Lembo 2009.

Methods	Design: Parallel Blinding: Yes Attempt to confirm patient blinding?: Not stated but the author stated that Streitberger needle, which was used in this trial, has previously been validated in other studies Dropouts/withdrawals: During the second 3 weeks, 8/78 drop‐outs in acupuncture group and 5/75 in sham acupuncture group Total duration: 3 weeks treatment immediately followed by an evaluation, no follow up reported Type of analysis reported: Intention to treat analysis
Participants	Setting: in a single outpatient research centre, USA Mean age (+/‐SD or Range): 37.5 (14.6) years for acupuncture group, 38.9 (14.1) years for sham acupuncture group, 39.0 (14.0) for wait list group Men/Women (n/n): 54/176 Recruitment method: Participants were recruited from advertisements in media, fliers, and through referrals from health professionals Minimum duration of IBS symptoms: Rome II criteria for the last 3 months with symptom onset at least 6 months prior to diagnosis Actual duration of IBS symptoms before enrollment: IBS was present for > 1 year in 96% of participants in acupuncture group, 91% of participants in sham acupuncture group and 95% of participants in wait list group Diagnosis of IBS required to be eligible? (if yes, describe how patients were verified to have IBS): Rome II criteria with a score of ≥ 150 on the symptom severity scale Evaluation to rule out organic gastrointestinal disease: Reported Predominant symptoms or stool patterns of participants: Alternating symptoms were most common (53%); diarrhea (25%) was slightly more common than constipation (21%). Diarrhea was most common, and constipation was least common, in the sham acupuncture group Hospital inpatients? (Y/N; if Y list number inpatients): No Were people with a history of acupuncture treatment excluded?: Yes
Interventions	ACUPUNCTURE N allocated to acupuncture: 78 Style of acupuncture: Chinese Points selection: Flexible formula for specific symptoms Points stimulated: Six main fixed acupoints and 11 optional points. The fixed points are very commonly used in IBS patients and included Conception Vessel 10, Stomach 25, Liver 3, Spleen 4, Pericardium 6, and Stomach 37. The optional points were Stomach 36 and Conception Vessel 4 (for the Chinese diagnosis of deficiency), Large Intestine 4 Liver 14 (for stagnant qi or energy), Stomach 40, Large Intestine 11 (for dampness), Stomach 27 (for cold), Conception Vessel 12 (for "retention of food"), Gall Bladder 34 (for "damp heat"), and Spleen 10 and Spleen 6 (for "blood stasis") Description of acupuncturist qualifications: "Four licensed acupuncturists, each with more than 2,000 hours of professional training and more than 4 years of post‐graduate experience, performed the acupuncture in this study" Total length of treatment period (weeks): 3 Number of sessions target (mean): 6 Times per week: 2 Number of points used (mean): 6 fixed acupoints plus optional points. If the acupuncturist felt strongly that a fixed main point would be less desirable than an optimal point, they were allowed to replace a single fixed point with an optional point Insertion depth: Not reported Was De Qi reportedly sought?: Yes Duration (mins): 20 min Method of stimulation: Manipulation CONTROL GROUP A INTERVENTION (sham, if used): Sham acupuncture with Streitberger needles N allocated to control group A: 75 Points selection: Predetermined "non‐acupuncture" points in the relative vicinity of the genuine points. At least 5 and a maximum of 11 "non‐acupuncture" points Points stimulated: Predetermined "non‐acupuncture" points in the relative vicinity of the genuine points. At least 5 and a maximum of 11 "non‐acupuncture" points. Acupuncturists were also encouraged to slightly switch or adjust their point selection within the parameters of the study protocol from treatment to treatment Total length of treatment period: 3 weeks Number of sessions target (mean): 6 Times per week: 2 Number of points used: At least 5 and a maximum of 11 "non‐acupuncture" points Insertion depth: Non‐insertion Was De Qi sought?: No Duration (mins): ˜20 Method of stimulation: No CONTROL GROUP B: Waitlist N allocated to control group B: 77 Total length of treatment period: 3 weeks Number of sessions target (mean): NA Times per week: NA Duration (mins): NA Any co‐interventions in all groups?: Participants were allowed to continue their IBS medications (e.g. fiber, anti‐spasmodics, and loperamide) as long as they had been on stable doses for at least 30 days before entering the study and agreed not to change medications or dosages during the trial
Outcomes	Symptom severity: 1.  IBS Adequate Relief (IBS‐AR): "IBS‐AR is a dichotomous single item that asks participants, 'Over the past week have you had adequate relief of your IBS symptoms?' A responder was defined as a patient who answered this question affirmatively" 2. IBS Symptom Severity Scale: "The IBS‐SSS contains five questions that are rated on a 100‐point visual analog scale, namely, the severity of abdominal pain, the frequency of abdominal pain, the severity of abdominal distention, dissatisfaction with bowel habits, and interference with the quality of life. All five components contribute to the score equally, yielding a theoretical range of 0 to 500, with a higher score indicating a worse condition. Earlier studies have established that scores < 175 represent mild IBS symptoms, 175 to 300 represent moderate severity, and scores > 300 represent severe IBS. A decrease of 50 points on the IBS‐SSS has been shown to correlate with improvement in clinical symptoms. We therefore defined patients with a decrease of 50 points on the IBS‐SSS as responders in this study." Measured as change in score from baseline for each group Quality of life: "The IBS‐QOL is a 34‐item measure assessing the degree to which IBS interferes with a patient's quality of life. Each item is rated on a 5‐point Likert scale and all items are summed. The total score is then converted linearly to a 100‐ point scale, with higher scores indicating an improved quality of life. We defined responders as patients whose IBS‐QOL scores improved by 10 points from baseline." Measured as change in score from baseline for each group" Time