Improvement in pain and bowel function in female irritable bowel patients with alosetron, a 5‐HT3 receptor antagonist Randomized trials published in some Chinese journals: how many are randomized? A Treatment Trial of Acupuncture in IBS Patients Effects of Gut-Directed Hypnotherapy on IBS in Different Clinical Settings—Results From Two Randomized, Controlled Trials Interpretive Bias in Acupuncture Research? [Comparative studies of the effectiveness of brief psychotherapy, acupuncture and papaverin therapy in patients with irritable bowel syndrome]. Acupuncture in patients with chronic low back pain: a randomized controlled trial. Acupuncture for irritable bowel syndrome: a blinded placebo-controlled trial. Sham device v inert pill: randomised controlled trial of two placebo treatments Unequal group sizes in randomised trials: guarding against guessing How well are randomized controlled trials reported in the dermatology literature? Mindfulness Training Reduces the Severity of Irritable Bowel Syndrome in Women: Results of a Randomized Controlled Trial Acupuncture for patients with migraine: a randomized controlled trial. Predictive value of the rome criteria for diagnosing the irritable bowel syndrome Tegaserod, a 5‐HT4 receptor partial agonist, relieves symptoms in irritable bowel syndrome patients with abdominal pain, bloating and constipation Standards for reporting interventions in controlled trials of acupuncture: the STRICTA recommendations. Predictors of health care seeking for irritable bowel syndrome: a population based study The impact of patient expectations on outcomes in four randomized controlled trials of acupuncture in patients with chronic pain Validation of a specific quality of life questionnaire for functional digestive disorders Adverse events following acupuncture: prospective survey of 32 000 consultations with doctors and physiotherapists Rectal Hypersensitivity Reduced by Acupoint TENS in Patients with Diarrhea-Predominant Irritable Bowel Syndrome: A Pilot Study Active albuterol or placebo, sham acupuncture, or no intervention in asthma. Acupuncture compared to placebo‐acupuncture for postoperative nausea and vomiting prophylaxis: A randomised placebo‐controlled patient and observer blind trial Introducing a placebo needle into acupuncture research How bad are the symptoms and bowel dysfunction of patients with the irritable bowel syndrome? A prospective, controlled study with emphasis on stool form. Lessons from a Trial of Acupuncture and Massage for Low Back Pain: Patient Expectations and Treatment Effects Acupuncture Treatment for Irritable Bowel Syndrome The role of acupuncture in the treatment of irritable bowel syndrome: a pilot study. Symptom Management for Irritable Bowel Syndrome: A Pilot Randomized Controlled Trial of Acupuncture/Moxibustion Randomised clinical trial comparing the effects of acupuncture and a newly designed placebo needle in rotator cuff tendinitis [Clinical observation on acupuncture combined with microorganism pharmaceutical preparations for treatment of irritable bowel syndrome of constipation type]. Acupuncture for Irritable Bowel Syndrome – An Exploratory Randomised Controlled Trial Acupuncture treatment in irritable bowel syndrome Clinical evaluation of Soothing Gan (肝) and invigorating Pi (脾) acupuncture treatment on diarrhea-predominant irritable bowel syndrome
: No currently available treatment provides consistent relief of irritable bowel syndrome . Colonic sensory and motor function are modulated partly through 5HT3‐receptors Background The approximately 1100 medical journals now active in China are publishing a rapidly increasing number of research reports , including many studies identified by their authors as r and omized controlled trials . It has been noticed that these reports mostly present positive results , and their quality and authenticity have consequently been called into question . We investigated the adequacy of r and omization  of clinical trials published in recent years in China to determine how many of them met acceptable st and ards for allocating participants to treatment groups . Methods The China National Knowledge Infrastructure electronic data base was search ed for reports of r and omized controlled trials on 20 common diseases published from January 1994 to June 2005 . From this sample , a subset of trials that appeared to have used r and omization methods was selected . Twenty-one investigators trained in the relevant knowledge , communication skills and quality control issues interviewed the original authors of these trials about the participant r and omization methods and related quality -control features of their trials . Results From an initial sample of 37,313 articles identified in the China National Knowledge Infrastructure data base , we found 3137 apparent r and omized controlled trials . Of these , 1452 were studies of conventional medicine ( published in 411 journals ) and 1685 were studies of traditional Chinese medicine ( published in 352 journals ) . Interviews with the authors of 2235 of these reports revealed that only 207 studies adhered to accepted methodology for r and omization and could on those grounds be deemed authentic r and omized controlled trials ( 6.8 % , 95 % confidence interval 5.9–7.7 ) . There was no statistically significant difference in the rate of authenticity between r and omized controlled trials of traditional interventions and those of conventional interventions . R and omized controlled trials conducted at hospitals affiliated to medical universities were more likely to be authentic than trials conducted at level 3 and level 2 hospitals ( relative risk 1.58 , 95 % confidence interval 1.18–2.13 , and relative risk 14.42 , 95 % confidence interval 9.40–22.10 , respectively ) . The likelihood of authenticity was higher in level 3 hospitals than in level 2 hospitals ( relative risk 9.32 , 95 % confidence interval 5.83–14.89 ) . All r and omized controlled trials of pre-market drug clinical trial were authentic by our criteria . Of the trials conducted at university-affiliated hospitals , 56.3 % were authentic ( 95 % confidence interval 32.0–81.0 ) . Conclusion Most reports of r and omized controlled trials published in some Chinese journals lacked an adequate description of r and omization . Similarly , most so called ' r and omized controlled trials ' were not real r and omized controlled trials owing toa lack of adequate underst and ing on the part of the authors of rigorous clinical trial design . All r and omized controlled trials of pre-market drug clinical trial included in this research were authentic . R and omized controlled trials conducted by authors in high level hospitals , especially in hospitals affiliated to medical universities had a higher rate of authenticity . That so many non-r and omized controlled trials were published as r and omized controlled trials reflected the fact that peer review needs to be improved and a good practice guide for peer review including how to identify the authenticity of the study urgently needs to be developed OBJECTIVES : This study aim ed to compare the effects of true and sham acupuncture in relieving symptoms of  irritable bowel syndrome ( IBS ) .  