, fusidic acid, nitazoxanide, teicoplanin, rifampin, rifaximin, bacitracin, cadazolid, LFF517, surotomycin and fidaxomicin. Most of the studies were active comparator studies comparing vancomycin with other antibiotics. One small study compared vancomycin to placebo. There were no other studies that compared antibiotic treatment to a placebo or a 'no treatment' control group. The risk of bias was rated as high for 17 of 22 included studies. Vancomycin was found to be more effective than metronidazole for achieving symptomatic cure. Seventy‐two per cent (318/444) of metronidazole patients achieved symptomatic cure compared to 79% (339/428) of vancomycin patients (RR 0.90, 95% CI 0.84 to 0.97; moderate quality evidence). Fidaxomicin was found to be more effective than vancomycin for achieving symptomatic cure. Seventy‐one per cent (407/572) of fidaxomicin patients achieved symptomatic cure compared to 61% (361/592) of vancomycin patients (RR 1.17, 95% CI 1.04 to 1.31; moderate quality evidence). Teicoplanin may be more effective than vancomycin for achieving a symptomatic cure. Eightly‐seven per cent (48/55) of teicoplanin patients achieved symptomatic cure compared to 73% (40/55) of vancomycin patients (RR 1.21, 95% CI 1.00 to 1.46; very low quality evidence). For other comparisons including the one placebo‐controlled study the quality of evidence was low or very low due to imprecision and in many cases high risk of bias because of attrition and lack of blinding. One hundred and forty deaths were reported in the studies, all of which were attributed by study authors to the co‐morbidities of the participants that lead to acquiring CDI. Although many other adverse events were reported during therapy, these were attributed to the participants' co‐morbidities. The only adverse events directly attributed to study medication were rare nausea and transient elevation of liver enzymes. Recent cost data (July 2016) for a 10 day course of treatment shows that metronidazole 500 mg is the least expensive antibiotic with a cost of USD 13 (Health Warehouse). Vancomycin 125 mg costs USD 1779 (Walgreens for 56 tablets) compared to fidaxomicin 200 mg at USD 3453.83 or more (Optimer Pharmaceuticals) and teicoplanin at approximately USD 83.67 (GBP 71.40, British National Formulary). No firm conclusions can be drawn regarding the efficacy of antibiotic treatment in severe CDI as most studies excluded patients with severe disease. The lack of any 'no treatment' control studies does not allow for any conclusions regarding the need for antibiotic treatment in patients with mild CDI beyond withdrawal of the initiating antibiotic. Nonetheless, moderate quality evidence suggests that vancomycin is superior to metronidazole and fidaxomicin is superior to vancomycin. The differences in effectiveness between these antibiotics were not too large and the advantage of metronidazole is its far lower cost compared to the other two antibiotics. The quality of evidence for teicoplanin is very low. Adequately powered studies are needed to determine if teicoplanin performs as well as the other antibiotics. A trial comparing the two cheapest antibiotics, metronidazole and teicoplanin, would be of interest. |
t33 | t33_28 | no | Vancomycin 125 mg costs USD 1779 compared to fidaxomicin 200 mg at USD 3453.83 or more and teicoplanin at approximately USD 83.67. | Clostridium difficile ( C. difficile ) is recognized as a frequent cause of antibiotic‐associated diarrhoea and colitis. This review is an update of a previously published Cochrane review. Objectives The aim of this review is to investigate the efficacy and safety of antibiotic therapy for C. difficile‐ associated diarrhoea (CDAD), or C. difficile infection (CDI), being synonymous terms. Search methods We searched MEDLINE, EMBASE, CENTRAL and the Cochrane IBD Group Specialized Trials Register from inception to 26 January 2017. We also searched clinicaltrials.gov and clinicaltrialsregister.eu for ongoing trials. Selection criteria Only randomised controlled trials assessing antibiotic treatment for CDI were included in the review. Data collection and analysis Three authors independently assessed abstracts and full text articles for inclusion and extracted data. The risk of bias was independently rated by two authors. For dichotomous outcomes, we calculated the risk ratio (RR) and corresponding 95% confidence interval (95% CI). We pooled data using a fixed‐effect model, except where significant heterogeneity was detected, at which time a random‐effects model was used. The following outcomes were sought: sustained symptomatic cure (defined as initial symptomatic response and no recurrence of CDI), sustained bacteriologic cure, adverse reactions to the intervention, death and cost. Twenty‐two studies (3215 participants) were included. The majority of studies enrolled patients with mild to moderate CDI who could tolerate oral antibiotics. Sixteen of the included studies excluded patients with severe CDI and few patients with severe CDI were included in the other six studies. Twelve different antibiotics were investigated: vancomycin, metronidazole, fusidic acid, nitazoxanide, teicoplanin, rifampin, rifaximin, bacitracin, cadazolid, LFF517, surotomycin and fidaxomicin. Most of the studies were active comparator studies comparing vancomycin with other antibiotics. One small study compared vancomycin to placebo. There were no other studies that compared antibiotic treatment to a placebo or a 'no treatment' control group. The risk of bias was rated as high for 17 of 22 included studies. Vancomycin was found to be more effective than metronidazole for achieving symptomatic cure. Seventy‐two per cent (318/444) of metronidazole patients achieved symptomatic cure compared to 79% (339/428) of vancomycin patients (RR 0.90, 95% CI 0.84 to 0.97; moderate quality evidence). Fidaxomicin was found to be more effective than vancomycin for achieving symptomatic cure. Seventy‐one per cent (407/572) of fidaxomicin patients achieved symptomatic cure compared to 61% (361/592) of vancomycin patients (RR 1.17, 95% CI 1.04 to 1.31; moderate quality evidence). Teicoplanin may be more effective than vancomycin for achieving a symptomatic cure. Eightly‐seven per cent (48/55) of teicoplanin patients achieved symptomatic cure compared to 73% (40/55) of vancomycin patients (RR 1.21, 95% CI 1.00 to 1.46; very low quality evidence). For other comparisons including the one placebo‐controlled study the quality of evidence was low or very low due to imprecision and in many cases high risk of bias because of attrition and lack of blinding. One hundred and forty deaths were reported in the studies, all of which were attributed by study authors to the co‐morbidities of the participants that lead to acquiring CDI. Although many other adverse events were reported during therapy, these were attributed to the participants' co‐morbidities. The only adverse events directly attributed to study medication were rare nausea and transient elevation of liver enzymes. Recent cost data (July 2016) for a 10 day course of treatment shows that metronidazole 500 mg is the least expensive antibiotic with a cost of USD 13 (Health Warehouse). Vancomycin 125 mg costs USD 1779 (Walgreens for 56 tablets) compared to fidaxomicin 200 mg at USD 3453.83 or more (Optimer Pharmaceuticals) and teicoplanin at approximately USD 83.67 (GBP 71.40, British National Formulary). No firm conclusions can be drawn regarding the efficacy of antibiotic treatment in severe CDI as most studies excluded patients with severe disease. The lack of any 'no treatment' control studies does not allow for any conclusions regarding the need for antibiotic treatment in patients with mild CDI beyond withdrawal of the initiating antibiotic. Nonetheless, moderate quality evidence suggests that vancomycin is superior to metronidazole and fidaxomicin is superior to vancomycin. The differences in effectiveness between these antibiotics were not too large and the advantage of metronidazole is its far lower cost compared to the other two antibiotics. The quality of evidence for teicoplanin is very low. Adequately powered studies are needed to determine if teicoplanin performs as well as the other antibiotics. A trial comparing the two cheapest antibiotics, metronidazole and teicoplanin, would be of interest. |
t33 | t33_29 | no | Conclusion No firm conclusions can be drawn regarding the effectiveness of antibiotic treatment in severe CDI as most studies excluded these patients. | Clostridium difficile ( C. difficile ) is recognized as a frequent cause of antibiotic‐associated diarrhoea and colitis. This review is an update of a previously published Cochrane review. Objectives The aim of this review is to investigate the efficacy and safety of antibiotic therapy for C. difficile‐ associated diarrhoea (CDAD), or C. difficile infection (CDI), being synonymous terms. Search methods We searched MEDLINE, EMBASE, CENTRAL and the Cochrane IBD Group Specialized Trials Register from inception to 26 January 2017. We also searched clinicaltrials.gov and clinicaltrialsregister.eu for ongoing trials. Selection criteria Only randomised controlled trials assessing antibiotic treatment for CDI were included in the review. Data collection and analysis Three authors independently assessed abstracts and full text articles for inclusion and extracted data. The risk of bias was independently rated by two authors. For dichotomous outcomes, we calculated the risk ratio (RR) and corresponding 95% confidence interval (95% CI). We pooled data using a fixed‐effect model, except where significant heterogeneity was detected, at which time a random‐effects model was used. The following outcomes were sought: sustained symptomatic cure (defined as initial symptomatic response and no recurrence of CDI), sustained bacteriologic cure, adverse reactions to the intervention, death and cost. Twenty‐two studies (3215 participants) were included. The majority of studies enrolled patients with mild to moderate CDI who could tolerate oral antibiotics. Sixteen of the included studies excluded patients with severe CDI and few patients with severe CDI were included in the other six studies. Twelve different antibiotics were investigated: vancomycin, metronidazole, fusidic acid, nitazoxanide, teicoplanin, rifampin, rifaximin, bacitracin, cadazolid, LFF517, surotomycin and fidaxomicin. Most of the studies were active comparator studies comparing vancomycin with other antibiotics. One small study compared vancomycin to placebo. There were no other studies that compared antibiotic treatment to a placebo or a 'no treatment' control group. The risk of bias was rated as high for 17 of 22 included studies. Vancomycin was found to be more effective than metronidazole for achieving symptomatic cure. Seventy‐two per cent (318/444) of metronidazole patients achieved symptomatic cure compared to 79% (339/428) of vancomycin patients (RR 0.90, 95% CI 0.84 to 0.97; moderate quality evidence). Fidaxomicin was found to be more effective than vancomycin for achieving symptomatic cure. Seventy‐one per cent (407/572) of fidaxomicin patients achieved symptomatic cure compared to 61% (361/592) of vancomycin patients (RR 1.17, 95% CI 1.04 to 1.31; moderate quality evidence). Teicoplanin may be more effective than vancomycin for achieving a symptomatic cure. Eightly‐seven per cent (48/55) of teicoplanin patients achieved symptomatic cure compared to 73% (40/55) of vancomycin patients (RR 1.21, 95% CI 1.00 to 1.46; very low quality evidence). For other comparisons including the one placebo‐controlled study the quality of evidence was low or very low due to imprecision and in many cases high risk of bias because of attrition and lack of blinding. One hundred and forty deaths were reported in the studies, all of which were attributed by study authors to the co‐morbidities of the participants that lead to acquiring CDI. Although many other adverse events were reported during therapy, these were attributed to the participants' co‐morbidities. The only adverse events directly attributed to study medication were rare nausea and transient elevation of liver enzymes. Recent cost data (July 2016) for a 10 day course of treatment shows that metronidazole 500 mg is the least expensive antibiotic with a cost of USD 13 (Health Warehouse). Vancomycin 125 mg costs USD 1779 (Walgreens for 56 tablets) compared to fidaxomicin 200 mg at USD 3453.83 or more (Optimer Pharmaceuticals) and teicoplanin at approximately USD 83.67 (GBP 71.40, British National Formulary). No firm conclusions can be drawn regarding the efficacy of antibiotic treatment in severe CDI as most studies excluded patients with severe disease. The lack of any 'no treatment' control studies does not allow for any conclusions regarding the need for antibiotic treatment in patients with mild CDI beyond withdrawal of the initiating antibiotic. Nonetheless, moderate quality evidence suggests that vancomycin is superior to metronidazole and fidaxomicin is superior to vancomycin. The differences in effectiveness between these antibiotics were not too large and the advantage of metronidazole is its far lower cost compared to the other two antibiotics. The quality of evidence for teicoplanin is very low. Adequately powered studies are needed to determine if teicoplanin performs as well as the other antibiotics. A trial comparing the two cheapest antibiotics, metronidazole and teicoplanin, would be of interest. |
t33 | t33_30 | no | The lack of any 'no treatment' control studies does not allow for any conclusions regarding the need for antibiotic treatment in patients with mild CDI beyond withdrawal of the antibiotic that caused CDI. | Clostridium difficile ( C. difficile ) is recognized as a frequent cause of antibiotic‐associated diarrhoea and colitis. This review is an update of a previously published Cochrane review. Objectives The aim of this review is to investigate the efficacy and safety of antibiotic therapy for C. difficile‐ associated diarrhoea (CDAD), or C. difficile infection (CDI), being synonymous terms. Search methods We searched MEDLINE, EMBASE, CENTRAL and the Cochrane IBD Group Specialized Trials Register from inception to 26 January 2017. We also searched clinicaltrials.gov and clinicaltrialsregister.eu for ongoing trials. Selection criteria Only randomised controlled trials assessing antibiotic treatment for CDI were included in the review. Data collection and analysis Three authors independently assessed abstracts and full text articles for inclusion and extracted data. The risk of bias was independently rated by two authors. For dichotomous outcomes, we calculated the risk ratio (RR) and corresponding 95% confidence interval (95% CI). We pooled data using a fixed‐effect model, except where significant heterogeneity was detected, at which time a random‐effects model was used. The following outcomes were sought: sustained symptomatic cure (defined as initial symptomatic response and no recurrence of CDI), sustained bacteriologic cure, adverse reactions to the intervention, death and cost. Twenty‐two studies (3215 participants) were included. The majority of studies enrolled patients with mild to moderate CDI who could tolerate oral antibiotics. Sixteen of the included studies excluded patients with severe CDI and few patients with severe CDI were included in the other six studies. Twelve different antibiotics were investigated: vancomycin, metronidazole, fusidic acid, nitazoxanide, teicoplanin, rifampin, rifaximin, bacitracin, cadazolid, LFF517, surotomycin and fidaxomicin. Most of the studies were active comparator studies comparing vancomycin with other antibiotics. One small study compared vancomycin to placebo. There were no other studies that compared antibiotic treatment to a placebo or a 'no treatment' control group. The risk of bias was rated as high for 17 of 22 included studies. Vancomycin was found to be more effective than metronidazole for achieving symptomatic cure. Seventy‐two per cent (318/444) of metronidazole patients achieved symptomatic cure compared to 79% (339/428) of vancomycin patients (RR 0.90, 95% CI 0.84 to 0.97; moderate quality evidence). Fidaxomicin was found to be more effective than vancomycin for achieving symptomatic cure. Seventy‐one per cent (407/572) of fidaxomicin patients achieved symptomatic cure compared to 61% (361/592) of vancomycin patients (RR 1.17, 95% CI 1.04 to 1.31; moderate quality evidence). Teicoplanin may be more effective than vancomycin for achieving a symptomatic cure. Eightly‐seven per cent (48/55) of teicoplanin patients achieved symptomatic cure compared to 73% (40/55) of vancomycin patients (RR 1.21, 95% CI 1.00 to 1.46; very low quality evidence). For other comparisons including the one placebo‐controlled study the quality of evidence was low or very low due to imprecision and in many cases high risk of bias because of attrition and lack of blinding. One hundred and forty deaths were reported in the studies, all of which were attributed by study authors to the co‐morbidities of the participants that lead to acquiring CDI. Although many other adverse events were reported during therapy, these were attributed to the participants' co‐morbidities. The only adverse events directly attributed to study medication were rare nausea and transient elevation of liver enzymes. Recent cost data (July 2016) for a 10 day course of treatment shows that metronidazole 500 mg is the least expensive antibiotic with a cost of USD 13 (Health Warehouse). Vancomycin 125 mg costs USD 1779 (Walgreens for 56 tablets) compared to fidaxomicin 200 mg at USD 3453.83 or more (Optimer Pharmaceuticals) and teicoplanin at approximately USD 83.67 (GBP 71.40, British National Formulary). No firm conclusions can be drawn regarding the efficacy of antibiotic treatment in severe CDI as most studies excluded patients with severe disease. The lack of any 'no treatment' control studies does not allow for any conclusions regarding the need for antibiotic treatment in patients with mild CDI beyond withdrawal of the initiating antibiotic. Nonetheless, moderate quality evidence suggests that vancomycin is superior to metronidazole and fidaxomicin is superior to vancomycin. The differences in effectiveness between these antibiotics were not too large and the advantage of metronidazole is its far lower cost compared to the other two antibiotics. The quality of evidence for teicoplanin is very low. Adequately powered studies are needed to determine if teicoplanin performs as well as the other antibiotics. A trial comparing the two cheapest antibiotics, metronidazole and teicoplanin, would be of interest. |
t33 | t33_31 | no | Nonetheless, moderate quality evidence suggests that vancomycin is superior to metronidazole and fidaxomicin is superior to vancomycin. | Clostridium difficile ( C. difficile ) is recognized as a frequent cause of antibiotic‐associated diarrhoea and colitis. This review is an update of a previously published Cochrane review. Objectives The aim of this review is to investigate the efficacy and safety of antibiotic therapy for C. difficile‐ associated diarrhoea (CDAD), or C. difficile infection (CDI), being synonymous terms. Search methods We searched MEDLINE, EMBASE, CENTRAL and the Cochrane IBD Group Specialized Trials Register from inception to 26 January 2017. We also searched clinicaltrials.gov and clinicaltrialsregister.eu for ongoing trials. Selection criteria Only randomised controlled trials assessing antibiotic treatment for CDI were included in the review. Data collection and analysis Three authors independently assessed abstracts and full text articles for inclusion and extracted data. The risk of bias was independently rated by two authors. For dichotomous outcomes, we calculated the risk ratio (RR) and corresponding 95% confidence interval (95% CI). We pooled data using a fixed‐effect model, except where significant heterogeneity was detected, at which time a random‐effects model was used. The following outcomes were sought: sustained symptomatic cure (defined as initial symptomatic response and no recurrence of CDI), sustained bacteriologic cure, adverse reactions to the intervention, death and cost. Twenty‐two studies (3215 participants) were included. The majority of studies enrolled patients with mild to moderate CDI who could tolerate oral antibiotics. Sixteen of the included studies excluded patients with severe CDI and few patients with severe CDI were included in the other six studies. Twelve different antibiotics were investigated: vancomycin, metronidazole, fusidic acid, nitazoxanide, teicoplanin, rifampin, rifaximin, bacitracin, cadazolid, LFF517, surotomycin and fidaxomicin. Most of the studies were active comparator studies comparing vancomycin with other antibiotics. One small study compared vancomycin to placebo. There were no other studies that compared antibiotic treatment to a placebo or a 'no treatment' control group. The risk of bias was rated as high for 17 of 22 included studies. Vancomycin was found to be more effective than metronidazole for achieving symptomatic cure. Seventy‐two per cent (318/444) of metronidazole patients achieved symptomatic cure compared to 79% (339/428) of vancomycin patients (RR 0.90, 95% CI 0.84 to 0.97; moderate quality evidence). Fidaxomicin was found to be more effective than vancomycin for achieving symptomatic cure. Seventy‐one per cent (407/572) of fidaxomicin patients achieved symptomatic cure compared to 61% (361/592) of vancomycin patients (RR 1.17, 95% CI 1.04 to 1.31; moderate quality evidence). Teicoplanin may be more effective than vancomycin for achieving a symptomatic cure. Eightly‐seven per cent (48/55) of teicoplanin patients achieved symptomatic cure compared to 73% (40/55) of vancomycin patients (RR 1.21, 95% CI 1.00 to 1.46; very low quality evidence). For other comparisons including the one placebo‐controlled study the quality of evidence was low or very low due to imprecision and in many cases high risk of bias because of attrition and lack of blinding. One hundred and forty deaths were reported in the studies, all of which were attributed by study authors to the co‐morbidities of the participants that lead to acquiring CDI. Although many other adverse events were reported during therapy, these were attributed to the participants' co‐morbidities. The only adverse events directly attributed to study medication were rare nausea and transient elevation of liver enzymes. Recent cost data (July 2016) for a 10 day course of treatment shows that metronidazole 500 mg is the least expensive antibiotic with a cost of USD 13 (Health Warehouse). Vancomycin 125 mg costs USD 1779 (Walgreens for 56 tablets) compared to fidaxomicin 200 mg at USD 3453.83 or more (Optimer Pharmaceuticals) and teicoplanin at approximately USD 83.67 (GBP 71.40, British National Formulary). No firm conclusions can be drawn regarding the efficacy of antibiotic treatment in severe CDI as most studies excluded patients with severe disease. The lack of any 'no treatment' control studies does not allow for any conclusions regarding the need for antibiotic treatment in patients with mild CDI beyond withdrawal of the initiating antibiotic. Nonetheless, moderate quality evidence suggests that vancomycin is superior to metronidazole and fidaxomicin is superior to vancomycin. The differences in effectiveness between these antibiotics were not too large and the advantage of metronidazole is its far lower cost compared to the other two antibiotics. The quality of evidence for teicoplanin is very low. Adequately powered studies are needed to determine if teicoplanin performs as well as the other antibiotics. A trial comparing the two cheapest antibiotics, metronidazole and teicoplanin, would be of interest. |
t33 | t33_32 | no | The differences in effectiveness between these antibiotics were not too large and the advantage of metronidazole is its far lower cost compared to the other antibiotics. | Clostridium difficile ( C. difficile ) is recognized as a frequent cause of antibiotic‐associated diarrhoea and colitis. This review is an update of a previously published Cochrane review. Objectives The aim of this review is to investigate the efficacy and safety of antibiotic therapy for C. difficile‐ associated diarrhoea (CDAD), or C. difficile infection (CDI), being synonymous terms. Search methods We searched MEDLINE, EMBASE, CENTRAL and the Cochrane IBD Group Specialized Trials Register from inception to 26 January 2017. We also searched clinicaltrials.gov and clinicaltrialsregister.eu for ongoing trials. Selection criteria Only randomised controlled trials assessing antibiotic treatment for CDI were included in the review. Data collection and analysis Three authors independently assessed abstracts and full text articles for inclusion and extracted data. The risk of bias was independently rated by two authors. For dichotomous outcomes, we calculated the risk ratio (RR) and corresponding 95% confidence interval (95% CI). We pooled data using a fixed‐effect model, except where significant heterogeneity was detected, at which time a random‐effects model was used. The following outcomes were sought: sustained symptomatic cure (defined as initial symptomatic response and no recurrence of CDI), sustained bacteriologic cure, adverse reactions to the intervention, death and cost. Twenty‐two studies (3215 participants) were included. The majority of studies enrolled patients with mild to moderate CDI who could tolerate oral antibiotics. Sixteen of the included studies excluded patients with severe CDI and few patients with severe CDI were included in the other six studies. Twelve different antibiotics were investigated: vancomycin, metronidazole, fusidic acid, nitazoxanide, teicoplanin, rifampin, rifaximin, bacitracin, cadazolid, LFF517, surotomycin and fidaxomicin. Most of the studies were active comparator studies comparing vancomycin with other antibiotics. One small study compared vancomycin to placebo. There were no other studies that compared antibiotic treatment to a placebo or a 'no treatment' control group. The risk of bias was rated as high for 17 of 22 included studies. Vancomycin was found to be more effective than metronidazole for achieving symptomatic cure. Seventy‐two per cent (318/444) of metronidazole patients achieved symptomatic cure compared to 79% (339/428) of vancomycin patients (RR 0.90, 95% CI 0.84 to 0.97; moderate quality evidence). Fidaxomicin was found to be more effective than vancomycin for achieving symptomatic cure. Seventy‐one per cent (407/572) of fidaxomicin patients achieved symptomatic cure compared to 61% (361/592) of vancomycin patients (RR 1.17, 95% CI 1.04 to 1.31; moderate quality evidence). Teicoplanin may be more effective than vancomycin for achieving a symptomatic cure. Eightly‐seven per cent (48/55) of teicoplanin patients achieved symptomatic cure compared to 73% (40/55) of vancomycin patients (RR 1.21, 95% CI 1.00 to 1.46; very low quality evidence). For other comparisons including the one placebo‐controlled study the quality of evidence was low or very low due to imprecision and in many cases high risk of bias because of attrition and lack of blinding. One hundred and forty deaths were reported in the studies, all of which were attributed by study authors to the co‐morbidities of the participants that lead to acquiring CDI. Although many other adverse events were reported during therapy, these were attributed to the participants' co‐morbidities. The only adverse events directly attributed to study medication were rare nausea and transient elevation of liver enzymes. Recent cost data (July 2016) for a 10 day course of treatment shows that metronidazole 500 mg is the least expensive antibiotic with a cost of USD 13 (Health Warehouse). Vancomycin 125 mg costs USD 1779 (Walgreens for 56 tablets) compared to fidaxomicin 200 mg at USD 3453.83 or more (Optimer Pharmaceuticals) and teicoplanin at approximately USD 83.67 (GBP 71.40, British National Formulary). No firm conclusions can be drawn regarding the efficacy of antibiotic treatment in severe CDI as most studies excluded patients with severe disease. The lack of any 'no treatment' control studies does not allow for any conclusions regarding the need for antibiotic treatment in patients with mild CDI beyond withdrawal of the initiating antibiotic. Nonetheless, moderate quality evidence suggests that vancomycin is superior to metronidazole and fidaxomicin is superior to vancomycin. The differences in effectiveness between these antibiotics were not too large and the advantage of metronidazole is its far lower cost compared to the other two antibiotics. The quality of evidence for teicoplanin is very low. Adequately powered studies are needed to determine if teicoplanin performs as well as the other antibiotics. A trial comparing the two cheapest antibiotics, metronidazole and teicoplanin, would be of interest. |
t33 | t33_33 | no | Larger studies are needed to determine if teicoplanin performs as well as the other antibiotics. | Clostridium difficile ( C. difficile ) is recognized as a frequent cause of antibiotic‐associated diarrhoea and colitis. This review is an update of a previously published Cochrane review. Objectives The aim of this review is to investigate the efficacy and safety of antibiotic therapy for C. difficile‐ associated diarrhoea (CDAD), or C. difficile infection (CDI), being synonymous terms. Search methods We searched MEDLINE, EMBASE, CENTRAL and the Cochrane IBD Group Specialized Trials Register from inception to 26 January 2017. We also searched clinicaltrials.gov and clinicaltrialsregister.eu for ongoing trials. Selection criteria Only randomised controlled trials assessing antibiotic treatment for CDI were included in the review. Data collection and analysis Three authors independently assessed abstracts and full text articles for inclusion and extracted data. The risk of bias was independently rated by two authors. For dichotomous outcomes, we calculated the risk ratio (RR) and corresponding 95% confidence interval (95% CI). We pooled data using a fixed‐effect model, except where significant heterogeneity was detected, at which time a random‐effects model was used. The following outcomes were sought: sustained symptomatic cure (defined as initial symptomatic response and no recurrence of CDI), sustained bacteriologic cure, adverse reactions to the intervention, death and cost. Twenty‐two studies (3215 participants) were included. The majority of studies enrolled patients with mild to moderate CDI who could tolerate oral antibiotics. Sixteen of the included studies excluded patients with severe CDI and few patients with severe CDI were included in the other six studies. Twelve different antibiotics were investigated: vancomycin, metronidazole, fusidic acid, nitazoxanide, teicoplanin, rifampin, rifaximin, bacitracin, cadazolid, LFF517, surotomycin and fidaxomicin. Most of the studies were active comparator studies comparing vancomycin with other antibiotics. One small study compared vancomycin to placebo. There were no other studies that compared antibiotic treatment to a placebo or a 'no treatment' control group. The risk of bias was rated as high for 17 of 22 included studies. Vancomycin was found to be more effective than metronidazole for achieving symptomatic cure. Seventy‐two per cent (318/444) of metronidazole patients achieved symptomatic cure compared to 79% (339/428) of vancomycin patients (RR 0.90, 95% CI 0.84 to 0.97; moderate quality evidence). Fidaxomicin was found to be more effective than vancomycin for achieving symptomatic cure. Seventy‐one per cent (407/572) of fidaxomicin patients achieved symptomatic cure compared to 61% (361/592) of vancomycin patients (RR 1.17, 95% CI 1.04 to 1.31; moderate quality evidence). Teicoplanin may be more effective than vancomycin for achieving a symptomatic cure. Eightly‐seven per cent (48/55) of teicoplanin patients achieved symptomatic cure compared to 73% (40/55) of vancomycin patients (RR 1.21, 95% CI 1.00 to 1.46; very low quality evidence). For other comparisons including the one placebo‐controlled study the quality of evidence was low or very low due to imprecision and in many cases high risk of bias because of attrition and lack of blinding. One hundred and forty deaths were reported in the studies, all of which were attributed by study authors to the co‐morbidities of the participants that lead to acquiring CDI. Although many other adverse events were reported during therapy, these were attributed to the participants' co‐morbidities. The only adverse events directly attributed to study medication were rare nausea and transient elevation of liver enzymes. Recent cost data (July 2016) for a 10 day course of treatment shows that metronidazole 500 mg is the least expensive antibiotic with a cost of USD 13 (Health Warehouse). Vancomycin 125 mg costs USD 1779 (Walgreens for 56 tablets) compared to fidaxomicin 200 mg at USD 3453.83 or more (Optimer Pharmaceuticals) and teicoplanin at approximately USD 83.67 (GBP 71.40, British National Formulary). No firm conclusions can be drawn regarding the efficacy of antibiotic treatment in severe CDI as most studies excluded patients with severe disease. The lack of any 'no treatment' control studies does not allow for any conclusions regarding the need for antibiotic treatment in patients with mild CDI beyond withdrawal of the initiating antibiotic. Nonetheless, moderate quality evidence suggests that vancomycin is superior to metronidazole and fidaxomicin is superior to vancomycin. The differences in effectiveness between these antibiotics were not too large and the advantage of metronidazole is its far lower cost compared to the other two antibiotics. The quality of evidence for teicoplanin is very low. Adequately powered studies are needed to determine if teicoplanin performs as well as the other antibiotics. A trial comparing the two cheapest antibiotics, metronidazole and teicoplanin, would be of interest. |
t33 | t33_34 | no | A trial comparing the two cheapest antibiotics, metronidazole and teicoplanin would be of interest. | Clostridium difficile ( C. difficile ) is recognized as a frequent cause of antibiotic‐associated diarrhoea and colitis. This review is an update of a previously published Cochrane review. Objectives The aim of this review is to investigate the efficacy and safety of antibiotic therapy for C. difficile‐ associated diarrhoea (CDAD), or C. difficile infection (CDI), being synonymous terms. Search methods We searched MEDLINE, EMBASE, CENTRAL and the Cochrane IBD Group Specialized Trials Register from inception to 26 January 2017. We also searched clinicaltrials.gov and clinicaltrialsregister.eu for ongoing trials. Selection criteria Only randomised controlled trials assessing antibiotic treatment for CDI were included in the review. Data collection and analysis Three authors independently assessed abstracts and full text articles for inclusion and extracted data. The risk of bias was independently rated by two authors. For dichotomous outcomes, we calculated the risk ratio (RR) and corresponding 95% confidence interval (95% CI). We pooled data using a fixed‐effect model, except where significant heterogeneity was detected, at which time a random‐effects model was used. The following outcomes were sought: sustained symptomatic cure (defined as initial symptomatic response and no recurrence of CDI), sustained bacteriologic cure, adverse reactions to the intervention, death and cost. Twenty‐two studies (3215 participants) were included. The majority of studies enrolled patients with mild to moderate CDI who could tolerate oral antibiotics. Sixteen of the included studies excluded patients with severe CDI and few patients with severe CDI were included in the other six studies. Twelve different antibiotics were investigated: vancomycin, metronidazole, fusidic acid, nitazoxanide, teicoplanin, rifampin, rifaximin, bacitracin, cadazolid, LFF517, surotomycin and fidaxomicin. Most of the studies were active comparator studies comparing vancomycin with other antibiotics. One small study compared vancomycin to placebo. There were no other studies that compared antibiotic treatment to a placebo or a 'no treatment' control group. The risk of bias was rated as high for 17 of 22 included studies. Vancomycin was found to be more effective than metronidazole for achieving symptomatic cure. Seventy‐two per cent (318/444) of metronidazole patients achieved symptomatic cure compared to 79% (339/428) of vancomycin patients (RR 0.90, 95% CI 0.84 to 0.97; moderate quality evidence). Fidaxomicin was found to be more effective than vancomycin for achieving symptomatic cure. Seventy‐one per cent (407/572) of fidaxomicin patients achieved symptomatic cure compared to 61% (361/592) of vancomycin patients (RR 1.17, 95% CI 1.04 to 1.31; moderate quality evidence). Teicoplanin may be more effective than vancomycin for achieving a symptomatic cure. Eightly‐seven per cent (48/55) of teicoplanin patients achieved symptomatic cure compared to 73% (40/55) of vancomycin patients (RR 1.21, 95% CI 1.00 to 1.46; very low quality evidence). For other comparisons including the one placebo‐controlled study the quality of evidence was low or very low due to imprecision and in many cases high risk of bias because of attrition and lack of blinding. One hundred and forty deaths were reported in the studies, all of which were attributed by study authors to the co‐morbidities of the participants that lead to acquiring CDI. Although many other adverse events were reported during therapy, these were attributed to the participants' co‐morbidities. The only adverse events directly attributed to study medication were rare nausea and transient elevation of liver enzymes. Recent cost data (July 2016) for a 10 day course of treatment shows that metronidazole 500 mg is the least expensive antibiotic with a cost of USD 13 (Health Warehouse). Vancomycin 125 mg costs USD 1779 (Walgreens for 56 tablets) compared to fidaxomicin 200 mg at USD 3453.83 or more (Optimer Pharmaceuticals) and teicoplanin at approximately USD 83.67 (GBP 71.40, British National Formulary). No firm conclusions can be drawn regarding the efficacy of antibiotic treatment in severe CDI as most studies excluded patients with severe disease. The lack of any 'no treatment' control studies does not allow for any conclusions regarding the need for antibiotic treatment in patients with mild CDI beyond withdrawal of the initiating antibiotic. Nonetheless, moderate quality evidence suggests that vancomycin is superior to metronidazole and fidaxomicin is superior to vancomycin. The differences in effectiveness between these antibiotics were not too large and the advantage of metronidazole is its far lower cost compared to the other two antibiotics. The quality of evidence for teicoplanin is very low. Adequately powered studies are needed to determine if teicoplanin performs as well as the other antibiotics. A trial comparing the two cheapest antibiotics, metronidazole and teicoplanin, would be of interest. |
t34 | t34_1 | yes | We reviewed the evidence about the effect and safety of phytomedicines in people with sickle cell disease of all types, of any age, in any setting. | Sickle cell disease, a common recessively inherited haemoglobin disorder, affects people from sub‐Saharan Africa, the Middle East, Mediterranean basin, Indian subcontinent, Caribbean and South America. It is associated with complications and a reduced life expectancy. Phytomedicines (medicine derived from plants in their original state) encompass many of the plant remedies from traditional healers which the populations most affected would encounter. Laboratory research and limited clinical trials have suggested positive effects of phytomedicines both in vivo and in vitro. However, there has been little systematic appraisal of their benefits. This is an update of a Cochrane Review first published in 2004, and updated in 2010, 2013, and 2015. Objectives To assess the benefits and risks of phytomedicines in people with sickle cell disease of all types, of any age, in any setting. Search methods We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Haemoglobinopathies Trials Register, the International Standard Randomised Controlled Trial Number Register (ISRCTN), the Allied and Complimentary Medicine Database (AMED), ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). Dates of most recent searches: Cochrane Cystic Fibrosis and Genetic Disorders Haemoglobinopathies Trials Register: 10 April 2017; ISRCTN: 26 July 2017; AMED: 24 August 2017; ClinicalTrials.gov: 02 August 2017; and the WHO ICTRP: 27 July 2017. Selection criteria Randomised or quasi‐randomised trials with participants of all ages with sickle cell disease, in all settings, comparing the administration of phytomedicines, by any mode to placebo or conventional treatment, including blood transfusion and hydroxyurea. Data collection and analysis Both authors independently assessed trial quality and extracted data. Two trials (182 participants) and two phytomedicines Niprisan ® (also known as Nicosan ® ) and Ciklavit ® were included. The Phase IIB (pivotal) trial suggests that Niprisan ® was effective in reducing episodes of severe painful sickle cell disease crisis over a six‐month period (low‐quality evidence). It did not affect the risk of severe complications or the level of anaemia (low‐quality evidence). No serious adverse effects were reported. The single trial of Cajanus cajan (Ciklavit ® ) reported a possible benefit to individuals with painful crises (low‐quality evidence), and a possible adverse effect (non‐significant) on the level of anaemia (low‐quality evidence). While Niprisan ® appeared to be safe and effective in reducing severe painful crises over a six‐month follow‐up period, further trials are required to assess its role in the management of people with sickle cell disease and the results of its multicentre trials are awaited. Currently no conclusions can be made regarding the efficacy of Ciklavit ® . Based on the published results for Niprisan ® and in view of the limitations in data collection and analysis of both trials, phytomedicines may have a potential beneficial effect in reducing painful crises in sickle cell disease. This needs to be further validated in future trials. More trials are required on the safety and efficacy of phytomedicines used in managing sickle cell disease. |
t34 | t34_2 | no | Sickle cell disease is an inherited blood condition caused by defects in the production of haemoglobin. | Sickle cell disease, a common recessively inherited haemoglobin disorder, affects people from sub‐Saharan Africa, the Middle East, Mediterranean basin, Indian subcontinent, Caribbean and South America. It is associated with complications and a reduced life expectancy. Phytomedicines (medicine derived from plants in their original state) encompass many of the plant remedies from traditional healers which the populations most affected would encounter. Laboratory research and limited clinical trials have suggested positive effects of phytomedicines both in vivo and in vitro. However, there has been little systematic appraisal of their benefits. This is an update of a Cochrane Review first published in 2004, and updated in 2010, 2013, and 2015. Objectives To assess the benefits and risks of phytomedicines in people with sickle cell disease of all types, of any age, in any setting. Search methods We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Haemoglobinopathies Trials Register, the International Standard Randomised Controlled Trial Number Register (ISRCTN), the Allied and Complimentary Medicine Database (AMED), ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). Dates of most recent searches: Cochrane Cystic Fibrosis and Genetic Disorders Haemoglobinopathies Trials Register: 10 April 2017; ISRCTN: 26 July 2017; AMED: 24 August 2017; ClinicalTrials.gov: 02 August 2017; and the WHO ICTRP: 27 July 2017. Selection criteria Randomised or quasi‐randomised trials with participants of all ages with sickle cell disease, in all settings, comparing the administration of phytomedicines, by any mode to placebo or conventional treatment, including blood transfusion and hydroxyurea. Data collection and analysis Both authors independently assessed trial quality and extracted data. Two trials (182 participants) and two phytomedicines Niprisan ® (also known as Nicosan ® ) and Ciklavit ® were included. The Phase IIB (pivotal) trial suggests that Niprisan ® was effective in reducing episodes of severe painful sickle cell disease crisis over a six‐month period (low‐quality evidence). It did not affect the risk of severe complications or the level of anaemia (low‐quality evidence). No serious adverse effects were reported. The single trial of Cajanus cajan (Ciklavit ® ) reported a possible benefit to individuals with painful crises (low‐quality evidence), and a possible adverse effect (non‐significant) on the level of anaemia (low‐quality evidence). While Niprisan ® appeared to be safe and effective in reducing severe painful crises over a six‐month follow‐up period, further trials are required to assess its role in the management of people with sickle cell disease and the results of its multicentre trials are awaited. Currently no conclusions can be made regarding the efficacy of Ciklavit ® . Based on the published results for Niprisan ® and in view of the limitations in data collection and analysis of both trials, phytomedicines may have a potential beneficial effect in reducing painful crises in sickle cell disease. This needs to be further validated in future trials. More trials are required on the safety and efficacy of phytomedicines used in managing sickle cell disease. |
t34 | t34_3 | yes | Haemoglobin is the part of the red blood cell that carries oxygen across the body. | Sickle cell disease, a common recessively inherited haemoglobin disorder, affects people from sub‐Saharan Africa, the Middle East, Mediterranean basin, Indian subcontinent, Caribbean and South America. It is associated with complications and a reduced life expectancy. Phytomedicines (medicine derived from plants in their original state) encompass many of the plant remedies from traditional healers which the populations most affected would encounter. Laboratory research and limited clinical trials have suggested positive effects of phytomedicines both in vivo and in vitro. However, there has been little systematic appraisal of their benefits. This is an update of a Cochrane Review first published in 2004, and updated in 2010, 2013, and 2015. Objectives To assess the benefits and risks of phytomedicines in people with sickle cell disease of all types, of any age, in any setting. Search methods We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Haemoglobinopathies Trials Register, the International Standard Randomised Controlled Trial Number Register (ISRCTN), the Allied and Complimentary Medicine Database (AMED), ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). Dates of most recent searches: Cochrane Cystic Fibrosis and Genetic Disorders Haemoglobinopathies Trials Register: 10 April 2017; ISRCTN: 26 July 2017; AMED: 24 August 2017; ClinicalTrials.gov: 02 August 2017; and the WHO ICTRP: 27 July 2017. Selection criteria Randomised or quasi‐randomised trials with participants of all ages with sickle cell disease, in all settings, comparing the administration of phytomedicines, by any mode to placebo or conventional treatment, including blood transfusion and hydroxyurea. Data collection and analysis Both authors independently assessed trial quality and extracted data. Two trials (182 participants) and two phytomedicines Niprisan ® (also known as Nicosan ® ) and Ciklavit ® were included. The Phase IIB (pivotal) trial suggests that Niprisan ® was effective in reducing episodes of severe painful sickle cell disease crisis over a six‐month period (low‐quality evidence). It did not affect the risk of severe complications or the level of anaemia (low‐quality evidence). No serious adverse effects were reported. The single trial of Cajanus cajan (Ciklavit ® ) reported a possible benefit to individuals with painful crises (low‐quality evidence), and a possible adverse effect (non‐significant) on the level of anaemia (low‐quality evidence). While Niprisan ® appeared to be safe and effective in reducing severe painful crises over a six‐month follow‐up period, further trials are required to assess its role in the management of people with sickle cell disease and the results of its multicentre trials are awaited. Currently no conclusions can be made regarding the efficacy of Ciklavit ® . Based on the published results for Niprisan ® and in view of the limitations in data collection and analysis of both trials, phytomedicines may have a potential beneficial effect in reducing painful crises in sickle cell disease. This needs to be further validated in future trials. More trials are required on the safety and efficacy of phytomedicines used in managing sickle cell disease. |
t34 | t34_4 | yes | Sickle cell disease occurs when people inherit faulty genes responsible for producing haemoglobin from both parents. | Sickle cell disease, a common recessively inherited haemoglobin disorder, affects people from sub‐Saharan Africa, the Middle East, Mediterranean basin, Indian subcontinent, Caribbean and South America. It is associated with complications and a reduced life expectancy. Phytomedicines (medicine derived from plants in their original state) encompass many of the plant remedies from traditional healers which the populations most affected would encounter. Laboratory research and limited clinical trials have suggested positive effects of phytomedicines both in vivo and in vitro. However, there has been little systematic appraisal of their benefits. This is an update of a Cochrane Review first published in 2004, and updated in 2010, 2013, and 2015. Objectives To assess the benefits and risks of phytomedicines in people with sickle cell disease of all types, of any age, in any setting. Search methods We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Haemoglobinopathies Trials Register, the International Standard Randomised Controlled Trial Number Register (ISRCTN), the Allied and Complimentary Medicine Database (AMED), ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). Dates of most recent searches: Cochrane Cystic Fibrosis and Genetic Disorders Haemoglobinopathies Trials Register: 10 April 2017; ISRCTN: 26 July 2017; AMED: 24 August 2017; ClinicalTrials.gov: 02 August 2017; and the WHO ICTRP: 27 July 2017. Selection criteria Randomised or quasi‐randomised trials with participants of all ages with sickle cell disease, in all settings, comparing the administration of phytomedicines, by any mode to placebo or conventional treatment, including blood transfusion and hydroxyurea. Data collection and analysis Both authors independently assessed trial quality and extracted data. Two trials (182 participants) and two phytomedicines Niprisan ® (also known as Nicosan ® ) and Ciklavit ® were included. The Phase IIB (pivotal) trial suggests that Niprisan ® was effective in reducing episodes of severe painful sickle cell disease crisis over a six‐month period (low‐quality evidence). It did not affect the risk of severe complications or the level of anaemia (low‐quality evidence). No serious adverse effects were reported. The single trial of Cajanus cajan (Ciklavit ® ) reported a possible benefit to individuals with painful crises (low‐quality evidence), and a possible adverse effect (non‐significant) on the level of anaemia (low‐quality evidence). While Niprisan ® appeared to be safe and effective in reducing severe painful crises over a six‐month follow‐up period, further trials are required to assess its role in the management of people with sickle cell disease and the results of its multicentre trials are awaited. Currently no conclusions can be made regarding the efficacy of Ciklavit ® . Based on the published results for Niprisan ® and in view of the limitations in data collection and analysis of both trials, phytomedicines may have a potential beneficial effect in reducing painful crises in sickle cell disease. This needs to be further validated in future trials. More trials are required on the safety and efficacy of phytomedicines used in managing sickle cell disease. |