points of symptom measurement: The responder rates for the IBS‐AR, IBS‐SSS and IBS‐QOL were reported at 3 weeks. The scores (mean and SD) of IBS‐SSS and IBS‐QOL were reported at baseline and 3 weeks Author's conclusion: This study did not find evidence to support the superiority of acupuncture compared with sham acupuncture in the treatment of IBS Additional outcomes reported in the trial but not extracted: The responder rates and score (mean and SD) of IBS Global Improvement Scale (IBS‐GIS) were reported at 3 weeks. All study personnel, except the practitioners, were blinded to participant assignment Adverse effects: "Three adverse events were reported during the acupuncture vs. sham acupuncture phase of the study: (i) painful foot cramp after treatment (sham acupuncture), (ii) nausea or hip pain (true acupuncture), and (iii) rib pain after a fall (sham acupuncture). All of these events were considered to be unrelated to the study procedure"
Notes	Comments: Carefully worked, especially for the blinding of patients and evaluators For the quality of life outcome, symptom severity outcome and global improvement outcome, we combined the two acupuncture groups (i.e. augmented and limited) and the two sham groups (i.e. augmented and limited) shown in Table 1 by calculating a weighted mean for combined acupuncture and combined sham. For combining the two SDs for each group, we used the formula in Table 7.7.a in the Cochrane Handbook for Systematic Reviews of Interventions for combining SDs of global improvement outcome. We used the SDs of the baseline measure as an estimate of the SDs of the endpoint measure for symptom severity outcome and quality of life outcome For responder rates, the denominator for the response rate are the number available for follow‐up at that time‐point, not the number randomized Funding resources: "This research was made possible by National Institutes of Health (NIH) Grant 1R01 AT001414‐01 from the National Center for Complementary and Alternative Medicine (NCCAM) and the National Institutes of Digestive, Diabetes and Kidney Disease, Grant 1R21 AT002860‐01 from NCCAM and the OQ ce of Behavioral and Social Science Research (OBSSR), and Grants 1 R21 AT002564 and 1K24 AT004095 from NCCAM. 2 is research was also supported in part by Grant RR 01032 to the Beth Israel Deaconess Medical Center (BIDMC) General Clinical Research Center from the NIH and the Samueli Institute for Informational Biology."
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"...at the end of week 3, all patients who had received sham acupuncture were re‐randomized blindly to either acupuncture or continuation of sham acupuncture. This was stratified by the group assignment for the run‐in period (augmented vs. limited) and by the post run in pain score (< 30 vs. 30 on a 100‐point visual analog scale)." "We randomly assigned participants to the three study arms using permuted block randomization with variable block sizes and assignments provided in sequentially numbered opaque sealed envelopes. ... At three weeks, we used similar methods to randomise patients in the sham acupuncture groups to continue sham acupuncture or to switch to genuine acupuncture. This randomization was stratified by the level of abdominal pain at the three week visit (<30 v ≥30 on a 100 point visual analogue scale)"
Allocation concealment (selection bias)	Low risk	"We randomly assigned participants to the three study arms using permuted block randomization with variable block sizes and assignments provided in sequentially numbered opaque sealed envelopes. An administrative assistant, not otherwise involved in the study, opened the assignment envelopes and recorded the assignment of each participant in a confidential log. At three weeks, we used similar methods to randomise patients in the sham acupuncture groups to continue sham acupuncture or to switch to genuine acupuncture"
Blinding (performance bias and detection bias) All outcomes	Low risk	"In this study, we used Streitberger needles (22), a validated sham acupuncture device. This device has been shown to be indistinguishable from an actual acupuncture device; the "needle" does not pierce the skin but creates an illusion of doing so as it retracts into a hollow handle. Streitberger and true acupuncture needles were applied for an identical period of time. To avoid acupuncture pressure effect, sham needles were placed over predetermined "non‐acupuncture" points in the relative vicinity of the genuine points. Our team's precise method of using the sham needles is described elsewhere" "Although the trial was prospectively designed to investigate non‐specific effects in irritable bowel syndrome, its design included a nested acupuncture substudy that allowed potential participants in the "treatment" arms to be told, truthfully, that they had a 50% chance of receiving genuine acupuncture during the trial. When the study ended, a letter was sent to all participants explaining the exact purpose of the study and offering them the opportunity to withdraw their original consent to use their data. All study personnel, except the practitioners, were blinded to participant assignment. Blinded registered nurses who were otherwise unconnected to the study conducted assessments" No attempt to confirm patient blinding, although this may not be necessary, as the Streitberger needle has been previously validated
Incomplete outcome data (attrition bias) Short term	Low risk	There were 8(78) drop‐outs in acupuncture group and 5(75) in sham acupuncture group
Selective reporting (reporting bias)	Low risk	This trial reported outcomes for overall IBS symptom severity (IBS‐SSS) and health‐related quality of life (IBS‐QOL) at the completion of the 3 week treatment period, together with results for each outcome measured according to the methods section
Other bias	Low risk	“All analyses were intent‐to‐treat” “Table 2 displays demographics and baseline symptoms by treatment group.” Although no statistical comparisons are made between the two groups at baseline, the groups seem comparable on most variables. Most importantly, the true acupuncture and sham acupuncture groups had very similar baseline scores for the IBS‐SSS and the IBS‐QOL