METHODS : A total of 230 adult IBS patients ( 75 % females , average age : 38.4 years ) were r and omly assigned to 3 weeks of true or sham acupuncture ( 6 treatments ) after a 3-week “ run-in ” with sham acupuncture in an “ augmented ” or “ limited ” patient – practitioner interaction . A third arm of the study included a waitlist control group . The primary outcome was the IBS Global Improvement Scale ( IBS-GIS ) ( range : 1–7 ) ; secondary outcomes included the IBS Symptom Severity Scale ( IBS-SSS ) , the IBS Adequate Relief ( IBS-AR ) , and the IBS Quality of Life ( IBS-QOL ) . RESULTS : Although there was no statistically significant difference between acupuncture and sham acupuncture on the IBS-GIS ( 41 vs. 32 % , P=0.25 ) , both groups improved significantly compared with the waitlist control group ( 37 vs. 4 % , P=0.001 ) . Similarly , small differences that were not statistically significant favored acupuncture over the other three outcomes : IBS-AR ( 59 vs. 57 % , P=0.83 ) , IBS-SSS ( 31 vs. 21 % , P=0.18 ) , and IBS-QOL ( 17 vs. 13 % , P=0.56 ) . Eliminating responders during the run-in period did not substantively change the results . Side effects were generally mild and only slightly greater in the acupuncture group . CONCLUSIONS : This study did not find evidence to support the superiority of acupuncture compared with sham acupuncture in the treatment of IBS OBJECTIVES : Gut-directed hypnotherapy has been found to be effective in  irritable bowel syndrome ( IBS ) .  However , r and omized , controlled studies are rare and few have been performed outside highly specialized research centers . The objective of this study was to study the effect of gut-directed hypnotherapy in IBS in different clinical setting s outside the traditional research units . METHODS : The study population included IBS patients refractory to st and ard management . In study 1 , patients were r and omized to receive  gut-directed hypnotherapy  ( 12 sessions , 1 h/week ) in psychology private practice s or supportive therapy , whereas patients were r and omized to receive gut-directed hypnotherapy  in a small county hospital or to serve as waiting list controls in study 2 . Gastrointestinal symptom severity and quality of life were evaluated at baseline , at 3 months follow-up and after 1 year . RESULTS : We r and omized 138 IBS patients refractory to st and ard management , 90 in study 1 and 48 in study 2 . In both the studies , IBS-related symptoms were improved at 3 months in the gut-directed hypnotherapy groups ( P<0.05 ) , but not in the control groups ( ns ) . In study 1 , a significantly greater improvement of IBS-related symptom severity could be detected in the gut-directed hypnotherapy group than in the control group ( P<0.05 ) , and a trend in the same direction was seen in study 2 ( P=0.17 ) . The results seen at 3 months were sustained up to 1 year . CONCLUSIONS : Gut-directed hypnotherapy is an effective treatment alternative for patients with refractory IBS , but the effectiveness is lower when the therapy is given outside the highly specialized research centers Acupuncture is one of the most widely used and broadly research ed of the complementary and alternative therapies , but high- quality trials generally show no benefit over sham acupuncture . Many would view this result as evidence of ineffectiveness for this intervention . This discussion article focuses on the report of a large multicenter r and omized controlled trial of  acupuncture for chronic low-back pain ( CLBP ) in the lay and academic press , the ensuing discussion , and its impact on both clinical practice and service provision . The authors suggest that interpretive bias has affected reporting , leading to question able conclusions and advocacy in favor of this form of care that may exceed the evidence . They also suggest that a lack of underst and ing of research into the placebo effect may have contributed to confusion in the interpretation of these trials At a comparison among 5 therapy methods the  small psychotherapy  with a success-rate of 74 % is high-significantly more prospero us than the other examined methods . The acupuncture with 31 % long-term success is significantly superior to the  pseudoacupuncture  ( 17.2 % ) . The papaverine therapy results in a long-lasting status free of symptoms in 17.2 % of the patients and is significantly different from the results of the papaverine-placebo-therapy ( 0 % ) . Distinct differences in the success-rates of the  small psychotherapy  with different therapists prove the role of the personality and the perfection in mastering the methods with psychotherapeutic procedures . Comparable differences between the examiners were not found among the effects of a spasmolytic therapy BACKGROUND Acupuncture is widely used by patients with low back pain , although its effectiveness is unclear . We investigated the efficacy of acupuncture compared with minimal acupuncture and with no acupuncture in patients with chronic low back pain .  METHODS Patients were r and omized to treatment with acupuncture , minimal acupuncture ( superficial needling at nonacupuncture points ) , or a waiting list control . Acupuncture and minimal acupuncture were administered by specialized acupuncture physicians in 30 outpatient centers , and consisted of 12 sessions per patient over 8 weeks . Patients completed st and ardized question naires at baseline and at 8 , 26 , and 52 weeks after r and omization . The primary outcome variable was the change in low back pain intensity from baseline to the end of week 8 , as determined on a visual analog scale ( range , 0 - 100 mm ) . RESULTS A total of 298 patients ( 67.8 % female ; mean + /- SD age , 59 + /- 9 years ) were included . Between baseline and week 8 , pain intensity decreased by a mean + /- SD of 28.7 + /- 30.3 mm in the acupuncture group , 23.6 + /- 31.0 mm in the minimal acupuncture group , and 6.9 + /- 22.0 mm in the waiting list group . The difference for the acupuncture vs minimal acupuncture group was 5.1 mm ( 95 % confidence interval , -3.7 to 13.9 mm ; P = .26 ) , and the difference for the acupuncture vs waiting list group was 21.7 mm ( 95 % confidence interval , 13.9 - 30.0 mm ; P<.001 ) . Also , at 26 ( P=.96 ) and 52 ( P=.61 ) weeks , pain did not differ significantly between the acupuncture and the minimal acupuncture groups . CONCLUSION Acupuncture was more effective in improving pain than no acupuncture treatment in patients with chronic low back pain , whereas there were no significant differences between acupuncture and minimal acupuncture AIM Irritable bowel syndrome ( IBS ) is a common disorder and many patients fail to find adequate relief from conventional therapies for their symptoms . This study tests the cl aim that acupuncture is effective for a majority of these patients . METHODS A prospect i ve , blinded , sham acupuncture-controlled trial of traditional Chinese acupuncture was performed at a single postgraduate teaching