Randomized trials published in some Chinese journals: how many are randomized? A Treatment Trial of Acupuncture in IBS Patients 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 Adequate relief as an endpoint in clinical trials in irritable bowel syndrome. Predictive value of the rome criteria for diagnosing the irritable bowel syndrome Validation of a specific quality of life questionnaire for functional digestive disorders The York acupuncture safety study: prospective survey of 34 000 treatments by traditional acupuncturists Adverse events following acupuncture: prospective survey of 32 000 consultations with doctors and physiotherapists Active albuterol or placebo, sham acupuncture, or no intervention in asthma. 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. A comparison of the Rome and Manning criteria for case identification in epidemiological investigations of irritable bowel syndrome Lessons from a Trial of Acupuncture and Massage for Low Back Pain: Patient Expectations and Treatment Effects Acupuncture Treatment for Irritable Bowel Syndrome Symptom Management for Irritable Bowel Syndrome: A Pilot Randomized Controlled Trial of Acupuncture/Moxibustion Acupuncture for Irritable Bowel Syndrome – An Exploratory Randomised Controlled Trial Clinical evaluation of Soothing Gan (肝) and invigorating Pi (脾) acupuncture treatment on diarrhea-predominant irritable bowel syndrome
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 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 Irritable bowel syndrome is characterized by recurrent abdominal pain and altered bowel function . In design ing studies to evaluate new treatments for this disease , however , it is difficult to select appropriate endpoints to reflect improvement in the range of symptoms of the syndrome . In the present study we evaluated the parameter of adequate relief of abdominal pain and discomfort , as perceived by the patients , as a key endpoint for efficacy in the treatment of patients with irritable bowel syndrome .  Abdominal pain and bowel function data were collected daily from 370 patients with the disease during treatment with  placebo or a novel potent 5HT3 receptor antagonist . Once every 7 days adequate relief of pain and discomfort was assessed . Quality -of-life data were collected using self-administered question naires . The endpoint of adequate relief was significantly ( P < 0.05 ) correlated with improvement in pain severity scores , percentage of pain-free days , percentage of days with urgency , improvement in stool frequency and consistency , and quality -of-life parameters . Adequate relief of pain and discomfort is significantly correlated with changes in multiple parameters associated with irritable bowel syndrome and can be used as an endpoint for assessing response to therapy in these patients 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 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 Recent reports have highlighted the importance of having good evidence on the safety of acupuncture . 1 2 Sound evidence on the risks associated with acupuncture is , however , scarce.3 Our primary aim , therefore , was to describe the type and frequency of adverse events after acupuncture . A secondary aim was to examine mild transient reactions associated with  acupuncture  , some of which may indicate a positive response to treatment . The study involved a prospect i ve postal audit of treatments undertaken during a four week period in 2000 . All 1848 professional acupuncturists who were members of the British Acupuncture Council and were practising in the United Kingdom were invited to record details of adverse events and mild transient reactions after treatment . St and ardised self report forms were used . Participating practitioners also provided information on themselves , including age , sex , length of training , and years of practice . To have a 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 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 . ) 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 OBJECTIVE : The aim of this study was to estimate the prevalence of irritable bowel syndrome using different st and ard definitions ( Rome and Manning criteria ) and to determine the degree of agreement between these definitions . METHODS : A population -based , cross-sectional survey study was conducted by mailing a valid , reliable question naire to an age- and gender-stratified r and om sample of residents of Olmsted County , MN , aged 30–69 yr . The threshold for a positive diagnosis of irritable bowel was varied from two to four of the six Manning criteria and from two to three of the five defecation disorders in the Rome criteria . Unadjusted as well as age- and gender-adjusted prevalence rates were calculated for each of the five definitions of IBS . Percent agreement and κ statistics were calculated to assess agreement between the definitions . RESULTS : Question naires were returned by 643 of 892 eligible subjects ( 72 % response rate ) . The age- and gender-adjusted prevalence of IBS varied from 20.4 % using a threshold of two symptoms in the Manning criteria to 8.5 % using a threshold of three defecation disorders in the Rome criteria . The percent agreement for each comparison of Manning and Rome definitions was always > 90 % . The κ values ranged from 0.55 to 0.78 , with the best agreement occurring between a threshold of three symptoms of Manning and two defecation disorders in Rome . CONCLUSIONS : The prevalence of IBS varied substantially depending on the specific definition of IBS used . The range of prevalence estimates in Olmsted County was similar to other published figures when IBS definition was accounted for . These findings are useful in interpreting epidemiological and clinical studies of IBS 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 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 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 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
OBJECTIVES : Evidence -based treatment guidelines have been unable to provide evidence -based guidance on the effects of acupuncture for irritable bowel syndrome ( IBS ) because the only previous systematic review included only small , heterogeneous , and method ologically unsound trials .
We conducted a new systematic review and meta- analysis of r and omized controlled trials ( RCTs ) to estimate the effects of acupuncture for treating IBS .