Schneider 2006.

Methods	Design: Parallel Blinding: Yes Attempt to confirm patient blinding?: Not reported Dropouts/withdrawals: During 5 weeks treatment, 1/22 drop‐outs in acupuncture group and 1/21 in sham acupuncture group Total duration: 5 weeks treatment followed by an evaluation, additional follow‐up evaluation at 3 months after end of treatment Type of analysis reported: NA
Participants	Setting: at the outpatient clinic of the Department of Gastroenterology, University Medical Hospital, Germany Mean age (+/‐SD or Range): 47.63 (14.71) years in acupuncture group, 47.14 (16.01) years for sham acupuncture group Men/Women (n/n): 9/34 Recruitment method: "Patients were recruited at the outpatient clinic of the Department of Gastroenterology, University Medical Hospital, via gastroenterology specialists in private practice in the Heidelberg area, and via advertisements in local newspapers" Minimum duration of IBS symptoms: 12 weeks out of the last 12 months Duration of IBS symptoms before enrollment: < 2 years in 3 patients, 2 to 10 years in 14 patients, > 10 years in 25 patients Diagnosis of IBS required to be eligible? (if yes, describe how patients were verified to have IBS): Rome II criteria Evaluation to rule out organic gastrointestinal disease: Reported Predominant symptoms or stool patterns of participants: Alternating symptoms (17/43) and diarrhea (17/43) were more common than constipation (5/43) or normal stool habits (4/43) Hospital inpatients? (Y/N; if Y list number inpatients): No Were people with a history of acupuncture treatment excluded?: Assumedly no, only patients who received AC treatment within the last three months were excluded
Interventions	ACUPUNCTURE N allocated to acupuncture: 22 Style of acupuncture: Chinese Points selection: Fixed formula Points stimulated: Liver 3, Stomach 36, Spleen 6, Conception 12, Stomach 21, Stomach 25, Heart 7, Du Mai 20. Description of acupuncturist qualifications: "AC was performed by an experienced female acupuncturist (SB) and by a trained female research assistant (CW)" Total length of treatment period (weeks): 5 Number of sessions target (mean): 10 Times per week: 2 Number of points used (mean): 8 points (14 needles for both sides) Insertion depth: Not reported Was De Qi reportedly sought?: Yes Duration (mins): Not reported Method of stimulation: Manipulation CONTROL GROUP A INTERVENTION (sham, if used): Sham acupuncture with a blunted telescopic placebo needle N allocated to control group A: 21 Points selection: fixed formula Points stimulated: 2 cm adjacent to the real AC point, the AC point LG 20 was not needled Total length of treatment period: 5 weeks Number of sessions target (mean): 10 Times per week: 2 Number of points used: 7 points (13 needles for both sides) Insertion depth: Non‐insertion Was De Qi sought?: No Duration (mins): Not reported Method of stimulation: Not applicable Any co‐interventions in all groups?: Not reported
Outcomes	Symptom severity: Not assessed Quality of life: "Patients completed two QOL questionnaires that were used to assess any effects of symptomatic improvement by AC on their overall QOL: (a) FDDQL assesses disease related impact of bowel symptoms on quality of life, measured with 43 items on eight subscales: daily activity disease related anxiety, diet, sleep, discomfort, health perception, coping with disease, and impact of stress. Scores for subscales are added to a global QOL scale ranging from 0 to 100. FDDQL has an internal consistency of 0.94 (Cronbach’s alpha); (b) the health related quality of life questionnaire (SF‐36) is a validated global measure of health related quality of life unrelated to specific diseases that has been widely used in a variety of diseases. It uses 36 items to assess eight scales (bodily function, bodily role, bodily pain, general health, vitality, social function, emotional role, and physical well being)." Measured as score for each time points for each group Time points of symptom measurement: "Both questionnaires (FDDQL and SF‐36) were given prior to treatment (t1), immediately after 10 AC treatments (t2=five weeks after the first treatment), and three months after the last treatment (t3). Improvement in the global score of FDDQL immediately after the 10 treatments (t2) was the primary end point of the study. The other subscales of the FDDQL and the SF‐36 were defined as secondary end points. Outcome measures at t3 were also defined as secondary end points" Author's conclusion: Acupuncture in IBS is primarily a placebo response Adverse effects: Not reported