hospital in Europe . Sixty patients with well-established IBS were recruited . The blinded comparator was sham acupuncture administered by the second of two acupuncturists who alone was aware of the r and omization , and who otherwise followed the prescription of the first . The primary end-point was a defined fall in the symptom score at 13 wk ( by intention to treat ) . The prior expectation was a 30 % placebo response , and a response rate of 70 % from acupuncture , for which the study was adequately powered . RESULTS Patients in treated and sham groups improved significantly during the study -mean improvement in scores being equal ( minus 1.9 ) and significant for both ( P<0.05 ; one-tailed t test ) . There was a small numeric but non-significant difference between the response rate in patients receiving acupuncture ( 40.7 % ) and sham treatment ( 31.2 % ) . Several secondary end-points marginally favored active treatment , but an improved symptom score of any degree of magnitude occurred more often with sham therapy ( 65.6 % vs 59.2 % ) . For no criterion was statistical significance approached . CONCLUSION Traditional Chinese acupuncture is relatively ineffective in IBS in the European hospital setting , and the magnitude of any effect appears insufficient to warrant investment in acupuncture services Abstract Objective To investigate whether a sham device ( a vali date d sham acupuncture needle ) has a greater placebo effect than an inert pill in patients with persistent arm pain . Design A single blind r and omised controlled trial created from the two week placebo run-in periods for two nested trials that compared acupuncture and amitriptyline with their respective placebo controls . Comparison of participants who remained on placebo continued beyond the run-in period to the end of the study . Setting Academic medical centre . Participants 270 adults with arm pain due to repetitive use that had lasted at least three months despite treatment and who scored ≥3 on a 10 point pain scale . Interventions Acupuncture with sham device twice a week for six weeks or placebo pill once a day for eight weeks . Main outcome measures Arm pain measured on a 10 point pain scale . Secondary outcomes were symptoms measured by the Levine symptom severity scale , function measured by Pransky 's upper extremity function scale , and grip strength . Results Pain decreased during the two week placebo run-in period in both the sham device and placebo pill groups , but changes were not different between the groups ( −0.14 , 95 % confidence interval −0.52 to 0.25 , P = 0.49 ) . Changes in severity scores for arm symptoms and grip strength were similar between groups , but arm function improved more in the placebo pill group ( 2.0 , 0.06 to 3.92 , P = 0.04 ) . Longitudinal regression analyses that followed participants throughout the treatment period showed significantly greater downward slopes per week on the 10 point arm pain scale in the sham device group than in the placebo pill group ( −0.33 ( −0.40 to −0.26 ) v −0.15 ( −0.21 to −0.09 ) , P = 0.0001 ) and on the symptom severity scale ( −0.07 ( −0.09 to −0.05 ) v −0.05 ( −0.06 to −0.03 ) , P = 0.02 ) . Differences were not significant , however , on the function scale or for grip strength . Reported adverse effects were different in the two groups . Conclusions The sham device had greater effects than the placebo pill on self reported pain and severity of symptoms over the entire course of treatment but not during the two week placebo run in . Placebo effects seem to be malleable and depend on the behaviours embedded in medical rituals We cringe at the pervasive notion that a r and omised trial needs to yield equal sample sizes in the comparison groups . Unfortunately , that conceptual misunderst and ing can lead to bias by investigators who force e quality , especially if by non-scientific means . In simple , unrestricted , r and omised trials ( analogous to repeated coin-tossing ) , the sizes of groups should indicate r and om variation . In other words , some discrepancy between the numbers in the comparison groups would be expected . The appeal of equal group sizes in a simple r and omised controlled trial is cosmetic , not scientific . Moreover , other r and omisation schemes , termed restricted r and omisation , force e quality by departing from simple r and omisation . Forcing equal group sizes , however , potentially harms the unpredictability of treatment assignments , especially when using permuted-block r and omisation in non-double-blinded trials . Diminished unpredictability can allow bias to creep into a trial . Overall , investigators underuse simple r and omisation and overuse fixed-block r and omisation . For non-double-blinded trials larger than 200 participants , investigators should use simple r and omisation more often and accept moderate disparities in group sizes . Such unpredictability reflects the essence of r and omness . We endorse the generation of mildly unequal group sizes and encourage an appreciation of such inequalities . For non-double-blinded r and omised controlled trials with a sample size of less than 200 overall or within any principal stratum or subgroup , urn r and omisation enhances unpredictability compared with blocking . A simpler alternative , our mixed r and omisation approach , attains unpredictability within the context of the currently understood simple r and omisation and permuted-block methods . Simple r and omisation contributes the unpredictability whereas permuted-block r and omisation contributes the balance , but avoids the perfect balance that can result in selection bias OBJECTIVE To assess the method ological quality of the design and reporting of  r and omized controlled trials published in one major dermatology specialty journal . DESIGN AND DATA SOURCES In a survey of all published parallel group r and omized controlled trials , we found 73 reports with allocation described as r and omized from all issues of Clinical and Experimental Dermatology from its inception in 1976 through 1997 . MAIN OUTCOME MEASURES Direct and indirect measures of the adequacy of r and omization , trial sample size , baseline comparisons , and intention-to-treat analysis . RESULTS H and search ing identified 73 r and omized controlled trials , but only 31 of these were found by search ing MEDLINE for the publication type clinical trials . Of the 73 r and omized controlled trials , 68 contained sufficient information to include in the analysis . Only 1 study ( 1 % ) reported the method of r and om sequence generation , and only 5 studies ( 7 % ) reported adequate concealment of allocation . Among 38 trials that used simple r and omization , the sample sizes in the comparison groups were identical in 22 occasions , raising the possibility that simple r and omization might not have been adequately generated or concealed . Most trials ( 88 % ) excluded some r and omized participants from their analysis . The median sample size was 23 per trial . Only 1 trial reported sample size and statistical power considerations and had an a priori