t34 | t34_5 | no | A variety of complications and a reduced life expectancy are linked with sickle cell disease. | Sickle cell disease, a common recessively inherited haemoglobin disorder, affects people from sub‐Saharan Africa, the Middle East, Mediterranean basin, Indian subcontinent, Caribbean and South America. It is associated with complications and a reduced life expectancy. Phytomedicines (medicine derived from plants in their original state) encompass many of the plant remedies from traditional healers which the populations most affected would encounter. Laboratory research and limited clinical trials have suggested positive effects of phytomedicines both in vivo and in vitro. However, there has been little systematic appraisal of their benefits. This is an update of a Cochrane Review first published in 2004, and updated in 2010, 2013, and 2015. Objectives To assess the benefits and risks of phytomedicines in people with sickle cell disease of all types, of any age, in any setting. Search methods We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Haemoglobinopathies Trials Register, the International Standard Randomised Controlled Trial Number Register (ISRCTN), the Allied and Complimentary Medicine Database (AMED), ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). Dates of most recent searches: Cochrane Cystic Fibrosis and Genetic Disorders Haemoglobinopathies Trials Register: 10 April 2017; ISRCTN: 26 July 2017; AMED: 24 August 2017; ClinicalTrials.gov: 02 August 2017; and the WHO ICTRP: 27 July 2017. Selection criteria Randomised or quasi‐randomised trials with participants of all ages with sickle cell disease, in all settings, comparing the administration of phytomedicines, by any mode to placebo or conventional treatment, including blood transfusion and hydroxyurea. Data collection and analysis Both authors independently assessed trial quality and extracted data. Two trials (182 participants) and two phytomedicines Niprisan ® (also known as Nicosan ® ) and Ciklavit ® were included. The Phase IIB (pivotal) trial suggests that Niprisan ® was effective in reducing episodes of severe painful sickle cell disease crisis over a six‐month period (low‐quality evidence). It did not affect the risk of severe complications or the level of anaemia (low‐quality evidence). No serious adverse effects were reported. The single trial of Cajanus cajan (Ciklavit ® ) reported a possible benefit to individuals with painful crises (low‐quality evidence), and a possible adverse effect (non‐significant) on the level of anaemia (low‐quality evidence). While Niprisan ® appeared to be safe and effective in reducing severe painful crises over a six‐month follow‐up period, further trials are required to assess its role in the management of people with sickle cell disease and the results of its multicentre trials are awaited. Currently no conclusions can be made regarding the efficacy of Ciklavit ® . Based on the published results for Niprisan ® and in view of the limitations in data collection and analysis of both trials, phytomedicines may have a potential beneficial effect in reducing painful crises in sickle cell disease. This needs to be further validated in future trials. More trials are required on the safety and efficacy of phytomedicines used in managing sickle cell disease. |
t34 | t34_6 | no | Phytomedicines are medicines derived from plants in their original state. | Sickle cell disease, a common recessively inherited haemoglobin disorder, affects people from sub‐Saharan Africa, the Middle East, Mediterranean basin, Indian subcontinent, Caribbean and South America. It is associated with complications and a reduced life expectancy. Phytomedicines (medicine derived from plants in their original state) encompass many of the plant remedies from traditional healers which the populations most affected would encounter. Laboratory research and limited clinical trials have suggested positive effects of phytomedicines both in vivo and in vitro. However, there has been little systematic appraisal of their benefits. This is an update of a Cochrane Review first published in 2004, and updated in 2010, 2013, and 2015. Objectives To assess the benefits and risks of phytomedicines in people with sickle cell disease of all types, of any age, in any setting. Search methods We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Haemoglobinopathies Trials Register, the International Standard Randomised Controlled Trial Number Register (ISRCTN), the Allied and Complimentary Medicine Database (AMED), ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). Dates of most recent searches: Cochrane Cystic Fibrosis and Genetic Disorders Haemoglobinopathies Trials Register: 10 April 2017; ISRCTN: 26 July 2017; AMED: 24 August 2017; ClinicalTrials.gov: 02 August 2017; and the WHO ICTRP: 27 July 2017. Selection criteria Randomised or quasi‐randomised trials with participants of all ages with sickle cell disease, in all settings, comparing the administration of phytomedicines, by any mode to placebo or conventional treatment, including blood transfusion and hydroxyurea. Data collection and analysis Both authors independently assessed trial quality and extracted data. Two trials (182 participants) and two phytomedicines Niprisan ® (also known as Nicosan ® ) and Ciklavit ® were included. The Phase IIB (pivotal) trial suggests that Niprisan ® was effective in reducing episodes of severe painful sickle cell disease crisis over a six‐month period (low‐quality evidence). It did not affect the risk of severe complications or the level of anaemia (low‐quality evidence). No serious adverse effects were reported. The single trial of Cajanus cajan (Ciklavit ® ) reported a possible benefit to individuals with painful crises (low‐quality evidence), and a possible adverse effect (non‐significant) on the level of anaemia (low‐quality evidence). While Niprisan ® appeared to be safe and effective in reducing severe painful crises over a six‐month follow‐up period, further trials are required to assess its role in the management of people with sickle cell disease and the results of its multicentre trials are awaited. Currently no conclusions can be made regarding the efficacy of Ciklavit ® . Based on the published results for Niprisan ® and in view of the limitations in data collection and analysis of both trials, phytomedicines may have a potential beneficial effect in reducing painful crises in sickle cell disease. This needs to be further validated in future trials. More trials are required on the safety and efficacy of phytomedicines used in managing sickle cell disease. |
t34 | t34_7 | no | People with sickle cell disease may come across them in terms of plant‐remedies from traditional healers. | Sickle cell disease, a common recessively inherited haemoglobin disorder, affects people from sub‐Saharan Africa, the Middle East, Mediterranean basin, Indian subcontinent, Caribbean and South America. It is associated with complications and a reduced life expectancy. Phytomedicines (medicine derived from plants in their original state) encompass many of the plant remedies from traditional healers which the populations most affected would encounter. Laboratory research and limited clinical trials have suggested positive effects of phytomedicines both in vivo and in vitro. However, there has been little systematic appraisal of their benefits. This is an update of a Cochrane Review first published in 2004, and updated in 2010, 2013, and 2015. Objectives To assess the benefits and risks of phytomedicines in people with sickle cell disease of all types, of any age, in any setting. Search methods We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Haemoglobinopathies Trials Register, the International Standard Randomised Controlled Trial Number Register (ISRCTN), the Allied and Complimentary Medicine Database (AMED), ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). Dates of most recent searches: Cochrane Cystic Fibrosis and Genetic Disorders Haemoglobinopathies Trials Register: 10 April 2017; ISRCTN: 26 July 2017; AMED: 24 August 2017; ClinicalTrials.gov: 02 August 2017; and the WHO ICTRP: 27 July 2017. Selection criteria Randomised or quasi‐randomised trials with participants of all ages with sickle cell disease, in all settings, comparing the administration of phytomedicines, by any mode to placebo or conventional treatment, including blood transfusion and hydroxyurea. Data collection and analysis Both authors independently assessed trial quality and extracted data. Two trials (182 participants) and two phytomedicines Niprisan ® (also known as Nicosan ® ) and Ciklavit ® were included. The Phase IIB (pivotal) trial suggests that Niprisan ® was effective in reducing episodes of severe painful sickle cell disease crisis over a six‐month period (low‐quality evidence). It did not affect the risk of severe complications or the level of anaemia (low‐quality evidence). No serious adverse effects were reported. The single trial of Cajanus cajan (Ciklavit ® ) reported a possible benefit to individuals with painful crises (low‐quality evidence), and a possible adverse effect (non‐significant) on the level of anaemia (low‐quality evidence). While Niprisan ® appeared to be safe and effective in reducing severe painful crises over a six‐month follow‐up period, further trials are required to assess its role in the management of people with sickle cell disease and the results of its multicentre trials are awaited. Currently no conclusions can be made regarding the efficacy of Ciklavit ® . Based on the published results for Niprisan ® and in view of the limitations in data collection and analysis of both trials, phytomedicines may have a potential beneficial effect in reducing painful crises in sickle cell disease. This needs to be further validated in future trials. More trials are required on the safety and efficacy of phytomedicines used in managing sickle cell disease. |
t34 | t34_8 | no | Their benefits have not been evaluated systematically. | Sickle cell disease, a common recessively inherited haemoglobin disorder, affects people from sub‐Saharan Africa, the Middle East, Mediterranean basin, Indian subcontinent, Caribbean and South America. It is associated with complications and a reduced life expectancy. Phytomedicines (medicine derived from plants in their original state) encompass many of the plant remedies from traditional healers which the populations most affected would encounter. Laboratory research and limited clinical trials have suggested positive effects of phytomedicines both in vivo and in vitro. However, there has been little systematic appraisal of their benefits. This is an update of a Cochrane Review first published in 2004, and updated in 2010, 2013, and 2015. Objectives To assess the benefits and risks of phytomedicines in people with sickle cell disease of all types, of any age, in any setting. Search methods We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Haemoglobinopathies Trials Register, the International Standard Randomised Controlled Trial Number Register (ISRCTN), the Allied and Complimentary Medicine Database (AMED), ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). Dates of most recent searches: Cochrane Cystic Fibrosis and Genetic Disorders Haemoglobinopathies Trials Register: 10 April 2017; ISRCTN: 26 July 2017; AMED: 24 August 2017; ClinicalTrials.gov: 02 August 2017; and the WHO ICTRP: 27 July 2017. Selection criteria Randomised or quasi‐randomised trials with participants of all ages with sickle cell disease, in all settings, comparing the administration of phytomedicines, by any mode to placebo or conventional treatment, including blood transfusion and hydroxyurea. Data collection and analysis Both authors independently assessed trial quality and extracted data. Two trials (182 participants) and two phytomedicines Niprisan ® (also known as Nicosan ® ) and Ciklavit ® were included. The Phase IIB (pivotal) trial suggests that Niprisan ® was effective in reducing episodes of severe painful sickle cell disease crisis over a six‐month period (low‐quality evidence). It did not affect the risk of severe complications or the level of anaemia (low‐quality evidence). No serious adverse effects were reported. The single trial of Cajanus cajan (Ciklavit ® ) reported a possible benefit to individuals with painful crises (low‐quality evidence), and a possible adverse effect (non‐significant) on the level of anaemia (low‐quality evidence). While Niprisan ® appeared to be safe and effective in reducing severe painful crises over a six‐month follow‐up period, further trials are required to assess its role in the management of people with sickle cell disease and the results of its multicentre trials are awaited. Currently no conclusions can be made regarding the efficacy of Ciklavit ® . Based on the published results for Niprisan ® and in view of the limitations in data collection and analysis of both trials, phytomedicines may have a potential beneficial effect in reducing painful crises in sickle cell disease. This needs to be further validated in future trials. More trials are required on the safety and efficacy of phytomedicines used in managing sickle cell disease. |
t34 | t34_9 | no | Laboratory work has long suggested that these medicines may help to ease the symptoms of sickle cell disease. | Sickle cell disease, a common recessively inherited haemoglobin disorder, affects people from sub‐Saharan Africa, the Middle East, Mediterranean basin, Indian subcontinent, Caribbean and South America. It is associated with complications and a reduced life expectancy. Phytomedicines (medicine derived from plants in their original state) encompass many of the plant remedies from traditional healers which the populations most affected would encounter. Laboratory research and limited clinical trials have suggested positive effects of phytomedicines both in vivo and in vitro. However, there has been little systematic appraisal of their benefits. This is an update of a Cochrane Review first published in 2004, and updated in 2010, 2013, and 2015. Objectives To assess the benefits and risks of phytomedicines in people with sickle cell disease of all types, of any age, in any setting. Search methods We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Haemoglobinopathies Trials Register, the International Standard Randomised Controlled Trial Number Register (ISRCTN), the Allied and Complimentary Medicine Database (AMED), ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). Dates of most recent searches: Cochrane Cystic Fibrosis and Genetic Disorders Haemoglobinopathies Trials Register: 10 April 2017; ISRCTN: 26 July 2017; AMED: 24 August 2017; ClinicalTrials.gov: 02 August 2017; and the WHO ICTRP: 27 July 2017. Selection criteria Randomised or quasi‐randomised trials with participants of all ages with sickle cell disease, in all settings, comparing the administration of phytomedicines, by any mode to placebo or conventional treatment, including blood transfusion and hydroxyurea. Data collection and analysis Both authors independently assessed trial quality and extracted data. Two trials (182 participants) and two phytomedicines Niprisan ® (also known as Nicosan ® ) and Ciklavit ® were included. The Phase IIB (pivotal) trial suggests that Niprisan ® was effective in reducing episodes of severe painful sickle cell disease crisis over a six‐month period (low‐quality evidence). It did not affect the risk of severe complications or the level of anaemia (low‐quality evidence). No serious adverse effects were reported. The single trial of Cajanus cajan (Ciklavit ® ) reported a possible benefit to individuals with painful crises (low‐quality evidence), and a possible adverse effect (non‐significant) on the level of anaemia (low‐quality evidence). While Niprisan ® appeared to be safe and effective in reducing severe painful crises over a six‐month follow‐up period, further trials are required to assess its role in the management of people with sickle cell disease and the results of its multicentre trials are awaited. Currently no conclusions can be made regarding the efficacy of Ciklavit ® . Based on the published results for Niprisan ® and in view of the limitations in data collection and analysis of both trials, phytomedicines may have a potential beneficial effect in reducing painful crises in sickle cell disease. This needs to be further validated in future trials. More trials are required on the safety and efficacy of phytomedicines used in managing sickle cell disease. |
t34 | t34_10 | no | Two trials (182 participants) and two phytomedicines Niprisan ® (also known as Nicosan ® ) and Ciklavit ® were included. | Sickle cell disease, a common recessively inherited haemoglobin disorder, affects people from sub‐Saharan Africa, the Middle East, Mediterranean basin, Indian subcontinent, Caribbean and South America. It is associated with complications and a reduced life expectancy. Phytomedicines (medicine derived from plants in their original state) encompass many of the plant remedies from traditional healers which the populations most affected would encounter. Laboratory research and limited clinical trials have suggested positive effects of phytomedicines both in vivo and in vitro. However, there has been little systematic appraisal of their benefits. This is an update of a Cochrane Review first published in 2004, and updated in 2010, 2013, and 2015. Objectives To assess the benefits and risks of phytomedicines in people with sickle cell disease of all types, of any age, in any setting. Search methods We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Haemoglobinopathies Trials Register, the International Standard Randomised Controlled Trial Number Register (ISRCTN), the Allied and Complimentary Medicine Database (AMED), ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). Dates of most recent searches: Cochrane Cystic Fibrosis and Genetic Disorders Haemoglobinopathies Trials Register: 10 April 2017; ISRCTN: 26 July 2017; AMED: 24 August 2017; ClinicalTrials.gov: 02 August 2017; and the WHO ICTRP: 27 July 2017. Selection criteria Randomised or quasi‐randomised trials with participants of all ages with sickle cell disease, in all settings, comparing the administration of phytomedicines, by any mode to placebo or conventional treatment, including blood transfusion and hydroxyurea. Data collection and analysis Both authors independently assessed trial quality and extracted data. Two trials (182 participants) and two phytomedicines Niprisan ® (also known as Nicosan ® ) and Ciklavit ® were included. The Phase IIB (pivotal) trial suggests that Niprisan ® was effective in reducing episodes of severe painful sickle cell disease crisis over a six‐month period (low‐quality evidence). It did not affect the risk of severe complications or the level of anaemia (low‐quality evidence). No serious adverse effects were reported. The single trial of Cajanus cajan (Ciklavit ® ) reported a possible benefit to individuals with painful crises (low‐quality evidence), and a possible adverse effect (non‐significant) on the level of anaemia (low‐quality evidence). While Niprisan ® appeared to be safe and effective in reducing severe painful crises over a six‐month follow‐up period, further trials are required to assess its role in the management of people with sickle cell disease and the results of its multicentre trials are awaited. Currently no conclusions can be made regarding the efficacy of Ciklavit ® . Based on the published results for Niprisan ® and in view of the limitations in data collection and analysis of both trials, phytomedicines may have a potential beneficial effect in reducing painful crises in sickle cell disease. This needs to be further validated in future trials. More trials are required on the safety and efficacy of phytomedicines used in managing sickle cell disease. |
t34 | t34_11 | no | This review found that Niprisan ® may help to reduce episodes of sickle cell disease crises associated with severe pain. | Sickle cell disease, a common recessively inherited haemoglobin disorder, affects people from sub‐Saharan Africa, the Middle East, Mediterranean basin, Indian subcontinent, Caribbean and South America. It is associated with complications and a reduced life expectancy. Phytomedicines (medicine derived from plants in their original state) encompass many of the plant remedies from traditional healers which the populations most affected would encounter. Laboratory research and limited clinical trials have suggested positive effects of phytomedicines both in vivo and in vitro. However, there has been little systematic appraisal of their benefits. This is an update of a Cochrane Review first published in 2004, and updated in 2010, 2013, and 2015. Objectives To assess the benefits and risks of phytomedicines in people with sickle cell disease of all types, of any age, in any setting. Search methods We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Haemoglobinopathies Trials Register, the International Standard Randomised Controlled Trial Number Register (ISRCTN), the Allied and Complimentary Medicine Database (AMED), ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). Dates of most recent searches: Cochrane Cystic Fibrosis and Genetic Disorders Haemoglobinopathies Trials Register: 10 April 2017; ISRCTN: 26 July 2017; AMED: 24 August 2017; ClinicalTrials.gov: 02 August 2017; and the WHO ICTRP: 27 July 2017. Selection criteria Randomised or quasi‐randomised trials with participants of all ages with sickle cell disease, in all settings, comparing the administration of phytomedicines, by any mode to placebo or conventional treatment, including blood transfusion and hydroxyurea. Data collection and analysis Both authors independently assessed trial quality and extracted data. Two trials (182 participants) and two phytomedicines Niprisan ® (also known as Nicosan ® ) and Ciklavit ® were included. The Phase IIB (pivotal) trial suggests that Niprisan ® was effective in reducing episodes of severe painful sickle cell disease crisis over a six‐month period (low‐quality evidence). It did not affect the risk of severe complications or the level of anaemia (low‐quality evidence). No serious adverse effects were reported. The single trial of Cajanus cajan (Ciklavit ® ) reported a possible benefit to individuals with painful crises (low‐quality evidence), and a possible adverse effect (non‐significant) on the level of anaemia (low‐quality evidence). While Niprisan ® appeared to be safe and effective in reducing severe painful crises over a six‐month follow‐up period, further trials are required to assess its role in the management of people with sickle cell disease and the results of its multicentre trials are awaited. Currently no conclusions can be made regarding the efficacy of Ciklavit ® . Based on the published results for Niprisan ® and in view of the limitations in data collection and analysis of both trials, phytomedicines may have a potential beneficial effect in reducing painful crises in sickle cell disease. This needs to be further validated in future trials. More trials are required on the safety and efficacy of phytomedicines used in managing sickle cell disease. |
t34 | t34_12 | no | Ciklavit ® , which has been reported to reduce painful crises in people with sickle cell disease, deserves further study before recommendations can be made regarding its use. | Sickle cell disease, a common recessively inherited haemoglobin disorder, affects people from sub‐Saharan Africa, the Middle East, Mediterranean basin, Indian subcontinent, Caribbean and South America. It is associated with complications and a reduced life expectancy. Phytomedicines (medicine derived from plants in their original state) encompass many of the plant remedies from traditional healers which the populations most affected would encounter. Laboratory research and limited clinical trials have suggested positive effects of phytomedicines both in vivo and in vitro. However, there has been little systematic appraisal of their benefits. This is an update of a Cochrane Review first published in 2004, and updated in 2010, 2013, and 2015. Objectives To assess the benefits and risks of phytomedicines in people with sickle cell disease of all types, of any age, in any setting. Search methods We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Haemoglobinopathies Trials Register, the International Standard Randomised Controlled Trial Number Register (ISRCTN), the Allied and Complimentary Medicine Database (AMED), ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). Dates of most recent searches: Cochrane Cystic Fibrosis and Genetic Disorders Haemoglobinopathies Trials Register: 10 April 2017; ISRCTN: 26 July 2017; AMED: 24 August 2017; ClinicalTrials.gov: 02 August 2017; and the WHO ICTRP: 27 July 2017. Selection criteria Randomised or quasi‐randomised trials with participants of all ages with sickle cell disease, in all settings, comparing the administration of phytomedicines, by any mode to placebo or conventional treatment, including blood transfusion and hydroxyurea. Data collection and analysis Both authors independently assessed trial quality and extracted data. Two trials (182 participants) and two phytomedicines Niprisan ® (also known as Nicosan ® ) and Ciklavit ® were included. The Phase IIB (pivotal) trial suggests that Niprisan ® was effective in reducing episodes of severe painful sickle cell disease crisis over a six‐month period (low‐quality evidence). It did not affect the risk of severe complications or the level of anaemia (low‐quality evidence). No serious adverse effects were reported. The single trial of Cajanus cajan (Ciklavit ® ) reported a possible benefit to individuals with painful crises (low‐quality evidence), and a possible adverse effect (non‐significant) on the level of anaemia (low‐quality evidence). While Niprisan ® appeared to be safe and effective in reducing severe painful crises over a six‐month follow‐up period, further trials are required to assess its role in the management of people with sickle cell disease and the results of its multicentre trials are awaited. Currently no conclusions can be made regarding the efficacy of Ciklavit ® . Based on the published results for Niprisan ® and in view of the limitations in data collection and analysis of both trials, phytomedicines may have a potential beneficial effect in reducing painful crises in sickle cell disease. This needs to be further validated in future trials. More trials are required on the safety and efficacy of phytomedicines used in managing sickle cell disease. |
t34 | t34_13 | no | The trial of Ciklavit ® also reported a possible adverse effect on the level of anaemia. | Sickle cell disease, a common recessively inherited haemoglobin disorder, affects people from sub‐Saharan Africa, the Middle East, Mediterranean basin, Indian subcontinent, Caribbean and South America. It is associated with complications and a reduced life expectancy. Phytomedicines (medicine derived from plants in their original state) encompass many of the plant remedies from traditional healers which the populations most affected would encounter. Laboratory research and limited clinical trials have suggested positive effects of phytomedicines both in vivo and in vitro. However, there has been little systematic appraisal of their benefits. This is an update of a Cochrane Review first published in 2004, and updated in 2010, 2013, and 2015. Objectives To assess the benefits and risks of phytomedicines in people with sickle cell disease of all types, of any age, in any setting. Search methods We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Haemoglobinopathies Trials Register, the International Standard Randomised Controlled Trial Number Register (ISRCTN), the Allied and Complimentary Medicine Database (AMED), ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). Dates of most recent searches: Cochrane Cystic Fibrosis and Genetic Disorders Haemoglobinopathies Trials Register: 10 April 2017; ISRCTN: 26 July 2017; AMED: 24 August 2017; ClinicalTrials.gov: 02 August 2017; and the WHO ICTRP: 27 July 2017. Selection criteria Randomised or quasi‐randomised trials with participants of all ages with sickle cell disease, in all settings, comparing the administration of phytomedicines, by any mode to placebo or conventional treatment, including blood transfusion and hydroxyurea. Data collection and analysis Both authors independently assessed trial quality and extracted data. Two trials (182 participants) and two phytomedicines Niprisan ® (also known as Nicosan ® ) and Ciklavit ® were included. The Phase IIB (pivotal) trial suggests that Niprisan ® was effective in reducing episodes of severe painful sickle cell disease crisis over a six‐month period (low‐quality evidence). It did not affect the risk of severe complications or the level of anaemia (low‐quality evidence). No serious adverse effects were reported. The single trial of Cajanus cajan (Ciklavit ® ) reported a possible benefit to individuals with painful crises (low‐quality evidence), and a possible adverse effect (non‐significant) on the level of anaemia (low‐quality evidence). While Niprisan ® appeared to be safe and effective in reducing severe painful crises over a six‐month follow‐up period, further trials are required to assess its role in the management of people with sickle cell disease and the results of its multicentre trials are awaited. Currently no conclusions can be made regarding the efficacy of Ciklavit ® . Based on the published results for Niprisan ® and in view of the limitations in data collection and analysis of both trials, phytomedicines may have a potential beneficial effect in reducing painful crises in sickle cell disease. This needs to be further validated in future trials. More trials are required on the safety and efficacy of phytomedicines used in managing sickle cell disease. |
t34 | t34_14 | yes | Both formulations reported no serious adverse symptoms or derangement of liver or kidney function in the participants. | Sickle cell disease, a common recessively inherited haemoglobin disorder, affects people from sub‐Saharan Africa, the Middle East, Mediterranean basin, Indian subcontinent, Caribbean and South America. It is associated with complications and a reduced life expectancy. Phytomedicines (medicine derived from plants in their original state) encompass many of the plant remedies from traditional healers which the populations most affected would encounter. Laboratory research and limited clinical trials have suggested positive effects of phytomedicines both in vivo and in vitro. However, there has been little systematic appraisal of their benefits. This is an update of a Cochrane Review first published in 2004, and updated in 2010, 2013, and 2015. Objectives To assess the benefits and risks of phytomedicines in people with sickle cell disease of all types, of any age, in any setting. Search methods We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Haemoglobinopathies Trials Register, the International Standard Randomised Controlled Trial Number Register (ISRCTN), the Allied and Complimentary Medicine Database (AMED), ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). Dates of most recent searches: Cochrane Cystic Fibrosis and Genetic Disorders Haemoglobinopathies Trials Register: 10 April 2017; ISRCTN: 26 July 2017; AMED: 24 August 2017; ClinicalTrials.gov: 02 August 2017; and the WHO ICTRP: 27 July 2017. Selection criteria Randomised or quasi‐randomised trials with participants of all ages with sickle cell disease, in all settings, comparing the administration of phytomedicines, by any mode to placebo or conventional treatment, including blood transfusion and hydroxyurea. Data collection and analysis Both authors independently assessed trial quality and extracted data. Two trials (182 participants) and two phytomedicines Niprisan ® (also known as Nicosan ® ) and Ciklavit ® were included. The Phase IIB (pivotal) trial suggests that Niprisan ® was effective in reducing episodes of severe painful sickle cell disease crisis over a six‐month period (low‐quality evidence). It did not affect the risk of severe complications or the level of anaemia (low‐quality evidence). No serious adverse effects were reported. The single trial of Cajanus cajan (Ciklavit ® ) reported a possible benefit to individuals with painful crises (low‐quality evidence), and a possible adverse effect (non‐significant) on the level of anaemia (low‐quality evidence). While Niprisan ® appeared to be safe and effective in reducing severe painful crises over a six‐month follow‐up period, further trials are required to assess its role in the management of people with sickle cell disease and the results of its multicentre trials are awaited. Currently no conclusions can be made regarding the efficacy of Ciklavit ® . Based on the published results for Niprisan ® and in view of the limitations in data collection and analysis of both trials, phytomedicines may have a potential beneficial effect in reducing painful crises in sickle cell disease. This needs to be further validated in future trials. More trials are required on the safety and efficacy of phytomedicines used in managing sickle cell disease. |
t34 | t34_15 | yes | More detailed and larger trials of these medicines will need to be carried out before we can make any recommendations about their use. | Sickle cell disease, a common recessively inherited haemoglobin disorder, affects people from sub‐Saharan Africa, the Middle East, Mediterranean basin, Indian subcontinent, Caribbean and South America. It is associated with complications and a reduced life expectancy. Phytomedicines (medicine derived from plants in their original state) encompass many of the plant remedies from traditional healers which the populations most affected would encounter. Laboratory research and limited clinical trials have suggested positive effects of phytomedicines both in vivo and in vitro. However, there has been little systematic appraisal of their benefits. This is an update of a Cochrane Review first published in 2004, and updated in 2010, 2013, and 2015. Objectives To assess the benefits and risks of phytomedicines in people with sickle cell disease of all types, of any age, in any setting. Search methods We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Haemoglobinopathies Trials Register, the International Standard Randomised Controlled Trial Number Register (ISRCTN), the Allied and Complimentary Medicine Database (AMED), ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). Dates of most recent searches: Cochrane Cystic Fibrosis and Genetic Disorders Haemoglobinopathies Trials Register: 10 April 2017; ISRCTN: 26 July 2017; AMED: 24 August 2017; ClinicalTrials.gov: 02 August 2017; and the WHO ICTRP: 27 July 2017. Selection criteria Randomised or quasi‐randomised trials with participants of all ages with sickle cell disease, in all settings, comparing the administration of phytomedicines, by any mode to placebo or conventional treatment, including blood transfusion and hydroxyurea. Data collection and analysis Both authors independently assessed trial quality and extracted data. Two trials (182 participants) and two phytomedicines Niprisan ® (also known as Nicosan ® ) and Ciklavit ® were included. The Phase IIB (pivotal) trial suggests that Niprisan ® was effective in reducing episodes of severe painful sickle cell disease crisis over a six‐month period (low‐quality evidence). It did not affect the risk of severe complications or the level of anaemia (low‐quality evidence). No serious adverse effects were reported. The single trial of Cajanus cajan (Ciklavit ® ) reported a possible benefit to individuals with painful crises (low‐quality evidence), and a possible adverse effect (non‐significant) on the level of anaemia (low‐quality evidence). While Niprisan ® appeared to be safe and effective in reducing severe painful crises over a six‐month follow‐up period, further trials are required to assess its role in the management of people with sickle cell disease and the results of its multicentre trials are awaited. Currently no conclusions can be made regarding the efficacy of Ciklavit ® . Based on the published results for Niprisan ® and in view of the limitations in data collection and analysis of both trials, phytomedicines may have a potential beneficial effect in reducing painful crises in sickle cell disease. This needs to be further validated in future trials. More trials are required on the safety and efficacy of phytomedicines used in managing sickle cell disease. |
t34 | t34_16 | yes | Further research should also assess long‐term outcome measures. | Sickle cell disease, a common recessively inherited haemoglobin disorder, affects people from sub‐Saharan Africa, the Middle East, Mediterranean basin, Indian subcontinent, Caribbean and South America. It is associated with complications and a reduced life expectancy. Phytomedicines (medicine derived from plants in their original state) encompass many of the plant remedies from traditional healers which the populations most affected would encounter. Laboratory research and limited clinical trials have suggested positive effects of phytomedicines both in vivo and in vitro. However, there has been little systematic appraisal of their benefits. This is an update of a Cochrane Review first published in 2004, and updated in 2010, 2013, and 2015. Objectives To assess the benefits and risks of phytomedicines in people with sickle cell disease of all types, of any age, in any setting. Search methods We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Haemoglobinopathies Trials Register, the International Standard Randomised Controlled Trial Number Register (ISRCTN), the Allied and Complimentary Medicine Database (AMED), ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). Dates of most recent searches: Cochrane Cystic Fibrosis and Genetic Disorders Haemoglobinopathies Trials Register: 10 April 2017; ISRCTN: 26 July 2017; AMED: 24 August 2017; ClinicalTrials.gov: 02 August 2017; and the WHO ICTRP: 27 July 2017. Selection criteria Randomised or quasi‐randomised trials with participants of all ages with sickle cell disease, in all settings, comparing the administration of phytomedicines, by any mode to placebo or conventional treatment, including blood transfusion and hydroxyurea. Data collection and analysis Both authors independently assessed trial quality and extracted data. Two trials (182 participants) and two phytomedicines Niprisan ® (also known as Nicosan ® ) and Ciklavit ® were included. The Phase IIB (pivotal) trial suggests that Niprisan ® was effective in reducing episodes of severe painful sickle cell disease crisis over a six‐month period (low‐quality evidence). It did not affect the risk of severe complications or the level of anaemia (low‐quality evidence). No serious adverse effects were reported. The single trial of Cajanus cajan (Ciklavit ® ) reported a possible benefit to individuals with painful crises (low‐quality evidence), and a possible adverse effect (non‐significant) on the level of anaemia (low‐quality evidence). While Niprisan ® appeared to be safe and effective in reducing severe painful crises over a six‐month follow‐up period, further trials are required to assess its role in the management of people with sickle cell disease and the results of its multicentre trials are awaited. Currently no conclusions can be made regarding the efficacy of Ciklavit ® . Based on the published results for Niprisan ® and in view of the limitations in data collection and analysis of both trials, phytomedicines may have a potential beneficial effect in reducing painful crises in sickle cell disease. This needs to be further validated in future trials. More trials are required on the safety and efficacy of phytomedicines used in managing sickle cell disease. |
t35 | t35_1 | yes | An aneurysm is an abnormal localised widening (dilatation) of an artery. | Screening for abdominal aortic aneurysm (AAA) in selected groups is now performed in England, the USA and Sweden. Patients with aneurysms over 55 mm in diameter are generally considered for elective surgical repair. Patients with aneurysm diameters below or equal to 55 mm (termed 'small AAAs') are managed with aneurysm surveillance as there is currently insufficient evidence to recommend surgery in these cases. As more patients are screened, there will be an increasing number of small AAAs identified. There is interest in pharmaceutical interventions (for example angiotensin converting enzyme (ACE) inhibitors, antibiotics, beta‐blockers, statins) which could be given to such patients to delay or reverse aneurysm expansion and reduce the need for elective surgical repair. Objectives To assess the effects of medical treatment on the expansion rate of small abdominal aortic aneurysms. Search methods The Cochrane Peripheral Vascular Diseases Group Trials Search Co‐ordinator searched the Specialised Register (May 2012) and CENTRAL (2012, Issue 5). Clinical trials databases were searched for details of ongoing or unpublished studies. The reference lists of articles retrieved by electronic searches were searched for additional citations. Selection criteria We selected randomised trials in which patients with small AAAs allocated to medical treatment with the intention of retarding aneurysm expansion were compared to patients allocated to a placebo treatment, alternative medical treatment, a different regimen of the same drug or imaging surveillance alone. Data collection and analysis Two authors independently extracted the data and assessed the risk of bias in the trials. Meta‐analyses were used when heterogeneity was considered low. The two primary outcomes were the mean difference (MD) in aneurysm diameter and the odds ratio (OR) calculated to compare the number of individuals referred to AAA surgery in each group over the trial period. Seven trials involving 1558 participants were included in this review; 457 were involved in four trials of antibiotic medication, and 1101 were involved in three trials of beta‐blocker medication. Five of the studies were rated at a high risk of bias. Individually, all of the included trials reported non‐significant differences in AAA expansion rates between their intervention and control groups. The two major drug groups were then analysed separately. For AAA expansion it was only possible to combine two of the antibiotic trials in a meta‐analysis. This demonstrated that roxithromycin had a small but significant protective effect (MD ‐0.86 mm; 95% confidence interval (CI) ‐1.57 to ‐0.14). When referral to AAA surgery was compared (including all four antibiotic trials in the meta‐analysis), non‐significantly fewer patients were referred in the intervention groups (OR 0.96; 95% CI 0.59 to 1.57) than the control groups. When only the trials reporting actual elective surgery were included in a subgroup analysis, the result remained statistically non‐significant (OR 1.17; 95% CI 0.57 to 2.42). For the beta‐blocker trials, when all were combined in a meta‐analysis, there was a very small, non‐significant protective effect for propranolol on AAA expansion (MD ‐0.08 mm; 95% CI ‐0.25 to 0.10), and non‐significantly fewer patients were referred to AAA surgery in the propranolol group (OR 0.74; 95% CI 0.52 to 1.05). Bronchospasm and shortness of breath were the main adverse effects from the beta‐blockers. In one trial the adverse effects were reportedly so severe that the trial was stopped early after two years. There is some limited evidence that antibiotic medication may have a slight protective effect in retarding the expansion rates of small AAAs. The quality of the evidence makes it unclear whether this translates into fewer referrals to AAA surgery, owing mainly to the small sample sizes of the studies. Antibiotics were generally well tolerated with minimal adverse effects. Propranolol was poorly tolerated by patients in all of the beta‐blocker trials and demonstrated only minimal and non‐significant protective effects. Further research on beta‐blockers for AAA needs to consider the use of drugs other than propranolol. In general, there is surprisingly little high quality evidence on medical treatment for small AAAs, especially in relation to the use of newer beta‐blockers, ACE inhibitors and statins. |
t35 | t35_2 | yes | The most common place for such a dilatation is the abdominal aorta. | Screening for abdominal aortic aneurysm (AAA) in selected groups is now performed in England, the USA and Sweden. Patients with aneurysms over 55 mm in diameter are generally considered for elective surgical repair. Patients with aneurysm diameters below or equal to 55 mm (termed 'small AAAs') are managed with aneurysm surveillance as there is currently insufficient evidence to recommend surgery in these cases. As more patients are screened, there will be an increasing number of small AAAs identified. There is interest in pharmaceutical interventions (for example angiotensin converting enzyme (ACE) inhibitors, antibiotics, beta‐blockers, statins) which could be given to such patients to delay or reverse aneurysm expansion and reduce the need for elective surgical repair. Objectives To assess the effects of medical treatment on the expansion rate of small abdominal aortic aneurysms. Search methods The Cochrane Peripheral Vascular Diseases Group Trials Search Co‐ordinator searched the Specialised Register (May 2012) and CENTRAL (2012, Issue 5). Clinical trials databases were searched for details of ongoing or unpublished studies. The reference lists of articles retrieved by electronic searches were searched for additional citations. Selection criteria We selected randomised trials in which patients with small AAAs allocated to medical treatment with the intention of retarding aneurysm expansion were compared to patients allocated to a placebo treatment, alternative medical treatment, a different regimen of the same drug or imaging surveillance alone. Data collection and analysis Two authors independently extracted the data and assessed the risk of bias in the trials. Meta‐analyses were used when heterogeneity was considered low. The two primary outcomes were the mean difference (MD) in aneurysm diameter and the odds ratio (OR) calculated to compare the number of individuals referred to AAA surgery in each group over the trial period. Seven trials involving 1558 participants were included in this review; 457 were involved in four trials of antibiotic medication, and 1101 were involved in three trials of beta‐blocker medication. Five of the studies were rated at a high risk of bias. Individually, all of the included trials reported non‐significant differences in AAA expansion rates between their intervention and control groups. The two major drug groups were then analysed separately. For AAA expansion it was only possible to combine two of the antibiotic trials in a meta‐analysis. This demonstrated that roxithromycin had a small but significant protective effect (MD ‐0.86 mm; 95% confidence interval (CI) ‐1.57 to ‐0.14). When referral to AAA surgery was compared (including all four antibiotic trials in the meta‐analysis), non‐significantly fewer patients were referred in the intervention groups (OR 0.96; 95% CI 0.59 to 1.57) than the control groups. When only the trials reporting actual elective surgery were included in a subgroup analysis, the result remained statistically non‐significant (OR 1.17; 95% CI 0.57 to 2.42). For the beta‐blocker trials, when all were combined in a meta‐analysis, there was a very small, non‐significant protective effect for propranolol on AAA expansion (MD ‐0.08 mm; 95% CI ‐0.25 to 0.10), and non‐significantly fewer patients were referred to AAA surgery in the propranolol group (OR 0.74; 95% CI 0.52 to 1.05). Bronchospasm and shortness of breath were the main adverse effects from the beta‐blockers. In one trial the adverse effects were reportedly so severe that the trial was stopped early after two years. There is some limited evidence that antibiotic medication may have a slight protective effect in retarding the expansion rates of small AAAs. The quality of the evidence makes it unclear whether this translates into fewer referrals to AAA surgery, owing mainly to the small sample sizes of the studies. Antibiotics were generally well tolerated with minimal adverse effects. Propranolol was poorly tolerated by patients in all of the beta‐blocker trials and demonstrated only minimal and non‐significant protective effects. Further research on beta‐blockers for AAA needs to consider the use of drugs other than propranolol. In general, there is surprisingly little high quality evidence on medical treatment for small AAAs, especially in relation to the use of newer beta‐blockers, ACE inhibitors and statins. |
t35 | t35_3 | yes | This is the main artery linking the heart to the lower limbs and the organs of the abdomen, and a dilatation here is termed an abdominal aortic aneurysm (AAA). | Screening for abdominal aortic aneurysm (AAA) in selected groups is now performed in England, the USA and Sweden. Patients with aneurysms over 55 mm in diameter are generally considered for elective surgical repair. Patients with aneurysm diameters below or equal to 55 mm (termed 'small AAAs') are managed with aneurysm surveillance as there is currently insufficient evidence to recommend surgery in these cases. As more patients are screened, there will be an increasing number of small AAAs identified. There is interest in pharmaceutical interventions (for example angiotensin converting enzyme (ACE) inhibitors, antibiotics, beta‐blockers, statins) which could be given to such patients to delay or reverse aneurysm expansion and reduce the need for elective surgical repair. Objectives To assess the effects of medical treatment on the expansion rate of small abdominal aortic aneurysms. Search methods The Cochrane Peripheral Vascular Diseases Group Trials Search Co‐ordinator searched the Specialised Register (May 2012) and CENTRAL (2012, Issue 5). Clinical trials databases were searched for details of ongoing or unpublished studies. The reference lists of articles retrieved by electronic searches were searched for additional citations. Selection criteria We selected randomised trials in which patients with small AAAs allocated to medical treatment with the intention of retarding aneurysm expansion were compared to patients allocated to a placebo treatment, alternative medical treatment, a different regimen of the same drug or imaging surveillance alone. Data collection and analysis Two authors independently extracted the data and assessed the risk of bias in the trials. Meta‐analyses were used when heterogeneity was considered low. The two primary outcomes were the mean difference (MD) in aneurysm diameter and the odds ratio (OR) calculated to compare the number of individuals referred to AAA surgery in each group over the trial period. Seven trials involving 1558 participants were included in this review; 457 were involved in four trials of antibiotic medication, and 1101 were involved in three trials of beta‐blocker medication. Five of the studies were rated at a high risk of bias. Individually, all of the included trials reported non‐significant differences in AAA expansion rates between their intervention and control groups. The two major drug groups were then analysed separately. For AAA expansion it was only possible to combine two of the antibiotic trials in a meta‐analysis. This demonstrated that roxithromycin had a small but significant protective effect (MD ‐0.86 mm; 95% confidence interval (CI) ‐1.57 to ‐0.14). When referral to AAA surgery was compared (including all four antibiotic trials in the meta‐analysis), non‐significantly fewer patients were referred in the intervention groups (OR 0.96; 95% CI 0.59 to 1.57) than the control groups. When only the trials reporting actual elective surgery were included in a subgroup analysis, the result remained statistically non‐significant (OR 1.17; 95% CI 0.57 to 2.42). For the beta‐blocker trials, when all were combined in a meta‐analysis, there was a very small, non‐significant protective effect for propranolol on AAA expansion (MD ‐0.08 mm; 95% CI ‐0.25 to 0.10), and non‐significantly fewer patients were referred to AAA surgery in the propranolol group (OR 0.74; 95% CI 0.52 to 1.05). Bronchospasm and shortness of breath were the main adverse effects from the beta‐blockers. In one trial the adverse effects were reportedly so severe that the trial was stopped early after two years. There is some limited evidence that antibiotic medication may have a slight protective effect in retarding the expansion rates of small AAAs. The quality of the evidence makes it unclear whether this translates into fewer referrals to AAA surgery, owing mainly to the small sample sizes of the studies. Antibiotics were generally well tolerated with minimal adverse effects. Propranolol was poorly tolerated by patients in all of the beta‐blocker trials and demonstrated only minimal and non‐significant protective effects. Further research on beta‐blockers for AAA needs to consider the use of drugs other than propranolol. In general, there is surprisingly little high quality evidence on medical treatment for small AAAs, especially in relation to the use of newer beta‐blockers, ACE inhibitors and statins. |