Notes	Comments: Carefully worked, especially for the blinding of evaluator Weak points: small sample size Means and SEMs of quality of life could be measured with a ruler in Fig.1 for short term and long term. SDs were calculated following the formula: SD = SEM * sqrt (N) No information about response rate was reported The first author Antonius Schneider was contacted by email to request information about randomization. He replied with detailed information on January 27, 2011 Funding sources: "The trial was financially supported by the German Medical Acupuncture Association (DAGFA). The funding source had no involvement in design, performance, or analysis of the study"
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Block randomization was done by a central telephone centre" [Computer generated random list (randomization with Excel)]
Allocation concealment (selection bias)	Low risk	"Block randomization was done by a central telephone centre so that neither the patient nor the investigator (AS) knew whether the patient would receive AC or SAC. The randomization result was told to the acupuncturist (SB, CW) directly after informed consent"
Blinding (performance bias and detection bias) All outcomes	Low risk	"In the control group, patients received SAC with a blunted telescopic placebo needle (Asia Med) that simulates an AC procedure without penetrating the skin. The efficiency of this method has been shown in various studies. Each SAC procedure was performed 2 cm adjacent to the real AC point to avoid acupressure effects. In the SAC group, the AC point LG 20 was not needled as fixation of the plaster is not possible on the head due to hair." "Only one patient in the entire study population had received AC in the past. She was able to identify SAC and declined to participate in the study after the third treatment" No attempt to confirm patient blinding, although this may not be necessary in this case because the Streitberger needle has been previously validated. The Asia Med needle is the same as the Streitberger needle, which has previously been validated in other studies (Streitberger 1998; Kleinhenz 1999; Streitberger 2004) and the Streitberger needles were placed close to the genuine points. Therefore, the sham was likely to be indistinguishable from the true acupuncture
Incomplete outcome data (attrition bias) Short term	Low risk	"Only one patient in the entire study population had received AC in the past. She was able to identify SAC and declined to participate in the study after the third treatment. Another female patient declined to participate after five treatments due to time constraints. Thus two patients dropped out during the course of the study"  During 5 weeks treatment, 1/22 drop‐outs in acupuncture group and 1/21 drop‐outs in sham acupuncture group
Selective reporting (reporting bias)	Low risk	"Both questionnaires (FDDQL and SF‐36) were given prior to treatment (t1), immediately after 10 AC treatments (t2 = five weeks after the first treatment), and three months after the last treatment (t3). Improvement in the global score of FDDQL immediately after the 10 treatments (t2) was the primary end point of the study. The other subscales of the FDDQL and the SF‐36 were defined as secondary end points. Outcome measures at t3 were also defined as secondary end points" Global scale and subscales of FDDQL were reported at baseline, 5 weeks and 17 weeks Differences of FDDQL global and sub scales between two groups were reported at 5 weeks and 17 weeks Only statistical comparison of SF‐36 scales between and within the two groups were reported in Results section. Results were reported for each outcome measured according to the Methods section, and a health‐related quality of life outcome (the FDDQL) was reported at end of treatment and at follow up
Other bias	Low risk	Although ITT analysis was not reported, there were very few drop‐outs, so the degree of "missingness" would be unlikely to affect the estimate of the treatment effect in this trial “There were no differences in age or sex between the groups at entry” The "Symptoms at study entry" section/paragraph includes the following text: “The BDQ illustrates the degree and severity of bowel symptoms among the patients…No differences were seen between those who received AC or SAC after assessment”