main hypothesis . CONCLUSIONS H and search ing is important for locating all relevant trials . There is the need for higher method ological quality in clinical trial reporting in dermatology journals . The adoption of the CONSORT ( Consoli date d St and ards of Reporting Trials ) statement and checklist for the reporting of trials should enhance the validity of and strengthen the evidence from clinical trials reports OBJECTIVES : This prospect i ve , r and omized controlled trial explored the feasibility and efficacy of a group program of mindfulness training , a cognitive-behavioral technique , for women with irritable bowel syndrome ( IBS ) . The technique involves training in intentionally attending to present-moment experience and non-judgmental awareness of body sensations and emotions . METHODS : Seventy-five female IBS patients were r and omly assigned to eight weekly and one half-day intensive sessions of either mindfulness group ( MG ) training or a support group ( SG ) . Participants completed the IBS severity scale ( primary outcome ) , IBS- quality of life , brief symptom inventory-18 , visceral sensitivity index , treatment credibility scale , and five-facet mindfulness question naire before and after treatment and at 3-month follow-up . RESULTS : Women in the MG showed greater reductions in IBS symptom severity immediately after training ( 26.4 % vs. 6.2 % reduction ; P=0.006 ) and at 3-month follow-up ( 38.2 % vs. 11.8 % ; P=0.001 ) relative to SG . Changes in quality of life , psychological distress , and visceral anxiety were not significantly different between groups immediately after treatment , but evidence d significantly greater improvements in the MG than in the SG at the 3-month follow-up . Mindfulness scores increased significantly more in the MG after treatment , confirming effective learning of mindfulness skills . Participants ’ ratings of the credibility of their assigned interventions , measured after the first group session , were not different between groups . CONCLUSIONS : This r and omized controlled trial demonstrated that mindfulness training has a substantial therapeutic effect on bowel symptom severity , improves health-related quality of life , and reduces distress . The beneficial effects persist for at least 3 months after group training CONTEXT Acupuncture is widely used to prevent migraine attacks , but the available evidence of its benefit is scarce . OBJECTIVE To investigate the effectiveness of acupuncture compared with sham acupuncture and with no acupuncture in patients with migraine . DESIGN , SETTING , AND PATIENTS Three-group , r and omized , controlled trial ( April 2002-January 2003 ) involving 302 patients ( 88 % women ) , mean ( SD ) age of 43 ( 11 ) years , with migraine headaches , based on International Headache Society criteria . Patients were treated at 18 outpatient centers in Germany . INTERVENTIONS Acupuncture , sham acupuncture , or waiting list control . Acupuncture and sham acupuncture were administered by specialized physicians and consisted of 12 sessions per patient over 8 weeks . Patients completed headache diaries from 4 weeks before to 12 weeks after r and omization and from week 21 to 24 after r and omization . MAIN OUTCOME MEASURES Difference in headache days of moderate or severe intensity between the 4 weeks before and weeks 9 to 12 after r and omization . RESULTS Between baseline and weeks 9 to 12 , the mean ( SD ) number of days with headache of moderate or severe intensity decreased by 2.2 ( 2.7 ) days from a baseline of 5.2 ( 2.5 ) days in the acupuncture group compared with a decrease to 2.2 ( 2.7 ) days from a baseline of 5.0 ( 2.4 ) days in the sham acupuncture group , and by 0.8 ( 2.0 ) days from a baseline if 5.4 ( 3.0 ) days in the waiting list group . No difference was detected between the acupuncture and the sham acupuncture groups ( 0.0 days , 95 % confidence interval , -0.7 to 0.7 days ; P = .96 ) while there was a difference between the acupuncture group compared with the waiting list group ( 1.4 days ; 95 % confidence interval ; 0.8 - 2.1 days ; P<.001 ) . The proportion of responders ( reduction in headache days by at least 50 % ) was 51 % in the acupuncture group , 53 % in the sham acupuncture group , and 15 % in the waiting list group . CONCLUSION Acupuncture was no more effective than sham acupuncture in reducing migraine headaches although both interventions were more effective than a waiting list control Objective : Our aim was to examine the predictive value of the Rome criteria and absence of so-called “ red flags ” of clinical practice for diagnosing  irritable bowel syndrome .  Red flags were relevant abnormalities on physical examination , documented weight loss , nocturnal symptoms , blood in stools , history of antibiotic use , and family history of colon cancer . Methods : In retrospective studies , 98 patients who had one or more Rome criteria and lacked red flags were identified by chart review of a 1-yr period . In prospect i ve studies , 95 patients were identified who met the Rome criteria and lacked red flags .  Sensitivity , specificity , predictive value of Rome criteria , and absence of red flags were determined . Consultant 's final diagnosis was the gold st and ard . Investigations before and after referral were recorded and reason for referral was determined in prospect i ve studies . Results : In the retrospective series , the Rome criteria and absence of red flags had a sensitivity of 65 % , specificity of 100 % , and positive predictive value of 100 % . None of these patients required revision of their diagnosis during a 2-yr follow-up . In the prospect i ve study , the positive predictive value was 98 % . More than 50 % of the patients in this group had been referred because of diagnostic uncertainty and 24 % had had an abdominal ultrasound ; 66 % of those < 45 yr old underwent at least partial colonic evaluation . Conclusion : These findings suggest that the Rome criteria combined with a lack of red flags have a very high predictive value for diagnosing  irritable bowel syndrome .  