t35 | t35_4 | yes | About 4% of men over 55 years of age have an AAA, but it is less common in women. | Screening for abdominal aortic aneurysm (AAA) in selected groups is now performed in England, the USA and Sweden. Patients with aneurysms over 55 mm in diameter are generally considered for elective surgical repair. Patients with aneurysm diameters below or equal to 55 mm (termed 'small AAAs') are managed with aneurysm surveillance as there is currently insufficient evidence to recommend surgery in these cases. As more patients are screened, there will be an increasing number of small AAAs identified. There is interest in pharmaceutical interventions (for example angiotensin converting enzyme (ACE) inhibitors, antibiotics, beta‐blockers, statins) which could be given to such patients to delay or reverse aneurysm expansion and reduce the need for elective surgical repair. Objectives To assess the effects of medical treatment on the expansion rate of small abdominal aortic aneurysms. Search methods The Cochrane Peripheral Vascular Diseases Group Trials Search Co‐ordinator searched the Specialised Register (May 2012) and CENTRAL (2012, Issue 5). Clinical trials databases were searched for details of ongoing or unpublished studies. The reference lists of articles retrieved by electronic searches were searched for additional citations. Selection criteria We selected randomised trials in which patients with small AAAs allocated to medical treatment with the intention of retarding aneurysm expansion were compared to patients allocated to a placebo treatment, alternative medical treatment, a different regimen of the same drug or imaging surveillance alone. Data collection and analysis Two authors independently extracted the data and assessed the risk of bias in the trials. Meta‐analyses were used when heterogeneity was considered low. The two primary outcomes were the mean difference (MD) in aneurysm diameter and the odds ratio (OR) calculated to compare the number of individuals referred to AAA surgery in each group over the trial period. Seven trials involving 1558 participants were included in this review; 457 were involved in four trials of antibiotic medication, and 1101 were involved in three trials of beta‐blocker medication. Five of the studies were rated at a high risk of bias. Individually, all of the included trials reported non‐significant differences in AAA expansion rates between their intervention and control groups. The two major drug groups were then analysed separately. For AAA expansion it was only possible to combine two of the antibiotic trials in a meta‐analysis. This demonstrated that roxithromycin had a small but significant protective effect (MD ‐0.86 mm; 95% confidence interval (CI) ‐1.57 to ‐0.14). When referral to AAA surgery was compared (including all four antibiotic trials in the meta‐analysis), non‐significantly fewer patients were referred in the intervention groups (OR 0.96; 95% CI 0.59 to 1.57) than the control groups. When only the trials reporting actual elective surgery were included in a subgroup analysis, the result remained statistically non‐significant (OR 1.17; 95% CI 0.57 to 2.42). For the beta‐blocker trials, when all were combined in a meta‐analysis, there was a very small, non‐significant protective effect for propranolol on AAA expansion (MD ‐0.08 mm; 95% CI ‐0.25 to 0.10), and non‐significantly fewer patients were referred to AAA surgery in the propranolol group (OR 0.74; 95% CI 0.52 to 1.05). Bronchospasm and shortness of breath were the main adverse effects from the beta‐blockers. In one trial the adverse effects were reportedly so severe that the trial was stopped early after two years. There is some limited evidence that antibiotic medication may have a slight protective effect in retarding the expansion rates of small AAAs. The quality of the evidence makes it unclear whether this translates into fewer referrals to AAA surgery, owing mainly to the small sample sizes of the studies. Antibiotics were generally well tolerated with minimal adverse effects. Propranolol was poorly tolerated by patients in all of the beta‐blocker trials and demonstrated only minimal and non‐significant protective effects. Further research on beta‐blockers for AAA needs to consider the use of drugs other than propranolol. In general, there is surprisingly little high quality evidence on medical treatment for small AAAs, especially in relation to the use of newer beta‐blockers, ACE inhibitors and statins. |
t35 | t35_5 | yes | Aneurysms over 55 mm in diameter carry a high risk of rupture, and rupture carries a high risk of death. | Screening for abdominal aortic aneurysm (AAA) in selected groups is now performed in England, the USA and Sweden. Patients with aneurysms over 55 mm in diameter are generally considered for elective surgical repair. Patients with aneurysm diameters below or equal to 55 mm (termed 'small AAAs') are managed with aneurysm surveillance as there is currently insufficient evidence to recommend surgery in these cases. As more patients are screened, there will be an increasing number of small AAAs identified. There is interest in pharmaceutical interventions (for example angiotensin converting enzyme (ACE) inhibitors, antibiotics, beta‐blockers, statins) which could be given to such patients to delay or reverse aneurysm expansion and reduce the need for elective surgical repair. Objectives To assess the effects of medical treatment on the expansion rate of small abdominal aortic aneurysms. Search methods The Cochrane Peripheral Vascular Diseases Group Trials Search Co‐ordinator searched the Specialised Register (May 2012) and CENTRAL (2012, Issue 5). Clinical trials databases were searched for details of ongoing or unpublished studies. The reference lists of articles retrieved by electronic searches were searched for additional citations. Selection criteria We selected randomised trials in which patients with small AAAs allocated to medical treatment with the intention of retarding aneurysm expansion were compared to patients allocated to a placebo treatment, alternative medical treatment, a different regimen of the same drug or imaging surveillance alone. Data collection and analysis Two authors independently extracted the data and assessed the risk of bias in the trials. Meta‐analyses were used when heterogeneity was considered low. The two primary outcomes were the mean difference (MD) in aneurysm diameter and the odds ratio (OR) calculated to compare the number of individuals referred to AAA surgery in each group over the trial period. Seven trials involving 1558 participants were included in this review; 457 were involved in four trials of antibiotic medication, and 1101 were involved in three trials of beta‐blocker medication. Five of the studies were rated at a high risk of bias. Individually, all of the included trials reported non‐significant differences in AAA expansion rates between their intervention and control groups. The two major drug groups were then analysed separately. For AAA expansion it was only possible to combine two of the antibiotic trials in a meta‐analysis. This demonstrated that roxithromycin had a small but significant protective effect (MD ‐0.86 mm; 95% confidence interval (CI) ‐1.57 to ‐0.14). When referral to AAA surgery was compared (including all four antibiotic trials in the meta‐analysis), non‐significantly fewer patients were referred in the intervention groups (OR 0.96; 95% CI 0.59 to 1.57) than the control groups. When only the trials reporting actual elective surgery were included in a subgroup analysis, the result remained statistically non‐significant (OR 1.17; 95% CI 0.57 to 2.42). For the beta‐blocker trials, when all were combined in a meta‐analysis, there was a very small, non‐significant protective effect for propranolol on AAA expansion (MD ‐0.08 mm; 95% CI ‐0.25 to 0.10), and non‐significantly fewer patients were referred to AAA surgery in the propranolol group (OR 0.74; 95% CI 0.52 to 1.05). Bronchospasm and shortness of breath were the main adverse effects from the beta‐blockers. In one trial the adverse effects were reportedly so severe that the trial was stopped early after two years. There is some limited evidence that antibiotic medication may have a slight protective effect in retarding the expansion rates of small AAAs. The quality of the evidence makes it unclear whether this translates into fewer referrals to AAA surgery, owing mainly to the small sample sizes of the studies. Antibiotics were generally well tolerated with minimal adverse effects. Propranolol was poorly tolerated by patients in all of the beta‐blocker trials and demonstrated only minimal and non‐significant protective effects. Further research on beta‐blockers for AAA needs to consider the use of drugs other than propranolol. In general, there is surprisingly little high quality evidence on medical treatment for small AAAs, especially in relation to the use of newer beta‐blockers, ACE inhibitors and statins. |
t35 | t35_6 | yes | To reduce the risks, screening programmes using ultrasound scanning have been introduced for selected groups in a number of countries. | Screening for abdominal aortic aneurysm (AAA) in selected groups is now performed in England, the USA and Sweden. Patients with aneurysms over 55 mm in diameter are generally considered for elective surgical repair. Patients with aneurysm diameters below or equal to 55 mm (termed 'small AAAs') are managed with aneurysm surveillance as there is currently insufficient evidence to recommend surgery in these cases. As more patients are screened, there will be an increasing number of small AAAs identified. There is interest in pharmaceutical interventions (for example angiotensin converting enzyme (ACE) inhibitors, antibiotics, beta‐blockers, statins) which could be given to such patients to delay or reverse aneurysm expansion and reduce the need for elective surgical repair. Objectives To assess the effects of medical treatment on the expansion rate of small abdominal aortic aneurysms. Search methods The Cochrane Peripheral Vascular Diseases Group Trials Search Co‐ordinator searched the Specialised Register (May 2012) and CENTRAL (2012, Issue 5). Clinical trials databases were searched for details of ongoing or unpublished studies. The reference lists of articles retrieved by electronic searches were searched for additional citations. Selection criteria We selected randomised trials in which patients with small AAAs allocated to medical treatment with the intention of retarding aneurysm expansion were compared to patients allocated to a placebo treatment, alternative medical treatment, a different regimen of the same drug or imaging surveillance alone. Data collection and analysis Two authors independently extracted the data and assessed the risk of bias in the trials. Meta‐analyses were used when heterogeneity was considered low. The two primary outcomes were the mean difference (MD) in aneurysm diameter and the odds ratio (OR) calculated to compare the number of individuals referred to AAA surgery in each group over the trial period. Seven trials involving 1558 participants were included in this review; 457 were involved in four trials of antibiotic medication, and 1101 were involved in three trials of beta‐blocker medication. Five of the studies were rated at a high risk of bias. Individually, all of the included trials reported non‐significant differences in AAA expansion rates between their intervention and control groups. The two major drug groups were then analysed separately. For AAA expansion it was only possible to combine two of the antibiotic trials in a meta‐analysis. This demonstrated that roxithromycin had a small but significant protective effect (MD ‐0.86 mm; 95% confidence interval (CI) ‐1.57 to ‐0.14). When referral to AAA surgery was compared (including all four antibiotic trials in the meta‐analysis), non‐significantly fewer patients were referred in the intervention groups (OR 0.96; 95% CI 0.59 to 1.57) than the control groups. When only the trials reporting actual elective surgery were included in a subgroup analysis, the result remained statistically non‐significant (OR 1.17; 95% CI 0.57 to 2.42). For the beta‐blocker trials, when all were combined in a meta‐analysis, there was a very small, non‐significant protective effect for propranolol on AAA expansion (MD ‐0.08 mm; 95% CI ‐0.25 to 0.10), and non‐significantly fewer patients were referred to AAA surgery in the propranolol group (OR 0.74; 95% CI 0.52 to 1.05). Bronchospasm and shortness of breath were the main adverse effects from the beta‐blockers. In one trial the adverse effects were reportedly so severe that the trial was stopped early after two years. There is some limited evidence that antibiotic medication may have a slight protective effect in retarding the expansion rates of small AAAs. The quality of the evidence makes it unclear whether this translates into fewer referrals to AAA surgery, owing mainly to the small sample sizes of the studies. Antibiotics were generally well tolerated with minimal adverse effects. Propranolol was poorly tolerated by patients in all of the beta‐blocker trials and demonstrated only minimal and non‐significant protective effects. Further research on beta‐blockers for AAA needs to consider the use of drugs other than propranolol. In general, there is surprisingly little high quality evidence on medical treatment for small AAAs, especially in relation to the use of newer beta‐blockers, ACE inhibitors and statins. |
t35 | t35_7 | no | Patients with aneurysms over 55 mm are then evaluated for elective aneurysm repair. | Screening for abdominal aortic aneurysm (AAA) in selected groups is now performed in England, the USA and Sweden. Patients with aneurysms over 55 mm in diameter are generally considered for elective surgical repair. Patients with aneurysm diameters below or equal to 55 mm (termed 'small AAAs') are managed with aneurysm surveillance as there is currently insufficient evidence to recommend surgery in these cases. As more patients are screened, there will be an increasing number of small AAAs identified. There is interest in pharmaceutical interventions (for example angiotensin converting enzyme (ACE) inhibitors, antibiotics, beta‐blockers, statins) which could be given to such patients to delay or reverse aneurysm expansion and reduce the need for elective surgical repair. Objectives To assess the effects of medical treatment on the expansion rate of small abdominal aortic aneurysms. Search methods The Cochrane Peripheral Vascular Diseases Group Trials Search Co‐ordinator searched the Specialised Register (May 2012) and CENTRAL (2012, Issue 5). Clinical trials databases were searched for details of ongoing or unpublished studies. The reference lists of articles retrieved by electronic searches were searched for additional citations. Selection criteria We selected randomised trials in which patients with small AAAs allocated to medical treatment with the intention of retarding aneurysm expansion were compared to patients allocated to a placebo treatment, alternative medical treatment, a different regimen of the same drug or imaging surveillance alone. Data collection and analysis Two authors independently extracted the data and assessed the risk of bias in the trials. Meta‐analyses were used when heterogeneity was considered low. The two primary outcomes were the mean difference (MD) in aneurysm diameter and the odds ratio (OR) calculated to compare the number of individuals referred to AAA surgery in each group over the trial period. Seven trials involving 1558 participants were included in this review; 457 were involved in four trials of antibiotic medication, and 1101 were involved in three trials of beta‐blocker medication. Five of the studies were rated at a high risk of bias. Individually, all of the included trials reported non‐significant differences in AAA expansion rates between their intervention and control groups. The two major drug groups were then analysed separately. For AAA expansion it was only possible to combine two of the antibiotic trials in a meta‐analysis. This demonstrated that roxithromycin had a small but significant protective effect (MD ‐0.86 mm; 95% confidence interval (CI) ‐1.57 to ‐0.14). When referral to AAA surgery was compared (including all four antibiotic trials in the meta‐analysis), non‐significantly fewer patients were referred in the intervention groups (OR 0.96; 95% CI 0.59 to 1.57) than the control groups. When only the trials reporting actual elective surgery were included in a subgroup analysis, the result remained statistically non‐significant (OR 1.17; 95% CI 0.57 to 2.42). For the beta‐blocker trials, when all were combined in a meta‐analysis, there was a very small, non‐significant protective effect for propranolol on AAA expansion (MD ‐0.08 mm; 95% CI ‐0.25 to 0.10), and non‐significantly fewer patients were referred to AAA surgery in the propranolol group (OR 0.74; 95% CI 0.52 to 1.05). Bronchospasm and shortness of breath were the main adverse effects from the beta‐blockers. In one trial the adverse effects were reportedly so severe that the trial was stopped early after two years. There is some limited evidence that antibiotic medication may have a slight protective effect in retarding the expansion rates of small AAAs. The quality of the evidence makes it unclear whether this translates into fewer referrals to AAA surgery, owing mainly to the small sample sizes of the studies. Antibiotics were generally well tolerated with minimal adverse effects. Propranolol was poorly tolerated by patients in all of the beta‐blocker trials and demonstrated only minimal and non‐significant protective effects. Further research on beta‐blockers for AAA needs to consider the use of drugs other than propranolol. In general, there is surprisingly little high quality evidence on medical treatment for small AAAs, especially in relation to the use of newer beta‐blockers, ACE inhibitors and statins. |
t35 | t35_8 | yes | For aneurysms at or below the 55 mm cut‐off, the current treatment is 'watchful waiting', where the aneurysm is repeatedly scanned over time to see if it is enlarging. | Screening for abdominal aortic aneurysm (AAA) in selected groups is now performed in England, the USA and Sweden. Patients with aneurysms over 55 mm in diameter are generally considered for elective surgical repair. Patients with aneurysm diameters below or equal to 55 mm (termed 'small AAAs') are managed with aneurysm surveillance as there is currently insufficient evidence to recommend surgery in these cases. As more patients are screened, there will be an increasing number of small AAAs identified. There is interest in pharmaceutical interventions (for example angiotensin converting enzyme (ACE) inhibitors, antibiotics, beta‐blockers, statins) which could be given to such patients to delay or reverse aneurysm expansion and reduce the need for elective surgical repair. Objectives To assess the effects of medical treatment on the expansion rate of small abdominal aortic aneurysms. Search methods The Cochrane Peripheral Vascular Diseases Group Trials Search Co‐ordinator searched the Specialised Register (May 2012) and CENTRAL (2012, Issue 5). Clinical trials databases were searched for details of ongoing or unpublished studies. The reference lists of articles retrieved by electronic searches were searched for additional citations. Selection criteria We selected randomised trials in which patients with small AAAs allocated to medical treatment with the intention of retarding aneurysm expansion were compared to patients allocated to a placebo treatment, alternative medical treatment, a different regimen of the same drug or imaging surveillance alone. Data collection and analysis Two authors independently extracted the data and assessed the risk of bias in the trials. Meta‐analyses were used when heterogeneity was considered low. The two primary outcomes were the mean difference (MD) in aneurysm diameter and the odds ratio (OR) calculated to compare the number of individuals referred to AAA surgery in each group over the trial period. Seven trials involving 1558 participants were included in this review; 457 were involved in four trials of antibiotic medication, and 1101 were involved in three trials of beta‐blocker medication. Five of the studies were rated at a high risk of bias. Individually, all of the included trials reported non‐significant differences in AAA expansion rates between their intervention and control groups. The two major drug groups were then analysed separately. For AAA expansion it was only possible to combine two of the antibiotic trials in a meta‐analysis. This demonstrated that roxithromycin had a small but significant protective effect (MD ‐0.86 mm; 95% confidence interval (CI) ‐1.57 to ‐0.14). When referral to AAA surgery was compared (including all four antibiotic trials in the meta‐analysis), non‐significantly fewer patients were referred in the intervention groups (OR 0.96; 95% CI 0.59 to 1.57) than the control groups. When only the trials reporting actual elective surgery were included in a subgroup analysis, the result remained statistically non‐significant (OR 1.17; 95% CI 0.57 to 2.42). For the beta‐blocker trials, when all were combined in a meta‐analysis, there was a very small, non‐significant protective effect for propranolol on AAA expansion (MD ‐0.08 mm; 95% CI ‐0.25 to 0.10), and non‐significantly fewer patients were referred to AAA surgery in the propranolol group (OR 0.74; 95% CI 0.52 to 1.05). Bronchospasm and shortness of breath were the main adverse effects from the beta‐blockers. In one trial the adverse effects were reportedly so severe that the trial was stopped early after two years. There is some limited evidence that antibiotic medication may have a slight protective effect in retarding the expansion rates of small AAAs. The quality of the evidence makes it unclear whether this translates into fewer referrals to AAA surgery, owing mainly to the small sample sizes of the studies. Antibiotics were generally well tolerated with minimal adverse effects. Propranolol was poorly tolerated by patients in all of the beta‐blocker trials and demonstrated only minimal and non‐significant protective effects. Further research on beta‐blockers for AAA needs to consider the use of drugs other than propranolol. In general, there is surprisingly little high quality evidence on medical treatment for small AAAs, especially in relation to the use of newer beta‐blockers, ACE inhibitors and statins. |
t35 | t35_9 | no | This review aimed to identify medical treatments which could slow or even reverse aneurysm growth, and thus delay or avoid the need for elective surgery. | Screening for abdominal aortic aneurysm (AAA) in selected groups is now performed in England, the USA and Sweden. Patients with aneurysms over 55 mm in diameter are generally considered for elective surgical repair. Patients with aneurysm diameters below or equal to 55 mm (termed 'small AAAs') are managed with aneurysm surveillance as there is currently insufficient evidence to recommend surgery in these cases. As more patients are screened, there will be an increasing number of small AAAs identified. There is interest in pharmaceutical interventions (for example angiotensin converting enzyme (ACE) inhibitors, antibiotics, beta‐blockers, statins) which could be given to such patients to delay or reverse aneurysm expansion and reduce the need for elective surgical repair. Objectives To assess the effects of medical treatment on the expansion rate of small abdominal aortic aneurysms. Search methods The Cochrane Peripheral Vascular Diseases Group Trials Search Co‐ordinator searched the Specialised Register (May 2012) and CENTRAL (2012, Issue 5). Clinical trials databases were searched for details of ongoing or unpublished studies. The reference lists of articles retrieved by electronic searches were searched for additional citations. Selection criteria We selected randomised trials in which patients with small AAAs allocated to medical treatment with the intention of retarding aneurysm expansion were compared to patients allocated to a placebo treatment, alternative medical treatment, a different regimen of the same drug or imaging surveillance alone. Data collection and analysis Two authors independently extracted the data and assessed the risk of bias in the trials. Meta‐analyses were used when heterogeneity was considered low. The two primary outcomes were the mean difference (MD) in aneurysm diameter and the odds ratio (OR) calculated to compare the number of individuals referred to AAA surgery in each group over the trial period. Seven trials involving 1558 participants were included in this review; 457 were involved in four trials of antibiotic medication, and 1101 were involved in three trials of beta‐blocker medication. Five of the studies were rated at a high risk of bias. Individually, all of the included trials reported non‐significant differences in AAA expansion rates between their intervention and control groups. The two major drug groups were then analysed separately. For AAA expansion it was only possible to combine two of the antibiotic trials in a meta‐analysis. This demonstrated that roxithromycin had a small but significant protective effect (MD ‐0.86 mm; 95% confidence interval (CI) ‐1.57 to ‐0.14). When referral to AAA surgery was compared (including all four antibiotic trials in the meta‐analysis), non‐significantly fewer patients were referred in the intervention groups (OR 0.96; 95% CI 0.59 to 1.57) than the control groups. When only the trials reporting actual elective surgery were included in a subgroup analysis, the result remained statistically non‐significant (OR 1.17; 95% CI 0.57 to 2.42). For the beta‐blocker trials, when all were combined in a meta‐analysis, there was a very small, non‐significant protective effect for propranolol on AAA expansion (MD ‐0.08 mm; 95% CI ‐0.25 to 0.10), and non‐significantly fewer patients were referred to AAA surgery in the propranolol group (OR 0.74; 95% CI 0.52 to 1.05). Bronchospasm and shortness of breath were the main adverse effects from the beta‐blockers. In one trial the adverse effects were reportedly so severe that the trial was stopped early after two years. There is some limited evidence that antibiotic medication may have a slight protective effect in retarding the expansion rates of small AAAs. The quality of the evidence makes it unclear whether this translates into fewer referrals to AAA surgery, owing mainly to the small sample sizes of the studies. Antibiotics were generally well tolerated with minimal adverse effects. Propranolol was poorly tolerated by patients in all of the beta‐blocker trials and demonstrated only minimal and non‐significant protective effects. Further research on beta‐blockers for AAA needs to consider the use of drugs other than propranolol. In general, there is surprisingly little high quality evidence on medical treatment for small AAAs, especially in relation to the use of newer beta‐blockers, ACE inhibitors and statins. |
t35 | t35_10 | no | We identified seven trials involving 1558 participants where the aneurysm diameters of patients randomised to receive medical treatment were compared to those participants given a control medication or surveillance imaging alone. | Screening for abdominal aortic aneurysm (AAA) in selected groups is now performed in England, the USA and Sweden. Patients with aneurysms over 55 mm in diameter are generally considered for elective surgical repair. Patients with aneurysm diameters below or equal to 55 mm (termed 'small AAAs') are managed with aneurysm surveillance as there is currently insufficient evidence to recommend surgery in these cases. As more patients are screened, there will be an increasing number of small AAAs identified. There is interest in pharmaceutical interventions (for example angiotensin converting enzyme (ACE) inhibitors, antibiotics, beta‐blockers, statins) which could be given to such patients to delay or reverse aneurysm expansion and reduce the need for elective surgical repair. Objectives To assess the effects of medical treatment on the expansion rate of small abdominal aortic aneurysms. Search methods The Cochrane Peripheral Vascular Diseases Group Trials Search Co‐ordinator searched the Specialised Register (May 2012) and CENTRAL (2012, Issue 5). Clinical trials databases were searched for details of ongoing or unpublished studies. The reference lists of articles retrieved by electronic searches were searched for additional citations. Selection criteria We selected randomised trials in which patients with small AAAs allocated to medical treatment with the intention of retarding aneurysm expansion were compared to patients allocated to a placebo treatment, alternative medical treatment, a different regimen of the same drug or imaging surveillance alone. Data collection and analysis Two authors independently extracted the data and assessed the risk of bias in the trials. Meta‐analyses were used when heterogeneity was considered low. The two primary outcomes were the mean difference (MD) in aneurysm diameter and the odds ratio (OR) calculated to compare the number of individuals referred to AAA surgery in each group over the trial period. Seven trials involving 1558 participants were included in this review; 457 were involved in four trials of antibiotic medication, and 1101 were involved in three trials of beta‐blocker medication. Five of the studies were rated at a high risk of bias. Individually, all of the included trials reported non‐significant differences in AAA expansion rates between their intervention and control groups. The two major drug groups were then analysed separately. For AAA expansion it was only possible to combine two of the antibiotic trials in a meta‐analysis. This demonstrated that roxithromycin had a small but significant protective effect (MD ‐0.86 mm; 95% confidence interval (CI) ‐1.57 to ‐0.14). When referral to AAA surgery was compared (including all four antibiotic trials in the meta‐analysis), non‐significantly fewer patients were referred in the intervention groups (OR 0.96; 95% CI 0.59 to 1.57) than the control groups. When only the trials reporting actual elective surgery were included in a subgroup analysis, the result remained statistically non‐significant (OR 1.17; 95% CI 0.57 to 2.42). For the beta‐blocker trials, when all were combined in a meta‐analysis, there was a very small, non‐significant protective effect for propranolol on AAA expansion (MD ‐0.08 mm; 95% CI ‐0.25 to 0.10), and non‐significantly fewer patients were referred to AAA surgery in the propranolol group (OR 0.74; 95% CI 0.52 to 1.05). Bronchospasm and shortness of breath were the main adverse effects from the beta‐blockers. In one trial the adverse effects were reportedly so severe that the trial was stopped early after two years. There is some limited evidence that antibiotic medication may have a slight protective effect in retarding the expansion rates of small AAAs. The quality of the evidence makes it unclear whether this translates into fewer referrals to AAA surgery, owing mainly to the small sample sizes of the studies. Antibiotics were generally well tolerated with minimal adverse effects. Propranolol was poorly tolerated by patients in all of the beta‐blocker trials and demonstrated only minimal and non‐significant protective effects. Further research on beta‐blockers for AAA needs to consider the use of drugs other than propranolol. In general, there is surprisingly little high quality evidence on medical treatment for small AAAs, especially in relation to the use of newer beta‐blockers, ACE inhibitors and statins. |
t35 | t35_11 | yes | Four trials studied the effects of antibiotics on slowing aneurysm growth, and showed a small protective effect. | Screening for abdominal aortic aneurysm (AAA) in selected groups is now performed in England, the USA and Sweden. Patients with aneurysms over 55 mm in diameter are generally considered for elective surgical repair. Patients with aneurysm diameters below or equal to 55 mm (termed 'small AAAs') are managed with aneurysm surveillance as there is currently insufficient evidence to recommend surgery in these cases. As more patients are screened, there will be an increasing number of small AAAs identified. There is interest in pharmaceutical interventions (for example angiotensin converting enzyme (ACE) inhibitors, antibiotics, beta‐blockers, statins) which could be given to such patients to delay or reverse aneurysm expansion and reduce the need for elective surgical repair. Objectives To assess the effects of medical treatment on the expansion rate of small abdominal aortic aneurysms. Search methods The Cochrane Peripheral Vascular Diseases Group Trials Search Co‐ordinator searched the Specialised Register (May 2012) and CENTRAL (2012, Issue 5). Clinical trials databases were searched for details of ongoing or unpublished studies. The reference lists of articles retrieved by electronic searches were searched for additional citations. Selection criteria We selected randomised trials in which patients with small AAAs allocated to medical treatment with the intention of retarding aneurysm expansion were compared to patients allocated to a placebo treatment, alternative medical treatment, a different regimen of the same drug or imaging surveillance alone. Data collection and analysis Two authors independently extracted the data and assessed the risk of bias in the trials. Meta‐analyses were used when heterogeneity was considered low. The two primary outcomes were the mean difference (MD) in aneurysm diameter and the odds ratio (OR) calculated to compare the number of individuals referred to AAA surgery in each group over the trial period. Seven trials involving 1558 participants were included in this review; 457 were involved in four trials of antibiotic medication, and 1101 were involved in three trials of beta‐blocker medication. Five of the studies were rated at a high risk of bias. Individually, all of the included trials reported non‐significant differences in AAA expansion rates between their intervention and control groups. The two major drug groups were then analysed separately. For AAA expansion it was only possible to combine two of the antibiotic trials in a meta‐analysis. This demonstrated that roxithromycin had a small but significant protective effect (MD ‐0.86 mm; 95% confidence interval (CI) ‐1.57 to ‐0.14). When referral to AAA surgery was compared (including all four antibiotic trials in the meta‐analysis), non‐significantly fewer patients were referred in the intervention groups (OR 0.96; 95% CI 0.59 to 1.57) than the control groups. When only the trials reporting actual elective surgery were included in a subgroup analysis, the result remained statistically non‐significant (OR 1.17; 95% CI 0.57 to 2.42). For the beta‐blocker trials, when all were combined in a meta‐analysis, there was a very small, non‐significant protective effect for propranolol on AAA expansion (MD ‐0.08 mm; 95% CI ‐0.25 to 0.10), and non‐significantly fewer patients were referred to AAA surgery in the propranolol group (OR 0.74; 95% CI 0.52 to 1.05). Bronchospasm and shortness of breath were the main adverse effects from the beta‐blockers. In one trial the adverse effects were reportedly so severe that the trial was stopped early after two years. There is some limited evidence that antibiotic medication may have a slight protective effect in retarding the expansion rates of small AAAs. The quality of the evidence makes it unclear whether this translates into fewer referrals to AAA surgery, owing mainly to the small sample sizes of the studies. Antibiotics were generally well tolerated with minimal adverse effects. Propranolol was poorly tolerated by patients in all of the beta‐blocker trials and demonstrated only minimal and non‐significant protective effects. Further research on beta‐blockers for AAA needs to consider the use of drugs other than propranolol. In general, there is surprisingly little high quality evidence on medical treatment for small AAAs, especially in relation to the use of newer beta‐blockers, ACE inhibitors and statins. |
t35 | t35_12 | yes | Three trials studied the effects of beta‐blockers, and demonstrated a very small protective effect. | Screening for abdominal aortic aneurysm (AAA) in selected groups is now performed in England, the USA and Sweden. Patients with aneurysms over 55 mm in diameter are generally considered for elective surgical repair. Patients with aneurysm diameters below or equal to 55 mm (termed 'small AAAs') are managed with aneurysm surveillance as there is currently insufficient evidence to recommend surgery in these cases. As more patients are screened, there will be an increasing number of small AAAs identified. There is interest in pharmaceutical interventions (for example angiotensin converting enzyme (ACE) inhibitors, antibiotics, beta‐blockers, statins) which could be given to such patients to delay or reverse aneurysm expansion and reduce the need for elective surgical repair. Objectives To assess the effects of medical treatment on the expansion rate of small abdominal aortic aneurysms. Search methods The Cochrane Peripheral Vascular Diseases Group Trials Search Co‐ordinator searched the Specialised Register (May 2012) and CENTRAL (2012, Issue 5). Clinical trials databases were searched for details of ongoing or unpublished studies. The reference lists of articles retrieved by electronic searches were searched for additional citations. Selection criteria We selected randomised trials in which patients with small AAAs allocated to medical treatment with the intention of retarding aneurysm expansion were compared to patients allocated to a placebo treatment, alternative medical treatment, a different regimen of the same drug or imaging surveillance alone. Data collection and analysis Two authors independently extracted the data and assessed the risk of bias in the trials. Meta‐analyses were used when heterogeneity was considered low. The two primary outcomes were the mean difference (MD) in aneurysm diameter and the odds ratio (OR) calculated to compare the number of individuals referred to AAA surgery in each group over the trial period. Seven trials involving 1558 participants were included in this review; 457 were involved in four trials of antibiotic medication, and 1101 were involved in three trials of beta‐blocker medication. Five of the studies were rated at a high risk of bias. Individually, all of the included trials reported non‐significant differences in AAA expansion rates between their intervention and control groups. The two major drug groups were then analysed separately. For AAA expansion it was only possible to combine two of the antibiotic trials in a meta‐analysis. This demonstrated that roxithromycin had a small but significant protective effect (MD ‐0.86 mm; 95% confidence interval (CI) ‐1.57 to ‐0.14). When referral to AAA surgery was compared (including all four antibiotic trials in the meta‐analysis), non‐significantly fewer patients were referred in the intervention groups (OR 0.96; 95% CI 0.59 to 1.57) than the control groups. When only the trials reporting actual elective surgery were included in a subgroup analysis, the result remained statistically non‐significant (OR 1.17; 95% CI 0.57 to 2.42). For the beta‐blocker trials, when all were combined in a meta‐analysis, there was a very small, non‐significant protective effect for propranolol on AAA expansion (MD ‐0.08 mm; 95% CI ‐0.25 to 0.10), and non‐significantly fewer patients were referred to AAA surgery in the propranolol group (OR 0.74; 95% CI 0.52 to 1.05). Bronchospasm and shortness of breath were the main adverse effects from the beta‐blockers. In one trial the adverse effects were reportedly so severe that the trial was stopped early after two years. There is some limited evidence that antibiotic medication may have a slight protective effect in retarding the expansion rates of small AAAs. The quality of the evidence makes it unclear whether this translates into fewer referrals to AAA surgery, owing mainly to the small sample sizes of the studies. Antibiotics were generally well tolerated with minimal adverse effects. Propranolol was poorly tolerated by patients in all of the beta‐blocker trials and demonstrated only minimal and non‐significant protective effects. Further research on beta‐blockers for AAA needs to consider the use of drugs other than propranolol. In general, there is surprisingly little high quality evidence on medical treatment for small AAAs, especially in relation to the use of newer beta‐blockers, ACE inhibitors and statins. |
t35 | t35_13 | no | Notably, the beta‐blocker drugs were associated with a large number of adverse effects. | Screening for abdominal aortic aneurysm (AAA) in selected groups is now performed in England, the USA and Sweden. Patients with aneurysms over 55 mm in diameter are generally considered for elective surgical repair. Patients with aneurysm diameters below or equal to 55 mm (termed 'small AAAs') are managed with aneurysm surveillance as there is currently insufficient evidence to recommend surgery in these cases. As more patients are screened, there will be an increasing number of small AAAs identified. There is interest in pharmaceutical interventions (for example angiotensin converting enzyme (ACE) inhibitors, antibiotics, beta‐blockers, statins) which could be given to such patients to delay or reverse aneurysm expansion and reduce the need for elective surgical repair. Objectives To assess the effects of medical treatment on the expansion rate of small abdominal aortic aneurysms. Search methods The Cochrane Peripheral Vascular Diseases Group Trials Search Co‐ordinator searched the Specialised Register (May 2012) and CENTRAL (2012, Issue 5). Clinical trials databases were searched for details of ongoing or unpublished studies. The reference lists of articles retrieved by electronic searches were searched for additional citations. Selection criteria We selected randomised trials in which patients with small AAAs allocated to medical treatment with the intention of retarding aneurysm expansion were compared to patients allocated to a placebo treatment, alternative medical treatment, a different regimen of the same drug or imaging surveillance alone. Data collection and analysis Two authors independently extracted the data and assessed the risk of bias in the trials. Meta‐analyses were used when heterogeneity was considered low. The two primary outcomes were the mean difference (MD) in aneurysm diameter and the odds ratio (OR) calculated to compare the number of individuals referred to AAA surgery in each group over the trial period. Seven trials involving 1558 participants were included in this review; 457 were involved in four trials of antibiotic medication, and 1101 were involved in three trials of beta‐blocker medication. Five of the studies were rated at a high risk of bias. Individually, all of the included trials reported non‐significant differences in AAA expansion rates between their intervention and control groups. The two major drug groups were then analysed separately. For AAA expansion it was only possible to combine two of the antibiotic trials in a meta‐analysis. This demonstrated that roxithromycin had a small but significant protective effect (MD ‐0.86 mm; 95% confidence interval (CI) ‐1.57 to ‐0.14). When referral to AAA surgery was compared (including all four antibiotic trials in the meta‐analysis), non‐significantly fewer patients were referred in the intervention groups (OR 0.96; 95% CI 0.59 to 1.57) than the control groups. When only the trials reporting actual elective surgery were included in a subgroup analysis, the result remained statistically non‐significant (OR 1.17; 95% CI 0.57 to 2.42). For the beta‐blocker trials, when all were combined in a meta‐analysis, there was a very small, non‐significant protective effect for propranolol on AAA expansion (MD ‐0.08 mm; 95% CI ‐0.25 to 0.10), and non‐significantly fewer patients were referred to AAA surgery in the propranolol group (OR 0.74; 95% CI 0.52 to 1.05). Bronchospasm and shortness of breath were the main adverse effects from the beta‐blockers. In one trial the adverse effects were reportedly so severe that the trial was stopped early after two years. There is some limited evidence that antibiotic medication may have a slight protective effect in retarding the expansion rates of small AAAs. The quality of the evidence makes it unclear whether this translates into fewer referrals to AAA surgery, owing mainly to the small sample sizes of the studies. Antibiotics were generally well tolerated with minimal adverse effects. Propranolol was poorly tolerated by patients in all of the beta‐blocker trials and demonstrated only minimal and non‐significant protective effects. Further research on beta‐blockers for AAA needs to consider the use of drugs other than propranolol. In general, there is surprisingly little high quality evidence on medical treatment for small AAAs, especially in relation to the use of newer beta‐blockers, ACE inhibitors and statins. |
t35 | t35_14 | no | It was unclear whether either drug type delayed referral to aneurysm surgery. | Screening for abdominal aortic aneurysm (AAA) in selected groups is now performed in England, the USA and Sweden. Patients with aneurysms over 55 mm in diameter are generally considered for elective surgical repair. Patients with aneurysm diameters below or equal to 55 mm (termed 'small AAAs') are managed with aneurysm surveillance as there is currently insufficient evidence to recommend surgery in these cases. As more patients are screened, there will be an increasing number of small AAAs identified. There is interest in pharmaceutical interventions (for example angiotensin converting enzyme (ACE) inhibitors, antibiotics, beta‐blockers, statins) which could be given to such patients to delay or reverse aneurysm expansion and reduce the need for elective surgical repair. Objectives To assess the effects of medical treatment on the expansion rate of small abdominal aortic aneurysms. Search methods The Cochrane Peripheral Vascular Diseases Group Trials Search Co‐ordinator searched the Specialised Register (May 2012) and CENTRAL (2012, Issue 5). Clinical trials databases were searched for details of ongoing or unpublished studies. The reference lists of articles retrieved by electronic searches were searched for additional citations. Selection criteria We selected randomised trials in which patients with small AAAs allocated to medical treatment with the intention of retarding aneurysm expansion were compared to patients allocated to a placebo treatment, alternative medical treatment, a different regimen of the same drug or imaging surveillance alone. Data collection and analysis Two authors independently extracted the data and assessed the risk of bias in the trials. Meta‐analyses were used when heterogeneity was considered low. The two primary outcomes were the mean difference (MD) in aneurysm diameter and the odds ratio (OR) calculated to compare the number of individuals referred to AAA surgery in each group over the trial period. Seven trials involving 1558 participants were included in this review; 457 were involved in four trials of antibiotic medication, and 1101 were involved in three trials of beta‐blocker medication. Five of the studies were rated at a high risk of bias. Individually, all of the included trials reported non‐significant differences in AAA expansion rates between their intervention and control groups. The two major drug groups were then analysed separately. For AAA expansion it was only possible to combine two of the antibiotic trials in a meta‐analysis. This demonstrated that roxithromycin had a small but significant protective effect (MD ‐0.86 mm; 95% confidence interval (CI) ‐1.57 to ‐0.14). When referral to AAA surgery was compared (including all four antibiotic trials in the meta‐analysis), non‐significantly fewer patients were referred in the intervention groups (OR 0.96; 95% CI 0.59 to 1.57) than the control groups. When only the trials reporting actual elective surgery were included in a subgroup analysis, the result remained statistically non‐significant (OR 1.17; 95% CI 0.57 to 2.42). For the beta‐blocker trials, when all were combined in a meta‐analysis, there was a very small, non‐significant protective effect for propranolol on AAA expansion (MD ‐0.08 mm; 95% CI ‐0.25 to 0.10), and non‐significantly fewer patients were referred to AAA surgery in the propranolol group (OR 0.74; 95% CI 0.52 to 1.05). Bronchospasm and shortness of breath were the main adverse effects from the beta‐blockers. In one trial the adverse effects were reportedly so severe that the trial was stopped early after two years. There is some limited evidence that antibiotic medication may have a slight protective effect in retarding the expansion rates of small AAAs. The quality of the evidence makes it unclear whether this translates into fewer referrals to AAA surgery, owing mainly to the small sample sizes of the studies. Antibiotics were generally well tolerated with minimal adverse effects. Propranolol was poorly tolerated by patients in all of the beta‐blocker trials and demonstrated only minimal and non‐significant protective effects. Further research on beta‐blockers for AAA needs to consider the use of drugs other than propranolol. In general, there is surprisingly little high quality evidence on medical treatment for small AAAs, especially in relation to the use of newer beta‐blockers, ACE inhibitors and statins. |
