Chen 2009.

Methods	Design: Parallel Blinding: No Attempt to confirm patient blinding?: No Dropouts/withdrawals: Not reported in the article [In order to ensure the number of 30 participants for both groups, the participants who withdrew during the 4 weeks treatment were eliminated from the trial and new participants were recruited. The author could not recall the number of the dropouts] Total duration: 4 weeks treatment followed by an evaluation, no follow up reported Type of analysis reported: Not reported
Participants	Setting: Outpatient and inpatient of the First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine from Jan 2005 to May 2006, Guangzhou, China Mean age (+/‐ Standard Deviation or Range): Not reported. The age range for acupuncture plus patented Chinese medicine group was 18 to 63 years; the age range for patented Chinese medicine alone group was 18 to 65 years Men/Women (number/number): 27/33 Recruitment method: Not reported 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: Not reported. The duration range for acupuncture plus patented Chinese medicine group was 14 months to 12 years; the duration range for patented Chinese medicine alone group was 12 months to 15 years Diagnosis of IBS required for eligibility?: Rome II criteria and diagnostic criteria for liver‐qi stagnation with spleen deficiency according to the Guiding Principles for Clinical Study of New Chinese Medicine Evaluation to rule out organic gastrointestinal disease: Yes Predominant symptoms or stool patterns of participants: Not reported Hospital inpatients?: Yes, the number inpatients was not reported Were people with a history of acupuncture treatment excluded?: Not reported
Interventions	ACUPUNCTURE (Warming needle moxibustion) plus patented Chinese medicine Number allocated to acupuncture: 30 Style of acupuncture: Chinese warming needle Points selection: Flexible formula Points stimulated: 2 main fixed acupoints and 2 to 5 optional points. The fixed points were bilateral ST 25 and BL 25. The optional points were HT 7, PC 6, LR 3 and SP6 for restlessness, insomnia, anxiety and suspiciousness; ST 37, GV 20, GV 1 and BL 57 for a sense of incomplete emptying and down‐bearing sensation in the anus; CV 12, ST 36, SP 6, LR 3, SP 9 for abdominal pain or distension, bowel sounds and severe diarrhea; ST 37 and SJ 6 for constipation Description of acupuncturist qualifications: Not reported Total length of treatment period (weeks): 4 Number of sessions target (mean): 12 Times per week: 3 Number of points used (mean): 2 fixed acupoints plus 2 to 5 optional points Insertion depth: Not reported Was De Qi reportedly sought?: Yes Duration (minutes): 30 min Method of stimulation: Manipulation, even reinforcing ‐ reducing. Warming needle moxibustion only on bilateral ST 25 and BL 25, acupuncture on other optional acupoints Warming needle moxibustion means using needles to puncture in the acupoint first, then put a moxa cone on the needle handle and burn it. Co‐intervention: Patented Chinese medicine: Kang Tai Capsule (previously known as Shun Ji Decoction), 3 capsules, 3 times a day CONTROL GROUP A INTERVENTION: Patented Chinese medicine alone (Product name: Kang Tai Capsule (previously known as Shun Ji Decoction)) Number allocated to control group A: 30 Total length of treatment period: 4 weeks Number of sessions target (mean): 28 Days per week: 7 Times per day: 3 Dosage: 3 capsules / time Any co‐interventions in all groups?: Both groups were administered patented Chinese medicine
Outcomes	Symptom severity: IBS symptom score for TCM symptom (4‐point scoring system): 1) cured 2) improved 4) effective 4) no effect N (Efficacy index) = (symptom score before treatment ‐ symptom score after treatment) / symptom score before treatment * 100% 1) Recovery: N > = 90% 2) Markedly effective: 70% = < N = < 90% 3) Improvement: 30% = < N = < 70% 4) Failure: N = < 30% Quality of life: Functional gastrointestinal disease and quality of life scale created by Prof. Zhou FS, et al included assessment of field of disease, field of physiology, field of psychology, field of society and total score. There are 44 items in the QOL questionnaire. This does not appear to be a validated scale Time points of symptom measurement: The responder rates of IBS symptom score for TCM symptom were reported after 4 weeks treatment. The quality of life score in total and for each field were reported before and after treatment Author's conclusion: “Both treatment methods could improve the clinical symptoms and increase the patient’s quality of life. The total effective rate in the treatment group was slightly higher than the control group” Additional outcomes reported in the trial but not extracted: Symptom scales for 9 items including abdominal paindegree, frequency of abdominal pain, abdominal distension, upset and insomnia, anxiety and suspicion, loose stool, feeling of unfinished defection, asthenia and loss of appetite before treatment, 2 weeks and 4 weeks Adverse effects: “No adverse effects appeared in all participants”
Notes	Comments: Funding sources: [No funding] randomization: [Drawing of lots] Allocation: [No specific method was used to conceal the allocation] Reason for identical numbers assigned to the two groups: [The author said if the patient number of one group started to exceed 30, they assigned the additional patients into the other group. The number of patients assigned in this non‐random manner was not available from the author] Information in square brackets was provided by the first author Chen YQ, in a telephone survey on July 23, 2011 We dichotomized cured, improved, effective and no effect into the 2 categories of improved or not improved according to the methods section of the review
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	“Sixty IBS cases of liver‐qi stagnation with spleen deficiency were randomized into a treatment and control group by single‐blind method” [We used drawing of lots. If the number of patient of one group started to exceed 30, they assigned the additional patients into the other group]
Allocation concealment (selection bias)	High risk	[No specific method was used to conceal the allocation]
Blinding (performance bias and detection bias) All outcomes	High risk	[Quality of life scales were evaluated by participants themselves. The IBS symptom score for TCM symptom were evaluated by the first author who knew the group assignment of the participants]
Incomplete outcome data (attrition bias) Short term	Unclear risk	The dropouts were not reported in the article [In order to ensure the number of 30 participants for both groups, the participants who withdrew during the 4 weeks treatment were eliminated from the trial and new participants were recruited. The first author could not recall the number of the dropouts
Selective reporting (reporting bias)	Low risk	This trial reported outcomes for IBS symptom score for TCM symptom at the completion of the 4 week treatment period and quality of life scale before and after treatment
Other bias	Unclear risk	ITT analysis was not reported and the author also could not recall the number of dropouts, so we could not estimate whether the "missingness" would affect the treatment effect in this trial. “There was no significant difference in gender, age and duration between the two groups.” The P values were 0.417 for gender, 1.0 for age and 0.919 for duration between the two groups There were no P values reported for the comparison of quality of life scale and each symptom score between two groups at baseline, but according to the mean(SD) of quality of life scale in Table 8 and symptom score for each item in Table 4 in Chen YQ 2006 Master’s thesis, the 2 groups appeared comparable at baseline.