Application of these diagnostic criteria has the potential to alter utilization of health care re sources To investigate the efficacy and safety of tegaserod , a novel 5‐HT4 receptor partial agonist , in a r and omized , double‐blind , placebo‐controlled , 12‐week treatment , multicentre study Acupuncture treatment and control group interventions in parallel-group r and omised trials of acupuncture are not always precisely reported . In an attempt to improve st and ards , an international group of experienced acupuncturists and research ers devised a set of recommendations , design ating them STRICTA : ST and ards for Reporting Interventions in Controlled Trials of Acupuncture . In a further consensus-building round , the editors of several journals helped redraft the recommendations . These follow the Consoli date d St and ards for Reporting Trials ( CONSORT ) format , acting as an extension of the CONSORT guidelines for the specific requirements of acupuncture studies . Participating journals are publishing the STRICTA recommendations and requesting prospect i ve authors to adhere to them when preparing reports for publication . Other journals are invited to adopt these recommendations . The intended outcome is that interventions in controlled trials of acupuncture  will be more adequately reported , thereby facilitating an improvement in critical appraisal , analysis and replication of trials Background —It has been suggested that psychological factors rather than symptoms drive subjects with irritable bowel syndrome ( IBS ) to seek medical care , but this issue has not been tackled in a population based study . Aim —To identify whether psychological factors or abuse explain health care seeking for IBS . Methods —A sample of residents of Penrith ( a Sydney suburb representative of the Australian population ) selected r and omly from the electoral rolls ( that by law include the entire population ⩾18 years ) was mailed a vali date d self-report question naire . Measured were gastrointestinal symptoms including the Manning ( and Rome ) criteria for IBS , health care seeking , neuroticism ( Eysenck Personality Question naire ) , psychological morbidity ( General Health Question naire : GHQ ) and sexual , physical and emotional abuse ( including the st and ardised Drossman questions ) . Results —Among 730 subjects , 96 ( 13 % , 95 % confidence interval ( CI ) 11–16 % ) had IBS by the Manning criteria . Of those with IBS , 73 % ( 95 % CI 63–81 % ) had sought medical care for abdominal pain or discomfort . Only increasing pain severity ( odds ratio ( OR ) = 2.10 , 95 % CI 1.11–3.95 ) and duration of pain ( OR=1.53 , 95 % CI 1.10–2.13 ) were independently associated with seeking health care for IBS . Pain severity was also predictive of recent care seeking ( OR=1.74 , 95 % CI 1.12–1.96 ) . Neuroticism , psychological morbidity and abuse history were not significant predictors . Conclusion —Psychological factors do not seem to explain health care seeking among community subjects with IBS Abstract In a pooled analysis of four r and omized controlled trials of acupuncture in patients with migraine , tension‐type headache , chronic low back pain , and osteoarthritis of the knee we investigated the influence of expectations on clinical outcome . The 864 patients included in the analysis received either 12 sessions of  acupuncture or minimal ( i.e. sham ) acupuncture ( superficial needling of non‐acupuncture points ) over an 8 week period . Patients were asked at baseline whether they considered acupuncture to be an effective therapy in general and what they personally expected from the treatment . After three acupuncture sessions patients were asked how confident they were that they would benefit from the treatment strategy they were receiving . Patients were classified as responders if the respective main outcome measure improved by at least fifty percent . Both univariate and multivariate analyses adjusted for potential confounders ( such as condition , intervention group , age , sex , duration of complaints , etc . ) consistently showed a significant influence of attitudes and expectations on outcome . After completion of treatment , the odds ratio for response between patients considering acupuncture an effective or highly effective therapy and patients who were more sceptical was 1.67 ( 95 % confidence interval 1.20–2.32 ) . For personal expectations and confidence after the third session , odds ratios were 2.03 ( 1.26–3.26 ) and 2.35 ( 1.68–3.30 ) , respectively . Results from the 6‐month follow‐up were similar . In conclusion , in our trials a significant association was shown between better improvement and higher outcome expectations BACKGROUND Dyspepsia and irritable bowel syndrome are suitable conditions for assessment of quality of life . Their similarities justify the elaboration of a single specific question naire for the two conditions . AIMS To examine the process leading to the validation of the psychometric properties of the functional digestive disorders  quality of life question naire ( FDDQL ) . METHODS Initially , the question naire was given to 154 patients , to assess its acceptability and reproducibility , analyse its content , and reduce the number of items . Its responsiveness was tested during two therapeutic trials which included 428 patients . The question naire has been translated into French , English , and German . The psychometric validation study was conducted in France , United Kingdom , and Germany by 187 practitioners . A total of 401 patients with dyspepsia or irritable bowel syndrome , defined by the Rome criteria , filled in the FDDQL and generic SF-36 question naires . RESULTS The structure of the FDDQL scales was checked by factorial analysis . Its reliability was expressed by a Cronbach ’s α coefficient of 0.94 . Assessment of its discriminant validity showed that the more severe the functional digestive disorders , the more impaired the quality of life ( p<0.05 ) . Concurrent validity was supported by the correlation found between the FDDQL and SF-36 question naire scales . The final version of the question naire contains 43 items belonging to eight domains . CONCLUSIONS The properties of the FDDQL question naire , available in French , English , and German , make it appropriate for use in clinical trials design ed to evaluate its responsiveness to treatment among patients with dyspepsia and irritable bowel syndrome Acupuncture is increasingly popular , but it is not free from risk for the patient.1 Safety is best established with prospect i ve surveys . Our aim was to ascertain the incidence of adverse events related to acupuncture treatment , as currently practised in Britain by doctors and physiotherapists . Volunteer acupuncture practitioners were recruited through journals circulated to members of the British Medical Acupuncture Society and the Acupuncture Association of Chartered Physiotherapists ( approximately 2750 members).2 A prospect i ve survey was undertaken using forms for intensive event monitoring that had been piloted previously.3 Minor adverse events were defined as “ any ill-effect , no matter how small , that is unintended and non-therapeutic , even if not unexpected . ” These events were reported every month , along with the total number of consultations . Minor or serious events that were considered to be “ significant”—“unusual , novel , dangerous , significantly inconvenient , or requiring further information”—were reported on separate forms when they occurred . Anonymous reporting was accepted . A sample size of Our aim was to compare rectal perception of patients with diarrhea-predominant irritable bowel syndrome ( IBS-D ) , constipation-predominant irritable bowel syndrome ( IBS-C ) , functional constipation ( FC ) , and healthy controls and to evaluate the therapeutic effect of acupoint transcutaneous electric nerve stimulation ( TENS ) .  