t35 | t35_15 | no | The accuracy of the results was limited by the low number of participants (especially important when trying to detect small changes in aneurysm growth rates) and some potentially damaging biases. | Screening for abdominal aortic aneurysm (AAA) in selected groups is now performed in England, the USA and Sweden. Patients with aneurysms over 55 mm in diameter are generally considered for elective surgical repair. Patients with aneurysm diameters below or equal to 55 mm (termed 'small AAAs') are managed with aneurysm surveillance as there is currently insufficient evidence to recommend surgery in these cases. As more patients are screened, there will be an increasing number of small AAAs identified. There is interest in pharmaceutical interventions (for example angiotensin converting enzyme (ACE) inhibitors, antibiotics, beta‐blockers, statins) which could be given to such patients to delay or reverse aneurysm expansion and reduce the need for elective surgical repair. Objectives To assess the effects of medical treatment on the expansion rate of small abdominal aortic aneurysms. Search methods The Cochrane Peripheral Vascular Diseases Group Trials Search Co‐ordinator searched the Specialised Register (May 2012) and CENTRAL (2012, Issue 5). Clinical trials databases were searched for details of ongoing or unpublished studies. The reference lists of articles retrieved by electronic searches were searched for additional citations. Selection criteria We selected randomised trials in which patients with small AAAs allocated to medical treatment with the intention of retarding aneurysm expansion were compared to patients allocated to a placebo treatment, alternative medical treatment, a different regimen of the same drug or imaging surveillance alone. Data collection and analysis Two authors independently extracted the data and assessed the risk of bias in the trials. Meta‐analyses were used when heterogeneity was considered low. The two primary outcomes were the mean difference (MD) in aneurysm diameter and the odds ratio (OR) calculated to compare the number of individuals referred to AAA surgery in each group over the trial period. Seven trials involving 1558 participants were included in this review; 457 were involved in four trials of antibiotic medication, and 1101 were involved in three trials of beta‐blocker medication. Five of the studies were rated at a high risk of bias. Individually, all of the included trials reported non‐significant differences in AAA expansion rates between their intervention and control groups. The two major drug groups were then analysed separately. For AAA expansion it was only possible to combine two of the antibiotic trials in a meta‐analysis. This demonstrated that roxithromycin had a small but significant protective effect (MD ‐0.86 mm; 95% confidence interval (CI) ‐1.57 to ‐0.14). When referral to AAA surgery was compared (including all four antibiotic trials in the meta‐analysis), non‐significantly fewer patients were referred in the intervention groups (OR 0.96; 95% CI 0.59 to 1.57) than the control groups. When only the trials reporting actual elective surgery were included in a subgroup analysis, the result remained statistically non‐significant (OR 1.17; 95% CI 0.57 to 2.42). For the beta‐blocker trials, when all were combined in a meta‐analysis, there was a very small, non‐significant protective effect for propranolol on AAA expansion (MD ‐0.08 mm; 95% CI ‐0.25 to 0.10), and non‐significantly fewer patients were referred to AAA surgery in the propranolol group (OR 0.74; 95% CI 0.52 to 1.05). Bronchospasm and shortness of breath were the main adverse effects from the beta‐blockers. In one trial the adverse effects were reportedly so severe that the trial was stopped early after two years. There is some limited evidence that antibiotic medication may have a slight protective effect in retarding the expansion rates of small AAAs. The quality of the evidence makes it unclear whether this translates into fewer referrals to AAA surgery, owing mainly to the small sample sizes of the studies. Antibiotics were generally well tolerated with minimal adverse effects. Propranolol was poorly tolerated by patients in all of the beta‐blocker trials and demonstrated only minimal and non‐significant protective effects. Further research on beta‐blockers for AAA needs to consider the use of drugs other than propranolol. In general, there is surprisingly little high quality evidence on medical treatment for small AAAs, especially in relation to the use of newer beta‐blockers, ACE inhibitors and statins. |
t36 | t36_1 | yes | Epilepsy is a disorder where recurrent seizures are caused by abnormal electrical discharges in the brain. | Epilepsy is a common neurological condition, with an estimated incidence of 50 per 100,000 persons. People with epilepsy may present with various types of immunological abnormalities, such as low serum immunoglobulin A (IgA) levels, lack of the immunoglobulin G (IgG) subclass and identification of certain types of antibodies. Intravenous immunoglobulin (IVIg) treatment may represent a valuable approach and its efficacy has important implications for epilepsy management. This is an update of a Cochrane review first published in 2011 and last updated in 2017. Objectives To examine the effects of IVIg on the frequency and duration of seizures, quality of life and adverse effects when used as monotherapy or as add‐on treatment for people with epilepsy. Search methods For the latest update, we searched the Cochrane Register of Studies (CRS Web) (20 December 2018), MEDLINE (Ovid, 1946 to 20 December 2018), Web of Science (1898 to 20 December 2018), ISRCTN registry (20 December 2018), WHO International Clinical Trials Registry Platform (ICTRP, 20 December 2018), the US National Institutes of Health ClinicalTrials.gov (20 December 2018), and reference lists of articles. Selection criteria Randomised or quasi‐randomised controlled trials of IVIg as monotherapy or add‐on treatment in people with epilepsy. Data collection and analysis Two review authors independently assessed the trials for inclusion and extracted data. We contacted study authors for additional information. Outcomes included percentage of people rendered seizure‐free, 50% or greater reduction in seizure frequency, adverse effects, treatment withdrawal and quality of life. We included one study (61 participants). The included study was a randomised, double‐blind, placebo‐controlled, multicentre trial which compared the treatment efficacy of IVIg as an add‐on with a placebo add‐on in patients with drug‐resistant epilepsy. Seizure freedom was not reported in the study. There was no significant difference between IVIg and placebo in 50% or greater reduction in seizure frequency (RR 1.89, 95% CI 0.85 to 4.21; one study, 58 participants; low‐certainty evidence). The study reported a statistically significant effect for global assessment in favour of IVIg (RR 3.29, 95% CI 1.13 to 9.57; one study, 60 participants; low‐certainty evidence). No adverse effects were demonstrated. We found no randomised controlled trials that investigated the effects of IVIg monotherapy for epilepsy. Overall, the included study was rated at low to unclear risk of bias. Using GRADE methodology, the certainty of the evidence was rated as low. We cannot draw any reliable conclusions regarding the efficacy of IVIg as a treatment for epilepsy. Further randomised controlled trials are needed. |
t36 | t36_2 | no | People with epilepsy may present with various types of immunological abnormalities. | Epilepsy is a common neurological condition, with an estimated incidence of 50 per 100,000 persons. People with epilepsy may present with various types of immunological abnormalities, such as low serum immunoglobulin A (IgA) levels, lack of the immunoglobulin G (IgG) subclass and identification of certain types of antibodies. Intravenous immunoglobulin (IVIg) treatment may represent a valuable approach and its efficacy has important implications for epilepsy management. This is an update of a Cochrane review first published in 2011 and last updated in 2017. Objectives To examine the effects of IVIg on the frequency and duration of seizures, quality of life and adverse effects when used as monotherapy or as add‐on treatment for people with epilepsy. Search methods For the latest update, we searched the Cochrane Register of Studies (CRS Web) (20 December 2018), MEDLINE (Ovid, 1946 to 20 December 2018), Web of Science (1898 to 20 December 2018), ISRCTN registry (20 December 2018), WHO International Clinical Trials Registry Platform (ICTRP, 20 December 2018), the US National Institutes of Health ClinicalTrials.gov (20 December 2018), and reference lists of articles. Selection criteria Randomised or quasi‐randomised controlled trials of IVIg as monotherapy or add‐on treatment in people with epilepsy. Data collection and analysis Two review authors independently assessed the trials for inclusion and extracted data. We contacted study authors for additional information. Outcomes included percentage of people rendered seizure‐free, 50% or greater reduction in seizure frequency, adverse effects, treatment withdrawal and quality of life. We included one study (61 participants). The included study was a randomised, double‐blind, placebo‐controlled, multicentre trial which compared the treatment efficacy of IVIg as an add‐on with a placebo add‐on in patients with drug‐resistant epilepsy. Seizure freedom was not reported in the study. There was no significant difference between IVIg and placebo in 50% or greater reduction in seizure frequency (RR 1.89, 95% CI 0.85 to 4.21; one study, 58 participants; low‐certainty evidence). The study reported a statistically significant effect for global assessment in favour of IVIg (RR 3.29, 95% CI 1.13 to 9.57; one study, 60 participants; low‐certainty evidence). No adverse effects were demonstrated. We found no randomised controlled trials that investigated the effects of IVIg monotherapy for epilepsy. Overall, the included study was rated at low to unclear risk of bias. Using GRADE methodology, the certainty of the evidence was rated as low. We cannot draw any reliable conclusions regarding the efficacy of IVIg as a treatment for epilepsy. Further randomised controlled trials are needed. |
t36 | t36_3 | yes | Most seizures can be controlled by antiepileptic drugs, but sometimes seizures develop which are resistant to these drugs. | Epilepsy is a common neurological condition, with an estimated incidence of 50 per 100,000 persons. People with epilepsy may present with various types of immunological abnormalities, such as low serum immunoglobulin A (IgA) levels, lack of the immunoglobulin G (IgG) subclass and identification of certain types of antibodies. Intravenous immunoglobulin (IVIg) treatment may represent a valuable approach and its efficacy has important implications for epilepsy management. This is an update of a Cochrane review first published in 2011 and last updated in 2017. Objectives To examine the effects of IVIg on the frequency and duration of seizures, quality of life and adverse effects when used as monotherapy or as add‐on treatment for people with epilepsy. Search methods For the latest update, we searched the Cochrane Register of Studies (CRS Web) (20 December 2018), MEDLINE (Ovid, 1946 to 20 December 2018), Web of Science (1898 to 20 December 2018), ISRCTN registry (20 December 2018), WHO International Clinical Trials Registry Platform (ICTRP, 20 December 2018), the US National Institutes of Health ClinicalTrials.gov (20 December 2018), and reference lists of articles. Selection criteria Randomised or quasi‐randomised controlled trials of IVIg as monotherapy or add‐on treatment in people with epilepsy. Data collection and analysis Two review authors independently assessed the trials for inclusion and extracted data. We contacted study authors for additional information. Outcomes included percentage of people rendered seizure‐free, 50% or greater reduction in seizure frequency, adverse effects, treatment withdrawal and quality of life. We included one study (61 participants). The included study was a randomised, double‐blind, placebo‐controlled, multicentre trial which compared the treatment efficacy of IVIg as an add‐on with a placebo add‐on in patients with drug‐resistant epilepsy. Seizure freedom was not reported in the study. There was no significant difference between IVIg and placebo in 50% or greater reduction in seizure frequency (RR 1.89, 95% CI 0.85 to 4.21; one study, 58 participants; low‐certainty evidence). The study reported a statistically significant effect for global assessment in favour of IVIg (RR 3.29, 95% CI 1.13 to 9.57; one study, 60 participants; low‐certainty evidence). No adverse effects were demonstrated. We found no randomised controlled trials that investigated the effects of IVIg monotherapy for epilepsy. Overall, the included study was rated at low to unclear risk of bias. Using GRADE methodology, the certainty of the evidence was rated as low. We cannot draw any reliable conclusions regarding the efficacy of IVIg as a treatment for epilepsy. Further randomised controlled trials are needed. |
t36 | t36_4 | yes | People may require other types of treatment, such as intravenous immunoglobulins (IVIg). | Epilepsy is a common neurological condition, with an estimated incidence of 50 per 100,000 persons. People with epilepsy may present with various types of immunological abnormalities, such as low serum immunoglobulin A (IgA) levels, lack of the immunoglobulin G (IgG) subclass and identification of certain types of antibodies. Intravenous immunoglobulin (IVIg) treatment may represent a valuable approach and its efficacy has important implications for epilepsy management. This is an update of a Cochrane review first published in 2011 and last updated in 2017. Objectives To examine the effects of IVIg on the frequency and duration of seizures, quality of life and adverse effects when used as monotherapy or as add‐on treatment for people with epilepsy. Search methods For the latest update, we searched the Cochrane Register of Studies (CRS Web) (20 December 2018), MEDLINE (Ovid, 1946 to 20 December 2018), Web of Science (1898 to 20 December 2018), ISRCTN registry (20 December 2018), WHO International Clinical Trials Registry Platform (ICTRP, 20 December 2018), the US National Institutes of Health ClinicalTrials.gov (20 December 2018), and reference lists of articles. Selection criteria Randomised or quasi‐randomised controlled trials of IVIg as monotherapy or add‐on treatment in people with epilepsy. Data collection and analysis Two review authors independently assessed the trials for inclusion and extracted data. We contacted study authors for additional information. Outcomes included percentage of people rendered seizure‐free, 50% or greater reduction in seizure frequency, adverse effects, treatment withdrawal and quality of life. We included one study (61 participants). The included study was a randomised, double‐blind, placebo‐controlled, multicentre trial which compared the treatment efficacy of IVIg as an add‐on with a placebo add‐on in patients with drug‐resistant epilepsy. Seizure freedom was not reported in the study. There was no significant difference between IVIg and placebo in 50% or greater reduction in seizure frequency (RR 1.89, 95% CI 0.85 to 4.21; one study, 58 participants; low‐certainty evidence). The study reported a statistically significant effect for global assessment in favour of IVIg (RR 3.29, 95% CI 1.13 to 9.57; one study, 60 participants; low‐certainty evidence). No adverse effects were demonstrated. We found no randomised controlled trials that investigated the effects of IVIg monotherapy for epilepsy. Overall, the included study was rated at low to unclear risk of bias. Using GRADE methodology, the certainty of the evidence was rated as low. We cannot draw any reliable conclusions regarding the efficacy of IVIg as a treatment for epilepsy. Further randomised controlled trials are needed. |
t36 | t36_5 | yes | IVIg is a sterile, purified blood product extracted from the plasma of blood donors. | Epilepsy is a common neurological condition, with an estimated incidence of 50 per 100,000 persons. People with epilepsy may present with various types of immunological abnormalities, such as low serum immunoglobulin A (IgA) levels, lack of the immunoglobulin G (IgG) subclass and identification of certain types of antibodies. Intravenous immunoglobulin (IVIg) treatment may represent a valuable approach and its efficacy has important implications for epilepsy management. This is an update of a Cochrane review first published in 2011 and last updated in 2017. Objectives To examine the effects of IVIg on the frequency and duration of seizures, quality of life and adverse effects when used as monotherapy or as add‐on treatment for people with epilepsy. Search methods For the latest update, we searched the Cochrane Register of Studies (CRS Web) (20 December 2018), MEDLINE (Ovid, 1946 to 20 December 2018), Web of Science (1898 to 20 December 2018), ISRCTN registry (20 December 2018), WHO International Clinical Trials Registry Platform (ICTRP, 20 December 2018), the US National Institutes of Health ClinicalTrials.gov (20 December 2018), and reference lists of articles. Selection criteria Randomised or quasi‐randomised controlled trials of IVIg as monotherapy or add‐on treatment in people with epilepsy. Data collection and analysis Two review authors independently assessed the trials for inclusion and extracted data. We contacted study authors for additional information. Outcomes included percentage of people rendered seizure‐free, 50% or greater reduction in seizure frequency, adverse effects, treatment withdrawal and quality of life. We included one study (61 participants). The included study was a randomised, double‐blind, placebo‐controlled, multicentre trial which compared the treatment efficacy of IVIg as an add‐on with a placebo add‐on in patients with drug‐resistant epilepsy. Seizure freedom was not reported in the study. There was no significant difference between IVIg and placebo in 50% or greater reduction in seizure frequency (RR 1.89, 95% CI 0.85 to 4.21; one study, 58 participants; low‐certainty evidence). The study reported a statistically significant effect for global assessment in favour of IVIg (RR 3.29, 95% CI 1.13 to 9.57; one study, 60 participants; low‐certainty evidence). No adverse effects were demonstrated. We found no randomised controlled trials that investigated the effects of IVIg monotherapy for epilepsy. Overall, the included study was rated at low to unclear risk of bias. Using GRADE methodology, the certainty of the evidence was rated as low. We cannot draw any reliable conclusions regarding the efficacy of IVIg as a treatment for epilepsy. Further randomised controlled trials are needed. |
t36 | t36_6 | no | IVIg treatment may present a valuable approach and its efficacy has important implications for epilepsy management. | Epilepsy is a common neurological condition, with an estimated incidence of 50 per 100,000 persons. People with epilepsy may present with various types of immunological abnormalities, such as low serum immunoglobulin A (IgA) levels, lack of the immunoglobulin G (IgG) subclass and identification of certain types of antibodies. Intravenous immunoglobulin (IVIg) treatment may represent a valuable approach and its efficacy has important implications for epilepsy management. This is an update of a Cochrane review first published in 2011 and last updated in 2017. Objectives To examine the effects of IVIg on the frequency and duration of seizures, quality of life and adverse effects when used as monotherapy or as add‐on treatment for people with epilepsy. Search methods For the latest update, we searched the Cochrane Register of Studies (CRS Web) (20 December 2018), MEDLINE (Ovid, 1946 to 20 December 2018), Web of Science (1898 to 20 December 2018), ISRCTN registry (20 December 2018), WHO International Clinical Trials Registry Platform (ICTRP, 20 December 2018), the US National Institutes of Health ClinicalTrials.gov (20 December 2018), and reference lists of articles. Selection criteria Randomised or quasi‐randomised controlled trials of IVIg as monotherapy or add‐on treatment in people with epilepsy. Data collection and analysis Two review authors independently assessed the trials for inclusion and extracted data. We contacted study authors for additional information. Outcomes included percentage of people rendered seizure‐free, 50% or greater reduction in seizure frequency, adverse effects, treatment withdrawal and quality of life. We included one study (61 participants). The included study was a randomised, double‐blind, placebo‐controlled, multicentre trial which compared the treatment efficacy of IVIg as an add‐on with a placebo add‐on in patients with drug‐resistant epilepsy. Seizure freedom was not reported in the study. There was no significant difference between IVIg and placebo in 50% or greater reduction in seizure frequency (RR 1.89, 95% CI 0.85 to 4.21; one study, 58 participants; low‐certainty evidence). The study reported a statistically significant effect for global assessment in favour of IVIg (RR 3.29, 95% CI 1.13 to 9.57; one study, 60 participants; low‐certainty evidence). No adverse effects were demonstrated. We found no randomised controlled trials that investigated the effects of IVIg monotherapy for epilepsy. Overall, the included study was rated at low to unclear risk of bias. Using GRADE methodology, the certainty of the evidence was rated as low. We cannot draw any reliable conclusions regarding the efficacy of IVIg as a treatment for epilepsy. Further randomised controlled trials are needed. |
t36 | t36_7 | no | This review assessed the efficacy of IVg as a treatment for the control of epilepsy. | Epilepsy is a common neurological condition, with an estimated incidence of 50 per 100,000 persons. People with epilepsy may present with various types of immunological abnormalities, such as low serum immunoglobulin A (IgA) levels, lack of the immunoglobulin G (IgG) subclass and identification of certain types of antibodies. Intravenous immunoglobulin (IVIg) treatment may represent a valuable approach and its efficacy has important implications for epilepsy management. This is an update of a Cochrane review first published in 2011 and last updated in 2017. Objectives To examine the effects of IVIg on the frequency and duration of seizures, quality of life and adverse effects when used as monotherapy or as add‐on treatment for people with epilepsy. Search methods For the latest update, we searched the Cochrane Register of Studies (CRS Web) (20 December 2018), MEDLINE (Ovid, 1946 to 20 December 2018), Web of Science (1898 to 20 December 2018), ISRCTN registry (20 December 2018), WHO International Clinical Trials Registry Platform (ICTRP, 20 December 2018), the US National Institutes of Health ClinicalTrials.gov (20 December 2018), and reference lists of articles. Selection criteria Randomised or quasi‐randomised controlled trials of IVIg as monotherapy or add‐on treatment in people with epilepsy. Data collection and analysis Two review authors independently assessed the trials for inclusion and extracted data. We contacted study authors for additional information. Outcomes included percentage of people rendered seizure‐free, 50% or greater reduction in seizure frequency, adverse effects, treatment withdrawal and quality of life. We included one study (61 participants). The included study was a randomised, double‐blind, placebo‐controlled, multicentre trial which compared the treatment efficacy of IVIg as an add‐on with a placebo add‐on in patients with drug‐resistant epilepsy. Seizure freedom was not reported in the study. There was no significant difference between IVIg and placebo in 50% or greater reduction in seizure frequency (RR 1.89, 95% CI 0.85 to 4.21; one study, 58 participants; low‐certainty evidence). The study reported a statistically significant effect for global assessment in favour of IVIg (RR 3.29, 95% CI 1.13 to 9.57; one study, 60 participants; low‐certainty evidence). No adverse effects were demonstrated. We found no randomised controlled trials that investigated the effects of IVIg monotherapy for epilepsy. Overall, the included study was rated at low to unclear risk of bias. Using GRADE methodology, the certainty of the evidence was rated as low. We cannot draw any reliable conclusions regarding the efficacy of IVIg as a treatment for epilepsy. Further randomised controlled trials are needed. |
t36 | t36_8 | no | Only one study (61 participants) which compared the treatment efficacy of IVIg as an add‐on with a placebo add‐on in patients with drug‐resistant epilepsy was included. | Epilepsy is a common neurological condition, with an estimated incidence of 50 per 100,000 persons. People with epilepsy may present with various types of immunological abnormalities, such as low serum immunoglobulin A (IgA) levels, lack of the immunoglobulin G (IgG) subclass and identification of certain types of antibodies. Intravenous immunoglobulin (IVIg) treatment may represent a valuable approach and its efficacy has important implications for epilepsy management. This is an update of a Cochrane review first published in 2011 and last updated in 2017. Objectives To examine the effects of IVIg on the frequency and duration of seizures, quality of life and adverse effects when used as monotherapy or as add‐on treatment for people with epilepsy. Search methods For the latest update, we searched the Cochrane Register of Studies (CRS Web) (20 December 2018), MEDLINE (Ovid, 1946 to 20 December 2018), Web of Science (1898 to 20 December 2018), ISRCTN registry (20 December 2018), WHO International Clinical Trials Registry Platform (ICTRP, 20 December 2018), the US National Institutes of Health ClinicalTrials.gov (20 December 2018), and reference lists of articles. Selection criteria Randomised or quasi‐randomised controlled trials of IVIg as monotherapy or add‐on treatment in people with epilepsy. Data collection and analysis Two review authors independently assessed the trials for inclusion and extracted data. We contacted study authors for additional information. Outcomes included percentage of people rendered seizure‐free, 50% or greater reduction in seizure frequency, adverse effects, treatment withdrawal and quality of life. We included one study (61 participants). The included study was a randomised, double‐blind, placebo‐controlled, multicentre trial which compared the treatment efficacy of IVIg as an add‐on with a placebo add‐on in patients with drug‐resistant epilepsy. Seizure freedom was not reported in the study. There was no significant difference between IVIg and placebo in 50% or greater reduction in seizure frequency (RR 1.89, 95% CI 0.85 to 4.21; one study, 58 participants; low‐certainty evidence). The study reported a statistically significant effect for global assessment in favour of IVIg (RR 3.29, 95% CI 1.13 to 9.57; one study, 60 participants; low‐certainty evidence). No adverse effects were demonstrated. We found no randomised controlled trials that investigated the effects of IVIg monotherapy for epilepsy. Overall, the included study was rated at low to unclear risk of bias. Using GRADE methodology, the certainty of the evidence was rated as low. We cannot draw any reliable conclusions regarding the efficacy of IVIg as a treatment for epilepsy. Further randomised controlled trials are needed. |
t36 | t36_9 | no | Results Results of the review suggest that there is no convincing evidence to support the use of IVIg as a treatment for epilepsy and further randomised controlled trials are needed. | Epilepsy is a common neurological condition, with an estimated incidence of 50 per 100,000 persons. People with epilepsy may present with various types of immunological abnormalities, such as low serum immunoglobulin A (IgA) levels, lack of the immunoglobulin G (IgG) subclass and identification of certain types of antibodies. Intravenous immunoglobulin (IVIg) treatment may represent a valuable approach and its efficacy has important implications for epilepsy management. This is an update of a Cochrane review first published in 2011 and last updated in 2017. Objectives To examine the effects of IVIg on the frequency and duration of seizures, quality of life and adverse effects when used as monotherapy or as add‐on treatment for people with epilepsy. Search methods For the latest update, we searched the Cochrane Register of Studies (CRS Web) (20 December 2018), MEDLINE (Ovid, 1946 to 20 December 2018), Web of Science (1898 to 20 December 2018), ISRCTN registry (20 December 2018), WHO International Clinical Trials Registry Platform (ICTRP, 20 December 2018), the US National Institutes of Health ClinicalTrials.gov (20 December 2018), and reference lists of articles. Selection criteria Randomised or quasi‐randomised controlled trials of IVIg as monotherapy or add‐on treatment in people with epilepsy. Data collection and analysis Two review authors independently assessed the trials for inclusion and extracted data. We contacted study authors for additional information. Outcomes included percentage of people rendered seizure‐free, 50% or greater reduction in seizure frequency, adverse effects, treatment withdrawal and quality of life. We included one study (61 participants). The included study was a randomised, double‐blind, placebo‐controlled, multicentre trial which compared the treatment efficacy of IVIg as an add‐on with a placebo add‐on in patients with drug‐resistant epilepsy. Seizure freedom was not reported in the study. There was no significant difference between IVIg and placebo in 50% or greater reduction in seizure frequency (RR 1.89, 95% CI 0.85 to 4.21; one study, 58 participants; low‐certainty evidence). The study reported a statistically significant effect for global assessment in favour of IVIg (RR 3.29, 95% CI 1.13 to 9.57; one study, 60 participants; low‐certainty evidence). No adverse effects were demonstrated. We found no randomised controlled trials that investigated the effects of IVIg monotherapy for epilepsy. Overall, the included study was rated at low to unclear risk of bias. Using GRADE methodology, the certainty of the evidence was rated as low. We cannot draw any reliable conclusions regarding the efficacy of IVIg as a treatment for epilepsy. Further randomised controlled trials are needed. |
t36 | t36_10 | no | Certainty of the evidence The included study was rated at low to unclear risk of bias. | Epilepsy is a common neurological condition, with an estimated incidence of 50 per 100,000 persons. People with epilepsy may present with various types of immunological abnormalities, such as low serum immunoglobulin A (IgA) levels, lack of the immunoglobulin G (IgG) subclass and identification of certain types of antibodies. Intravenous immunoglobulin (IVIg) treatment may represent a valuable approach and its efficacy has important implications for epilepsy management. This is an update of a Cochrane review first published in 2011 and last updated in 2017. Objectives To examine the effects of IVIg on the frequency and duration of seizures, quality of life and adverse effects when used as monotherapy or as add‐on treatment for people with epilepsy. Search methods For the latest update, we searched the Cochrane Register of Studies (CRS Web) (20 December 2018), MEDLINE (Ovid, 1946 to 20 December 2018), Web of Science (1898 to 20 December 2018), ISRCTN registry (20 December 2018), WHO International Clinical Trials Registry Platform (ICTRP, 20 December 2018), the US National Institutes of Health ClinicalTrials.gov (20 December 2018), and reference lists of articles. Selection criteria Randomised or quasi‐randomised controlled trials of IVIg as monotherapy or add‐on treatment in people with epilepsy. Data collection and analysis Two review authors independently assessed the trials for inclusion and extracted data. We contacted study authors for additional information. Outcomes included percentage of people rendered seizure‐free, 50% or greater reduction in seizure frequency, adverse effects, treatment withdrawal and quality of life. We included one study (61 participants). The included study was a randomised, double‐blind, placebo‐controlled, multicentre trial which compared the treatment efficacy of IVIg as an add‐on with a placebo add‐on in patients with drug‐resistant epilepsy. Seizure freedom was not reported in the study. There was no significant difference between IVIg and placebo in 50% or greater reduction in seizure frequency (RR 1.89, 95% CI 0.85 to 4.21; one study, 58 participants; low‐certainty evidence). The study reported a statistically significant effect for global assessment in favour of IVIg (RR 3.29, 95% CI 1.13 to 9.57; one study, 60 participants; low‐certainty evidence). No adverse effects were demonstrated. We found no randomised controlled trials that investigated the effects of IVIg monotherapy for epilepsy. Overall, the included study was rated at low to unclear risk of bias. Using GRADE methodology, the certainty of the evidence was rated as low. We cannot draw any reliable conclusions regarding the efficacy of IVIg as a treatment for epilepsy. Further randomised controlled trials are needed. |
t36 | t36_11 | no | Using GRADE methodology, the certainty of the evidence was rated as low. | Epilepsy is a common neurological condition, with an estimated incidence of 50 per 100,000 persons. People with epilepsy may present with various types of immunological abnormalities, such as low serum immunoglobulin A (IgA) levels, lack of the immunoglobulin G (IgG) subclass and identification of certain types of antibodies. Intravenous immunoglobulin (IVIg) treatment may represent a valuable approach and its efficacy has important implications for epilepsy management. This is an update of a Cochrane review first published in 2011 and last updated in 2017. Objectives To examine the effects of IVIg on the frequency and duration of seizures, quality of life and adverse effects when used as monotherapy or as add‐on treatment for people with epilepsy. Search methods For the latest update, we searched the Cochrane Register of Studies (CRS Web) (20 December 2018), MEDLINE (Ovid, 1946 to 20 December 2018), Web of Science (1898 to 20 December 2018), ISRCTN registry (20 December 2018), WHO International Clinical Trials Registry Platform (ICTRP, 20 December 2018), the US National Institutes of Health ClinicalTrials.gov (20 December 2018), and reference lists of articles. Selection criteria Randomised or quasi‐randomised controlled trials of IVIg as monotherapy or add‐on treatment in people with epilepsy. Data collection and analysis Two review authors independently assessed the trials for inclusion and extracted data. We contacted study authors for additional information. Outcomes included percentage of people rendered seizure‐free, 50% or greater reduction in seizure frequency, adverse effects, treatment withdrawal and quality of life. We included one study (61 participants). The included study was a randomised, double‐blind, placebo‐controlled, multicentre trial which compared the treatment efficacy of IVIg as an add‐on with a placebo add‐on in patients with drug‐resistant epilepsy. Seizure freedom was not reported in the study. There was no significant difference between IVIg and placebo in 50% or greater reduction in seizure frequency (RR 1.89, 95% CI 0.85 to 4.21; one study, 58 participants; low‐certainty evidence). The study reported a statistically significant effect for global assessment in favour of IVIg (RR 3.29, 95% CI 1.13 to 9.57; one study, 60 participants; low‐certainty evidence). No adverse effects were demonstrated. We found no randomised controlled trials that investigated the effects of IVIg monotherapy for epilepsy. Overall, the included study was rated at low to unclear risk of bias. Using GRADE methodology, the certainty of the evidence was rated as low. We cannot draw any reliable conclusions regarding the efficacy of IVIg as a treatment for epilepsy. Further randomised controlled trials are needed. |
t36 | t36_12 | yes | This means that the true effect may be substantially different from what was found. | Epilepsy is a common neurological condition, with an estimated incidence of 50 per 100,000 persons. People with epilepsy may present with various types of immunological abnormalities, such as low serum immunoglobulin A (IgA) levels, lack of the immunoglobulin G (IgG) subclass and identification of certain types of antibodies. Intravenous immunoglobulin (IVIg) treatment may represent a valuable approach and its efficacy has important implications for epilepsy management. This is an update of a Cochrane review first published in 2011 and last updated in 2017. Objectives To examine the effects of IVIg on the frequency and duration of seizures, quality of life and adverse effects when used as monotherapy or as add‐on treatment for people with epilepsy. Search methods For the latest update, we searched the Cochrane Register of Studies (CRS Web) (20 December 2018), MEDLINE (Ovid, 1946 to 20 December 2018), Web of Science (1898 to 20 December 2018), ISRCTN registry (20 December 2018), WHO International Clinical Trials Registry Platform (ICTRP, 20 December 2018), the US National Institutes of Health ClinicalTrials.gov (20 December 2018), and reference lists of articles. Selection criteria Randomised or quasi‐randomised controlled trials of IVIg as monotherapy or add‐on treatment in people with epilepsy. Data collection and analysis Two review authors independently assessed the trials for inclusion and extracted data. We contacted study authors for additional information. Outcomes included percentage of people rendered seizure‐free, 50% or greater reduction in seizure frequency, adverse effects, treatment withdrawal and quality of life. We included one study (61 participants). The included study was a randomised, double‐blind, placebo‐controlled, multicentre trial which compared the treatment efficacy of IVIg as an add‐on with a placebo add‐on in patients with drug‐resistant epilepsy. Seizure freedom was not reported in the study. There was no significant difference between IVIg and placebo in 50% or greater reduction in seizure frequency (RR 1.89, 95% CI 0.85 to 4.21; one study, 58 participants; low‐certainty evidence). The study reported a statistically significant effect for global assessment in favour of IVIg (RR 3.29, 95% CI 1.13 to 9.57; one study, 60 participants; low‐certainty evidence). No adverse effects were demonstrated. We found no randomised controlled trials that investigated the effects of IVIg monotherapy for epilepsy. Overall, the included study was rated at low to unclear risk of bias. Using GRADE methodology, the certainty of the evidence was rated as low. We cannot draw any reliable conclusions regarding the efficacy of IVIg as a treatment for epilepsy. Further randomised controlled trials are needed. |
t37 | t37_1 | no | We reviewed the evidence for treatment with nebulised hypertonic saline compared to placebo or other agents for improving mucus clearance in the lungs of people with cystic fibrosis (CF). | Impaired mucociliary clearance characterises lung disease in cystic fibrosis (CF). Hypertonic saline enhances mucociliary clearance and may lessen the destructive inflammatory process in the airways. This is an update of a previously published review. Objectives To investigate efficacy and tolerability of treatment with nebulised hypertonic saline on people with CF compared to placebo and or other treatments that enhance mucociliary clearance. Search methods We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Cystic Fibrosis Trials Register, comprising references identified from comprehensive electronic database searches, handsearches of relevant journals and abstract books of conference proceedings. We also searched ongoing trials databases. Date of most recent searches: 08 August 2018. Selection criteria Randomised and quasi‐randomised controlled trials assessing hypertonic saline compared to placebo or other mucolytic therapy, for any duration or dose regimen in people with CF (any age or disease severity). Data collection and analysis Two authors independently reviewed all identified trials and data, and assessed trial quality. A total of 17 trials (966 participants, aged 4 months to 63 years) were included; 19 trials were excluded, three trials are ongoing and 16 are awaiting classification. We judged 14 of the 17 included trials to have a high risk of bias due to participants ability to discern the taste of the solutions. Hypertonic saline 3% to 7% versus placebo At four weeks, we found very low‐quality evidence from three placebo‐controlled trials (n = 225) that hypertonic saline (3% to 7%, 10 mL twice‐daily) increased the mean change from baseline of the forced expiratory volume at one second (FEV 1 ) (% predicted) by 3.44% (95% confidence interval (CI) 0.67 to 6.21), but there was no difference between groups in lung clearance index in one small trial (n = 10). By 48 weeks the effect was slightly smaller in one trial (n = 134), 2.31% (95% CI ‐2.72 to 7.34) (low‐quality evidence). No deaths occurred in the trials. Two trials reporting data on exacerbations were not combined as the age difference between the participants in the trials was too great . One trial (162 adults) found 0.5 fewer exacerbations requiring antibiotics per person in the hypertonic saline group; the second trial (243 children, average age of two years) found no difference between groups (low‐quality evidence). There was insufficient evidence reported across the trials to determine the rate of different adverse events such as cough, chest tightness, tonsillitis and vomiting (very low‐quality evidence). Four trials (n = 80) found very low‐quality evidence that sputum clearance was better with hypertonic saline. A further trial was performed in adults with an acute exacerbation of lung disease (n = 132). The effects of hypertonic saline on short‐term lung function, 5.10% higher (14.67% lower to 24.87% higher) and the time to the subsequent exacerbation post‐discharge, hazard ratio 0.86 (95% CI 0.57 to 1.30) are uncertain (low‐quality evidence). No deaths were reported. Cough and wheeze were reported but no serious adverse events (very low‐quality evidence). Hypertonic saline versus mucus mobilising treatments Three trials compared a similar dose of hypertonic saline to recombinant deoxyribonuclease (rhDNase); two (61 participants) provided data for inclusion in the review. There was insufficient evidence from one three‐week trial (14 participants) to determine the effects of hypertonic saline on FEV 1 % predicted, mean difference (MD) 1.60% (95% CI ‐7.96 to 11.16) (very low‐quality evidence). In the second trial, rhDNase led to a greater increase in FEV 1 % predicted than hypertonic saline (5 mL twice daily) at 12 weeks in participants with moderate to severe lung disease, MD 8.00% (95% CI 2.00 to 14.00) (low‐quality evidence). One cross‐over trial (47 participants) reported 15 exacerbations during treatment with hypertonic saline and 18 exacerbations in the rhDNase group (low‐quality evidence). Increased cough was reported in 13 participants using hypertonic saline and 17 on daily rhDNase in one cross‐over trial of 47 people (low‐quality evidence). There was insufficient evidence to assess rates of other adverse events reported. No deaths were reported. One trial (12 participants) compared hypertonic saline to amiloride and one (29 participants) to sodium‐2‐mercaptoethane sulphonate. Neither trial found a difference between treatments in any measures of sputum clearance; additionally the comparison of hypertonic saline and sodium‐2‐mercaptoethane sulphonate reported no differences in courses of antibiotics or adverse events (very low‐quality evidence). One trial (12 participants) compared hypertonic saline to mannitol but did not report lung function at relevant time points for this review; there were no differences in sputum clearance, but mannitol was reported to be more 'irritating' (very low‐quality evidence). Regular use of nebulised hypertonic saline by adults and children over the age of 12 years with CF results in an improvement in lung function after four weeks (very low‐quality evidence from three trials), but this was not sustained at 48 weeks (low‐quality evidence from one trial). The review did show that nebulised hypertonic saline reduced the frequency of pulmonary exacerbations (although we found insufficient evidence for this outcome in children under six years of age) and may have a small effect on improvement in quality of life in adults. Evidence from one small cross‐over trial in children indicates that rhDNase may lead to better lung function at three months; qualifying this we highlight that while the study did demonstrate that the improvement in FEV 1 was greater with daily rHDNase, there were no differences seen in any of the secondary outcomes. Hypertonic saline does appear to be an effective adjunct to physiotherapy during acute exacerbations of lung disease in adults. However, for the outcomes assessed, the quality of the evidence ranged from very low to at best moderate, according to the GRADE criteria. |
t37 | t37_2 | yes | People with CF produce large amounts of thick mucus which is difficult to clear and blocks up their airways. | Impaired mucociliary clearance characterises lung disease in cystic fibrosis (CF). Hypertonic saline enhances mucociliary clearance and may lessen the destructive inflammatory process in the airways. This is an update of a previously published review. Objectives To investigate efficacy and tolerability of treatment with nebulised hypertonic saline on people with CF compared to placebo and or other treatments that enhance mucociliary clearance. Search methods We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Cystic Fibrosis Trials Register, comprising references identified from comprehensive electronic database searches, handsearches of relevant journals and abstract books of conference proceedings. We also searched ongoing trials databases. Date of most recent searches: 08 August 2018. Selection criteria Randomised and quasi‐randomised controlled trials assessing hypertonic saline compared to placebo or other mucolytic therapy, for any duration or dose regimen in people with CF (any age or disease severity). Data collection and analysis Two authors independently reviewed all identified trials and data, and assessed trial quality. A total of 17 trials (966 participants, aged 4 months to 63 years) were included; 19 trials were excluded, three trials are ongoing and 16 are awaiting classification. We judged 14 of the 17 included trials to have a high risk of bias due to participants ability to discern the taste of the solutions. Hypertonic saline 3% to 7% versus placebo At four weeks, we found very low‐quality evidence from three placebo‐controlled trials (n = 225) that hypertonic saline (3% to 7%, 10 mL twice‐daily) increased the mean change from baseline of the forced expiratory volume at one second (FEV 1 ) (% predicted) by 3.44% (95% confidence interval (CI) 0.67 to 6.21), but there was no difference between groups in lung clearance index in one small trial (n = 10). By 48 weeks the effect was slightly smaller in one trial (n = 134), 2.31% (95% CI ‐2.72 to 7.34) (low‐quality evidence). No deaths occurred in the trials. Two trials reporting data on exacerbations were not combined as the age difference between the participants in the trials was too great . One trial (162 adults) found 0.5 fewer exacerbations requiring antibiotics per person in the hypertonic saline group; the second trial (243 children, average age of two years) found no difference between groups (low‐quality evidence). There was insufficient evidence reported across the trials to determine the rate of different adverse events such as cough, chest tightness, tonsillitis and vomiting (very low‐quality evidence). Four trials (n = 80) found very low‐quality evidence that sputum clearance was better with hypertonic saline. A further trial was performed in adults with an acute exacerbation of lung disease (n = 132). The effects of hypertonic saline on short‐term lung function, 5.10% higher (14.67% lower to 24.87% higher) and the time to the subsequent exacerbation post‐discharge, hazard ratio 0.86 (95% CI 0.57 to 1.30) are uncertain (low‐quality evidence). No deaths were reported. Cough and wheeze were reported but no serious adverse events (very low‐quality evidence). Hypertonic saline versus mucus mobilising treatments Three trials compared a similar dose of hypertonic saline to recombinant deoxyribonuclease (rhDNase); two (61 participants) provided data for inclusion in the review. There was insufficient evidence from one three‐week trial (14 participants) to determine the effects of hypertonic saline on FEV 1 % predicted, mean difference (MD) 1.60% (95% CI ‐7.96 to 11.16) (very low‐quality evidence). In the second trial, rhDNase led to a greater increase in FEV 1 % predicted than hypertonic saline (5 mL twice daily) at 12 weeks in participants with moderate to severe lung disease, MD 8.00% (95% CI 2.00 to 14.00) (low‐quality evidence). One cross‐over trial (47 participants) reported 15 exacerbations during treatment with hypertonic saline and 18 exacerbations in the rhDNase group (low‐quality evidence). Increased cough was reported in 13 participants using hypertonic saline and 17 on daily rhDNase in one cross‐over trial of 47 people (low‐quality evidence). There was insufficient evidence to assess rates of other adverse events reported. No deaths were reported. One trial (12 participants) compared hypertonic saline to amiloride and one (29 participants) to sodium‐2‐mercaptoethane sulphonate. Neither trial found a difference between treatments in any measures of sputum clearance; additionally the comparison of hypertonic saline and sodium‐2‐mercaptoethane sulphonate reported no differences in courses of antibiotics or adverse events (very low‐quality evidence). One trial (12 participants) compared hypertonic saline to mannitol but did not report lung function at relevant time points for this review; there were no differences in sputum clearance, but mannitol was reported to be more 'irritating' (very low‐quality evidence). Regular use of nebulised hypertonic saline by adults and children over the age of 12 years with CF results in an improvement in lung function after four weeks (very low‐quality evidence from three trials), but this was not sustained at 48 weeks (low‐quality evidence from one trial). The review did show that nebulised hypertonic saline reduced the frequency of pulmonary exacerbations (although we found insufficient evidence for this outcome in children under six years of age) and may have a small effect on improvement in quality of life in adults. Evidence from one small cross‐over trial in children indicates that rhDNase may lead to better lung function at three months; qualifying this we highlight that while the study did demonstrate that the improvement in FEV 1 was greater with daily rHDNase, there were no differences seen in any of the secondary outcomes. Hypertonic saline does appear to be an effective adjunct to physiotherapy during acute exacerbations of lung disease in adults. However, for the outcomes assessed, the quality of the evidence ranged from very low to at best moderate, according to the GRADE criteria. |
t37 | t37_3 | yes | Chest physiotherapy or medication e.g. hypertonic saline, or both combined, are used to try and clear this mucus from the airways. | Impaired mucociliary clearance characterises lung disease in cystic fibrosis (CF). Hypertonic saline enhances mucociliary clearance and may lessen the destructive inflammatory process in the airways. This is an update of a previously published review. Objectives To investigate efficacy and tolerability of treatment with nebulised hypertonic saline on people with CF compared to placebo and or other treatments that enhance mucociliary clearance. Search methods We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Cystic Fibrosis Trials Register, comprising references identified from comprehensive electronic database searches, handsearches of relevant journals and abstract books of conference proceedings. We also searched ongoing trials databases. Date of most recent searches: 08 August 2018. Selection criteria Randomised and quasi‐randomised controlled trials assessing hypertonic saline compared to placebo or other mucolytic therapy, for any duration or dose regimen in people with CF (any age or disease severity). Data collection and analysis Two authors independently reviewed all identified trials and data, and assessed trial quality. A total of 17 trials (966 participants, aged 4 months to 63 years) were included; 19 trials were excluded, three trials are ongoing and 16 are awaiting classification. We judged 14 of the 17 included trials to have a high risk of bias due to participants ability to discern the taste of the solutions. Hypertonic saline 3% to 7% versus placebo At four weeks, we found very low‐quality evidence from three placebo‐controlled trials (n = 225) that hypertonic saline (3% to 7%, 10 mL twice‐daily) increased the mean change from baseline of the forced expiratory volume at one second (FEV 1 ) (% predicted) by 3.44% (95% confidence interval (CI) 0.67 to 6.21), but there was no difference between groups in lung clearance index in one small trial (n = 10). By 48 weeks the effect was slightly smaller in one trial (n = 134), 2.31% (95% CI ‐2.72 to 7.34) (low‐quality evidence). No deaths occurred in the trials. Two trials reporting data on exacerbations were not combined as the age difference between the participants in the trials was too great . One trial (162 adults) found 0.5 fewer exacerbations requiring antibiotics per person in the hypertonic saline group; the second trial (243 children, average age of two years) found no difference between groups (low‐quality evidence). There was insufficient evidence reported across the trials to determine the rate of different adverse events such as cough, chest tightness, tonsillitis and vomiting (very low‐quality evidence). Four trials (n = 80) found very low‐quality evidence that sputum clearance was better with hypertonic saline. A further trial was performed in adults with an acute exacerbation of lung disease (n = 132). The effects of hypertonic saline on short‐term lung function, 5.10% higher (14.67% lower to 24.87% higher) and the time to the subsequent exacerbation post‐discharge, hazard ratio 0.86 (95% CI 0.57 to 1.30) are uncertain (low‐quality evidence). No deaths were reported. Cough and wheeze were reported but no serious adverse events (very low‐quality evidence). Hypertonic saline versus mucus mobilising treatments Three trials compared a similar dose of hypertonic saline to recombinant deoxyribonuclease (rhDNase); two (61 participants) provided data for inclusion in the review. There was insufficient evidence from one three‐week trial (14 participants) to determine the effects of hypertonic saline on FEV 1 % predicted, mean difference (MD) 1.60% (95% CI ‐7.96 to 11.16) (very low‐quality evidence). In the second trial, rhDNase led to a greater increase in FEV 1 % predicted than hypertonic saline (5 mL twice daily) at 12 weeks in participants with moderate to severe lung disease, MD 8.00% (95% CI 2.00 to 14.00) (low‐quality evidence). One cross‐over trial (47 participants) reported 15 exacerbations during treatment with hypertonic saline and 18 exacerbations in the rhDNase group (low‐quality evidence). Increased cough was reported in 13 participants using hypertonic saline and 17 on daily rhDNase in one cross‐over trial of 47 people (low‐quality evidence). There was insufficient evidence to assess rates of other adverse events reported. No deaths were reported. One trial (12 participants) compared hypertonic saline to amiloride and one (29 participants) to sodium‐2‐mercaptoethane sulphonate. Neither trial found a difference between treatments in any measures of sputum clearance; additionally the comparison of hypertonic saline and sodium‐2‐mercaptoethane sulphonate reported no differences in courses of antibiotics or adverse events (very low‐quality evidence). One trial (12 participants) compared hypertonic saline to mannitol but did not report lung function at relevant time points for this review; there were no differences in sputum clearance, but mannitol was reported to be more 'irritating' (very low‐quality evidence). Regular use of nebulised hypertonic saline by adults and children over the age of 12 years with CF results in an improvement in lung function after four weeks (very low‐quality evidence from three trials), but this was not sustained at 48 weeks (low‐quality evidence from one trial). The review did show that nebulised hypertonic saline reduced the frequency of pulmonary exacerbations (although we found insufficient evidence for this outcome in children under six years of age) and may have a small effect on improvement in quality of life in adults. Evidence from one small cross‐over trial in children indicates that rhDNase may lead to better lung function at three months; qualifying this we highlight that while the study did demonstrate that the improvement in FEV 1 was greater with daily rHDNase, there were no differences seen in any of the secondary outcomes. Hypertonic saline does appear to be an effective adjunct to physiotherapy during acute exacerbations of lung disease in adults. However, for the outcomes assessed, the quality of the evidence ranged from very low to at best moderate, according to the GRADE criteria. |
t37 | t37_4 | yes | Hypertonic saline is water with a concentration of 3% to 7% salt and is inhaled as a fine mist. | Impaired mucociliary clearance characterises lung disease in cystic fibrosis (CF). Hypertonic saline enhances mucociliary clearance and may lessen the destructive inflammatory process in the airways. This is an update of a previously published review. Objectives To investigate efficacy and tolerability of treatment with nebulised hypertonic saline on people with CF compared to placebo and or other treatments that enhance mucociliary clearance. Search methods We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Cystic Fibrosis Trials Register, comprising references identified from comprehensive electronic database searches, handsearches of relevant journals and abstract books of conference proceedings. We also searched ongoing trials databases. Date of most recent searches: 08 August 2018. Selection criteria Randomised and quasi‐randomised controlled trials assessing hypertonic saline compared to placebo or other mucolytic therapy, for any duration or dose regimen in people with CF (any age or disease severity). Data collection and analysis Two authors independently reviewed all identified trials and data, and assessed trial quality. A total of 17 trials (966 participants, aged 4 months to 63 years) were included; 19 trials were excluded, three trials are ongoing and 16 are awaiting classification. We judged 14 of the 17 included trials to have a high risk of bias due to participants ability to discern the taste of the solutions. Hypertonic saline 3% to 7% versus placebo At four weeks, we found very low‐quality evidence from three placebo‐controlled trials (n = 225) that hypertonic saline (3% to 7%, 10 mL twice‐daily) increased the mean change from baseline of the forced expiratory volume at one second (FEV 1 ) (% predicted) by 3.44% (95% confidence interval (CI) 0.67 to 6.21), but there was no difference between groups in lung clearance index in one small trial (n = 10). By 48 weeks the effect was slightly smaller in one trial (n = 134), 2.31% (95% CI ‐2.72 to 7.34) (low‐quality evidence). No deaths occurred in the trials. Two trials reporting data on exacerbations were not combined as the age difference between the participants in the trials was too great . One trial (162 adults) found 0.5 fewer exacerbations requiring antibiotics per person in the hypertonic saline group; the second trial (243 children, average age of two years) found no difference between groups (low‐quality evidence). There was insufficient evidence reported across the trials to determine the rate of different adverse events such as cough, chest tightness, tonsillitis and vomiting (very low‐quality evidence). Four trials (n = 80) found very low‐quality evidence that sputum clearance was better with hypertonic saline. A further trial was performed in adults with an acute exacerbation of lung disease (n = 132). The effects of hypertonic saline on short‐term lung function, 5.10% higher (14.67% lower to 24.87% higher) and the time to the subsequent exacerbation post‐discharge, hazard ratio 0.86 (95% CI 0.57 to 1.30) are uncertain (low‐quality evidence). No deaths were reported. Cough and wheeze were reported but no serious adverse events (very low‐quality evidence). Hypertonic saline versus mucus mobilising treatments Three trials compared a similar dose of hypertonic saline to recombinant deoxyribonuclease (rhDNase); two (61 participants) provided data for inclusion in the review. There was insufficient evidence from one three‐week trial (14 participants) to determine the effects of hypertonic saline on FEV 1 % predicted, mean difference (MD) 1.60% (95% CI ‐7.96 to 11.16) (very low‐quality evidence). In the second trial, rhDNase led to a greater increase in FEV 1 % predicted than hypertonic saline (5 mL twice daily) at 12 weeks in participants with moderate to severe lung disease, MD 8.00% (95% CI 2.00 to 14.00) (low‐quality evidence). One cross‐over trial (47 participants) reported 15 exacerbations during treatment with hypertonic saline and 18 exacerbations in the rhDNase group (low‐quality evidence). Increased cough was reported in 13 participants using hypertonic saline and 17 on daily rhDNase in one cross‐over trial of 47 people (low‐quality evidence). There was insufficient evidence to assess rates of other adverse events reported. No deaths were reported. One trial (12 participants) compared hypertonic saline to amiloride and one (29 participants) to sodium‐2‐mercaptoethane sulphonate. Neither trial found a difference between treatments in any measures of sputum clearance; additionally the comparison of hypertonic saline and sodium‐2‐mercaptoethane sulphonate reported no differences in courses of antibiotics or adverse events (very low‐quality evidence). One trial (12 participants) compared hypertonic saline to mannitol but did not report lung function at relevant time points for this review; there were no differences in sputum clearance, but mannitol was reported to be more 'irritating' (very low‐quality evidence). Regular use of nebulised hypertonic saline by adults and children over the age of 12 years with CF results in an improvement in lung function after four weeks (very low‐quality evidence from three trials), but this was not sustained at 48 weeks (low‐quality evidence from one trial). The review did show that nebulised hypertonic saline reduced the frequency of pulmonary exacerbations (although we found insufficient evidence for this outcome in children under six years of age) and may have a small effect on improvement in quality of life in adults. Evidence from one small cross‐over trial in children indicates that rhDNase may lead to better lung function at three months; qualifying this we highlight that while the study did demonstrate that the improvement in FEV 1 was greater with daily rHDNase, there were no differences seen in any of the secondary outcomes. Hypertonic saline does appear to be an effective adjunct to physiotherapy during acute exacerbations of lung disease in adults. However, for the outcomes assessed, the quality of the evidence ranged from very low to at best moderate, according to the GRADE criteria. |
t37 | t37_5 | no | Trial characteristics We included 17 trials with 966 participants with CF aged between 4 months and 63 years. | Impaired mucociliary clearance characterises lung disease in cystic fibrosis (CF). Hypertonic saline enhances mucociliary clearance and may lessen the destructive inflammatory process in the airways. This is an update of a previously published review. Objectives To investigate efficacy and tolerability of treatment with nebulised hypertonic saline on people with CF compared to placebo and or other treatments that enhance mucociliary clearance. Search methods We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Cystic Fibrosis Trials Register, comprising references identified from comprehensive electronic database searches, handsearches of relevant journals and abstract books of conference proceedings. We also searched ongoing trials databases. Date of most recent searches: 08 August 2018. Selection criteria Randomised and quasi‐randomised controlled trials assessing hypertonic saline compared to placebo or other mucolytic therapy, for any duration or dose regimen in people with CF (any age or disease severity). Data collection and analysis Two authors independently reviewed all identified trials and data, and assessed trial quality. A total of 17 trials (966 participants, aged 4 months to 63 years) were included; 19 trials were excluded, three trials are ongoing and 16 are awaiting classification. We judged 14 of the 17 included trials to have a high risk of bias due to participants ability to discern the taste of the solutions. Hypertonic saline 3% to 7% versus placebo At four weeks, we found very low‐quality evidence from three placebo‐controlled trials (n = 225) that hypertonic saline (3% to 7%, 10 mL twice‐daily) increased the mean change from baseline of the forced expiratory volume at one second (FEV 1 ) (% predicted) by 3.44% (95% confidence interval (CI) 0.67 to 6.21), but there was no difference between groups in lung clearance index in one small trial (n = 10). By 48 weeks the effect was slightly smaller in one trial (n = 134), 2.31% (95% CI ‐2.72 to 7.34) (low‐quality evidence). No deaths occurred in the trials. Two trials reporting data on exacerbations were not combined as the age difference between the participants in the trials was too great . One trial (162 adults) found 0.5 fewer exacerbations requiring antibiotics per person in the hypertonic saline group; the second trial (243 children, average age of two years) found no difference between groups (low‐quality evidence). There was insufficient evidence reported across the trials to determine the rate of different adverse events such as cough, chest tightness, tonsillitis and vomiting (very low‐quality evidence). Four trials (n = 80) found very low‐quality evidence that sputum clearance was better with hypertonic saline. A further trial was performed in adults with an acute exacerbation of lung disease (n = 132). The effects of hypertonic saline on short‐term lung function, 5.10% higher (14.67% lower to 24.87% higher) and the time to the subsequent exacerbation post‐discharge, hazard ratio 0.86 (95% CI 0.57 to 1.30) are uncertain (low‐quality evidence). No deaths were reported. Cough and wheeze were reported but no serious adverse events (very low‐quality evidence). Hypertonic saline versus mucus mobilising treatments Three trials compared a similar dose of hypertonic saline to recombinant deoxyribonuclease (rhDNase); two (61 participants) provided data for inclusion in the review. There was insufficient evidence from one three‐week trial (14 participants) to determine the effects of hypertonic saline on FEV 1 % predicted, mean difference (MD) 1.60% (95% CI ‐7.96 to 11.16) (very low‐quality evidence). In the second trial, rhDNase led to a greater increase in FEV 1 % predicted than hypertonic saline (5 mL twice daily) at 12 weeks in participants with moderate to severe lung disease, MD 8.00% (95% CI 2.00 to 14.00) (low‐quality evidence). One cross‐over trial (47 participants) reported 15 exacerbations during treatment with hypertonic saline and 18 exacerbations in the rhDNase group (low‐quality evidence). Increased cough was reported in 13 participants using hypertonic saline and 17 on daily rhDNase in one cross‐over trial of 47 people (low‐quality evidence). There was insufficient evidence to assess rates of other adverse events reported. No deaths were reported. One trial (12 participants) compared hypertonic saline to amiloride and one (29 participants) to sodium‐2‐mercaptoethane sulphonate. Neither trial found a difference between treatments in any measures of sputum clearance; additionally the comparison of hypertonic saline and sodium‐2‐mercaptoethane sulphonate reported no differences in courses of antibiotics or adverse events (very low‐quality evidence). One trial (12 participants) compared hypertonic saline to mannitol but did not report lung function at relevant time points for this review; there were no differences in sputum clearance, but mannitol was reported to be more 'irritating' (very low‐quality evidence). Regular use of nebulised hypertonic saline by adults and children over the age of 12 years with CF results in an improvement in lung function after four weeks (very low‐quality evidence from three trials), but this was not sustained at 48 weeks (low‐quality evidence from one trial). The review did show that nebulised hypertonic saline reduced the frequency of pulmonary exacerbations (although we found insufficient evidence for this outcome in children under six years of age) and may have a small effect on improvement in quality of life in adults. Evidence from one small cross‐over trial in children indicates that rhDNase may lead to better lung function at three months; qualifying this we highlight that while the study did demonstrate that the improvement in FEV 1 was greater with daily rHDNase, there were no differences seen in any of the secondary outcomes. Hypertonic saline does appear to be an effective adjunct to physiotherapy during acute exacerbations of lung disease in adults. However, for the outcomes assessed, the quality of the evidence ranged from very low to at best moderate, according to the GRADE criteria. |
t37 | t37_6 | yes | Eleven trials compared hypertonic saline to isotonic saline (water with 0.12 to 0.9% salt (described as placebo (a dummy treatment)); one trial compared isotonic saline and voluntary cough to hypertonic saline or mannitol 300 mg; three trials compared hypertonic saline to rhDNase (Pulmozyme®); one trial compared hypertonic saline to amiloride; and one trial compared hypertonic saline to Mistabron®. | Impaired mucociliary clearance characterises lung disease in cystic fibrosis (CF). Hypertonic saline enhances mucociliary clearance and may lessen the destructive inflammatory process in the airways. This is an update of a previously published review. Objectives To investigate efficacy and tolerability of treatment with nebulised hypertonic saline on people with CF compared to placebo and or other treatments that enhance mucociliary clearance. Search methods We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Cystic Fibrosis Trials Register, comprising references identified from comprehensive electronic database searches, handsearches of relevant journals and abstract books of conference proceedings. We also searched ongoing trials databases. Date of most recent searches: 08 August 2018. Selection criteria Randomised and quasi‐randomised controlled trials assessing hypertonic saline compared to placebo or other mucolytic therapy, for any duration or dose regimen in people with CF (any age or disease severity). Data collection and analysis Two authors independently reviewed all identified trials and data, and assessed trial quality. A total of 17 trials (966 participants, aged 4 months to 63 years) were included; 19 trials were excluded, three trials are ongoing and 16 are awaiting classification. We judged 14 of the 17 included trials to have a high risk of bias due to participants ability to discern the taste of the solutions. Hypertonic saline 3% to 7% versus placebo At four weeks, we found very low‐quality evidence from three placebo‐controlled trials (n = 225) that hypertonic saline (3% to 7%, 10 mL twice‐daily) increased the mean change from baseline of the forced expiratory volume at one second (FEV 1 ) (% predicted) by 3.44% (95% confidence interval (CI) 0.67 to 6.21), but there was no difference between groups in lung clearance index in one small trial (n = 10). By 48 weeks the effect was slightly smaller in one trial (n = 134), 2.31% (95% CI ‐2.72 to 7.34) (low‐quality evidence). No deaths occurred in the trials. Two trials reporting data on exacerbations were not combined as the age difference between the participants in the trials was too great . One trial (162 adults) found 0.5 fewer exacerbations requiring antibiotics per person in the hypertonic saline group; the second trial (243 children, average age of two years) found no difference between groups (low‐quality evidence). There was insufficient evidence reported across the trials to determine the rate of different adverse events such as cough, chest tightness, tonsillitis and vomiting (very low‐quality evidence). Four trials (n = 80) found very low‐quality evidence that sputum clearance was better with hypertonic saline. A further trial was performed in adults with an acute exacerbation of lung disease (n = 132). The effects of hypertonic saline on short‐term lung function, 5.10% higher (14.67% lower to 24.87% higher) and the time to the subsequent exacerbation post‐discharge, hazard ratio 0.86 (95% CI 0.57 to 1.30) are uncertain (low‐quality evidence). No deaths were reported. Cough and wheeze were reported but no serious adverse events (very low‐quality evidence). Hypertonic saline versus mucus mobilising treatments Three trials compared a similar dose of hypertonic saline to recombinant deoxyribonuclease (rhDNase); two (61 participants) provided data for inclusion in the review. There was insufficient evidence from one three‐week trial (14 participants) to determine the effects of hypertonic saline on FEV 1 % predicted, mean difference (MD) 1.60% (95% CI ‐7.96 to 11.16) (very low‐quality evidence). In the second trial, rhDNase led to a greater increase in FEV 1 % predicted than hypertonic saline (5 mL twice daily) at 12 weeks in participants with moderate to severe lung disease, MD 8.00% (95% CI 2.00 to 14.00) (low‐quality evidence). One cross‐over trial (47 participants) reported 15 exacerbations during treatment with hypertonic saline and 18 exacerbations in the rhDNase group (low‐quality evidence). Increased cough was reported in 13 participants using hypertonic saline and 17 on daily rhDNase in one cross‐over trial of 47 people (low‐quality evidence). There was insufficient evidence to assess rates of other adverse events reported. No deaths were reported. One trial (12 participants) compared hypertonic saline to amiloride and one (29 participants) to sodium‐2‐mercaptoethane sulphonate. Neither trial found a difference between treatments in any measures of sputum clearance; additionally the comparison of hypertonic saline and sodium‐2‐mercaptoethane sulphonate reported no differences in courses of antibiotics or adverse events (very low‐quality evidence). One trial (12 participants) compared hypertonic saline to mannitol but did not report lung function at relevant time points for this review; there were no differences in sputum clearance, but mannitol was reported to be more 'irritating' (very low‐quality evidence). Regular use of nebulised hypertonic saline by adults and children over the age of 12 years with CF results in an improvement in lung function after four weeks (very low‐quality evidence from three trials), but this was not sustained at 48 weeks (low‐quality evidence from one trial). The review did show that nebulised hypertonic saline reduced the frequency of pulmonary exacerbations (although we found insufficient evidence for this outcome in children under six years of age) and may have a small effect on improvement in quality of life in adults. Evidence from one small cross‐over trial in children indicates that rhDNase may lead to better lung function at three months; qualifying this we highlight that while the study did demonstrate that the improvement in FEV 1 was greater with daily rHDNase, there were no differences seen in any of the secondary outcomes. Hypertonic saline does appear to be an effective adjunct to physiotherapy during acute exacerbations of lung disease in adults. However, for the outcomes assessed, the quality of the evidence ranged from very low to at best moderate, according to the GRADE criteria. |
t37 | t37_7 | yes | Trials assessed different concentrations of hypertonic saline with different nebulisers and different treatment schedules; the most common treatment was twice‐daily 7% hypertonic saline and the most common nebuliser was ultrasonic. | Impaired mucociliary clearance characterises lung disease in cystic fibrosis (CF). Hypertonic saline enhances mucociliary clearance and may lessen the destructive inflammatory process in the airways. This is an update of a previously published review. Objectives To investigate efficacy and tolerability of treatment with nebulised hypertonic saline on people with CF compared to placebo and or other treatments that enhance mucociliary clearance. Search methods We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Cystic Fibrosis Trials Register, comprising references identified from comprehensive electronic database searches, handsearches of relevant journals and abstract books of conference proceedings. We also searched ongoing trials databases. Date of most recent searches: 08 August 2018. Selection criteria Randomised and quasi‐randomised controlled trials assessing hypertonic saline compared to placebo or other mucolytic therapy, for any duration or dose regimen in people with CF (any age or disease severity). Data collection and analysis Two authors independently reviewed all identified trials and data, and assessed trial quality. A total of 17 trials (966 participants, aged 4 months to 63 years) were included; 19 trials were excluded, three trials are ongoing and 16 are awaiting classification. We judged 14 of the 17 included trials to have a high risk of bias due to participants ability to discern the taste of the solutions. Hypertonic saline 3% to 7% versus placebo At four weeks, we found very low‐quality evidence from three placebo‐controlled trials (n = 225) that hypertonic saline (3% to 7%, 10 mL twice‐daily) increased the mean change from baseline of the forced expiratory volume at one second (FEV 1 ) (% predicted) by 3.44% (95% confidence interval (CI) 0.67 to 6.21), but there was no difference between groups in lung clearance index in one small trial (n = 10). By 48 weeks the effect was slightly smaller in one trial (n = 134), 2.31% (95% CI ‐2.72 to 7.34) (low‐quality evidence). No deaths occurred in the trials. Two trials reporting data on exacerbations were not combined as the age difference between the participants in the trials was too great . One trial (162 adults) found 0.5 fewer exacerbations requiring antibiotics per person in the hypertonic saline group; the second trial (243 children, average age of two years) found no difference between groups (low‐quality evidence). There was insufficient evidence reported across the trials to determine the rate of different adverse events such as cough, chest tightness, tonsillitis and vomiting (very low‐quality evidence). Four trials (n = 80) found very low‐quality evidence that sputum clearance was better with hypertonic saline. A further trial was performed in adults with an acute exacerbation of lung disease (n = 132). The effects of hypertonic saline on short‐term lung function, 5.10% higher (14.67% lower to 24.87% higher) and the time to the subsequent exacerbation post‐discharge, hazard ratio 0.86 (95% CI 0.57 to 1.30) are uncertain (low‐quality evidence). No deaths were reported. Cough and wheeze were reported but no serious adverse events (very low‐quality evidence). Hypertonic saline versus mucus mobilising treatments Three trials compared a similar dose of hypertonic saline to recombinant deoxyribonuclease (rhDNase); two (61 participants) provided data for inclusion in the review. There was insufficient evidence from one three‐week trial (14 participants) to determine the effects of hypertonic saline on FEV 1 % predicted, mean difference (MD) 1.60% (95% CI ‐7.96 to 11.16) (very low‐quality evidence). In the second trial, rhDNase led to a greater increase in FEV 1 % predicted than hypertonic saline (5 mL twice daily) at 12 weeks in participants with moderate to severe lung disease, MD 8.00% (95% CI 2.00 to 14.00) (low‐quality evidence). One cross‐over trial (47 participants) reported 15 exacerbations during treatment with hypertonic saline and 18 exacerbations in the rhDNase group (low‐quality evidence). Increased cough was reported in 13 participants using hypertonic saline and 17 on daily rhDNase in one cross‐over trial of 47 people (low‐quality evidence). There was insufficient evidence to assess rates of other adverse events reported. No deaths were reported. One trial (12 participants) compared hypertonic saline to amiloride and one (29 participants) to sodium‐2‐mercaptoethane sulphonate. Neither trial found a difference between treatments in any measures of sputum clearance; additionally the comparison of hypertonic saline and sodium‐2‐mercaptoethane sulphonate reported no differences in courses of antibiotics or adverse events (very low‐quality evidence). One trial (12 participants) compared hypertonic saline to mannitol but did not report lung function at relevant time points for this review; there were no differences in sputum clearance, but mannitol was reported to be more 'irritating' (very low‐quality evidence). Regular use of nebulised hypertonic saline by adults and children over the age of 12 years with CF results in an improvement in lung function after four weeks (very low‐quality evidence from three trials), but this was not sustained at 48 weeks (low‐quality evidence from one trial). The review did show that nebulised hypertonic saline reduced the frequency of pulmonary exacerbations (although we found insufficient evidence for this outcome in children under six years of age) and may have a small effect on improvement in quality of life in adults. Evidence from one small cross‐over trial in children indicates that rhDNase may lead to better lung function at three months; qualifying this we highlight that while the study did demonstrate that the improvement in FEV 1 was greater with daily rHDNase, there were no differences seen in any of the secondary outcomes. Hypertonic saline does appear to be an effective adjunct to physiotherapy during acute exacerbations of lung disease in adults. However, for the outcomes assessed, the quality of the evidence ranged from very low to at best moderate, according to the GRADE criteria. |
t37 | t37_8 | yes | Most trials treated people with a bronchodilator to widen the airways before giving the hypertonic saline. | Impaired mucociliary clearance characterises lung disease in cystic fibrosis (CF). Hypertonic saline enhances mucociliary clearance and may lessen the destructive inflammatory process in the airways. This is an update of a previously published review. Objectives To investigate efficacy and tolerability of treatment with nebulised hypertonic saline on people with CF compared to placebo and or other treatments that enhance mucociliary clearance. Search methods We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Cystic Fibrosis Trials Register, comprising references identified from comprehensive electronic database searches, handsearches of relevant journals and abstract books of conference proceedings. We also searched ongoing trials databases. Date of most recent searches: 08 August 2018. Selection criteria Randomised and quasi‐randomised controlled trials assessing hypertonic saline compared to placebo or other mucolytic therapy, for any duration or dose regimen in people with CF (any age or disease severity). Data collection and analysis Two authors independently reviewed all identified trials and data, and assessed trial quality. A total of 17 trials (966 participants, aged 4 months to 63 years) were included; 19 trials were excluded, three trials are ongoing and 16 are awaiting classification. We judged 14 of the 17 included trials to have a high risk of bias due to participants ability to discern the taste of the solutions. Hypertonic saline 3% to 7% versus placebo At four weeks, we found very low‐quality evidence from three placebo‐controlled trials (n = 225) that hypertonic saline (3% to 7%, 10 mL twice‐daily) increased the mean change from baseline of the forced expiratory volume at one second (FEV 1 ) (% predicted) by 3.44% (95% confidence interval (CI) 0.67 to 6.21), but there was no difference between groups in lung clearance index in one small trial (n = 10). By 48 weeks the effect was slightly smaller in one trial (n = 134), 2.31% (95% CI ‐2.72 to 7.34) (low‐quality evidence). No deaths occurred in the trials. Two trials reporting data on exacerbations were not combined as the age difference between the participants in the trials was too great . One trial (162 adults) found 0.5 fewer exacerbations requiring antibiotics per person in the hypertonic saline group; the second trial (243 children, average age of two years) found no difference between groups (low‐quality evidence). There was insufficient evidence reported across the trials to determine the rate of different adverse events such as cough, chest tightness, tonsillitis and vomiting (very low‐quality evidence). Four trials (n = 80) found very low‐quality evidence that sputum clearance was better with hypertonic saline. A further trial was performed in adults with an acute exacerbation of lung disease (n = 132). The effects of hypertonic saline on short‐term lung function, 5.10% higher (14.67% lower to 24.87% higher) and the time to the subsequent exacerbation post‐discharge, hazard ratio 0.86 (95% CI 0.57 to 1.30) are uncertain (low‐quality evidence). No deaths were reported. Cough and wheeze were reported but no serious adverse events (very low‐quality evidence). Hypertonic saline versus mucus mobilising treatments Three trials compared a similar dose of hypertonic saline to recombinant deoxyribonuclease (rhDNase); two (61 participants) provided data for inclusion in the review. There was insufficient evidence from one three‐week trial (14 participants) to determine the effects of hypertonic saline on FEV 1 % predicted, mean difference (MD) 1.60% (95% CI ‐7.96 to 11.16) (very low‐quality evidence). In the second trial, rhDNase led to a greater increase in FEV 1 % predicted than hypertonic saline (5 mL twice daily) at 12 weeks in participants with moderate to severe lung disease, MD 8.00% (95% CI 2.00 to 14.00) (low‐quality evidence). One cross‐over trial (47 participants) reported 15 exacerbations during treatment with hypertonic saline and 18 exacerbations in the rhDNase group (low‐quality evidence). Increased cough was reported in 13 participants using hypertonic saline and 17 on daily rhDNase in one cross‐over trial of 47 people (low‐quality evidence). There was insufficient evidence to assess rates of other adverse events reported. No deaths were reported. One trial (12 participants) compared hypertonic saline to amiloride and one (29 participants) to sodium‐2‐mercaptoethane sulphonate. Neither trial found a difference between treatments in any measures of sputum clearance; additionally the comparison of hypertonic saline and sodium‐2‐mercaptoethane sulphonate reported no differences in courses of antibiotics or adverse events (very low‐quality evidence). One trial (12 participants) compared hypertonic saline to mannitol but did not report lung function at relevant time points for this review; there were no differences in sputum clearance, but mannitol was reported to be more 'irritating' (very low‐quality evidence). Regular use of nebulised hypertonic saline by adults and children over the age of 12 years with CF results in an improvement in lung function after four weeks (very low‐quality evidence from three trials), but this was not sustained at 48 weeks (low‐quality evidence from one trial). The review did show that nebulised hypertonic saline reduced the frequency of pulmonary exacerbations (although we found insufficient evidence for this outcome in children under six years of age) and may have a small effect on improvement in quality of life in adults. Evidence from one small cross‐over trial in children indicates that rhDNase may lead to better lung function at three months; qualifying this we highlight that while the study did demonstrate that the improvement in FEV 1 was greater with daily rHDNase, there were no differences seen in any of the secondary outcomes. Hypertonic saline does appear to be an effective adjunct to physiotherapy during acute exacerbations of lung disease in adults. However, for the outcomes assessed, the quality of the evidence ranged from very low to at best moderate, according to the GRADE criteria. |
t37 | t37_9 | no | Hypertonic saline 3% to 7% versus placebo In three trials (225 people) lung function improved after four weeks, but only one trial (164 people) reported results after 48 weeks, and showed no difference in lung function. | Impaired mucociliary clearance characterises lung disease in cystic fibrosis (CF). Hypertonic saline enhances mucociliary clearance and may lessen the destructive inflammatory process in the airways. This is an update of a previously published review. Objectives To investigate efficacy and tolerability of treatment with nebulised hypertonic saline on people with CF compared to placebo and or other treatments that enhance mucociliary clearance. Search methods We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Cystic Fibrosis Trials Register, comprising references identified from comprehensive electronic database searches, handsearches of relevant journals and abstract books of conference proceedings. We also searched ongoing trials databases. Date of most recent searches: 08 August 2018. Selection criteria Randomised and quasi‐randomised controlled trials assessing hypertonic saline compared to placebo or other mucolytic therapy, for any duration or dose regimen in people with CF (any age or disease severity). Data collection and analysis Two authors independently reviewed all identified trials and data, and assessed trial quality. A total of 17 trials (966 participants, aged 4 months to 63 years) were included; 19 trials were excluded, three trials are ongoing and 16 are awaiting classification. We judged 14 of the 17 included trials to have a high risk of bias due to participants ability to discern the taste of the solutions. Hypertonic saline 3% to 7% versus placebo At four weeks, we found very low‐quality evidence from three placebo‐controlled trials (n = 225) that hypertonic saline (3% to 7%, 10 mL twice‐daily) increased the mean change from baseline of the forced expiratory volume at one second (FEV 1 ) (% predicted) by 3.44% (95% confidence interval (CI) 0.67 to 6.21), but there was no difference between groups in lung clearance index in one small trial (n = 10). By 48 weeks the effect was slightly smaller in one trial (n = 134), 2.31% (95% CI ‐2.72 to 7.34) (low‐quality evidence). No deaths occurred in the trials. Two trials reporting data on exacerbations were not combined as the age difference between the participants in the trials was too great . One trial (162 adults) found 0.5 fewer exacerbations requiring antibiotics per person in the hypertonic saline group; the second trial (243 children, average age of two years) found no difference between groups (low‐quality evidence). There was insufficient evidence reported across the trials to determine the rate of different adverse events such as cough, chest tightness, tonsillitis and vomiting (very low‐quality evidence). Four trials (n = 80) found very low‐quality evidence that sputum clearance was better with hypertonic saline. A further trial was performed in adults with an acute exacerbation of lung disease (n = 132). The effects of hypertonic saline on short‐term lung function, 5.10% higher (14.67% lower to 24.87% higher) and the time to the subsequent exacerbation post‐discharge, hazard ratio 0.86 (95% CI 0.57 to 1.30) are uncertain (low‐quality evidence). No deaths were reported. Cough and wheeze were reported but no serious adverse events (very low‐quality evidence). Hypertonic saline versus mucus mobilising treatments Three trials compared a similar dose of hypertonic saline to recombinant deoxyribonuclease (rhDNase); two (61 participants) provided data for inclusion in the review. There was insufficient evidence from one three‐week trial (14 participants) to determine the effects of hypertonic saline on FEV 1 % predicted, mean difference (MD) 1.60% (95% CI ‐7.96 to 11.16) (very low‐quality evidence). In the second trial, rhDNase led to a greater increase in FEV 1 % predicted than hypertonic saline (5 mL twice daily) at 12 weeks in participants with moderate to severe lung disease, MD 8.00% (95% CI 2.00 to 14.00) (low‐quality evidence). One cross‐over trial (47 participants) reported 15 exacerbations during treatment with hypertonic saline and 18 exacerbations in the rhDNase group (low‐quality evidence). Increased cough was reported in 13 participants using hypertonic saline and 17 on daily rhDNase in one cross‐over trial of 47 people (low‐quality evidence). There was insufficient evidence to assess rates of other adverse events reported. No deaths were reported. One trial (12 participants) compared hypertonic saline to amiloride and one (29 participants) to sodium‐2‐mercaptoethane sulphonate. Neither trial found a difference between treatments in any measures of sputum clearance; additionally the comparison of hypertonic saline and sodium‐2‐mercaptoethane sulphonate reported no differences in courses of antibiotics or adverse events (very low‐quality evidence). One trial (12 participants) compared hypertonic saline to mannitol but did not report lung function at relevant time points for this review; there were no differences in sputum clearance, but mannitol was reported to be more 'irritating' (very low‐quality evidence). Regular use of nebulised hypertonic saline by adults and children over the age of 12 years with CF results in an improvement in lung function after four weeks (very low‐quality evidence from three trials), but this was not sustained at 48 weeks (low‐quality evidence from one trial). The review did show that nebulised hypertonic saline reduced the frequency of pulmonary exacerbations (although we found insufficient evidence for this outcome in children under six years of age) and may have a small effect on improvement in quality of life in adults. Evidence from one small cross‐over trial in children indicates that rhDNase may lead to better lung function at three months; qualifying this we highlight that while the study did demonstrate that the improvement in FEV 1 was greater with daily rHDNase, there were no differences seen in any of the secondary outcomes. Hypertonic saline does appear to be an effective adjunct to physiotherapy during acute exacerbations of lung disease in adults. However, for the outcomes assessed, the quality of the evidence ranged from very low to at best moderate, according to the GRADE criteria. |
t37 | t37_10 | no | One adult trial reported fewer exacerbations needing antibiotics with hypertonic saline than with placebo, but a trial in children found no difference in this outcome. | Impaired mucociliary clearance characterises lung disease in cystic fibrosis (CF). Hypertonic saline enhances mucociliary clearance and may lessen the destructive inflammatory process in the airways. This is an update of a previously published review. Objectives To investigate efficacy and tolerability of treatment with nebulised hypertonic saline on people with CF compared to placebo and or other treatments that enhance mucociliary clearance. Search methods We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Cystic Fibrosis Trials Register, comprising references identified from comprehensive electronic database searches, handsearches of relevant journals and abstract books of conference proceedings. We also searched ongoing trials databases. Date of most recent searches: 08 August 2018. Selection criteria Randomised and quasi‐randomised controlled trials assessing hypertonic saline compared to placebo or other mucolytic therapy, for any duration or dose regimen in people with CF (any age or disease severity). Data collection and analysis Two authors independently reviewed all identified trials and data, and assessed trial quality. A total of 17 trials (966 participants, aged 4 months to 63 years) were included; 19 trials were excluded, three trials are ongoing and 16 are awaiting classification. We judged 14 of the 17 included trials to have a high risk of bias due to participants ability to discern the taste of the solutions. Hypertonic saline 3% to 7% versus placebo At four weeks, we found very low‐quality evidence from three placebo‐controlled trials (n = 225) that hypertonic saline (3% to 7%, 10 mL twice‐daily) increased the mean change from baseline of the forced expiratory volume at one second (FEV 1 ) (% predicted) by 3.44% (95% confidence interval (CI) 0.67 to 6.21), but there was no difference between groups in lung clearance index in one small trial (n = 10). By 48 weeks the effect was slightly smaller in one trial (n = 134), 2.31% (95% CI ‐2.72 to 7.34) (low‐quality evidence). No deaths occurred in the trials. Two trials reporting data on exacerbations were not combined as the age difference between the participants in the trials was too great . One trial (162 adults) found 0.5 fewer exacerbations requiring antibiotics per person in the hypertonic saline group; the second trial (243 children, average age of two years) found no difference between groups (low‐quality evidence). There was insufficient evidence reported across the trials to determine the rate of different adverse events such as cough, chest tightness, tonsillitis and vomiting (very low‐quality evidence). Four trials (n = 80) found very low‐quality evidence that sputum clearance was better with hypertonic saline. A further trial was performed in adults with an acute exacerbation of lung disease (n = 132). The effects of hypertonic saline on short‐term lung function, 5.10% higher (14.67% lower to 24.87% higher) and the time to the subsequent exacerbation post‐discharge, hazard ratio 0.86 (95% CI 0.57 to 1.30) are uncertain (low‐quality evidence). No deaths were reported. Cough and wheeze were reported but no serious adverse events (very low‐quality evidence). Hypertonic saline versus mucus mobilising treatments Three trials compared a similar dose of hypertonic saline to recombinant deoxyribonuclease (rhDNase); two (61 participants) provided data for inclusion in the review. There was insufficient evidence from one three‐week trial (14 participants) to determine the effects of hypertonic saline on FEV 1 % predicted, mean difference (MD) 1.60% (95% CI ‐7.96 to 11.16) (very low‐quality evidence). In the second trial, rhDNase led to a greater increase in FEV 1 % predicted than hypertonic saline (5 mL twice daily) at 12 weeks in participants with moderate to severe lung disease, MD 8.00% (95% CI 2.00 to 14.00) (low‐quality evidence). One cross‐over trial (47 participants) reported 15 exacerbations during treatment with hypertonic saline and 18 exacerbations in the rhDNase group (low‐quality evidence). Increased cough was reported in 13 participants using hypertonic saline and 17 on daily rhDNase in one cross‐over trial of 47 people (low‐quality evidence). There was insufficient evidence to assess rates of other adverse events reported. No deaths were reported. One trial (12 participants) compared hypertonic saline to amiloride and one (29 participants) to sodium‐2‐mercaptoethane sulphonate. Neither trial found a difference between treatments in any measures of sputum clearance; additionally the comparison of hypertonic saline and sodium‐2‐mercaptoethane sulphonate reported no differences in courses of antibiotics or adverse events (very low‐quality evidence). One trial (12 participants) compared hypertonic saline to mannitol but did not report lung function at relevant time points for this review; there were no differences in sputum clearance, but mannitol was reported to be more 'irritating' (very low‐quality evidence). Regular use of nebulised hypertonic saline by adults and children over the age of 12 years with CF results in an improvement in lung function after four weeks (very low‐quality evidence from three trials), but this was not sustained at 48 weeks (low‐quality evidence from one trial). The review did show that nebulised hypertonic saline reduced the frequency of pulmonary exacerbations (although we found insufficient evidence for this outcome in children under six years of age) and may have a small effect on improvement in quality of life in adults. Evidence from one small cross‐over trial in children indicates that rhDNase may lead to better lung function at three months; qualifying this we highlight that while the study did demonstrate that the improvement in FEV 1 was greater with daily rHDNase, there were no differences seen in any of the secondary outcomes. Hypertonic saline does appear to be an effective adjunct to physiotherapy during acute exacerbations of lung disease in adults. However, for the outcomes assessed, the quality of the evidence ranged from very low to at best moderate, according to the GRADE criteria. |