Age- and sex-matched patients ( 24 IBS-D , 20 IBS-C , and 30 FC ) were selected , and 30 volunteers served as healthy controls . Rectal sensory thresholds were evaluated by  rectal balloon distension . Short- and long-term acupoint TENS was given respectively . IBS-D patients had significantly lower rectal sensory thresholds of the first sensation of stool , urgency of defecation , and pain than IBS-C or FC patients or healthy controls ( P < 0.05 ) , but there were no differences in rectal sensory thresholds among IBS-C and FC patients and healthy controls . In each group , females had significantly lower rectal sensory thresholds than males ( P < 0.05 ) , but there was no difference between younger ( ≤50 years old ) and older ( > 50 years old ) patients . Short-term acupoint TENS  increased rectal sensory thresholds of IBS-D patients . After 2-month acupoint TENS treatment in IBS-D patients , rectal sensory thresholds were significantly increased , stool times and the intensity of abdominal pain were decreased , and psychological scores were relieved to normal . Lowered rectal perception threshold is a hallmark of IBS-D patients . Females have significantly lower rectal sensory thresholds than males . Acupoint TENS is effective to treat BACKGROUND In prospect i ve experimental studies in patients with asthma , it is difficult to determine whether responses to placebo differ from the natural course of physiological changes that occur without any intervention . We compared the effects of a bronchodilator , two placebo interventions , and no intervention on outcomes in patients with asthma . METHODS In a double-blind , crossover pilot study , we r and omly assigned 46 patients with asthma to active treatment with an albuterol inhaler , a placebo inhaler , sham acupuncture , or no intervention . Using a block design , we administered one each of these four interventions in r and om order during four sequential visits ( 3 to 7 days apart ) ; this procedure was repeated in two more blocks of visits ( for a total of 12 visits by each patient ) . At each visit , spirometry was performed repeatedly over a period of 2 hours . Maximum forced expiratory volume in 1 second ( FEV(1 ) ) was measured , and patients ' self-reported improvement ratings were recorded . RESULTS Among the 39 patients who completed the study , albuterol result ed in a 20 % increase in FEV(1 ) , as compared with approximately 7 % with each of the other three interventions ( P<0.001 ) . However , patients ' reports of improvement after the intervention did not differ significantly for the albuterol inhaler ( 50 % improvement ) , placebo inhaler ( 45 % ) , or sham acupuncture ( 46 % ) , but the subjective improvement with all three of these interventions was significantly greater than that with the no-intervention control ( 21 % ) ( P<0.001 ) . CONCLUSIONS Although albuterol , but not the two placebo interventions , improved FEV(1 ) in these patients with asthma , albuterol provided no incremental benefit with respect to the self-reported outcomes . Placebo effects can be clinical ly meaningful and can rival the effects of active medication in patients with asthma . However , from a clinical -management and research - design perspective , patient self-reports can be unreliable . An assessment of untreated responses in asthma may be essential in evaluating patient-reported outcomes . ( Funded by the National Center for Complementary and Alternative Medicine . ) This r and omised , placebo‐controlled , patient and observer blinded trial was conducted to determine whether acupuncture at the acupuncture point P6 is effective in preventing postoperative nausea and vomiting ( PONV ) compared to placebo acupuncture .  Female patients ( n = 220 ) scheduled for gynaecological or breast surgery were r and omly assigned to two groups receiving either acupuncture ( n = 109 ) or placebo acupuncture ( n = 111 ) . Each group was stratified for type of surgery and included two subgroups receiving intervention either before or after induction of anaesthesia . The incidence of PONV and /or antiemetic rescue medication within 24 h after surgery was the main outcome measure which showed no statistically significant difference between groups ( 43.7 % acupuncture , 50.9 % placebo , p = 0.27 ) . The differences were more pronounced for patients having gynaecological surgery ( 48.9 % acupuncture , 67.6 % placebo , p = 0.07 ) than for those having breast surgery ( 38.7 % acupuncture , 40.3 % placebo , p = 0.86 ) . The secondary outcome , vomiting , was significantly reduced by acupuncture from 39.6 % to 24.8 % ( p = 0.03 ) . Subgroup analysis showed no difference between applications of acupuncture before compared to after induction of anaesthesia BACKGROUND A problem acupuncture research has to face is the concept of a control group . If , in control groups , non-acupoint needling is done , physiological acupuncture effects are implied . Therefore the effects shown in this group are often close to those shown in the acupuncture group . In other trials , control groups have received obviously different treatments , such as transcutaneous electrical nervous stimulation or TENS-laser treatment ; it is not clear if the effects of acupuncture are due only to the psychological effects of the treatment . METHODS We developed a placebo acupuncture needle , with which it should be possible to simulate an acupuncture procedure without penetrating the skin . In a cross-over experiment with 60 volunteers we tested whether needling with the placebo needle feels any different from real acupuncture . FINDINGS Of 60 volunteers , 54 felt a penetration with acupuncture  ( mean visual analogue scale [ VAS ] 13.4 ; SD 10.58 ) and 47 felt it with placebo ( VAS 8.86 ; SD 10.55 ) , 34 felt a dull pain sensation ( DEQI ) with acupuncture and 13 with placebo . None of the volunteers suspected that the needle may not have penetrated the skin . INTERPRETATION The placebo needle is sufficiently credible to be used in investigations of the effects of acupuncture Since it is not known whether the symptoms and bowel function of patients with the irritable bowel syndrome are truly abnormal we used diaries and frequent telephone interviews over a 31 day period to assess symptoms , defecation , and stool types in 26 unselected female hospital patients with the irritable bowel syndrome , 27 women who admitted to recurrent colonic pain but had not consulted a doctor ( non-complainers ) , and 27 healthy control subjects . Unexpectedly , abdominal pain and bloating occurred in most of the control subjects . Pain , however , was six times more frequent in the patients and was more often considered severe . Bloating occurred three times more often . Defecation was more frequent , more erratic in timing and stool form , and more likely to produce stools of extreme forms , indicating rapid fluctuations in intestinal transit time . Urgency was four times more prevalent in patients than control subjects . Straining to finish defecating was nine times more prevalent and was often accompanied by feelings of incomplete evacuation -- a combination which could lead to the misdiagnosis of constipation . The normal relation between stool form and the above symptoms was distorted , possibly due to rectal irritability . Non-complainers