t37 | t37_11 | no | There was not enough information to properly assess adverse events such as cough, chest tightness, tonsillitis and vomiting. | Impaired mucociliary clearance characterises lung disease in cystic fibrosis (CF). Hypertonic saline enhances mucociliary clearance and may lessen the destructive inflammatory process in the airways. This is an update of a previously published review. Objectives To investigate efficacy and tolerability of treatment with nebulised hypertonic saline on people with CF compared to placebo and or other treatments that enhance mucociliary clearance. Search methods We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Cystic Fibrosis Trials Register, comprising references identified from comprehensive electronic database searches, handsearches of relevant journals and abstract books of conference proceedings. We also searched ongoing trials databases. Date of most recent searches: 08 August 2018. Selection criteria Randomised and quasi‐randomised controlled trials assessing hypertonic saline compared to placebo or other mucolytic therapy, for any duration or dose regimen in people with CF (any age or disease severity). Data collection and analysis Two authors independently reviewed all identified trials and data, and assessed trial quality. A total of 17 trials (966 participants, aged 4 months to 63 years) were included; 19 trials were excluded, three trials are ongoing and 16 are awaiting classification. We judged 14 of the 17 included trials to have a high risk of bias due to participants ability to discern the taste of the solutions. Hypertonic saline 3% to 7% versus placebo At four weeks, we found very low‐quality evidence from three placebo‐controlled trials (n = 225) that hypertonic saline (3% to 7%, 10 mL twice‐daily) increased the mean change from baseline of the forced expiratory volume at one second (FEV 1 ) (% predicted) by 3.44% (95% confidence interval (CI) 0.67 to 6.21), but there was no difference between groups in lung clearance index in one small trial (n = 10). By 48 weeks the effect was slightly smaller in one trial (n = 134), 2.31% (95% CI ‐2.72 to 7.34) (low‐quality evidence). No deaths occurred in the trials. Two trials reporting data on exacerbations were not combined as the age difference between the participants in the trials was too great . One trial (162 adults) found 0.5 fewer exacerbations requiring antibiotics per person in the hypertonic saline group; the second trial (243 children, average age of two years) found no difference between groups (low‐quality evidence). There was insufficient evidence reported across the trials to determine the rate of different adverse events such as cough, chest tightness, tonsillitis and vomiting (very low‐quality evidence). Four trials (n = 80) found very low‐quality evidence that sputum clearance was better with hypertonic saline. A further trial was performed in adults with an acute exacerbation of lung disease (n = 132). The effects of hypertonic saline on short‐term lung function, 5.10% higher (14.67% lower to 24.87% higher) and the time to the subsequent exacerbation post‐discharge, hazard ratio 0.86 (95% CI 0.57 to 1.30) are uncertain (low‐quality evidence). No deaths were reported. Cough and wheeze were reported but no serious adverse events (very low‐quality evidence). Hypertonic saline versus mucus mobilising treatments Three trials compared a similar dose of hypertonic saline to recombinant deoxyribonuclease (rhDNase); two (61 participants) provided data for inclusion in the review. There was insufficient evidence from one three‐week trial (14 participants) to determine the effects of hypertonic saline on FEV 1 % predicted, mean difference (MD) 1.60% (95% CI ‐7.96 to 11.16) (very low‐quality evidence). In the second trial, rhDNase led to a greater increase in FEV 1 % predicted than hypertonic saline (5 mL twice daily) at 12 weeks in participants with moderate to severe lung disease, MD 8.00% (95% CI 2.00 to 14.00) (low‐quality evidence). One cross‐over trial (47 participants) reported 15 exacerbations during treatment with hypertonic saline and 18 exacerbations in the rhDNase group (low‐quality evidence). Increased cough was reported in 13 participants using hypertonic saline and 17 on daily rhDNase in one cross‐over trial of 47 people (low‐quality evidence). There was insufficient evidence to assess rates of other adverse events reported. No deaths were reported. One trial (12 participants) compared hypertonic saline to amiloride and one (29 participants) to sodium‐2‐mercaptoethane sulphonate. Neither trial found a difference between treatments in any measures of sputum clearance; additionally the comparison of hypertonic saline and sodium‐2‐mercaptoethane sulphonate reported no differences in courses of antibiotics or adverse events (very low‐quality evidence). One trial (12 participants) compared hypertonic saline to mannitol but did not report lung function at relevant time points for this review; there were no differences in sputum clearance, but mannitol was reported to be more 'irritating' (very low‐quality evidence). Regular use of nebulised hypertonic saline by adults and children over the age of 12 years with CF results in an improvement in lung function after four weeks (very low‐quality evidence from three trials), but this was not sustained at 48 weeks (low‐quality evidence from one trial). The review did show that nebulised hypertonic saline reduced the frequency of pulmonary exacerbations (although we found insufficient evidence for this outcome in children under six years of age) and may have a small effect on improvement in quality of life in adults. Evidence from one small cross‐over trial in children indicates that rhDNase may lead to better lung function at three months; qualifying this we highlight that while the study did demonstrate that the improvement in FEV 1 was greater with daily rHDNase, there were no differences seen in any of the secondary outcomes. Hypertonic saline does appear to be an effective adjunct to physiotherapy during acute exacerbations of lung disease in adults. However, for the outcomes assessed, the quality of the evidence ranged from very low to at best moderate, according to the GRADE criteria. |
t37 | t37_12 | no | In four trials (80 participants) sputum clearance was better with hypertonic saline. | Impaired mucociliary clearance characterises lung disease in cystic fibrosis (CF). Hypertonic saline enhances mucociliary clearance and may lessen the destructive inflammatory process in the airways. This is an update of a previously published review. Objectives To investigate efficacy and tolerability of treatment with nebulised hypertonic saline on people with CF compared to placebo and or other treatments that enhance mucociliary clearance. Search methods We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Cystic Fibrosis Trials Register, comprising references identified from comprehensive electronic database searches, handsearches of relevant journals and abstract books of conference proceedings. We also searched ongoing trials databases. Date of most recent searches: 08 August 2018. Selection criteria Randomised and quasi‐randomised controlled trials assessing hypertonic saline compared to placebo or other mucolytic therapy, for any duration or dose regimen in people with CF (any age or disease severity). Data collection and analysis Two authors independently reviewed all identified trials and data, and assessed trial quality. A total of 17 trials (966 participants, aged 4 months to 63 years) were included; 19 trials were excluded, three trials are ongoing and 16 are awaiting classification. We judged 14 of the 17 included trials to have a high risk of bias due to participants ability to discern the taste of the solutions. Hypertonic saline 3% to 7% versus placebo At four weeks, we found very low‐quality evidence from three placebo‐controlled trials (n = 225) that hypertonic saline (3% to 7%, 10 mL twice‐daily) increased the mean change from baseline of the forced expiratory volume at one second (FEV 1 ) (% predicted) by 3.44% (95% confidence interval (CI) 0.67 to 6.21), but there was no difference between groups in lung clearance index in one small trial (n = 10). By 48 weeks the effect was slightly smaller in one trial (n = 134), 2.31% (95% CI ‐2.72 to 7.34) (low‐quality evidence). No deaths occurred in the trials. Two trials reporting data on exacerbations were not combined as the age difference between the participants in the trials was too great . One trial (162 adults) found 0.5 fewer exacerbations requiring antibiotics per person in the hypertonic saline group; the second trial (243 children, average age of two years) found no difference between groups (low‐quality evidence). There was insufficient evidence reported across the trials to determine the rate of different adverse events such as cough, chest tightness, tonsillitis and vomiting (very low‐quality evidence). Four trials (n = 80) found very low‐quality evidence that sputum clearance was better with hypertonic saline. A further trial was performed in adults with an acute exacerbation of lung disease (n = 132). The effects of hypertonic saline on short‐term lung function, 5.10% higher (14.67% lower to 24.87% higher) and the time to the subsequent exacerbation post‐discharge, hazard ratio 0.86 (95% CI 0.57 to 1.30) are uncertain (low‐quality evidence). No deaths were reported. Cough and wheeze were reported but no serious adverse events (very low‐quality evidence). Hypertonic saline versus mucus mobilising treatments Three trials compared a similar dose of hypertonic saline to recombinant deoxyribonuclease (rhDNase); two (61 participants) provided data for inclusion in the review. There was insufficient evidence from one three‐week trial (14 participants) to determine the effects of hypertonic saline on FEV 1 % predicted, mean difference (MD) 1.60% (95% CI ‐7.96 to 11.16) (very low‐quality evidence). In the second trial, rhDNase led to a greater increase in FEV 1 % predicted than hypertonic saline (5 mL twice daily) at 12 weeks in participants with moderate to severe lung disease, MD 8.00% (95% CI 2.00 to 14.00) (low‐quality evidence). One cross‐over trial (47 participants) reported 15 exacerbations during treatment with hypertonic saline and 18 exacerbations in the rhDNase group (low‐quality evidence). Increased cough was reported in 13 participants using hypertonic saline and 17 on daily rhDNase in one cross‐over trial of 47 people (low‐quality evidence). There was insufficient evidence to assess rates of other adverse events reported. No deaths were reported. One trial (12 participants) compared hypertonic saline to amiloride and one (29 participants) to sodium‐2‐mercaptoethane sulphonate. Neither trial found a difference between treatments in any measures of sputum clearance; additionally the comparison of hypertonic saline and sodium‐2‐mercaptoethane sulphonate reported no differences in courses of antibiotics or adverse events (very low‐quality evidence). One trial (12 participants) compared hypertonic saline to mannitol but did not report lung function at relevant time points for this review; there were no differences in sputum clearance, but mannitol was reported to be more 'irritating' (very low‐quality evidence). Regular use of nebulised hypertonic saline by adults and children over the age of 12 years with CF results in an improvement in lung function after four weeks (very low‐quality evidence from three trials), but this was not sustained at 48 weeks (low‐quality evidence from one trial). The review did show that nebulised hypertonic saline reduced the frequency of pulmonary exacerbations (although we found insufficient evidence for this outcome in children under six years of age) and may have a small effect on improvement in quality of life in adults. Evidence from one small cross‐over trial in children indicates that rhDNase may lead to better lung function at three months; qualifying this we highlight that while the study did demonstrate that the improvement in FEV 1 was greater with daily rHDNase, there were no differences seen in any of the secondary outcomes. Hypertonic saline does appear to be an effective adjunct to physiotherapy during acute exacerbations of lung disease in adults. However, for the outcomes assessed, the quality of the evidence ranged from very low to at best moderate, according to the GRADE criteria. |
t37 | t37_13 | no | One trial in 132 adults with an exacerbation reported uncertain effects of hypertonic saline on short‐term lung function and the time to the next exacerbation after discharge from hospital. | Impaired mucociliary clearance characterises lung disease in cystic fibrosis (CF). Hypertonic saline enhances mucociliary clearance and may lessen the destructive inflammatory process in the airways. This is an update of a previously published review. Objectives To investigate efficacy and tolerability of treatment with nebulised hypertonic saline on people with CF compared to placebo and or other treatments that enhance mucociliary clearance. Search methods We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Cystic Fibrosis Trials Register, comprising references identified from comprehensive electronic database searches, handsearches of relevant journals and abstract books of conference proceedings. We also searched ongoing trials databases. Date of most recent searches: 08 August 2018. Selection criteria Randomised and quasi‐randomised controlled trials assessing hypertonic saline compared to placebo or other mucolytic therapy, for any duration or dose regimen in people with CF (any age or disease severity). Data collection and analysis Two authors independently reviewed all identified trials and data, and assessed trial quality. A total of 17 trials (966 participants, aged 4 months to 63 years) were included; 19 trials were excluded, three trials are ongoing and 16 are awaiting classification. We judged 14 of the 17 included trials to have a high risk of bias due to participants ability to discern the taste of the solutions. Hypertonic saline 3% to 7% versus placebo At four weeks, we found very low‐quality evidence from three placebo‐controlled trials (n = 225) that hypertonic saline (3% to 7%, 10 mL twice‐daily) increased the mean change from baseline of the forced expiratory volume at one second (FEV 1 ) (% predicted) by 3.44% (95% confidence interval (CI) 0.67 to 6.21), but there was no difference between groups in lung clearance index in one small trial (n = 10). By 48 weeks the effect was slightly smaller in one trial (n = 134), 2.31% (95% CI ‐2.72 to 7.34) (low‐quality evidence). No deaths occurred in the trials. Two trials reporting data on exacerbations were not combined as the age difference between the participants in the trials was too great . One trial (162 adults) found 0.5 fewer exacerbations requiring antibiotics per person in the hypertonic saline group; the second trial (243 children, average age of two years) found no difference between groups (low‐quality evidence). There was insufficient evidence reported across the trials to determine the rate of different adverse events such as cough, chest tightness, tonsillitis and vomiting (very low‐quality evidence). Four trials (n = 80) found very low‐quality evidence that sputum clearance was better with hypertonic saline. A further trial was performed in adults with an acute exacerbation of lung disease (n = 132). The effects of hypertonic saline on short‐term lung function, 5.10% higher (14.67% lower to 24.87% higher) and the time to the subsequent exacerbation post‐discharge, hazard ratio 0.86 (95% CI 0.57 to 1.30) are uncertain (low‐quality evidence). No deaths were reported. Cough and wheeze were reported but no serious adverse events (very low‐quality evidence). Hypertonic saline versus mucus mobilising treatments Three trials compared a similar dose of hypertonic saline to recombinant deoxyribonuclease (rhDNase); two (61 participants) provided data for inclusion in the review. There was insufficient evidence from one three‐week trial (14 participants) to determine the effects of hypertonic saline on FEV 1 % predicted, mean difference (MD) 1.60% (95% CI ‐7.96 to 11.16) (very low‐quality evidence). In the second trial, rhDNase led to a greater increase in FEV 1 % predicted than hypertonic saline (5 mL twice daily) at 12 weeks in participants with moderate to severe lung disease, MD 8.00% (95% CI 2.00 to 14.00) (low‐quality evidence). One cross‐over trial (47 participants) reported 15 exacerbations during treatment with hypertonic saline and 18 exacerbations in the rhDNase group (low‐quality evidence). Increased cough was reported in 13 participants using hypertonic saline and 17 on daily rhDNase in one cross‐over trial of 47 people (low‐quality evidence). There was insufficient evidence to assess rates of other adverse events reported. No deaths were reported. One trial (12 participants) compared hypertonic saline to amiloride and one (29 participants) to sodium‐2‐mercaptoethane sulphonate. Neither trial found a difference between treatments in any measures of sputum clearance; additionally the comparison of hypertonic saline and sodium‐2‐mercaptoethane sulphonate reported no differences in courses of antibiotics or adverse events (very low‐quality evidence). One trial (12 participants) compared hypertonic saline to mannitol but did not report lung function at relevant time points for this review; there were no differences in sputum clearance, but mannitol was reported to be more 'irritating' (very low‐quality evidence). Regular use of nebulised hypertonic saline by adults and children over the age of 12 years with CF results in an improvement in lung function after four weeks (very low‐quality evidence from three trials), but this was not sustained at 48 weeks (low‐quality evidence from one trial). The review did show that nebulised hypertonic saline reduced the frequency of pulmonary exacerbations (although we found insufficient evidence for this outcome in children under six years of age) and may have a small effect on improvement in quality of life in adults. Evidence from one small cross‐over trial in children indicates that rhDNase may lead to better lung function at three months; qualifying this we highlight that while the study did demonstrate that the improvement in FEV 1 was greater with daily rHDNase, there were no differences seen in any of the secondary outcomes. Hypertonic saline does appear to be an effective adjunct to physiotherapy during acute exacerbations of lung disease in adults. However, for the outcomes assessed, the quality of the evidence ranged from very low to at best moderate, according to the GRADE criteria. |
t37 | t37_14 | no | Side effects such as cough and wheeze were reported, but there were no serious side effects. | Impaired mucociliary clearance characterises lung disease in cystic fibrosis (CF). Hypertonic saline enhances mucociliary clearance and may lessen the destructive inflammatory process in the airways. This is an update of a previously published review. Objectives To investigate efficacy and tolerability of treatment with nebulised hypertonic saline on people with CF compared to placebo and or other treatments that enhance mucociliary clearance. Search methods We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Cystic Fibrosis Trials Register, comprising references identified from comprehensive electronic database searches, handsearches of relevant journals and abstract books of conference proceedings. We also searched ongoing trials databases. Date of most recent searches: 08 August 2018. Selection criteria Randomised and quasi‐randomised controlled trials assessing hypertonic saline compared to placebo or other mucolytic therapy, for any duration or dose regimen in people with CF (any age or disease severity). Data collection and analysis Two authors independently reviewed all identified trials and data, and assessed trial quality. A total of 17 trials (966 participants, aged 4 months to 63 years) were included; 19 trials were excluded, three trials are ongoing and 16 are awaiting classification. We judged 14 of the 17 included trials to have a high risk of bias due to participants ability to discern the taste of the solutions. Hypertonic saline 3% to 7% versus placebo At four weeks, we found very low‐quality evidence from three placebo‐controlled trials (n = 225) that hypertonic saline (3% to 7%, 10 mL twice‐daily) increased the mean change from baseline of the forced expiratory volume at one second (FEV 1 ) (% predicted) by 3.44% (95% confidence interval (CI) 0.67 to 6.21), but there was no difference between groups in lung clearance index in one small trial (n = 10). By 48 weeks the effect was slightly smaller in one trial (n = 134), 2.31% (95% CI ‐2.72 to 7.34) (low‐quality evidence). No deaths occurred in the trials. Two trials reporting data on exacerbations were not combined as the age difference between the participants in the trials was too great . One trial (162 adults) found 0.5 fewer exacerbations requiring antibiotics per person in the hypertonic saline group; the second trial (243 children, average age of two years) found no difference between groups (low‐quality evidence). There was insufficient evidence reported across the trials to determine the rate of different adverse events such as cough, chest tightness, tonsillitis and vomiting (very low‐quality evidence). Four trials (n = 80) found very low‐quality evidence that sputum clearance was better with hypertonic saline. A further trial was performed in adults with an acute exacerbation of lung disease (n = 132). The effects of hypertonic saline on short‐term lung function, 5.10% higher (14.67% lower to 24.87% higher) and the time to the subsequent exacerbation post‐discharge, hazard ratio 0.86 (95% CI 0.57 to 1.30) are uncertain (low‐quality evidence). No deaths were reported. Cough and wheeze were reported but no serious adverse events (very low‐quality evidence). Hypertonic saline versus mucus mobilising treatments Three trials compared a similar dose of hypertonic saline to recombinant deoxyribonuclease (rhDNase); two (61 participants) provided data for inclusion in the review. There was insufficient evidence from one three‐week trial (14 participants) to determine the effects of hypertonic saline on FEV 1 % predicted, mean difference (MD) 1.60% (95% CI ‐7.96 to 11.16) (very low‐quality evidence). In the second trial, rhDNase led to a greater increase in FEV 1 % predicted than hypertonic saline (5 mL twice daily) at 12 weeks in participants with moderate to severe lung disease, MD 8.00% (95% CI 2.00 to 14.00) (low‐quality evidence). One cross‐over trial (47 participants) reported 15 exacerbations during treatment with hypertonic saline and 18 exacerbations in the rhDNase group (low‐quality evidence). Increased cough was reported in 13 participants using hypertonic saline and 17 on daily rhDNase in one cross‐over trial of 47 people (low‐quality evidence). There was insufficient evidence to assess rates of other adverse events reported. No deaths were reported. One trial (12 participants) compared hypertonic saline to amiloride and one (29 participants) to sodium‐2‐mercaptoethane sulphonate. Neither trial found a difference between treatments in any measures of sputum clearance; additionally the comparison of hypertonic saline and sodium‐2‐mercaptoethane sulphonate reported no differences in courses of antibiotics or adverse events (very low‐quality evidence). One trial (12 participants) compared hypertonic saline to mannitol but did not report lung function at relevant time points for this review; there were no differences in sputum clearance, but mannitol was reported to be more 'irritating' (very low‐quality evidence). Regular use of nebulised hypertonic saline by adults and children over the age of 12 years with CF results in an improvement in lung function after four weeks (very low‐quality evidence from three trials), but this was not sustained at 48 weeks (low‐quality evidence from one trial). The review did show that nebulised hypertonic saline reduced the frequency of pulmonary exacerbations (although we found insufficient evidence for this outcome in children under six years of age) and may have a small effect on improvement in quality of life in adults. Evidence from one small cross‐over trial in children indicates that rhDNase may lead to better lung function at three months; qualifying this we highlight that while the study did demonstrate that the improvement in FEV 1 was greater with daily rHDNase, there were no differences seen in any of the secondary outcomes. Hypertonic saline does appear to be an effective adjunct to physiotherapy during acute exacerbations of lung disease in adults. However, for the outcomes assessed, the quality of the evidence ranged from very low to at best moderate, according to the GRADE criteria. |
t37 | t37_15 | no | Hypertonic saline versus mucus mobilising treatments We could analyse data from two of the three trials comparing hypertonic saline to rhDNase (61 participants). | Impaired mucociliary clearance characterises lung disease in cystic fibrosis (CF). Hypertonic saline enhances mucociliary clearance and may lessen the destructive inflammatory process in the airways. This is an update of a previously published review. Objectives To investigate efficacy and tolerability of treatment with nebulised hypertonic saline on people with CF compared to placebo and or other treatments that enhance mucociliary clearance. Search methods We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Cystic Fibrosis Trials Register, comprising references identified from comprehensive electronic database searches, handsearches of relevant journals and abstract books of conference proceedings. We also searched ongoing trials databases. Date of most recent searches: 08 August 2018. Selection criteria Randomised and quasi‐randomised controlled trials assessing hypertonic saline compared to placebo or other mucolytic therapy, for any duration or dose regimen in people with CF (any age or disease severity). Data collection and analysis Two authors independently reviewed all identified trials and data, and assessed trial quality. A total of 17 trials (966 participants, aged 4 months to 63 years) were included; 19 trials were excluded, three trials are ongoing and 16 are awaiting classification. We judged 14 of the 17 included trials to have a high risk of bias due to participants ability to discern the taste of the solutions. Hypertonic saline 3% to 7% versus placebo At four weeks, we found very low‐quality evidence from three placebo‐controlled trials (n = 225) that hypertonic saline (3% to 7%, 10 mL twice‐daily) increased the mean change from baseline of the forced expiratory volume at one second (FEV 1 ) (% predicted) by 3.44% (95% confidence interval (CI) 0.67 to 6.21), but there was no difference between groups in lung clearance index in one small trial (n = 10). By 48 weeks the effect was slightly smaller in one trial (n = 134), 2.31% (95% CI ‐2.72 to 7.34) (low‐quality evidence). No deaths occurred in the trials. Two trials reporting data on exacerbations were not combined as the age difference between the participants in the trials was too great . One trial (162 adults) found 0.5 fewer exacerbations requiring antibiotics per person in the hypertonic saline group; the second trial (243 children, average age of two years) found no difference between groups (low‐quality evidence). There was insufficient evidence reported across the trials to determine the rate of different adverse events such as cough, chest tightness, tonsillitis and vomiting (very low‐quality evidence). Four trials (n = 80) found very low‐quality evidence that sputum clearance was better with hypertonic saline. A further trial was performed in adults with an acute exacerbation of lung disease (n = 132). The effects of hypertonic saline on short‐term lung function, 5.10% higher (14.67% lower to 24.87% higher) and the time to the subsequent exacerbation post‐discharge, hazard ratio 0.86 (95% CI 0.57 to 1.30) are uncertain (low‐quality evidence). No deaths were reported. Cough and wheeze were reported but no serious adverse events (very low‐quality evidence). Hypertonic saline versus mucus mobilising treatments Three trials compared a similar dose of hypertonic saline to recombinant deoxyribonuclease (rhDNase); two (61 participants) provided data for inclusion in the review. There was insufficient evidence from one three‐week trial (14 participants) to determine the effects of hypertonic saline on FEV 1 % predicted, mean difference (MD) 1.60% (95% CI ‐7.96 to 11.16) (very low‐quality evidence). In the second trial, rhDNase led to a greater increase in FEV 1 % predicted than hypertonic saline (5 mL twice daily) at 12 weeks in participants with moderate to severe lung disease, MD 8.00% (95% CI 2.00 to 14.00) (low‐quality evidence). One cross‐over trial (47 participants) reported 15 exacerbations during treatment with hypertonic saline and 18 exacerbations in the rhDNase group (low‐quality evidence). Increased cough was reported in 13 participants using hypertonic saline and 17 on daily rhDNase in one cross‐over trial of 47 people (low‐quality evidence). There was insufficient evidence to assess rates of other adverse events reported. No deaths were reported. One trial (12 participants) compared hypertonic saline to amiloride and one (29 participants) to sodium‐2‐mercaptoethane sulphonate. Neither trial found a difference between treatments in any measures of sputum clearance; additionally the comparison of hypertonic saline and sodium‐2‐mercaptoethane sulphonate reported no differences in courses of antibiotics or adverse events (very low‐quality evidence). One trial (12 participants) compared hypertonic saline to mannitol but did not report lung function at relevant time points for this review; there were no differences in sputum clearance, but mannitol was reported to be more 'irritating' (very low‐quality evidence). Regular use of nebulised hypertonic saline by adults and children over the age of 12 years with CF results in an improvement in lung function after four weeks (very low‐quality evidence from three trials), but this was not sustained at 48 weeks (low‐quality evidence from one trial). The review did show that nebulised hypertonic saline reduced the frequency of pulmonary exacerbations (although we found insufficient evidence for this outcome in children under six years of age) and may have a small effect on improvement in quality of life in adults. Evidence from one small cross‐over trial in children indicates that rhDNase may lead to better lung function at three months; qualifying this we highlight that while the study did demonstrate that the improvement in FEV 1 was greater with daily rHDNase, there were no differences seen in any of the secondary outcomes. Hypertonic saline does appear to be an effective adjunct to physiotherapy during acute exacerbations of lung disease in adults. However, for the outcomes assessed, the quality of the evidence ranged from very low to at best moderate, according to the GRADE criteria. |
t37 | t37_16 | no | In one trial there was no difference in lung function at three weeks, but the second reported rhDNase led to a greater increase in lung function at 12 weeks in people with moderate to severe disease. | Impaired mucociliary clearance characterises lung disease in cystic fibrosis (CF). Hypertonic saline enhances mucociliary clearance and may lessen the destructive inflammatory process in the airways. This is an update of a previously published review. Objectives To investigate efficacy and tolerability of treatment with nebulised hypertonic saline on people with CF compared to placebo and or other treatments that enhance mucociliary clearance. Search methods We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Cystic Fibrosis Trials Register, comprising references identified from comprehensive electronic database searches, handsearches of relevant journals and abstract books of conference proceedings. We also searched ongoing trials databases. Date of most recent searches: 08 August 2018. Selection criteria Randomised and quasi‐randomised controlled trials assessing hypertonic saline compared to placebo or other mucolytic therapy, for any duration or dose regimen in people with CF (any age or disease severity). Data collection and analysis Two authors independently reviewed all identified trials and data, and assessed trial quality. A total of 17 trials (966 participants, aged 4 months to 63 years) were included; 19 trials were excluded, three trials are ongoing and 16 are awaiting classification. We judged 14 of the 17 included trials to have a high risk of bias due to participants ability to discern the taste of the solutions. Hypertonic saline 3% to 7% versus placebo At four weeks, we found very low‐quality evidence from three placebo‐controlled trials (n = 225) that hypertonic saline (3% to 7%, 10 mL twice‐daily) increased the mean change from baseline of the forced expiratory volume at one second (FEV 1 ) (% predicted) by 3.44% (95% confidence interval (CI) 0.67 to 6.21), but there was no difference between groups in lung clearance index in one small trial (n = 10). By 48 weeks the effect was slightly smaller in one trial (n = 134), 2.31% (95% CI ‐2.72 to 7.34) (low‐quality evidence). No deaths occurred in the trials. Two trials reporting data on exacerbations were not combined as the age difference between the participants in the trials was too great . One trial (162 adults) found 0.5 fewer exacerbations requiring antibiotics per person in the hypertonic saline group; the second trial (243 children, average age of two years) found no difference between groups (low‐quality evidence). There was insufficient evidence reported across the trials to determine the rate of different adverse events such as cough, chest tightness, tonsillitis and vomiting (very low‐quality evidence). Four trials (n = 80) found very low‐quality evidence that sputum clearance was better with hypertonic saline. A further trial was performed in adults with an acute exacerbation of lung disease (n = 132). The effects of hypertonic saline on short‐term lung function, 5.10% higher (14.67% lower to 24.87% higher) and the time to the subsequent exacerbation post‐discharge, hazard ratio 0.86 (95% CI 0.57 to 1.30) are uncertain (low‐quality evidence). No deaths were reported. Cough and wheeze were reported but no serious adverse events (very low‐quality evidence). Hypertonic saline versus mucus mobilising treatments Three trials compared a similar dose of hypertonic saline to recombinant deoxyribonuclease (rhDNase); two (61 participants) provided data for inclusion in the review. There was insufficient evidence from one three‐week trial (14 participants) to determine the effects of hypertonic saline on FEV 1 % predicted, mean difference (MD) 1.60% (95% CI ‐7.96 to 11.16) (very low‐quality evidence). In the second trial, rhDNase led to a greater increase in FEV 1 % predicted than hypertonic saline (5 mL twice daily) at 12 weeks in participants with moderate to severe lung disease, MD 8.00% (95% CI 2.00 to 14.00) (low‐quality evidence). One cross‐over trial (47 participants) reported 15 exacerbations during treatment with hypertonic saline and 18 exacerbations in the rhDNase group (low‐quality evidence). Increased cough was reported in 13 participants using hypertonic saline and 17 on daily rhDNase in one cross‐over trial of 47 people (low‐quality evidence). There was insufficient evidence to assess rates of other adverse events reported. No deaths were reported. One trial (12 participants) compared hypertonic saline to amiloride and one (29 participants) to sodium‐2‐mercaptoethane sulphonate. Neither trial found a difference between treatments in any measures of sputum clearance; additionally the comparison of hypertonic saline and sodium‐2‐mercaptoethane sulphonate reported no differences in courses of antibiotics or adverse events (very low‐quality evidence). One trial (12 participants) compared hypertonic saline to mannitol but did not report lung function at relevant time points for this review; there were no differences in sputum clearance, but mannitol was reported to be more 'irritating' (very low‐quality evidence). Regular use of nebulised hypertonic saline by adults and children over the age of 12 years with CF results in an improvement in lung function after four weeks (very low‐quality evidence from three trials), but this was not sustained at 48 weeks (low‐quality evidence from one trial). The review did show that nebulised hypertonic saline reduced the frequency of pulmonary exacerbations (although we found insufficient evidence for this outcome in children under six years of age) and may have a small effect on improvement in quality of life in adults. Evidence from one small cross‐over trial in children indicates that rhDNase may lead to better lung function at three months; qualifying this we highlight that while the study did demonstrate that the improvement in FEV 1 was greater with daily rHDNase, there were no differences seen in any of the secondary outcomes. Hypertonic saline does appear to be an effective adjunct to physiotherapy during acute exacerbations of lung disease in adults. However, for the outcomes assessed, the quality of the evidence ranged from very low to at best moderate, according to the GRADE criteria. |
t37 | t37_17 | no | One trial (47 participants) reported no difference in the number of exacerbations, but there was increased cough with hypertonic saline compared to rhDNase. | Impaired mucociliary clearance characterises lung disease in cystic fibrosis (CF). Hypertonic saline enhances mucociliary clearance and may lessen the destructive inflammatory process in the airways. This is an update of a previously published review. Objectives To investigate efficacy and tolerability of treatment with nebulised hypertonic saline on people with CF compared to placebo and or other treatments that enhance mucociliary clearance. Search methods We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Cystic Fibrosis Trials Register, comprising references identified from comprehensive electronic database searches, handsearches of relevant journals and abstract books of conference proceedings. We also searched ongoing trials databases. Date of most recent searches: 08 August 2018. Selection criteria Randomised and quasi‐randomised controlled trials assessing hypertonic saline compared to placebo or other mucolytic therapy, for any duration or dose regimen in people with CF (any age or disease severity). Data collection and analysis Two authors independently reviewed all identified trials and data, and assessed trial quality. A total of 17 trials (966 participants, aged 4 months to 63 years) were included; 19 trials were excluded, three trials are ongoing and 16 are awaiting classification. We judged 14 of the 17 included trials to have a high risk of bias due to participants ability to discern the taste of the solutions. Hypertonic saline 3% to 7% versus placebo At four weeks, we found very low‐quality evidence from three placebo‐controlled trials (n = 225) that hypertonic saline (3% to 7%, 10 mL twice‐daily) increased the mean change from baseline of the forced expiratory volume at one second (FEV 1 ) (% predicted) by 3.44% (95% confidence interval (CI) 0.67 to 6.21), but there was no difference between groups in lung clearance index in one small trial (n = 10). By 48 weeks the effect was slightly smaller in one trial (n = 134), 2.31% (95% CI ‐2.72 to 7.34) (low‐quality evidence). No deaths occurred in the trials. Two trials reporting data on exacerbations were not combined as the age difference between the participants in the trials was too great . One trial (162 adults) found 0.5 fewer exacerbations requiring antibiotics per person in the hypertonic saline group; the second trial (243 children, average age of two years) found no difference between groups (low‐quality evidence). There was insufficient evidence reported across the trials to determine the rate of different adverse events such as cough, chest tightness, tonsillitis and vomiting (very low‐quality evidence). Four trials (n = 80) found very low‐quality evidence that sputum clearance was better with hypertonic saline. A further trial was performed in adults with an acute exacerbation of lung disease (n = 132). The effects of hypertonic saline on short‐term lung function, 5.10% higher (14.67% lower to 24.87% higher) and the time to the subsequent exacerbation post‐discharge, hazard ratio 0.86 (95% CI 0.57 to 1.30) are uncertain (low‐quality evidence). No deaths were reported. Cough and wheeze were reported but no serious adverse events (very low‐quality evidence). Hypertonic saline versus mucus mobilising treatments Three trials compared a similar dose of hypertonic saline to recombinant deoxyribonuclease (rhDNase); two (61 participants) provided data for inclusion in the review. There was insufficient evidence from one three‐week trial (14 participants) to determine the effects of hypertonic saline on FEV 1 % predicted, mean difference (MD) 1.60% (95% CI ‐7.96 to 11.16) (very low‐quality evidence). In the second trial, rhDNase led to a greater increase in FEV 1 % predicted than hypertonic saline (5 mL twice daily) at 12 weeks in participants with moderate to severe lung disease, MD 8.00% (95% CI 2.00 to 14.00) (low‐quality evidence). One cross‐over trial (47 participants) reported 15 exacerbations during treatment with hypertonic saline and 18 exacerbations in the rhDNase group (low‐quality evidence). Increased cough was reported in 13 participants using hypertonic saline and 17 on daily rhDNase in one cross‐over trial of 47 people (low‐quality evidence). There was insufficient evidence to assess rates of other adverse events reported. No deaths were reported. One trial (12 participants) compared hypertonic saline to amiloride and one (29 participants) to sodium‐2‐mercaptoethane sulphonate. Neither trial found a difference between treatments in any measures of sputum clearance; additionally the comparison of hypertonic saline and sodium‐2‐mercaptoethane sulphonate reported no differences in courses of antibiotics or adverse events (very low‐quality evidence). One trial (12 participants) compared hypertonic saline to mannitol but did not report lung function at relevant time points for this review; there were no differences in sputum clearance, but mannitol was reported to be more 'irritating' (very low‐quality evidence). Regular use of nebulised hypertonic saline by adults and children over the age of 12 years with CF results in an improvement in lung function after four weeks (very low‐quality evidence from three trials), but this was not sustained at 48 weeks (low‐quality evidence from one trial). The review did show that nebulised hypertonic saline reduced the frequency of pulmonary exacerbations (although we found insufficient evidence for this outcome in children under six years of age) and may have a small effect on improvement in quality of life in adults. Evidence from one small cross‐over trial in children indicates that rhDNase may lead to better lung function at three months; qualifying this we highlight that while the study did demonstrate that the improvement in FEV 1 was greater with daily rHDNase, there were no differences seen in any of the secondary outcomes. Hypertonic saline does appear to be an effective adjunct to physiotherapy during acute exacerbations of lung disease in adults. However, for the outcomes assessed, the quality of the evidence ranged from very low to at best moderate, according to the GRADE criteria. |
t37 | t37_18 | no | There was not enough information to assess other side effects. | Impaired mucociliary clearance characterises lung disease in cystic fibrosis (CF). Hypertonic saline enhances mucociliary clearance and may lessen the destructive inflammatory process in the airways. This is an update of a previously published review. Objectives To investigate efficacy and tolerability of treatment with nebulised hypertonic saline on people with CF compared to placebo and or other treatments that enhance mucociliary clearance. Search methods We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Cystic Fibrosis Trials Register, comprising references identified from comprehensive electronic database searches, handsearches of relevant journals and abstract books of conference proceedings. We also searched ongoing trials databases. Date of most recent searches: 08 August 2018. Selection criteria Randomised and quasi‐randomised controlled trials assessing hypertonic saline compared to placebo or other mucolytic therapy, for any duration or dose regimen in people with CF (any age or disease severity). Data collection and analysis Two authors independently reviewed all identified trials and data, and assessed trial quality. A total of 17 trials (966 participants, aged 4 months to 63 years) were included; 19 trials were excluded, three trials are ongoing and 16 are awaiting classification. We judged 14 of the 17 included trials to have a high risk of bias due to participants ability to discern the taste of the solutions. Hypertonic saline 3% to 7% versus placebo At four weeks, we found very low‐quality evidence from three placebo‐controlled trials (n = 225) that hypertonic saline (3% to 7%, 10 mL twice‐daily) increased the mean change from baseline of the forced expiratory volume at one second (FEV 1 ) (% predicted) by 3.44% (95% confidence interval (CI) 0.67 to 6.21), but there was no difference between groups in lung clearance index in one small trial (n = 10). By 48 weeks the effect was slightly smaller in one trial (n = 134), 2.31% (95% CI ‐2.72 to 7.34) (low‐quality evidence). No deaths occurred in the trials. Two trials reporting data on exacerbations were not combined as the age difference between the participants in the trials was too great . One trial (162 adults) found 0.5 fewer exacerbations requiring antibiotics per person in the hypertonic saline group; the second trial (243 children, average age of two years) found no difference between groups (low‐quality evidence). There was insufficient evidence reported across the trials to determine the rate of different adverse events such as cough, chest tightness, tonsillitis and vomiting (very low‐quality evidence). Four trials (n = 80) found very low‐quality evidence that sputum clearance was better with hypertonic saline. A further trial was performed in adults with an acute exacerbation of lung disease (n = 132). The effects of hypertonic saline on short‐term lung function, 5.10% higher (14.67% lower to 24.87% higher) and the time to the subsequent exacerbation post‐discharge, hazard ratio 0.86 (95% CI 0.57 to 1.30) are uncertain (low‐quality evidence). No deaths were reported. Cough and wheeze were reported but no serious adverse events (very low‐quality evidence). Hypertonic saline versus mucus mobilising treatments Three trials compared a similar dose of hypertonic saline to recombinant deoxyribonuclease (rhDNase); two (61 participants) provided data for inclusion in the review. There was insufficient evidence from one three‐week trial (14 participants) to determine the effects of hypertonic saline on FEV 1 % predicted, mean difference (MD) 1.60% (95% CI ‐7.96 to 11.16) (very low‐quality evidence). In the second trial, rhDNase led to a greater increase in FEV 1 % predicted than hypertonic saline (5 mL twice daily) at 12 weeks in participants with moderate to severe lung disease, MD 8.00% (95% CI 2.00 to 14.00) (low‐quality evidence). One cross‐over trial (47 participants) reported 15 exacerbations during treatment with hypertonic saline and 18 exacerbations in the rhDNase group (low‐quality evidence). Increased cough was reported in 13 participants using hypertonic saline and 17 on daily rhDNase in one cross‐over trial of 47 people (low‐quality evidence). There was insufficient evidence to assess rates of other adverse events reported. No deaths were reported. One trial (12 participants) compared hypertonic saline to amiloride and one (29 participants) to sodium‐2‐mercaptoethane sulphonate. Neither trial found a difference between treatments in any measures of sputum clearance; additionally the comparison of hypertonic saline and sodium‐2‐mercaptoethane sulphonate reported no differences in courses of antibiotics or adverse events (very low‐quality evidence). One trial (12 participants) compared hypertonic saline to mannitol but did not report lung function at relevant time points for this review; there were no differences in sputum clearance, but mannitol was reported to be more 'irritating' (very low‐quality evidence). Regular use of nebulised hypertonic saline by adults and children over the age of 12 years with CF results in an improvement in lung function after four weeks (very low‐quality evidence from three trials), but this was not sustained at 48 weeks (low‐quality evidence from one trial). The review did show that nebulised hypertonic saline reduced the frequency of pulmonary exacerbations (although we found insufficient evidence for this outcome in children under six years of age) and may have a small effect on improvement in quality of life in adults. Evidence from one small cross‐over trial in children indicates that rhDNase may lead to better lung function at three months; qualifying this we highlight that while the study did demonstrate that the improvement in FEV 1 was greater with daily rHDNase, there were no differences seen in any of the secondary outcomes. Hypertonic saline does appear to be an effective adjunct to physiotherapy during acute exacerbations of lung disease in adults. However, for the outcomes assessed, the quality of the evidence ranged from very low to at best moderate, according to the GRADE criteria. |
t37 | t37_19 | no | One trial (12 participants) compared hypertonic saline to amiloride and one (n = 29) to Mistabron®. | Impaired mucociliary clearance characterises lung disease in cystic fibrosis (CF). Hypertonic saline enhances mucociliary clearance and may lessen the destructive inflammatory process in the airways. This is an update of a previously published review. Objectives To investigate efficacy and tolerability of treatment with nebulised hypertonic saline on people with CF compared to placebo and or other treatments that enhance mucociliary clearance. Search methods We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Cystic Fibrosis Trials Register, comprising references identified from comprehensive electronic database searches, handsearches of relevant journals and abstract books of conference proceedings. We also searched ongoing trials databases. Date of most recent searches: 08 August 2018. Selection criteria Randomised and quasi‐randomised controlled trials assessing hypertonic saline compared to placebo or other mucolytic therapy, for any duration or dose regimen in people with CF (any age or disease severity). Data collection and analysis Two authors independently reviewed all identified trials and data, and assessed trial quality. A total of 17 trials (966 participants, aged 4 months to 63 years) were included; 19 trials were excluded, three trials are ongoing and 16 are awaiting classification. We judged 14 of the 17 included trials to have a high risk of bias due to participants ability to discern the taste of the solutions. Hypertonic saline 3% to 7% versus placebo At four weeks, we found very low‐quality evidence from three placebo‐controlled trials (n = 225) that hypertonic saline (3% to 7%, 10 mL twice‐daily) increased the mean change from baseline of the forced expiratory volume at one second (FEV 1 ) (% predicted) by 3.44% (95% confidence interval (CI) 0.67 to 6.21), but there was no difference between groups in lung clearance index in one small trial (n = 10). By 48 weeks the effect was slightly smaller in one trial (n = 134), 2.31% (95% CI ‐2.72 to 7.34) (low‐quality evidence). No deaths occurred in the trials. Two trials reporting data on exacerbations were not combined as the age difference between the participants in the trials was too great . One trial (162 adults) found 0.5 fewer exacerbations requiring antibiotics per person in the hypertonic saline group; the second trial (243 children, average age of two years) found no difference between groups (low‐quality evidence). There was insufficient evidence reported across the trials to determine the rate of different adverse events such as cough, chest tightness, tonsillitis and vomiting (very low‐quality evidence). Four trials (n = 80) found very low‐quality evidence that sputum clearance was better with hypertonic saline. A further trial was performed in adults with an acute exacerbation of lung disease (n = 132). The effects of hypertonic saline on short‐term lung function, 5.10% higher (14.67% lower to 24.87% higher) and the time to the subsequent exacerbation post‐discharge, hazard ratio 0.86 (95% CI 0.57 to 1.30) are uncertain (low‐quality evidence). No deaths were reported. Cough and wheeze were reported but no serious adverse events (very low‐quality evidence). Hypertonic saline versus mucus mobilising treatments Three trials compared a similar dose of hypertonic saline to recombinant deoxyribonuclease (rhDNase); two (61 participants) provided data for inclusion in the review. There was insufficient evidence from one three‐week trial (14 participants) to determine the effects of hypertonic saline on FEV 1 % predicted, mean difference (MD) 1.60% (95% CI ‐7.96 to 11.16) (very low‐quality evidence). In the second trial, rhDNase led to a greater increase in FEV 1 % predicted than hypertonic saline (5 mL twice daily) at 12 weeks in participants with moderate to severe lung disease, MD 8.00% (95% CI 2.00 to 14.00) (low‐quality evidence). One cross‐over trial (47 participants) reported 15 exacerbations during treatment with hypertonic saline and 18 exacerbations in the rhDNase group (low‐quality evidence). Increased cough was reported in 13 participants using hypertonic saline and 17 on daily rhDNase in one cross‐over trial of 47 people (low‐quality evidence). There was insufficient evidence to assess rates of other adverse events reported. No deaths were reported. One trial (12 participants) compared hypertonic saline to amiloride and one (29 participants) to sodium‐2‐mercaptoethane sulphonate. Neither trial found a difference between treatments in any measures of sputum clearance; additionally the comparison of hypertonic saline and sodium‐2‐mercaptoethane sulphonate reported no differences in courses of antibiotics or adverse events (very low‐quality evidence). One trial (12 participants) compared hypertonic saline to mannitol but did not report lung function at relevant time points for this review; there were no differences in sputum clearance, but mannitol was reported to be more 'irritating' (very low‐quality evidence). Regular use of nebulised hypertonic saline by adults and children over the age of 12 years with CF results in an improvement in lung function after four weeks (very low‐quality evidence from three trials), but this was not sustained at 48 weeks (low‐quality evidence from one trial). The review did show that nebulised hypertonic saline reduced the frequency of pulmonary exacerbations (although we found insufficient evidence for this outcome in children under six years of age) and may have a small effect on improvement in quality of life in adults. Evidence from one small cross‐over trial in children indicates that rhDNase may lead to better lung function at three months; qualifying this we highlight that while the study did demonstrate that the improvement in FEV 1 was greater with daily rHDNase, there were no differences seen in any of the secondary outcomes. Hypertonic saline does appear to be an effective adjunct to physiotherapy during acute exacerbations of lung disease in adults. However, for the outcomes assessed, the quality of the evidence ranged from very low to at best moderate, according to the GRADE criteria. |