were intermediate between patients and control subjects in almost every parameter but were closer to control subjects than to patients . Patients with the irritable bowel syndrome have real cause for complaint and their bowel function is truly abnormal Study Design . A sub analysis of data derived from a r and omized clinical trial was performed . Objective . To evaluate the association of a patient ’s expectation for benefit from a specific treatment with improved functional outcome . Summary of Background Data . Psychosocial factors , ambiguous diagnoses , and lack of a clearly superior treatment have complicated the management of patients with chronic low back pain . The authors hypothesized that patient expectation for benefit from a specific treatment is associated with improved functional outcomes when that treatment is administered . Methods . In a r and omized trial , 135 patients with chronic low back pain who received acupuncture or massage were studied . Before r and omization , study participants were asked to describe their expectations regarding the helpfulness of each treatment on a scale of 0 to 10 . The primary outcome was level of function at 10 weeks as measured by the modified Rol and Disability scale . Results . After adjustment for baseline characteristics , improved function was observed for 86 % of the participants with higher expectations for the treatment they received , as compared with 68 % of those with lower expectations ( P = 0.01 ) . Furthermore , patients who expected greater benefit from massage than from acupuncture were more likely to experience better outcomes with massage than with acupuncture , and vice versa ( P = 0.03 ) . Conclusions . The results of this study suggest that patient expectations may influence clinical outcome independently of the treatment itself . In contrast , general optimism about treatment , divorced from a specific treatment , is not strongly associated with outcome . These results may have important implication s for clinical trial design and recruitment , and may help to explain the apparent success of some conventional and alternative therapies in trials that do not control for patient expectations . The findings also may be important for therapy choices made in the clinical setting Background / Aim : Irritable bowel syndrome is one of the most common gastrointestinal disorders in Western society , affecting around 15 % of the population , especially young adults . The cause(s ) of irritable bowel syndrome and effective treatment(s ) have remained elusive . This study aim ed at exploring the therapeutic value of acupuncture by comparing the responses of irritable bowel syndrome sufferers to true acupuncture versus sham acupuncture in a controlled double-blind study . Methods : Twenty-five patients who fulfilled the Rome criteria ( irritable bowel syndrome symptoms persisting for more than 1 year ) comprised the final study population . They were recruited through a ‘ call for ’ bulletin sent to gastroenterologists practicing in the region of our medical center .  True acupuncture was performed at LI-4 ( colonic meridian , needle only ) and sham acupuncture at BL-60 ( urinary vesicle meridian , needle only ) . Patient assignment to one of the two groups was r and om . Results : The effect of the first true acupuncture on overall symptoms and abdominal pain was a clear and significant improvement ( p = 0.05 ) . No comparable effect was seen in the second session . Conclusions : Although the true acupuncture results were consistently better , no difference was found between the two groups in the overall statistical analysis . We could not show a therapeutic benefit of this treatment modality in irritable bowel syndrome BACKGROUND / AIMS The aim of this pilot study was to investigate the potential value of acupuncture in the treatment of irritable bowel syndrome ( IBS ) . METHODOLOGY The study was an open design study of 7 patients with established irritable bowel syndrome in which assessment was by a diary card . RESULTS The results showed a significant improvement both in general well-being and in symptoms of bloating . CONCLUSIONS Acupuncture seems to be effective in the treatment of irritable bowel syndrome and merits further study The purpose of this pilot study was to assess the effect of an individualized traditional Chinese medicine ( TCM ) acupuncture and moxibustion ( Acu/Moxa ) treatment on symptom control in patients with irritable bowel syndrome ( IBS ) in a preliminary , r and omized , sham/placebo-controlled trial . Twenty-nine men and women with IBS were r and omized to either  individualized Acu/Moxa (  treatment  group ) or sham/placebo Acu/Moxa ( control group ) . All subjects were assessed by a diagnostic acupuncturist for a TCM evaluation and individualized point prescription . Only those subjects assigned to the experimental group received the individually prescribed treatment . The diagnostic acupuncturist did not administer treatments and was blind to treatment assignments . All subjects kept a symptom diary for the duration of the study , enabling measurement of symptom frequency , severity , and improvement . The Clinical Global Impression Scale was administered preintervention to establish baseline severity and on completion of the 4-week , eight-session treatment intervention . After 4 weeks of twice-weekly Acu/Moxa treatment , average daily abdominal pain/discomfort improved whereas the control group showed minimal reduction . This between-group difference adjusted for baseline difference was statistically significant . The intestinal gas , bloating , and stool consistency composite score showed a similar pattern of improvement . The findings indicate that Acu/Moxa treatment shows promise in the area of symptom management for IBS Acupuncture has gained increasing attention in the treatment of  chronic pain .  The lack of a satisfying placebo method has made it impossible to show whether needling is an important part of the method or whether the improvement felt by the patient is due to the therapeutic setting and psychological phenomena . Also , the effectiveness of acupuncture has not been demonstrated sufficiently . We treated 52 sportsmen with rotator cuff tendinitis in a r and omised single-blind clinical trial using a new placebo-needle as control . Patients were treated for 4 weeks . The primary endpoint of the trial was the change in the modified Constant-Murley-score from the baseline . Assessment of the treatment outcome was made by experienced orthopaedists not informed of the treatment allocation . Acupuncture with penetration of the skin was shown to be more effective than a similar therapeutic setting with placebo needling in the treatment of pain . The  acupuncture-group  improved 19.2 Constant-Murley-score points ( SD 16.1 , range from -13 to 50 ) , the  control-group  improved 8.37 points ( SD 14.56 , range from -20 to 41 ) , ( P=0.014 ; C.I. 2.3;19.4 ) . This study showed that needling is an important part of the acupuncture effect in the treatment of  chronic shoulder pain in athletes . No