t37 | t37_20 | no | Neither trial found a difference between treatments in any measures of sputum clearance. | Impaired mucociliary clearance characterises lung disease in cystic fibrosis (CF). Hypertonic saline enhances mucociliary clearance and may lessen the destructive inflammatory process in the airways. This is an update of a previously published review. Objectives To investigate efficacy and tolerability of treatment with nebulised hypertonic saline on people with CF compared to placebo and or other treatments that enhance mucociliary clearance. Search methods We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Cystic Fibrosis Trials Register, comprising references identified from comprehensive electronic database searches, handsearches of relevant journals and abstract books of conference proceedings. We also searched ongoing trials databases. Date of most recent searches: 08 August 2018. Selection criteria Randomised and quasi‐randomised controlled trials assessing hypertonic saline compared to placebo or other mucolytic therapy, for any duration or dose regimen in people with CF (any age or disease severity). Data collection and analysis Two authors independently reviewed all identified trials and data, and assessed trial quality. A total of 17 trials (966 participants, aged 4 months to 63 years) were included; 19 trials were excluded, three trials are ongoing and 16 are awaiting classification. We judged 14 of the 17 included trials to have a high risk of bias due to participants ability to discern the taste of the solutions. Hypertonic saline 3% to 7% versus placebo At four weeks, we found very low‐quality evidence from three placebo‐controlled trials (n = 225) that hypertonic saline (3% to 7%, 10 mL twice‐daily) increased the mean change from baseline of the forced expiratory volume at one second (FEV 1 ) (% predicted) by 3.44% (95% confidence interval (CI) 0.67 to 6.21), but there was no difference between groups in lung clearance index in one small trial (n = 10). By 48 weeks the effect was slightly smaller in one trial (n = 134), 2.31% (95% CI ‐2.72 to 7.34) (low‐quality evidence). No deaths occurred in the trials. Two trials reporting data on exacerbations were not combined as the age difference between the participants in the trials was too great . One trial (162 adults) found 0.5 fewer exacerbations requiring antibiotics per person in the hypertonic saline group; the second trial (243 children, average age of two years) found no difference between groups (low‐quality evidence). There was insufficient evidence reported across the trials to determine the rate of different adverse events such as cough, chest tightness, tonsillitis and vomiting (very low‐quality evidence). Four trials (n = 80) found very low‐quality evidence that sputum clearance was better with hypertonic saline. A further trial was performed in adults with an acute exacerbation of lung disease (n = 132). The effects of hypertonic saline on short‐term lung function, 5.10% higher (14.67% lower to 24.87% higher) and the time to the subsequent exacerbation post‐discharge, hazard ratio 0.86 (95% CI 0.57 to 1.30) are uncertain (low‐quality evidence). No deaths were reported. Cough and wheeze were reported but no serious adverse events (very low‐quality evidence). Hypertonic saline versus mucus mobilising treatments Three trials compared a similar dose of hypertonic saline to recombinant deoxyribonuclease (rhDNase); two (61 participants) provided data for inclusion in the review. There was insufficient evidence from one three‐week trial (14 participants) to determine the effects of hypertonic saline on FEV 1 % predicted, mean difference (MD) 1.60% (95% CI ‐7.96 to 11.16) (very low‐quality evidence). In the second trial, rhDNase led to a greater increase in FEV 1 % predicted than hypertonic saline (5 mL twice daily) at 12 weeks in participants with moderate to severe lung disease, MD 8.00% (95% CI 2.00 to 14.00) (low‐quality evidence). One cross‐over trial (47 participants) reported 15 exacerbations during treatment with hypertonic saline and 18 exacerbations in the rhDNase group (low‐quality evidence). Increased cough was reported in 13 participants using hypertonic saline and 17 on daily rhDNase in one cross‐over trial of 47 people (low‐quality evidence). There was insufficient evidence to assess rates of other adverse events reported. No deaths were reported. One trial (12 participants) compared hypertonic saline to amiloride and one (29 participants) to sodium‐2‐mercaptoethane sulphonate. Neither trial found a difference between treatments in any measures of sputum clearance; additionally the comparison of hypertonic saline and sodium‐2‐mercaptoethane sulphonate reported no differences in courses of antibiotics or adverse events (very low‐quality evidence). One trial (12 participants) compared hypertonic saline to mannitol but did not report lung function at relevant time points for this review; there were no differences in sputum clearance, but mannitol was reported to be more 'irritating' (very low‐quality evidence). Regular use of nebulised hypertonic saline by adults and children over the age of 12 years with CF results in an improvement in lung function after four weeks (very low‐quality evidence from three trials), but this was not sustained at 48 weeks (low‐quality evidence from one trial). The review did show that nebulised hypertonic saline reduced the frequency of pulmonary exacerbations (although we found insufficient evidence for this outcome in children under six years of age) and may have a small effect on improvement in quality of life in adults. Evidence from one small cross‐over trial in children indicates that rhDNase may lead to better lung function at three months; qualifying this we highlight that while the study did demonstrate that the improvement in FEV 1 was greater with daily rHDNase, there were no differences seen in any of the secondary outcomes. Hypertonic saline does appear to be an effective adjunct to physiotherapy during acute exacerbations of lung disease in adults. However, for the outcomes assessed, the quality of the evidence ranged from very low to at best moderate, according to the GRADE criteria. |
t37 | t37_21 | no | The trial comparing hypertonic saline and Mistabron® also reported no differences in how many antibiotic courses were prescribed or in side effects. | Impaired mucociliary clearance characterises lung disease in cystic fibrosis (CF). Hypertonic saline enhances mucociliary clearance and may lessen the destructive inflammatory process in the airways. This is an update of a previously published review. Objectives To investigate efficacy and tolerability of treatment with nebulised hypertonic saline on people with CF compared to placebo and or other treatments that enhance mucociliary clearance. Search methods We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Cystic Fibrosis Trials Register, comprising references identified from comprehensive electronic database searches, handsearches of relevant journals and abstract books of conference proceedings. We also searched ongoing trials databases. Date of most recent searches: 08 August 2018. Selection criteria Randomised and quasi‐randomised controlled trials assessing hypertonic saline compared to placebo or other mucolytic therapy, for any duration or dose regimen in people with CF (any age or disease severity). Data collection and analysis Two authors independently reviewed all identified trials and data, and assessed trial quality. A total of 17 trials (966 participants, aged 4 months to 63 years) were included; 19 trials were excluded, three trials are ongoing and 16 are awaiting classification. We judged 14 of the 17 included trials to have a high risk of bias due to participants ability to discern the taste of the solutions. Hypertonic saline 3% to 7% versus placebo At four weeks, we found very low‐quality evidence from three placebo‐controlled trials (n = 225) that hypertonic saline (3% to 7%, 10 mL twice‐daily) increased the mean change from baseline of the forced expiratory volume at one second (FEV 1 ) (% predicted) by 3.44% (95% confidence interval (CI) 0.67 to 6.21), but there was no difference between groups in lung clearance index in one small trial (n = 10). By 48 weeks the effect was slightly smaller in one trial (n = 134), 2.31% (95% CI ‐2.72 to 7.34) (low‐quality evidence). No deaths occurred in the trials. Two trials reporting data on exacerbations were not combined as the age difference between the participants in the trials was too great . One trial (162 adults) found 0.5 fewer exacerbations requiring antibiotics per person in the hypertonic saline group; the second trial (243 children, average age of two years) found no difference between groups (low‐quality evidence). There was insufficient evidence reported across the trials to determine the rate of different adverse events such as cough, chest tightness, tonsillitis and vomiting (very low‐quality evidence). Four trials (n = 80) found very low‐quality evidence that sputum clearance was better with hypertonic saline. A further trial was performed in adults with an acute exacerbation of lung disease (n = 132). The effects of hypertonic saline on short‐term lung function, 5.10% higher (14.67% lower to 24.87% higher) and the time to the subsequent exacerbation post‐discharge, hazard ratio 0.86 (95% CI 0.57 to 1.30) are uncertain (low‐quality evidence). No deaths were reported. Cough and wheeze were reported but no serious adverse events (very low‐quality evidence). Hypertonic saline versus mucus mobilising treatments Three trials compared a similar dose of hypertonic saline to recombinant deoxyribonuclease (rhDNase); two (61 participants) provided data for inclusion in the review. There was insufficient evidence from one three‐week trial (14 participants) to determine the effects of hypertonic saline on FEV 1 % predicted, mean difference (MD) 1.60% (95% CI ‐7.96 to 11.16) (very low‐quality evidence). In the second trial, rhDNase led to a greater increase in FEV 1 % predicted than hypertonic saline (5 mL twice daily) at 12 weeks in participants with moderate to severe lung disease, MD 8.00% (95% CI 2.00 to 14.00) (low‐quality evidence). One cross‐over trial (47 participants) reported 15 exacerbations during treatment with hypertonic saline and 18 exacerbations in the rhDNase group (low‐quality evidence). Increased cough was reported in 13 participants using hypertonic saline and 17 on daily rhDNase in one cross‐over trial of 47 people (low‐quality evidence). There was insufficient evidence to assess rates of other adverse events reported. No deaths were reported. One trial (12 participants) compared hypertonic saline to amiloride and one (29 participants) to sodium‐2‐mercaptoethane sulphonate. Neither trial found a difference between treatments in any measures of sputum clearance; additionally the comparison of hypertonic saline and sodium‐2‐mercaptoethane sulphonate reported no differences in courses of antibiotics or adverse events (very low‐quality evidence). One trial (12 participants) compared hypertonic saline to mannitol but did not report lung function at relevant time points for this review; there were no differences in sputum clearance, but mannitol was reported to be more 'irritating' (very low‐quality evidence). Regular use of nebulised hypertonic saline by adults and children over the age of 12 years with CF results in an improvement in lung function after four weeks (very low‐quality evidence from three trials), but this was not sustained at 48 weeks (low‐quality evidence from one trial). The review did show that nebulised hypertonic saline reduced the frequency of pulmonary exacerbations (although we found insufficient evidence for this outcome in children under six years of age) and may have a small effect on improvement in quality of life in adults. Evidence from one small cross‐over trial in children indicates that rhDNase may lead to better lung function at three months; qualifying this we highlight that while the study did demonstrate that the improvement in FEV 1 was greater with daily rHDNase, there were no differences seen in any of the secondary outcomes. Hypertonic saline does appear to be an effective adjunct to physiotherapy during acute exacerbations of lung disease in adults. However, for the outcomes assessed, the quality of the evidence ranged from very low to at best moderate, according to the GRADE criteria. |
t37 | t37_22 | no | The trial comparing hypertonic saline to mannitol (12 participants) did not report lung function at relevant time points for this review; there were no differences in sputum clearance, but mannitol was reported to be more 'irritating'. | Impaired mucociliary clearance characterises lung disease in cystic fibrosis (CF). Hypertonic saline enhances mucociliary clearance and may lessen the destructive inflammatory process in the airways. This is an update of a previously published review. Objectives To investigate efficacy and tolerability of treatment with nebulised hypertonic saline on people with CF compared to placebo and or other treatments that enhance mucociliary clearance. Search methods We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Cystic Fibrosis Trials Register, comprising references identified from comprehensive electronic database searches, handsearches of relevant journals and abstract books of conference proceedings. We also searched ongoing trials databases. Date of most recent searches: 08 August 2018. Selection criteria Randomised and quasi‐randomised controlled trials assessing hypertonic saline compared to placebo or other mucolytic therapy, for any duration or dose regimen in people with CF (any age or disease severity). Data collection and analysis Two authors independently reviewed all identified trials and data, and assessed trial quality. A total of 17 trials (966 participants, aged 4 months to 63 years) were included; 19 trials were excluded, three trials are ongoing and 16 are awaiting classification. We judged 14 of the 17 included trials to have a high risk of bias due to participants ability to discern the taste of the solutions. Hypertonic saline 3% to 7% versus placebo At four weeks, we found very low‐quality evidence from three placebo‐controlled trials (n = 225) that hypertonic saline (3% to 7%, 10 mL twice‐daily) increased the mean change from baseline of the forced expiratory volume at one second (FEV 1 ) (% predicted) by 3.44% (95% confidence interval (CI) 0.67 to 6.21), but there was no difference between groups in lung clearance index in one small trial (n = 10). By 48 weeks the effect was slightly smaller in one trial (n = 134), 2.31% (95% CI ‐2.72 to 7.34) (low‐quality evidence). No deaths occurred in the trials. Two trials reporting data on exacerbations were not combined as the age difference between the participants in the trials was too great . One trial (162 adults) found 0.5 fewer exacerbations requiring antibiotics per person in the hypertonic saline group; the second trial (243 children, average age of two years) found no difference between groups (low‐quality evidence). There was insufficient evidence reported across the trials to determine the rate of different adverse events such as cough, chest tightness, tonsillitis and vomiting (very low‐quality evidence). Four trials (n = 80) found very low‐quality evidence that sputum clearance was better with hypertonic saline. A further trial was performed in adults with an acute exacerbation of lung disease (n = 132). The effects of hypertonic saline on short‐term lung function, 5.10% higher (14.67% lower to 24.87% higher) and the time to the subsequent exacerbation post‐discharge, hazard ratio 0.86 (95% CI 0.57 to 1.30) are uncertain (low‐quality evidence). No deaths were reported. Cough and wheeze were reported but no serious adverse events (very low‐quality evidence). Hypertonic saline versus mucus mobilising treatments Three trials compared a similar dose of hypertonic saline to recombinant deoxyribonuclease (rhDNase); two (61 participants) provided data for inclusion in the review. There was insufficient evidence from one three‐week trial (14 participants) to determine the effects of hypertonic saline on FEV 1 % predicted, mean difference (MD) 1.60% (95% CI ‐7.96 to 11.16) (very low‐quality evidence). In the second trial, rhDNase led to a greater increase in FEV 1 % predicted than hypertonic saline (5 mL twice daily) at 12 weeks in participants with moderate to severe lung disease, MD 8.00% (95% CI 2.00 to 14.00) (low‐quality evidence). One cross‐over trial (47 participants) reported 15 exacerbations during treatment with hypertonic saline and 18 exacerbations in the rhDNase group (low‐quality evidence). Increased cough was reported in 13 participants using hypertonic saline and 17 on daily rhDNase in one cross‐over trial of 47 people (low‐quality evidence). There was insufficient evidence to assess rates of other adverse events reported. No deaths were reported. One trial (12 participants) compared hypertonic saline to amiloride and one (29 participants) to sodium‐2‐mercaptoethane sulphonate. Neither trial found a difference between treatments in any measures of sputum clearance; additionally the comparison of hypertonic saline and sodium‐2‐mercaptoethane sulphonate reported no differences in courses of antibiotics or adverse events (very low‐quality evidence). One trial (12 participants) compared hypertonic saline to mannitol but did not report lung function at relevant time points for this review; there were no differences in sputum clearance, but mannitol was reported to be more 'irritating' (very low‐quality evidence). Regular use of nebulised hypertonic saline by adults and children over the age of 12 years with CF results in an improvement in lung function after four weeks (very low‐quality evidence from three trials), but this was not sustained at 48 weeks (low‐quality evidence from one trial). The review did show that nebulised hypertonic saline reduced the frequency of pulmonary exacerbations (although we found insufficient evidence for this outcome in children under six years of age) and may have a small effect on improvement in quality of life in adults. Evidence from one small cross‐over trial in children indicates that rhDNase may lead to better lung function at three months; qualifying this we highlight that while the study did demonstrate that the improvement in FEV 1 was greater with daily rHDNase, there were no differences seen in any of the secondary outcomes. Hypertonic saline does appear to be an effective adjunct to physiotherapy during acute exacerbations of lung disease in adults. However, for the outcomes assessed, the quality of the evidence ranged from very low to at best moderate, according to the GRADE criteria. |
t38 | t38_1 | yes | Deep vein thrombosis (DVT) is a condition in which a blood clot forms in the deep vein of the leg or pelvis. | Deep venous thrombosis (DVT) occurs in approximately one in 1000 adults every year, and has an annual mortality of 14.6%. In particular, iliofemoral DVT can lead to recurrent thrombosis and post‐thrombotic syndrome (PTS), a painful condition which can lead to chronic venous insufficiency, oedema, and ulceration. It causes significant disability, impaired quality of life, and economic burden. Early thrombus removal techniques have been advocated in patients with an iliofemoral DVT in order to improve vein patency, prevent valvular dysfunction, and reduce future complications, such as post‐thrombotic syndrome and venous ulceration. One such technique is pharmacomechanical thrombectomy, a combination of catheter‐based thrombectomy and catheter‐directed thrombolysis. Objectives To assess the effects of pharmacomechanical thrombectomy versus anticoagulation (alone or with compression stockings), mechanical thrombectomy, thrombolysis, or other endovascular techniques in the management of people with acute DVT of the iliofemoral vein. Search methods The Cochrane Vascular Information Specialist searched the Specialised Register (last searched December 2015) and the Cochrane Register of Studies (last searched December 2015). We searched clinical trials databases for details of ongoing or unpublished studies and the reference lists of relevant articles retrieved by electronic searches for additional citations. Selection criteria Randomised controlled trials in which patients with an iliofemoral deep vein thrombosis were allocated to receive pharmacomechanical thrombectomy versus anticoagulation, mechanical thrombectomy, thrombolysis (systemic or catheter directed thrombolysis), or other endovascular techniques for the treatment of iliofemoral DVT. Data collection and analysis At least two review authors independently assessed studies identified for potential inclusion. We found no randomised controlled trials that met the eligibility criteria for this review. We identified one ongoing study. There were no randomised controlled trials that assessed the effects of pharmacomechanical thrombectomy versus anticoagulation (alone or with compression stockings), mechanical thrombectomy, thrombolysis, or other endovascular techniques in the management of people with acute DVT of the iliofemoral vein that met the eligibility criteria for this review. Further high quality randomised controlled trials are needed. |
t38 | t38_2 | no | It affects approximately 1 in 1000 people. | Deep venous thrombosis (DVT) occurs in approximately one in 1000 adults every year, and has an annual mortality of 14.6%. In particular, iliofemoral DVT can lead to recurrent thrombosis and post‐thrombotic syndrome (PTS), a painful condition which can lead to chronic venous insufficiency, oedema, and ulceration. It causes significant disability, impaired quality of life, and economic burden. Early thrombus removal techniques have been advocated in patients with an iliofemoral DVT in order to improve vein patency, prevent valvular dysfunction, and reduce future complications, such as post‐thrombotic syndrome and venous ulceration. One such technique is pharmacomechanical thrombectomy, a combination of catheter‐based thrombectomy and catheter‐directed thrombolysis. Objectives To assess the effects of pharmacomechanical thrombectomy versus anticoagulation (alone or with compression stockings), mechanical thrombectomy, thrombolysis, or other endovascular techniques in the management of people with acute DVT of the iliofemoral vein. Search methods The Cochrane Vascular Information Specialist searched the Specialised Register (last searched December 2015) and the Cochrane Register of Studies (last searched December 2015). We searched clinical trials databases for details of ongoing or unpublished studies and the reference lists of relevant articles retrieved by electronic searches for additional citations. Selection criteria Randomised controlled trials in which patients with an iliofemoral deep vein thrombosis were allocated to receive pharmacomechanical thrombectomy versus anticoagulation, mechanical thrombectomy, thrombolysis (systemic or catheter directed thrombolysis), or other endovascular techniques for the treatment of iliofemoral DVT. Data collection and analysis At least two review authors independently assessed studies identified for potential inclusion. We found no randomised controlled trials that met the eligibility criteria for this review. We identified one ongoing study. There were no randomised controlled trials that assessed the effects of pharmacomechanical thrombectomy versus anticoagulation (alone or with compression stockings), mechanical thrombectomy, thrombolysis, or other endovascular techniques in the management of people with acute DVT of the iliofemoral vein that met the eligibility criteria for this review. Further high quality randomised controlled trials are needed. |
t38 | t38_3 | yes | If it is not treated, the clot can travel in the blood, and block the arteries in the lungs. | Deep venous thrombosis (DVT) occurs in approximately one in 1000 adults every year, and has an annual mortality of 14.6%. In particular, iliofemoral DVT can lead to recurrent thrombosis and post‐thrombotic syndrome (PTS), a painful condition which can lead to chronic venous insufficiency, oedema, and ulceration. It causes significant disability, impaired quality of life, and economic burden. Early thrombus removal techniques have been advocated in patients with an iliofemoral DVT in order to improve vein patency, prevent valvular dysfunction, and reduce future complications, such as post‐thrombotic syndrome and venous ulceration. One such technique is pharmacomechanical thrombectomy, a combination of catheter‐based thrombectomy and catheter‐directed thrombolysis. Objectives To assess the effects of pharmacomechanical thrombectomy versus anticoagulation (alone or with compression stockings), mechanical thrombectomy, thrombolysis, or other endovascular techniques in the management of people with acute DVT of the iliofemoral vein. Search methods The Cochrane Vascular Information Specialist searched the Specialised Register (last searched December 2015) and the Cochrane Register of Studies (last searched December 2015). We searched clinical trials databases for details of ongoing or unpublished studies and the reference lists of relevant articles retrieved by electronic searches for additional citations. Selection criteria Randomised controlled trials in which patients with an iliofemoral deep vein thrombosis were allocated to receive pharmacomechanical thrombectomy versus anticoagulation, mechanical thrombectomy, thrombolysis (systemic or catheter directed thrombolysis), or other endovascular techniques for the treatment of iliofemoral DVT. Data collection and analysis At least two review authors independently assessed studies identified for potential inclusion. We found no randomised controlled trials that met the eligibility criteria for this review. We identified one ongoing study. There were no randomised controlled trials that assessed the effects of pharmacomechanical thrombectomy versus anticoagulation (alone or with compression stockings), mechanical thrombectomy, thrombolysis, or other endovascular techniques in the management of people with acute DVT of the iliofemoral vein that met the eligibility criteria for this review. Further high quality randomised controlled trials are needed. |
t38 | t38_4 | yes | This life‐threatening condition is called a pulmonary embolism and occurs in approximately 3 to 4 in 10,000 people. | Deep venous thrombosis (DVT) occurs in approximately one in 1000 adults every year, and has an annual mortality of 14.6%. In particular, iliofemoral DVT can lead to recurrent thrombosis and post‐thrombotic syndrome (PTS), a painful condition which can lead to chronic venous insufficiency, oedema, and ulceration. It causes significant disability, impaired quality of life, and economic burden. Early thrombus removal techniques have been advocated in patients with an iliofemoral DVT in order to improve vein patency, prevent valvular dysfunction, and reduce future complications, such as post‐thrombotic syndrome and venous ulceration. One such technique is pharmacomechanical thrombectomy, a combination of catheter‐based thrombectomy and catheter‐directed thrombolysis. Objectives To assess the effects of pharmacomechanical thrombectomy versus anticoagulation (alone or with compression stockings), mechanical thrombectomy, thrombolysis, or other endovascular techniques in the management of people with acute DVT of the iliofemoral vein. Search methods The Cochrane Vascular Information Specialist searched the Specialised Register (last searched December 2015) and the Cochrane Register of Studies (last searched December 2015). We searched clinical trials databases for details of ongoing or unpublished studies and the reference lists of relevant articles retrieved by electronic searches for additional citations. Selection criteria Randomised controlled trials in which patients with an iliofemoral deep vein thrombosis were allocated to receive pharmacomechanical thrombectomy versus anticoagulation, mechanical thrombectomy, thrombolysis (systemic or catheter directed thrombolysis), or other endovascular techniques for the treatment of iliofemoral DVT. Data collection and analysis At least two review authors independently assessed studies identified for potential inclusion. We found no randomised controlled trials that met the eligibility criteria for this review. We identified one ongoing study. There were no randomised controlled trials that assessed the effects of pharmacomechanical thrombectomy versus anticoagulation (alone or with compression stockings), mechanical thrombectomy, thrombolysis, or other endovascular techniques in the management of people with acute DVT of the iliofemoral vein that met the eligibility criteria for this review. Further high quality randomised controlled trials are needed. |
t38 | t38_5 | yes | Another side‐effect of DVT is post‐thrombotic syndrome (PTS), a condition in which the patient suffers pain, swelling, and changes in the skin of the leg, which can lead to an ulcer. | Deep venous thrombosis (DVT) occurs in approximately one in 1000 adults every year, and has an annual mortality of 14.6%. In particular, iliofemoral DVT can lead to recurrent thrombosis and post‐thrombotic syndrome (PTS), a painful condition which can lead to chronic venous insufficiency, oedema, and ulceration. It causes significant disability, impaired quality of life, and economic burden. Early thrombus removal techniques have been advocated in patients with an iliofemoral DVT in order to improve vein patency, prevent valvular dysfunction, and reduce future complications, such as post‐thrombotic syndrome and venous ulceration. One such technique is pharmacomechanical thrombectomy, a combination of catheter‐based thrombectomy and catheter‐directed thrombolysis. Objectives To assess the effects of pharmacomechanical thrombectomy versus anticoagulation (alone or with compression stockings), mechanical thrombectomy, thrombolysis, or other endovascular techniques in the management of people with acute DVT of the iliofemoral vein. Search methods The Cochrane Vascular Information Specialist searched the Specialised Register (last searched December 2015) and the Cochrane Register of Studies (last searched December 2015). We searched clinical trials databases for details of ongoing or unpublished studies and the reference lists of relevant articles retrieved by electronic searches for additional citations. Selection criteria Randomised controlled trials in which patients with an iliofemoral deep vein thrombosis were allocated to receive pharmacomechanical thrombectomy versus anticoagulation, mechanical thrombectomy, thrombolysis (systemic or catheter directed thrombolysis), or other endovascular techniques for the treatment of iliofemoral DVT. Data collection and analysis At least two review authors independently assessed studies identified for potential inclusion. We found no randomised controlled trials that met the eligibility criteria for this review. We identified one ongoing study. There were no randomised controlled trials that assessed the effects of pharmacomechanical thrombectomy versus anticoagulation (alone or with compression stockings), mechanical thrombectomy, thrombolysis, or other endovascular techniques in the management of people with acute DVT of the iliofemoral vein that met the eligibility criteria for this review. Further high quality randomised controlled trials are needed. |
t38 | t38_6 | yes | This causes significant disability and diminished qualify of life, and is costly to the healthcare system. | Deep venous thrombosis (DVT) occurs in approximately one in 1000 adults every year, and has an annual mortality of 14.6%. In particular, iliofemoral DVT can lead to recurrent thrombosis and post‐thrombotic syndrome (PTS), a painful condition which can lead to chronic venous insufficiency, oedema, and ulceration. It causes significant disability, impaired quality of life, and economic burden. Early thrombus removal techniques have been advocated in patients with an iliofemoral DVT in order to improve vein patency, prevent valvular dysfunction, and reduce future complications, such as post‐thrombotic syndrome and venous ulceration. One such technique is pharmacomechanical thrombectomy, a combination of catheter‐based thrombectomy and catheter‐directed thrombolysis. Objectives To assess the effects of pharmacomechanical thrombectomy versus anticoagulation (alone or with compression stockings), mechanical thrombectomy, thrombolysis, or other endovascular techniques in the management of people with acute DVT of the iliofemoral vein. Search methods The Cochrane Vascular Information Specialist searched the Specialised Register (last searched December 2015) and the Cochrane Register of Studies (last searched December 2015). We searched clinical trials databases for details of ongoing or unpublished studies and the reference lists of relevant articles retrieved by electronic searches for additional citations. Selection criteria Randomised controlled trials in which patients with an iliofemoral deep vein thrombosis were allocated to receive pharmacomechanical thrombectomy versus anticoagulation, mechanical thrombectomy, thrombolysis (systemic or catheter directed thrombolysis), or other endovascular techniques for the treatment of iliofemoral DVT. Data collection and analysis At least two review authors independently assessed studies identified for potential inclusion. We found no randomised controlled trials that met the eligibility criteria for this review. We identified one ongoing study. There were no randomised controlled trials that assessed the effects of pharmacomechanical thrombectomy versus anticoagulation (alone or with compression stockings), mechanical thrombectomy, thrombolysis, or other endovascular techniques in the management of people with acute DVT of the iliofemoral vein that met the eligibility criteria for this review. Further high quality randomised controlled trials are needed. |
t38 | t38_7 | yes | One way to prevent another blood clot or PTS is to remove the clot. | Deep venous thrombosis (DVT) occurs in approximately one in 1000 adults every year, and has an annual mortality of 14.6%. In particular, iliofemoral DVT can lead to recurrent thrombosis and post‐thrombotic syndrome (PTS), a painful condition which can lead to chronic venous insufficiency, oedema, and ulceration. It causes significant disability, impaired quality of life, and economic burden. Early thrombus removal techniques have been advocated in patients with an iliofemoral DVT in order to improve vein patency, prevent valvular dysfunction, and reduce future complications, such as post‐thrombotic syndrome and venous ulceration. One such technique is pharmacomechanical thrombectomy, a combination of catheter‐based thrombectomy and catheter‐directed thrombolysis. Objectives To assess the effects of pharmacomechanical thrombectomy versus anticoagulation (alone or with compression stockings), mechanical thrombectomy, thrombolysis, or other endovascular techniques in the management of people with acute DVT of the iliofemoral vein. Search methods The Cochrane Vascular Information Specialist searched the Specialised Register (last searched December 2015) and the Cochrane Register of Studies (last searched December 2015). We searched clinical trials databases for details of ongoing or unpublished studies and the reference lists of relevant articles retrieved by electronic searches for additional citations. Selection criteria Randomised controlled trials in which patients with an iliofemoral deep vein thrombosis were allocated to receive pharmacomechanical thrombectomy versus anticoagulation, mechanical thrombectomy, thrombolysis (systemic or catheter directed thrombolysis), or other endovascular techniques for the treatment of iliofemoral DVT. Data collection and analysis At least two review authors independently assessed studies identified for potential inclusion. We found no randomised controlled trials that met the eligibility criteria for this review. We identified one ongoing study. There were no randomised controlled trials that assessed the effects of pharmacomechanical thrombectomy versus anticoagulation (alone or with compression stockings), mechanical thrombectomy, thrombolysis, or other endovascular techniques in the management of people with acute DVT of the iliofemoral vein that met the eligibility criteria for this review. Further high quality randomised controlled trials are needed. |
t38 | t38_8 | yes | A catheter can be inserted into the vein and the clot removed directly (mechanical thrombectomy), the clot can be broken down through the use of drugs infused into a vein in the foot or directly at the site of the clot using a catheter and X‐ray control (pharmacomechanical thrombolysis), or a combination of the two procedures. | Deep venous thrombosis (DVT) occurs in approximately one in 1000 adults every year, and has an annual mortality of 14.6%. In particular, iliofemoral DVT can lead to recurrent thrombosis and post‐thrombotic syndrome (PTS), a painful condition which can lead to chronic venous insufficiency, oedema, and ulceration. It causes significant disability, impaired quality of life, and economic burden. Early thrombus removal techniques have been advocated in patients with an iliofemoral DVT in order to improve vein patency, prevent valvular dysfunction, and reduce future complications, such as post‐thrombotic syndrome and venous ulceration. One such technique is pharmacomechanical thrombectomy, a combination of catheter‐based thrombectomy and catheter‐directed thrombolysis. Objectives To assess the effects of pharmacomechanical thrombectomy versus anticoagulation (alone or with compression stockings), mechanical thrombectomy, thrombolysis, or other endovascular techniques in the management of people with acute DVT of the iliofemoral vein. Search methods The Cochrane Vascular Information Specialist searched the Specialised Register (last searched December 2015) and the Cochrane Register of Studies (last searched December 2015). We searched clinical trials databases for details of ongoing or unpublished studies and the reference lists of relevant articles retrieved by electronic searches for additional citations. Selection criteria Randomised controlled trials in which patients with an iliofemoral deep vein thrombosis were allocated to receive pharmacomechanical thrombectomy versus anticoagulation, mechanical thrombectomy, thrombolysis (systemic or catheter directed thrombolysis), or other endovascular techniques for the treatment of iliofemoral DVT. Data collection and analysis At least two review authors independently assessed studies identified for potential inclusion. We found no randomised controlled trials that met the eligibility criteria for this review. We identified one ongoing study. There were no randomised controlled trials that assessed the effects of pharmacomechanical thrombectomy versus anticoagulation (alone or with compression stockings), mechanical thrombectomy, thrombolysis, or other endovascular techniques in the management of people with acute DVT of the iliofemoral vein that met the eligibility criteria for this review. Further high quality randomised controlled trials are needed. |
t38 | t38_9 | no | This review aimed to measure how safe and effective pharmacomechanical thrombectomy is, compared to other techniques. | Deep venous thrombosis (DVT) occurs in approximately one in 1000 adults every year, and has an annual mortality of 14.6%. In particular, iliofemoral DVT can lead to recurrent thrombosis and post‐thrombotic syndrome (PTS), a painful condition which can lead to chronic venous insufficiency, oedema, and ulceration. It causes significant disability, impaired quality of life, and economic burden. Early thrombus removal techniques have been advocated in patients with an iliofemoral DVT in order to improve vein patency, prevent valvular dysfunction, and reduce future complications, such as post‐thrombotic syndrome and venous ulceration. One such technique is pharmacomechanical thrombectomy, a combination of catheter‐based thrombectomy and catheter‐directed thrombolysis. Objectives To assess the effects of pharmacomechanical thrombectomy versus anticoagulation (alone or with compression stockings), mechanical thrombectomy, thrombolysis, or other endovascular techniques in the management of people with acute DVT of the iliofemoral vein. Search methods The Cochrane Vascular Information Specialist searched the Specialised Register (last searched December 2015) and the Cochrane Register of Studies (last searched December 2015). We searched clinical trials databases for details of ongoing or unpublished studies and the reference lists of relevant articles retrieved by electronic searches for additional citations. Selection criteria Randomised controlled trials in which patients with an iliofemoral deep vein thrombosis were allocated to receive pharmacomechanical thrombectomy versus anticoagulation, mechanical thrombectomy, thrombolysis (systemic or catheter directed thrombolysis), or other endovascular techniques for the treatment of iliofemoral DVT. Data collection and analysis At least two review authors independently assessed studies identified for potential inclusion. We found no randomised controlled trials that met the eligibility criteria for this review. We identified one ongoing study. There were no randomised controlled trials that assessed the effects of pharmacomechanical thrombectomy versus anticoagulation (alone or with compression stockings), mechanical thrombectomy, thrombolysis, or other endovascular techniques in the management of people with acute DVT of the iliofemoral vein that met the eligibility criteria for this review. Further high quality randomised controlled trials are needed. |
t38 | t38_10 | no | There were no randomised controlled trials that met the inclusion criteria of this review (current until December 2015). | Deep venous thrombosis (DVT) occurs in approximately one in 1000 adults every year, and has an annual mortality of 14.6%. In particular, iliofemoral DVT can lead to recurrent thrombosis and post‐thrombotic syndrome (PTS), a painful condition which can lead to chronic venous insufficiency, oedema, and ulceration. It causes significant disability, impaired quality of life, and economic burden. Early thrombus removal techniques have been advocated in patients with an iliofemoral DVT in order to improve vein patency, prevent valvular dysfunction, and reduce future complications, such as post‐thrombotic syndrome and venous ulceration. One such technique is pharmacomechanical thrombectomy, a combination of catheter‐based thrombectomy and catheter‐directed thrombolysis. Objectives To assess the effects of pharmacomechanical thrombectomy versus anticoagulation (alone or with compression stockings), mechanical thrombectomy, thrombolysis, or other endovascular techniques in the management of people with acute DVT of the iliofemoral vein. Search methods The Cochrane Vascular Information Specialist searched the Specialised Register (last searched December 2015) and the Cochrane Register of Studies (last searched December 2015). We searched clinical trials databases for details of ongoing or unpublished studies and the reference lists of relevant articles retrieved by electronic searches for additional citations. Selection criteria Randomised controlled trials in which patients with an iliofemoral deep vein thrombosis were allocated to receive pharmacomechanical thrombectomy versus anticoagulation, mechanical thrombectomy, thrombolysis (systemic or catheter directed thrombolysis), or other endovascular techniques for the treatment of iliofemoral DVT. Data collection and analysis At least two review authors independently assessed studies identified for potential inclusion. We found no randomised controlled trials that met the eligibility criteria for this review. We identified one ongoing study. There were no randomised controlled trials that assessed the effects of pharmacomechanical thrombectomy versus anticoagulation (alone or with compression stockings), mechanical thrombectomy, thrombolysis, or other endovascular techniques in the management of people with acute DVT of the iliofemoral vein that met the eligibility criteria for this review. Further high quality randomised controlled trials are needed. |
t38 | t38_11 | no | At present, there is a lack of randomised controlled trials that examine the comparative effectiveness and safety of pharmacomechanical thrombectomy in the management of patients with DVT. | Deep venous thrombosis (DVT) occurs in approximately one in 1000 adults every year, and has an annual mortality of 14.6%. In particular, iliofemoral DVT can lead to recurrent thrombosis and post‐thrombotic syndrome (PTS), a painful condition which can lead to chronic venous insufficiency, oedema, and ulceration. It causes significant disability, impaired quality of life, and economic burden. Early thrombus removal techniques have been advocated in patients with an iliofemoral DVT in order to improve vein patency, prevent valvular dysfunction, and reduce future complications, such as post‐thrombotic syndrome and venous ulceration. One such technique is pharmacomechanical thrombectomy, a combination of catheter‐based thrombectomy and catheter‐directed thrombolysis. Objectives To assess the effects of pharmacomechanical thrombectomy versus anticoagulation (alone or with compression stockings), mechanical thrombectomy, thrombolysis, or other endovascular techniques in the management of people with acute DVT of the iliofemoral vein. Search methods The Cochrane Vascular Information Specialist searched the Specialised Register (last searched December 2015) and the Cochrane Register of Studies (last searched December 2015). We searched clinical trials databases for details of ongoing or unpublished studies and the reference lists of relevant articles retrieved by electronic searches for additional citations. Selection criteria Randomised controlled trials in which patients with an iliofemoral deep vein thrombosis were allocated to receive pharmacomechanical thrombectomy versus anticoagulation, mechanical thrombectomy, thrombolysis (systemic or catheter directed thrombolysis), or other endovascular techniques for the treatment of iliofemoral DVT. Data collection and analysis At least two review authors independently assessed studies identified for potential inclusion. We found no randomised controlled trials that met the eligibility criteria for this review. We identified one ongoing study. There were no randomised controlled trials that assessed the effects of pharmacomechanical thrombectomy versus anticoagulation (alone or with compression stockings), mechanical thrombectomy, thrombolysis, or other endovascular techniques in the management of people with acute DVT of the iliofemoral vein that met the eligibility criteria for this review. Further high quality randomised controlled trials are needed. |
t38 | t38_12 | no | Conclusion Further research is required before conclusions can be made. | Deep venous thrombosis (DVT) occurs in approximately one in 1000 adults every year, and has an annual mortality of 14.6%. In particular, iliofemoral DVT can lead to recurrent thrombosis and post‐thrombotic syndrome (PTS), a painful condition which can lead to chronic venous insufficiency, oedema, and ulceration. It causes significant disability, impaired quality of life, and economic burden. Early thrombus removal techniques have been advocated in patients with an iliofemoral DVT in order to improve vein patency, prevent valvular dysfunction, and reduce future complications, such as post‐thrombotic syndrome and venous ulceration. One such technique is pharmacomechanical thrombectomy, a combination of catheter‐based thrombectomy and catheter‐directed thrombolysis. Objectives To assess the effects of pharmacomechanical thrombectomy versus anticoagulation (alone or with compression stockings), mechanical thrombectomy, thrombolysis, or other endovascular techniques in the management of people with acute DVT of the iliofemoral vein. Search methods The Cochrane Vascular Information Specialist searched the Specialised Register (last searched December 2015) and the Cochrane Register of Studies (last searched December 2015). We searched clinical trials databases for details of ongoing or unpublished studies and the reference lists of relevant articles retrieved by electronic searches for additional citations. Selection criteria Randomised controlled trials in which patients with an iliofemoral deep vein thrombosis were allocated to receive pharmacomechanical thrombectomy versus anticoagulation, mechanical thrombectomy, thrombolysis (systemic or catheter directed thrombolysis), or other endovascular techniques for the treatment of iliofemoral DVT. Data collection and analysis At least two review authors independently assessed studies identified for potential inclusion. We found no randomised controlled trials that met the eligibility criteria for this review. We identified one ongoing study. There were no randomised controlled trials that assessed the effects of pharmacomechanical thrombectomy versus anticoagulation (alone or with compression stockings), mechanical thrombectomy, thrombolysis, or other endovascular techniques in the management of people with acute DVT of the iliofemoral vein that met the eligibility criteria for this review. Further high quality randomised controlled trials are needed. |