conclusions can be derived from this study concerning the importance of choosing points and the rules of Traditional Chinese Medicine . Using the new placebo method as control for other ailments could improve the evidence of specific  acupuncture effects beyond pain treatment OBJECTIVE To explore the best program for treatment of  irritable bowel syndrome ( IBS ) of constipation type . METHODS Ninety-five cases of IBS were r and omly divided into 3 groups . Group A ( n = 30 ) were treated by acupuncture combined with microorganism pharmaceutical preparations , group B ( n = 35 ) by oral administration of medicine for loosening the bowel to relieve constipation plus microorganism pharmaceutical preparations , and group C ( n = 30 ) by simple acupuncture . RESULTS The total effective rates were 90.0 % , 77.2 % and 66.7 % , in the group A , B and C , respectively , with a very significant differences as the group A compared with those in the groups B , C ( P < 0.01 ) , and with no significant difference as the group B compared with that of the group C ( P > 0 . 05 ) . The intestinal available bacteria , bilidobacteria and lactobacillus , increased and enteric bacilli decreased in varying degrees in the 3 groups . CONCLUSION Acupuncture combined with microorganism pharmaceutical preparations has a better therapeutic effect on irritable bowel syndrome of constipation type Background The evidence on the effectiveness of acupuncture for  irritable bowel syndrome ( IBS ) is inconclusive . However , many patients with IBS are self referring for acupuncture , therefore it is of interest to know whether acupuncture is effective or not . The aim of this study was to establish variability in the primary outcome measure to enable a sample size to be calculated for a full scale trial , and to explore feasibility and design criteria . Methods A pragmatic r and omised controlled trial compared 10 sessions of acupuncture plus usual GP care with usual GP care alone .  Thirty patients were recruited from four GP data bases in Birmingham , UK , and r and omised one-to-two to acupuncture or usual care alone .  The primary outcome was the IBS Symptom Severity Score ( SSS ) at three months ( maximum score 500 ) . Analysis was by intention-to-treat , and multiple imputation was used for missing data . Results From the data bases , 189 patients with IBS were identified , of whom 30 were eligible and consented to r and omisation . At three months , a statistically and clinical ly significant difference between groups of 138 points ( SD 90 ) in favour of acupuncture was observed on the IBS SSS ( 95 % CI : 66 to 210 ; P=0.001 ) using multiple imputation . For a full scale trial , we estimate that a sample size of 108 patients per arm is required , based on a minimum clinical ly significant change of 50 points , drawn from a primary care population of 140 000 . Conclusions We established the feasibility of a full scale trial , successfully recruiting patients and calculating the sample size required . The results of our pilot analysis suggest that more definitive research into acupuncture for IBS is merited . A pragmatic trial design will not be able to distinguish between acupuncture specific effects and placebo effects ; however , it is the design of choice to determine cost effectiveness Background and aims : Despite occasional positive reports on the efficacy of acupuncture ( AC ) on functions of the gastrointestinal tract , there is no conclusive evidence that AC is effective in the treatment of irritable bowel syndrome ( IBS ) . Patients and methods : Forty three patients with IBS according to the Rome II criteria were r and omly assigned to receive either AC ( n = 22 ) or sham acupuncture ( SAC ) ( n = 21 ) using the so-called “ Streitberger needle ” . Treatment duration was 10 sessions with an average of two AC sessions per week . The primary end point was improvement in quality of life ( QOL ) using the functional digestive diseases quality of life question naire ( FDDQL ) and a general quality of life question naire ( SF-36 ) , compared with baseline assessment s. QOL measurements were repeated three months after treatment . Results : Both the AC and SAC groups improved significantly in global QOL , as assessed by the FDDQL , at the end of treatment ( p = 0.022 ) , with no differences between the groups . SF-36 was insensitive to these changes ( except for pain ) . This effect was partially reversed three months later . Post hoc comparison of responders and non-responders in both groups combined revealed a significant prediction of the placebo response by two subscales of the FDDQL ( sleep , coping ) ( F = 6.746 , p = 0.003 ) in a stepwise regression model . Conclusions : Acupuncture in IBS is primarily a placebo response . Based on the small differences found between the AC and SAC groups , a study including 566 patients would be necessary to prove the efficacy of AC over SAC . The placebo response may be predicted by high coping capacity and low sleep quality in individual patients Objective To explore the effect of Soothing Gan ( 肝 ) and invigorating Pi ( 脾 ) ( SGIP ) acupuncture treatment on the clinical symptoms and quality of life ( QOL ) in patients with diarrhea-predominant irritable bowel syndrome ( IBS-D ) . Methods With a single-blinded r and omized control study adopted , 63 patients who met the inclusion criteria were assigned by a r and om number table to two groups , 31 in the treatment group and 32 in the drug control group . The treatment group received SGIP acupuncture therapy ; while the control group was treated orally with pinaverium bromide . The treatment duration of both groups was 28 days . The clinical efficacy was evaluated and compared by scoring patient ’s symptom and QOL . Results A significant difference was found by variance analysis in efficacies between the two groups ( P<0.01 ) , shown as the quicker initiation of effect ( P<0.05 ) and the more evident clinical improvement in symptoms along the increase in treatment duration , as well as the more significant elevation of QOL in the acupuncture treatment group ( P<0.01 ) . SGIP displayed its superiority especially in improving dysphoria , conflict behavior , dietary restrictions , and social responses . ConclusionS GIP acupuncture treatment could effectively alleviate the degree and frequency of symptoms ’ attack in IBS-D patients , such as abdominal pain , diarrhea , abdominal distension , etc . , markedly relieve the tenesmic sensation , with the efficacy better than that of pinaverium bromide , showing a preponderance in improving patient ’s QOL
BACKGROUND Irritable bowel syndrome ( IBS ) is a common , costly , and difficult to treat disorder that impairs health-related quality of life and work productivity .
Evidence -based treatment guidelines have been unable to provide guidance on the effects of acupuncture for IBS because the only previous systematic review included only small , heterogeneous and method ologically unsound trials .
OBJECTIVES The primary objectives were to assess the efficacy and safety of acupuncture for treating IBS .