t39 | t39_1 | yes | Allowing preterm infants to receive blood from the placenta after birth and before clamping the umbilical cord has health benefits for the baby and is not harmful for the mother. | Placental transfusion (by means of delayed cord clamping (DCC), cord milking, or cord stripping) confers benefits for preterm infants. It is not known if providing respiratory support to preterm infants before cord clamping improves outcomes. Objectives To assess the efficacy and safety of respiratory support provided during DCC compared with no respiratory support during placental transfusion (in the form of DCC, milking, or stripping) in preterm infants immediately after delivery. Search methods We used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL, 2017, Issue 5), MEDLINE via PubMed (1966 to 19 June 2017), Embase (1980 to 19 June 2017), and CINAHL (1982 to 19 June 2017). We also searched clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomized controlled trials and quasi‐randomized trials . Selection criteria Randomized, cluster randomized, or quasi‐randomized controlled trials enrolling preterm infants undergoing DCC, where one of the groups received respiratory support before cord clamping and the control group received no respiratory support before cord clamping. Data collection and analysis All review authors assisted with data collection, assessment, and extraction. Two review authors assessed the quality of evidence using the GRADE approach. We contacted study authors to request missing information. One study fulfilled the review criteria. In this study, 150 preterm infants of less than 32 weeks' gestation undergoing 60 second DCC were randomized to a group who received respiratory support in the form of continuous positive airway pressure (CPAP) or positive pressure ventilation during DCC and a group that did not receive respiratory support during the procedure. Mortality during hospital admission was not significantly different between groups with wide confidence intervals (CI) for magnitude of effect (risk ratio (RR) 1.67, 95% CI 0.41 to 6.73). The study did not report neurodevelopmental disability and death or disability at two to three years of age. There were no significant differences between groups in condition at birth (Apgar scores or intubation in the delivery room), use of inotropic agents (RR 1.25, CI 0.63 to 2.49), and receipt of blood transfusion (RR 1.03, 95% CI 0.70 to 1.54). In addition, there were no significant differences in the incidences of any intraventricular haemorrhage (RR 1.50, 95% CI 0.65 to 3.46) and severe intraventricular haemorrhage (RR 1.33, 95% CI 0.31 to 5.75). Several continuous variables were reported in subgroups depending on method of delivery. Unpublished data for each group as a whole was made available and showed peak haematocrit in the first 24 hours and duration of phototherapy did not differ significantly. Overall, the quality of evidence for several key neonatal outcomes (e.g. mortality and intraventricular haemorrhage) was low because of lack of precision with wide CIs. The results from one study with wide CIs for magnitude of effect do not provide evidence either for or against the use of respiratory support before clamping the umbilical cord. A greater body of evidence is required as many of the outcomes of interest to the review occurred infrequently. Similarly, the one included study cannot answer the question of whether the intervention is or is not harmful. |
t39 | t39_2 | yes | Most babies will start breathing or crying (or both) before the cord is clamped. | Placental transfusion (by means of delayed cord clamping (DCC), cord milking, or cord stripping) confers benefits for preterm infants. It is not known if providing respiratory support to preterm infants before cord clamping improves outcomes. Objectives To assess the efficacy and safety of respiratory support provided during DCC compared with no respiratory support during placental transfusion (in the form of DCC, milking, or stripping) in preterm infants immediately after delivery. Search methods We used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL, 2017, Issue 5), MEDLINE via PubMed (1966 to 19 June 2017), Embase (1980 to 19 June 2017), and CINAHL (1982 to 19 June 2017). We also searched clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomized controlled trials and quasi‐randomized trials . Selection criteria Randomized, cluster randomized, or quasi‐randomized controlled trials enrolling preterm infants undergoing DCC, where one of the groups received respiratory support before cord clamping and the control group received no respiratory support before cord clamping. Data collection and analysis All review authors assisted with data collection, assessment, and extraction. Two review authors assessed the quality of evidence using the GRADE approach. We contacted study authors to request missing information. One study fulfilled the review criteria. In this study, 150 preterm infants of less than 32 weeks' gestation undergoing 60 second DCC were randomized to a group who received respiratory support in the form of continuous positive airway pressure (CPAP) or positive pressure ventilation during DCC and a group that did not receive respiratory support during the procedure. Mortality during hospital admission was not significantly different between groups with wide confidence intervals (CI) for magnitude of effect (risk ratio (RR) 1.67, 95% CI 0.41 to 6.73). The study did not report neurodevelopmental disability and death or disability at two to three years of age. There were no significant differences between groups in condition at birth (Apgar scores or intubation in the delivery room), use of inotropic agents (RR 1.25, CI 0.63 to 2.49), and receipt of blood transfusion (RR 1.03, 95% CI 0.70 to 1.54). In addition, there were no significant differences in the incidences of any intraventricular haemorrhage (RR 1.50, 95% CI 0.65 to 3.46) and severe intraventricular haemorrhage (RR 1.33, 95% CI 0.31 to 5.75). Several continuous variables were reported in subgroups depending on method of delivery. Unpublished data for each group as a whole was made available and showed peak haematocrit in the first 24 hours and duration of phototherapy did not differ significantly. Overall, the quality of evidence for several key neonatal outcomes (e.g. mortality and intraventricular haemorrhage) was low because of lack of precision with wide CIs. The results from one study with wide CIs for magnitude of effect do not provide evidence either for or against the use of respiratory support before clamping the umbilical cord. A greater body of evidence is required as many of the outcomes of interest to the review occurred infrequently. Similarly, the one included study cannot answer the question of whether the intervention is or is not harmful. |
t39 | t39_3 | yes | However, some babies do not establish regular breathing during this time. | Placental transfusion (by means of delayed cord clamping (DCC), cord milking, or cord stripping) confers benefits for preterm infants. It is not known if providing respiratory support to preterm infants before cord clamping improves outcomes. Objectives To assess the efficacy and safety of respiratory support provided during DCC compared with no respiratory support during placental transfusion (in the form of DCC, milking, or stripping) in preterm infants immediately after delivery. Search methods We used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL, 2017, Issue 5), MEDLINE via PubMed (1966 to 19 June 2017), Embase (1980 to 19 June 2017), and CINAHL (1982 to 19 June 2017). We also searched clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomized controlled trials and quasi‐randomized trials . Selection criteria Randomized, cluster randomized, or quasi‐randomized controlled trials enrolling preterm infants undergoing DCC, where one of the groups received respiratory support before cord clamping and the control group received no respiratory support before cord clamping. Data collection and analysis All review authors assisted with data collection, assessment, and extraction. Two review authors assessed the quality of evidence using the GRADE approach. We contacted study authors to request missing information. One study fulfilled the review criteria. In this study, 150 preterm infants of less than 32 weeks' gestation undergoing 60 second DCC were randomized to a group who received respiratory support in the form of continuous positive airway pressure (CPAP) or positive pressure ventilation during DCC and a group that did not receive respiratory support during the procedure. Mortality during hospital admission was not significantly different between groups with wide confidence intervals (CI) for magnitude of effect (risk ratio (RR) 1.67, 95% CI 0.41 to 6.73). The study did not report neurodevelopmental disability and death or disability at two to three years of age. There were no significant differences between groups in condition at birth (Apgar scores or intubation in the delivery room), use of inotropic agents (RR 1.25, CI 0.63 to 2.49), and receipt of blood transfusion (RR 1.03, 95% CI 0.70 to 1.54). In addition, there were no significant differences in the incidences of any intraventricular haemorrhage (RR 1.50, 95% CI 0.65 to 3.46) and severe intraventricular haemorrhage (RR 1.33, 95% CI 0.31 to 5.75). Several continuous variables were reported in subgroups depending on method of delivery. Unpublished data for each group as a whole was made available and showed peak haematocrit in the first 24 hours and duration of phototherapy did not differ significantly. Overall, the quality of evidence for several key neonatal outcomes (e.g. mortality and intraventricular haemorrhage) was low because of lack of precision with wide CIs. The results from one study with wide CIs for magnitude of effect do not provide evidence either for or against the use of respiratory support before clamping the umbilical cord. A greater body of evidence is required as many of the outcomes of interest to the review occurred infrequently. Similarly, the one included study cannot answer the question of whether the intervention is or is not harmful. |
t39 | t39_4 | yes | After clamping the cord, most preterm babies are given some form of breathing support like continuous positive airway pressure (CPAP). | Placental transfusion (by means of delayed cord clamping (DCC), cord milking, or cord stripping) confers benefits for preterm infants. It is not known if providing respiratory support to preterm infants before cord clamping improves outcomes. Objectives To assess the efficacy and safety of respiratory support provided during DCC compared with no respiratory support during placental transfusion (in the form of DCC, milking, or stripping) in preterm infants immediately after delivery. Search methods We used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL, 2017, Issue 5), MEDLINE via PubMed (1966 to 19 June 2017), Embase (1980 to 19 June 2017), and CINAHL (1982 to 19 June 2017). We also searched clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomized controlled trials and quasi‐randomized trials . Selection criteria Randomized, cluster randomized, or quasi‐randomized controlled trials enrolling preterm infants undergoing DCC, where one of the groups received respiratory support before cord clamping and the control group received no respiratory support before cord clamping. Data collection and analysis All review authors assisted with data collection, assessment, and extraction. Two review authors assessed the quality of evidence using the GRADE approach. We contacted study authors to request missing information. One study fulfilled the review criteria. In this study, 150 preterm infants of less than 32 weeks' gestation undergoing 60 second DCC were randomized to a group who received respiratory support in the form of continuous positive airway pressure (CPAP) or positive pressure ventilation during DCC and a group that did not receive respiratory support during the procedure. Mortality during hospital admission was not significantly different between groups with wide confidence intervals (CI) for magnitude of effect (risk ratio (RR) 1.67, 95% CI 0.41 to 6.73). The study did not report neurodevelopmental disability and death or disability at two to three years of age. There were no significant differences between groups in condition at birth (Apgar scores or intubation in the delivery room), use of inotropic agents (RR 1.25, CI 0.63 to 2.49), and receipt of blood transfusion (RR 1.03, 95% CI 0.70 to 1.54). In addition, there were no significant differences in the incidences of any intraventricular haemorrhage (RR 1.50, 95% CI 0.65 to 3.46) and severe intraventricular haemorrhage (RR 1.33, 95% CI 0.31 to 5.75). Several continuous variables were reported in subgroups depending on method of delivery. Unpublished data for each group as a whole was made available and showed peak haematocrit in the first 24 hours and duration of phototherapy did not differ significantly. Overall, the quality of evidence for several key neonatal outcomes (e.g. mortality and intraventricular haemorrhage) was low because of lack of precision with wide CIs. The results from one study with wide CIs for magnitude of effect do not provide evidence either for or against the use of respiratory support before clamping the umbilical cord. A greater body of evidence is required as many of the outcomes of interest to the review occurred infrequently. Similarly, the one included study cannot answer the question of whether the intervention is or is not harmful. |
t39 | t39_5 | yes | CPAP applies continuous low air pressure to keep the airways open in babies who can breathe on their own. | Placental transfusion (by means of delayed cord clamping (DCC), cord milking, or cord stripping) confers benefits for preterm infants. It is not known if providing respiratory support to preterm infants before cord clamping improves outcomes. Objectives To assess the efficacy and safety of respiratory support provided during DCC compared with no respiratory support during placental transfusion (in the form of DCC, milking, or stripping) in preterm infants immediately after delivery. Search methods We used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL, 2017, Issue 5), MEDLINE via PubMed (1966 to 19 June 2017), Embase (1980 to 19 June 2017), and CINAHL (1982 to 19 June 2017). We also searched clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomized controlled trials and quasi‐randomized trials . Selection criteria Randomized, cluster randomized, or quasi‐randomized controlled trials enrolling preterm infants undergoing DCC, where one of the groups received respiratory support before cord clamping and the control group received no respiratory support before cord clamping. Data collection and analysis All review authors assisted with data collection, assessment, and extraction. Two review authors assessed the quality of evidence using the GRADE approach. We contacted study authors to request missing information. One study fulfilled the review criteria. In this study, 150 preterm infants of less than 32 weeks' gestation undergoing 60 second DCC were randomized to a group who received respiratory support in the form of continuous positive airway pressure (CPAP) or positive pressure ventilation during DCC and a group that did not receive respiratory support during the procedure. Mortality during hospital admission was not significantly different between groups with wide confidence intervals (CI) for magnitude of effect (risk ratio (RR) 1.67, 95% CI 0.41 to 6.73). The study did not report neurodevelopmental disability and death or disability at two to three years of age. There were no significant differences between groups in condition at birth (Apgar scores or intubation in the delivery room), use of inotropic agents (RR 1.25, CI 0.63 to 2.49), and receipt of blood transfusion (RR 1.03, 95% CI 0.70 to 1.54). In addition, there were no significant differences in the incidences of any intraventricular haemorrhage (RR 1.50, 95% CI 0.65 to 3.46) and severe intraventricular haemorrhage (RR 1.33, 95% CI 0.31 to 5.75). Several continuous variables were reported in subgroups depending on method of delivery. Unpublished data for each group as a whole was made available and showed peak haematocrit in the first 24 hours and duration of phototherapy did not differ significantly. Overall, the quality of evidence for several key neonatal outcomes (e.g. mortality and intraventricular haemorrhage) was low because of lack of precision with wide CIs. The results from one study with wide CIs for magnitude of effect do not provide evidence either for or against the use of respiratory support before clamping the umbilical cord. A greater body of evidence is required as many of the outcomes of interest to the review occurred infrequently. Similarly, the one included study cannot answer the question of whether the intervention is or is not harmful. |
t39 | t39_6 | no | The question for this review was whether it was beneficial to start the breathing support before the cord is clamped. | Placental transfusion (by means of delayed cord clamping (DCC), cord milking, or cord stripping) confers benefits for preterm infants. It is not known if providing respiratory support to preterm infants before cord clamping improves outcomes. Objectives To assess the efficacy and safety of respiratory support provided during DCC compared with no respiratory support during placental transfusion (in the form of DCC, milking, or stripping) in preterm infants immediately after delivery. Search methods We used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL, 2017, Issue 5), MEDLINE via PubMed (1966 to 19 June 2017), Embase (1980 to 19 June 2017), and CINAHL (1982 to 19 June 2017). We also searched clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomized controlled trials and quasi‐randomized trials . Selection criteria Randomized, cluster randomized, or quasi‐randomized controlled trials enrolling preterm infants undergoing DCC, where one of the groups received respiratory support before cord clamping and the control group received no respiratory support before cord clamping. Data collection and analysis All review authors assisted with data collection, assessment, and extraction. Two review authors assessed the quality of evidence using the GRADE approach. We contacted study authors to request missing information. One study fulfilled the review criteria. In this study, 150 preterm infants of less than 32 weeks' gestation undergoing 60 second DCC were randomized to a group who received respiratory support in the form of continuous positive airway pressure (CPAP) or positive pressure ventilation during DCC and a group that did not receive respiratory support during the procedure. Mortality during hospital admission was not significantly different between groups with wide confidence intervals (CI) for magnitude of effect (risk ratio (RR) 1.67, 95% CI 0.41 to 6.73). The study did not report neurodevelopmental disability and death or disability at two to three years of age. There were no significant differences between groups in condition at birth (Apgar scores or intubation in the delivery room), use of inotropic agents (RR 1.25, CI 0.63 to 2.49), and receipt of blood transfusion (RR 1.03, 95% CI 0.70 to 1.54). In addition, there were no significant differences in the incidences of any intraventricular haemorrhage (RR 1.50, 95% CI 0.65 to 3.46) and severe intraventricular haemorrhage (RR 1.33, 95% CI 0.31 to 5.75). Several continuous variables were reported in subgroups depending on method of delivery. Unpublished data for each group as a whole was made available and showed peak haematocrit in the first 24 hours and duration of phototherapy did not differ significantly. Overall, the quality of evidence for several key neonatal outcomes (e.g. mortality and intraventricular haemorrhage) was low because of lack of precision with wide CIs. The results from one study with wide CIs for magnitude of effect do not provide evidence either for or against the use of respiratory support before clamping the umbilical cord. A greater body of evidence is required as many of the outcomes of interest to the review occurred infrequently. Similarly, the one included study cannot answer the question of whether the intervention is or is not harmful. |
t39 | t39_7 | yes | Preterm infants born before 32 weeks' gestation (32 weeks from the first day of the woman's last period (menstruation) to the current date) who had clamping of the umbilical cord delayed for 60 seconds after birth were selected at random to enter a group of babies who received breathing support and a group of babies who did not receive breathing support. | Placental transfusion (by means of delayed cord clamping (DCC), cord milking, or cord stripping) confers benefits for preterm infants. It is not known if providing respiratory support to preterm infants before cord clamping improves outcomes. Objectives To assess the efficacy and safety of respiratory support provided during DCC compared with no respiratory support during placental transfusion (in the form of DCC, milking, or stripping) in preterm infants immediately after delivery. Search methods We used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL, 2017, Issue 5), MEDLINE via PubMed (1966 to 19 June 2017), Embase (1980 to 19 June 2017), and CINAHL (1982 to 19 June 2017). We also searched clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomized controlled trials and quasi‐randomized trials . Selection criteria Randomized, cluster randomized, or quasi‐randomized controlled trials enrolling preterm infants undergoing DCC, where one of the groups received respiratory support before cord clamping and the control group received no respiratory support before cord clamping. Data collection and analysis All review authors assisted with data collection, assessment, and extraction. Two review authors assessed the quality of evidence using the GRADE approach. We contacted study authors to request missing information. One study fulfilled the review criteria. In this study, 150 preterm infants of less than 32 weeks' gestation undergoing 60 second DCC were randomized to a group who received respiratory support in the form of continuous positive airway pressure (CPAP) or positive pressure ventilation during DCC and a group that did not receive respiratory support during the procedure. Mortality during hospital admission was not significantly different between groups with wide confidence intervals (CI) for magnitude of effect (risk ratio (RR) 1.67, 95% CI 0.41 to 6.73). The study did not report neurodevelopmental disability and death or disability at two to three years of age. There were no significant differences between groups in condition at birth (Apgar scores or intubation in the delivery room), use of inotropic agents (RR 1.25, CI 0.63 to 2.49), and receipt of blood transfusion (RR 1.03, 95% CI 0.70 to 1.54). In addition, there were no significant differences in the incidences of any intraventricular haemorrhage (RR 1.50, 95% CI 0.65 to 3.46) and severe intraventricular haemorrhage (RR 1.33, 95% CI 0.31 to 5.75). Several continuous variables were reported in subgroups depending on method of delivery. Unpublished data for each group as a whole was made available and showed peak haematocrit in the first 24 hours and duration of phototherapy did not differ significantly. Overall, the quality of evidence for several key neonatal outcomes (e.g. mortality and intraventricular haemorrhage) was low because of lack of precision with wide CIs. The results from one study with wide CIs for magnitude of effect do not provide evidence either for or against the use of respiratory support before clamping the umbilical cord. A greater body of evidence is required as many of the outcomes of interest to the review occurred infrequently. Similarly, the one included study cannot answer the question of whether the intervention is or is not harmful. |
t39 | t39_8 | yes | The breathing support was given after birth of the baby and before the cord was clamped. | Placental transfusion (by means of delayed cord clamping (DCC), cord milking, or cord stripping) confers benefits for preterm infants. It is not known if providing respiratory support to preterm infants before cord clamping improves outcomes. Objectives To assess the efficacy and safety of respiratory support provided during DCC compared with no respiratory support during placental transfusion (in the form of DCC, milking, or stripping) in preterm infants immediately after delivery. Search methods We used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL, 2017, Issue 5), MEDLINE via PubMed (1966 to 19 June 2017), Embase (1980 to 19 June 2017), and CINAHL (1982 to 19 June 2017). We also searched clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomized controlled trials and quasi‐randomized trials . Selection criteria Randomized, cluster randomized, or quasi‐randomized controlled trials enrolling preterm infants undergoing DCC, where one of the groups received respiratory support before cord clamping and the control group received no respiratory support before cord clamping. Data collection and analysis All review authors assisted with data collection, assessment, and extraction. Two review authors assessed the quality of evidence using the GRADE approach. We contacted study authors to request missing information. One study fulfilled the review criteria. In this study, 150 preterm infants of less than 32 weeks' gestation undergoing 60 second DCC were randomized to a group who received respiratory support in the form of continuous positive airway pressure (CPAP) or positive pressure ventilation during DCC and a group that did not receive respiratory support during the procedure. Mortality during hospital admission was not significantly different between groups with wide confidence intervals (CI) for magnitude of effect (risk ratio (RR) 1.67, 95% CI 0.41 to 6.73). The study did not report neurodevelopmental disability and death or disability at two to three years of age. There were no significant differences between groups in condition at birth (Apgar scores or intubation in the delivery room), use of inotropic agents (RR 1.25, CI 0.63 to 2.49), and receipt of blood transfusion (RR 1.03, 95% CI 0.70 to 1.54). In addition, there were no significant differences in the incidences of any intraventricular haemorrhage (RR 1.50, 95% CI 0.65 to 3.46) and severe intraventricular haemorrhage (RR 1.33, 95% CI 0.31 to 5.75). Several continuous variables were reported in subgroups depending on method of delivery. Unpublished data for each group as a whole was made available and showed peak haematocrit in the first 24 hours and duration of phototherapy did not differ significantly. Overall, the quality of evidence for several key neonatal outcomes (e.g. mortality and intraventricular haemorrhage) was low because of lack of precision with wide CIs. The results from one study with wide CIs for magnitude of effect do not provide evidence either for or against the use of respiratory support before clamping the umbilical cord. A greater body of evidence is required as many of the outcomes of interest to the review occurred infrequently. Similarly, the one included study cannot answer the question of whether the intervention is or is not harmful. |
t39 | t39_9 | yes | Breathing support was the use of CPAP for infants breathing on their own or applying intermittent airway pressure to expand the lungs in babies not breathing well on their own. | Placental transfusion (by means of delayed cord clamping (DCC), cord milking, or cord stripping) confers benefits for preterm infants. It is not known if providing respiratory support to preterm infants before cord clamping improves outcomes. Objectives To assess the efficacy and safety of respiratory support provided during DCC compared with no respiratory support during placental transfusion (in the form of DCC, milking, or stripping) in preterm infants immediately after delivery. Search methods We used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL, 2017, Issue 5), MEDLINE via PubMed (1966 to 19 June 2017), Embase (1980 to 19 June 2017), and CINAHL (1982 to 19 June 2017). We also searched clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomized controlled trials and quasi‐randomized trials . Selection criteria Randomized, cluster randomized, or quasi‐randomized controlled trials enrolling preterm infants undergoing DCC, where one of the groups received respiratory support before cord clamping and the control group received no respiratory support before cord clamping. Data collection and analysis All review authors assisted with data collection, assessment, and extraction. Two review authors assessed the quality of evidence using the GRADE approach. We contacted study authors to request missing information. One study fulfilled the review criteria. In this study, 150 preterm infants of less than 32 weeks' gestation undergoing 60 second DCC were randomized to a group who received respiratory support in the form of continuous positive airway pressure (CPAP) or positive pressure ventilation during DCC and a group that did not receive respiratory support during the procedure. Mortality during hospital admission was not significantly different between groups with wide confidence intervals (CI) for magnitude of effect (risk ratio (RR) 1.67, 95% CI 0.41 to 6.73). The study did not report neurodevelopmental disability and death or disability at two to three years of age. There were no significant differences between groups in condition at birth (Apgar scores or intubation in the delivery room), use of inotropic agents (RR 1.25, CI 0.63 to 2.49), and receipt of blood transfusion (RR 1.03, 95% CI 0.70 to 1.54). In addition, there were no significant differences in the incidences of any intraventricular haemorrhage (RR 1.50, 95% CI 0.65 to 3.46) and severe intraventricular haemorrhage (RR 1.33, 95% CI 0.31 to 5.75). Several continuous variables were reported in subgroups depending on method of delivery. Unpublished data for each group as a whole was made available and showed peak haematocrit in the first 24 hours and duration of phototherapy did not differ significantly. Overall, the quality of evidence for several key neonatal outcomes (e.g. mortality and intraventricular haemorrhage) was low because of lack of precision with wide CIs. The results from one study with wide CIs for magnitude of effect do not provide evidence either for or against the use of respiratory support before clamping the umbilical cord. A greater body of evidence is required as many of the outcomes of interest to the review occurred infrequently. Similarly, the one included study cannot answer the question of whether the intervention is or is not harmful. |
t39 | t39_10 | yes | Most of the study infants (83%) were delivered by caesarean section. | Placental transfusion (by means of delayed cord clamping (DCC), cord milking, or cord stripping) confers benefits for preterm infants. It is not known if providing respiratory support to preterm infants before cord clamping improves outcomes. Objectives To assess the efficacy and safety of respiratory support provided during DCC compared with no respiratory support during placental transfusion (in the form of DCC, milking, or stripping) in preterm infants immediately after delivery. Search methods We used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL, 2017, Issue 5), MEDLINE via PubMed (1966 to 19 June 2017), Embase (1980 to 19 June 2017), and CINAHL (1982 to 19 June 2017). We also searched clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomized controlled trials and quasi‐randomized trials . Selection criteria Randomized, cluster randomized, or quasi‐randomized controlled trials enrolling preterm infants undergoing DCC, where one of the groups received respiratory support before cord clamping and the control group received no respiratory support before cord clamping. Data collection and analysis All review authors assisted with data collection, assessment, and extraction. Two review authors assessed the quality of evidence using the GRADE approach. We contacted study authors to request missing information. One study fulfilled the review criteria. In this study, 150 preterm infants of less than 32 weeks' gestation undergoing 60 second DCC were randomized to a group who received respiratory support in the form of continuous positive airway pressure (CPAP) or positive pressure ventilation during DCC and a group that did not receive respiratory support during the procedure. Mortality during hospital admission was not significantly different between groups with wide confidence intervals (CI) for magnitude of effect (risk ratio (RR) 1.67, 95% CI 0.41 to 6.73). The study did not report neurodevelopmental disability and death or disability at two to three years of age. There were no significant differences between groups in condition at birth (Apgar scores or intubation in the delivery room), use of inotropic agents (RR 1.25, CI 0.63 to 2.49), and receipt of blood transfusion (RR 1.03, 95% CI 0.70 to 1.54). In addition, there were no significant differences in the incidences of any intraventricular haemorrhage (RR 1.50, 95% CI 0.65 to 3.46) and severe intraventricular haemorrhage (RR 1.33, 95% CI 0.31 to 5.75). Several continuous variables were reported in subgroups depending on method of delivery. Unpublished data for each group as a whole was made available and showed peak haematocrit in the first 24 hours and duration of phototherapy did not differ significantly. Overall, the quality of evidence for several key neonatal outcomes (e.g. mortality and intraventricular haemorrhage) was low because of lack of precision with wide CIs. The results from one study with wide CIs for magnitude of effect do not provide evidence either for or against the use of respiratory support before clamping the umbilical cord. A greater body of evidence is required as many of the outcomes of interest to the review occurred infrequently. Similarly, the one included study cannot answer the question of whether the intervention is or is not harmful. |
t39 | t39_11 | no | Key results: the single study included in the review did not provide sufficient evidence either for or against the use of breathing support before cord clamping. | Placental transfusion (by means of delayed cord clamping (DCC), cord milking, or cord stripping) confers benefits for preterm infants. It is not known if providing respiratory support to preterm infants before cord clamping improves outcomes. Objectives To assess the efficacy and safety of respiratory support provided during DCC compared with no respiratory support during placental transfusion (in the form of DCC, milking, or stripping) in preterm infants immediately after delivery. Search methods We used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL, 2017, Issue 5), MEDLINE via PubMed (1966 to 19 June 2017), Embase (1980 to 19 June 2017), and CINAHL (1982 to 19 June 2017). We also searched clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomized controlled trials and quasi‐randomized trials . Selection criteria Randomized, cluster randomized, or quasi‐randomized controlled trials enrolling preterm infants undergoing DCC, where one of the groups received respiratory support before cord clamping and the control group received no respiratory support before cord clamping. Data collection and analysis All review authors assisted with data collection, assessment, and extraction. Two review authors assessed the quality of evidence using the GRADE approach. We contacted study authors to request missing information. One study fulfilled the review criteria. In this study, 150 preterm infants of less than 32 weeks' gestation undergoing 60 second DCC were randomized to a group who received respiratory support in the form of continuous positive airway pressure (CPAP) or positive pressure ventilation during DCC and a group that did not receive respiratory support during the procedure. Mortality during hospital admission was not significantly different between groups with wide confidence intervals (CI) for magnitude of effect (risk ratio (RR) 1.67, 95% CI 0.41 to 6.73). The study did not report neurodevelopmental disability and death or disability at two to three years of age. There were no significant differences between groups in condition at birth (Apgar scores or intubation in the delivery room), use of inotropic agents (RR 1.25, CI 0.63 to 2.49), and receipt of blood transfusion (RR 1.03, 95% CI 0.70 to 1.54). In addition, there were no significant differences in the incidences of any intraventricular haemorrhage (RR 1.50, 95% CI 0.65 to 3.46) and severe intraventricular haemorrhage (RR 1.33, 95% CI 0.31 to 5.75). Several continuous variables were reported in subgroups depending on method of delivery. Unpublished data for each group as a whole was made available and showed peak haematocrit in the first 24 hours and duration of phototherapy did not differ significantly. Overall, the quality of evidence for several key neonatal outcomes (e.g. mortality and intraventricular haemorrhage) was low because of lack of precision with wide CIs. The results from one study with wide CIs for magnitude of effect do not provide evidence either for or against the use of respiratory support before clamping the umbilical cord. A greater body of evidence is required as many of the outcomes of interest to the review occurred infrequently. Similarly, the one included study cannot answer the question of whether the intervention is or is not harmful. |
t40 | t40_1 | no | The aim of this Cochrane review was to find out if acupuncture improves pain and function in people with hip osteoarthritis. | Hip osteoarthritis (OA) is a major cause of pain and functional limitation. Few hip OA treatments have been evaluated for safety and effectiveness. Acupuncture is a traditional Chinese medical therapy which aims to treat disease by inserting very thin needles at specific points on the body. Objectives To assess the benefits and harms of acupuncture in patients with hip OA. Search methods We searched Cochrane CENTRAL, MEDLINE, and Embase all through March 2018. Selection criteria We included randomized controlled trials (RCTs) that compared acupuncture with sham acupuncture, another active treatment, or no specific treatment; and RCTs that evaluated acupuncture as an addition to another treatment. Major outcomes were pain and function at the short term (i.e. < 3 months after randomization) and adverse events. Data collection and analysis We used standard methodological procedures expected by Cochrane. Six RCTs with 413 participants were included. Four RCTs included only people with OA of the hip, and two included a mix of people with OA of the hip and knee. All RCTs included primarily older participants, with a mean age range from 61 to 67 years, and a mean duration of hip OA pain from two to eight years. Approximately two‐thirds of participants were women. Two RCTs compared acupuncture versus sham acupuncture; the other four RCTs were not blinded. All results were evaluated at short term (i.e. four to nine weeks after randomization). In the two RCTs that compared acupuncture to sham acupuncture, the sham acupuncture control interventions were judged believable, but each sham acupuncture intervention was also judged to have a risk of weak acupuncture‐specific effects, due to placement of non‐penetrating needles at the correct acupuncture points in one RCT, and the use of penetrating needles not inserted at the correct points in the other RCT. For these two sham‐controlled RCTs, the risk of bias was low for all outcomes. The combined analysis of two sham‐controlled RCTs gave moderate quality evidence of little or no effect in reduction in pain for acupuncture relative to sham acupuncture. Due to the small sample sizes in the studies, the confidence interval includes both the possibility of moderate benefit and the possibility of no effect of acupuncture (120 participants; Standardized Mean Difference (SMD) ‐0.13, (95% Confidence Interval (CI) ‐0.49 to 0.22); 2.1 points greater improvement with acupuncture compared to sham acupuncture on 100 point scale (i.e., absolute percent change ‐2.1% (95% CI ‐7.9% to 3.6%)); relative percent change ‐4.1% (95% CI ‐15.6% to 7.0%)). Estimates of effect were similar for function (120 participants; SMD ‐0.15, (95% CI ‐0.51 to 0.21)). No pooled estimate, representative of the two sham‐controlled RCTs, could be calculated or reported for the quality of life outcome. The four other RCTs were unblinded comparative effectiveness RCTs, which compared (additional) acupuncture to four different active control treatments. There was low quality evidence that addition of acupuncture to the routine primary care that RCT participants were receiving from their physicians was associated with statistically significant and clinically relevant benefits, compared to the routine primary physician care alone, in pain (1 RCT; 137 participants; mean percent difference ‐22.9% (95% CI ‐29.2% to ‐16.6%); relative percent difference ‐46.5% (95% CI ‐59.3% to ‐33.7%)) and function (mean percent difference ‐19.0% (95% CI ‐24.41 to ‐13.59); relative percent difference ‐38.6% (95% CI ‐49.6% to ‐27.6%)). There was no statistically significant difference for mental quality of life and acupuncture showed a small, significant benefit for physical quality of life. The effects of acupuncture compared with either advice plus exercise or NSAIDs are uncertain. We are also uncertain whether acupuncture plus patient education improves pain, function, and quality of life, when compared to patient education alone. In general, the overall quality of the evidence for the four comparative effectiveness RCTs was low to very low, mainly due to the potential for biased reporting of patient‐assessed outcomes due to lack of blinding and sparse data. Information on safety was reported in four RCTs. Two RCTs reported minor side effects of acupuncture, which were primarily minor bruising, bleeding, or pain at needle insertion sites. Four RCTs reported on adverse events, and none reported any serious adverse events attributed to acupuncture. Acupuncture probably has little or no effect in reducing pain or improving function relative to sham acupuncture in people with hip osteoarthritis. Due to the small sample size in the studies, the confidence intervals include both the possibility of moderate benefits and the possibility of no effect of acupuncture. One unblinded trial found that acupuncture as an addition to routine primary physician care was associated with benefits on pain and function. However, these reported benefits are likely due at least partially to RCT participants' greater expectations of benefit from acupuncture. Possible side effects associated with acupuncture treatment were minor. |
t40 | t40_2 | no | We collected and analyzed all relevant studies to answer this question and found 6 relevant studies with 413 people. | Hip osteoarthritis (OA) is a major cause of pain and functional limitation. Few hip OA treatments have been evaluated for safety and effectiveness. Acupuncture is a traditional Chinese medical therapy which aims to treat disease by inserting very thin needles at specific points on the body. Objectives To assess the benefits and harms of acupuncture in patients with hip OA. Search methods We searched Cochrane CENTRAL, MEDLINE, and Embase all through March 2018. Selection criteria We included randomized controlled trials (RCTs) that compared acupuncture with sham acupuncture, another active treatment, or no specific treatment; and RCTs that evaluated acupuncture as an addition to another treatment. Major outcomes were pain and function at the short term (i.e. < 3 months after randomization) and adverse events. Data collection and analysis We used standard methodological procedures expected by Cochrane. Six RCTs with 413 participants were included. Four RCTs included only people with OA of the hip, and two included a mix of people with OA of the hip and knee. All RCTs included primarily older participants, with a mean age range from 61 to 67 years, and a mean duration of hip OA pain from two to eight years. Approximately two‐thirds of participants were women. Two RCTs compared acupuncture versus sham acupuncture; the other four RCTs were not blinded. All results were evaluated at short term (i.e. four to nine weeks after randomization). In the two RCTs that compared acupuncture to sham acupuncture, the sham acupuncture control interventions were judged believable, but each sham acupuncture intervention was also judged to have a risk of weak acupuncture‐specific effects, due to placement of non‐penetrating needles at the correct acupuncture points in one RCT, and the use of penetrating needles not inserted at the correct points in the other RCT. For these two sham‐controlled RCTs, the risk of bias was low for all outcomes. The combined analysis of two sham‐controlled RCTs gave moderate quality evidence of little or no effect in reduction in pain for acupuncture relative to sham acupuncture. Due to the small sample sizes in the studies, the confidence interval includes both the possibility of moderate benefit and the possibility of no effect of acupuncture (120 participants; Standardized Mean Difference (SMD) ‐0.13, (95% Confidence Interval (CI) ‐0.49 to 0.22); 2.1 points greater improvement with acupuncture compared to sham acupuncture on 100 point scale (i.e., absolute percent change ‐2.1% (95% CI ‐7.9% to 3.6%)); relative percent change ‐4.1% (95% CI ‐15.6% to 7.0%)). Estimates of effect were similar for function (120 participants; SMD ‐0.15, (95% CI ‐0.51 to 0.21)). No pooled estimate, representative of the two sham‐controlled RCTs, could be calculated or reported for the quality of life outcome. The four other RCTs were unblinded comparative effectiveness RCTs, which compared (additional) acupuncture to four different active control treatments. There was low quality evidence that addition of acupuncture to the routine primary care that RCT participants were receiving from their physicians was associated with statistically significant and clinically relevant benefits, compared to the routine primary physician care alone, in pain (1 RCT; 137 participants; mean percent difference ‐22.9% (95% CI ‐29.2% to ‐16.6%); relative percent difference ‐46.5% (95% CI ‐59.3% to ‐33.7%)) and function (mean percent difference ‐19.0% (95% CI ‐24.41 to ‐13.59); relative percent difference ‐38.6% (95% CI ‐49.6% to ‐27.6%)). There was no statistically significant difference for mental quality of life and acupuncture showed a small, significant benefit for physical quality of life. The effects of acupuncture compared with either advice plus exercise or NSAIDs are uncertain. We are also uncertain whether acupuncture plus patient education improves pain, function, and quality of life, when compared to patient education alone. In general, the overall quality of the evidence for the four comparative effectiveness RCTs was low to very low, mainly due to the potential for biased reporting of patient‐assessed outcomes due to lack of blinding and sparse data. Information on safety was reported in four RCTs. Two RCTs reported minor side effects of acupuncture, which were primarily minor bruising, bleeding, or pain at needle insertion sites. Four RCTs reported on adverse events, and none reported any serious adverse events attributed to acupuncture. Acupuncture probably has little or no effect in reducing pain or improving function relative to sham acupuncture in people with hip osteoarthritis. Due to the small sample size in the studies, the confidence intervals include both the possibility of moderate benefits and the possibility of no effect of acupuncture. One unblinded trial found that acupuncture as an addition to routine primary physician care was associated with benefits on pain and function. However, these reported benefits are likely due at least partially to RCT participants' greater expectations of benefit from acupuncture. Possible side effects associated with acupuncture treatment were minor. |
t40 | t40_3 | no | Key messages In people with hip osteoarthritis, at close to 8 weeks: Acupuncture probably results in little or no difference in pain or function compared to sham acupuncture. | Hip osteoarthritis (OA) is a major cause of pain and functional limitation. Few hip OA treatments have been evaluated for safety and effectiveness. Acupuncture is a traditional Chinese medical therapy which aims to treat disease by inserting very thin needles at specific points on the body. Objectives To assess the benefits and harms of acupuncture in patients with hip OA. Search methods We searched Cochrane CENTRAL, MEDLINE, and Embase all through March 2018. Selection criteria We included randomized controlled trials (RCTs) that compared acupuncture with sham acupuncture, another active treatment, or no specific treatment; and RCTs that evaluated acupuncture as an addition to another treatment. Major outcomes were pain and function at the short term (i.e. < 3 months after randomization) and adverse events. Data collection and analysis We used standard methodological procedures expected by Cochrane. Six RCTs with 413 participants were included. Four RCTs included only people with OA of the hip, and two included a mix of people with OA of the hip and knee. All RCTs included primarily older participants, with a mean age range from 61 to 67 years, and a mean duration of hip OA pain from two to eight years. Approximately two‐thirds of participants were women. Two RCTs compared acupuncture versus sham acupuncture; the other four RCTs were not blinded. All results were evaluated at short term (i.e. four to nine weeks after randomization). In the two RCTs that compared acupuncture to sham acupuncture, the sham acupuncture control interventions were judged believable, but each sham acupuncture intervention was also judged to have a risk of weak acupuncture‐specific effects, due to placement of non‐penetrating needles at the correct acupuncture points in one RCT, and the use of penetrating needles not inserted at the correct points in the other RCT. For these two sham‐controlled RCTs, the risk of bias was low for all outcomes. The combined analysis of two sham‐controlled RCTs gave moderate quality evidence of little or no effect in reduction in pain for acupuncture relative to sham acupuncture. Due to the small sample sizes in the studies, the confidence interval includes both the possibility of moderate benefit and the possibility of no effect of acupuncture (120 participants; Standardized Mean Difference (SMD) ‐0.13, (95% Confidence Interval (CI) ‐0.49 to 0.22); 2.1 points greater improvement with acupuncture compared to sham acupuncture on 100 point scale (i.e., absolute percent change ‐2.1% (95% CI ‐7.9% to 3.6%)); relative percent change ‐4.1% (95% CI ‐15.6% to 7.0%)). Estimates of effect were similar for function (120 participants; SMD ‐0.15, (95% CI ‐0.51 to 0.21)). No pooled estimate, representative of the two sham‐controlled RCTs, could be calculated or reported for the quality of life outcome. The four other RCTs were unblinded comparative effectiveness RCTs, which compared (additional) acupuncture to four different active control treatments. There was low quality evidence that addition of acupuncture to the routine primary care that RCT participants were receiving from their physicians was associated with statistically significant and clinically relevant benefits, compared to the routine primary physician care alone, in pain (1 RCT; 137 participants; mean percent difference ‐22.9% (95% CI ‐29.2% to ‐16.6%); relative percent difference ‐46.5% (95% CI ‐59.3% to ‐33.7%)) and function (mean percent difference ‐19.0% (95% CI ‐24.41 to ‐13.59); relative percent difference ‐38.6% (95% CI ‐49.6% to ‐27.6%)). There was no statistically significant difference for mental quality of life and acupuncture showed a small, significant benefit for physical quality of life. The effects of acupuncture compared with either advice plus exercise or NSAIDs are uncertain. We are also uncertain whether acupuncture plus patient education improves pain, function, and quality of life, when compared to patient education alone. In general, the overall quality of the evidence for the four comparative effectiveness RCTs was low to very low, mainly due to the potential for biased reporting of patient‐assessed outcomes due to lack of blinding and sparse data. Information on safety was reported in four RCTs. Two RCTs reported minor side effects of acupuncture, which were primarily minor bruising, bleeding, or pain at needle insertion sites. Four RCTs reported on adverse events, and none reported any serious adverse events attributed to acupuncture. Acupuncture probably has little or no effect in reducing pain or improving function relative to sham acupuncture in people with hip osteoarthritis. Due to the small sample size in the studies, the confidence intervals include both the possibility of moderate benefits and the possibility of no effect of acupuncture. One unblinded trial found that acupuncture as an addition to routine primary physician care was associated with benefits on pain and function. However, these reported benefits are likely due at least partially to RCT participants' greater expectations of benefit from acupuncture. Possible side effects associated with acupuncture treatment were minor. |
Subsets and Splits