Zeng 2010.
Methods | Design: Parallel
Blinding: No
Attempt to confirm patient blinding?: No
Dropouts/withdrawals: During the 4 weeks treatment, 4/33 drop‐outs in acupuncture group and 1/32 intrimebutine maleate group Total duration: 4 weeks treatment immediately followed by an evaluation, 2 month follow up reported Type of analysis reported: Not specified |
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Participants | Setting: Acupuncture outpatient and inpatient in Hangzhou Hospital of TCM from 2008 to 2009, China Mean age (+/‐ Standard Deviation or Range): 35.15 (7.23) years for acupuncture group, 34.70 (6.45) years for trimebutine maleate group Men/Women (number/number): 27/38 Acu/Moxa: 13/20, Medication: 14/18 Recruitment method: Not reported Minimum duration of IBS symptoms: Rome III criteria for the last 3 months with symptom onset at least 6 months prior to diagnosis Actual duration of IBS symptoms before enrollment: 15.24 (7.85) months for acupuncture group, 14.86 (7.77) months for trimebutine maleate group Diagnosis of IBS required for eligibility?: Rome III criteria for diarrhea‐predominant irritable bowel syndrome Evaluation to rule out organic gastrointestinal disease: Reported – exclusion criterion was no organic bowel disease and no other biochemical abnormalities Predominant symptoms or stool patterns of participants: The study only recruited patients with diarrhea‐predominant IBS Hospital inpatients?: Yes, the number of inpatients was not reported Were people with a history of acupuncture treatment excluded?: Not reported |
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Interventions | ACUPUNCTURE + MOXIBUSTION
Number allocated to acupuncture: 33
Style of acupuncture: Chinese
Points selection: Flexible formula
Points stimulated: 5 main fixed acupoints and 6 optional points. The fixed points are GV 7, CV 12, CV 4, CV 6 and ST 37. The optional points were LV 3, SP 9, BL 20, BL 21, BL 23 and BL 25
Description of acupuncturist qualifications: Not reported
Total length of treatment period (weeks): ˜4 weeks (30 days)
Number of sessions target (mean): 30
Times per week: 7
Number of points used (mean): 5 fixed acupoints plus 6 optional points
Insertion depth: Not reported
Was De Qi reportedly sought?: Not reported
Duration (minutes): 20 min
Method of stimulation: Manipulation with even method (Ping bu ping xie) Moxibustion procedure: After acupuncture, moxibustion was administrated mainly on CV 12, CV 6, CV 4, BL 20, BL 21 and BL 23. The moxa was made into a hemisphere with diameter of 4 cm and height of 2.5 cm, then it was put into a moxibustion box and ignited. The duration of moxibustion on each acupoint was 30 min (The duration of moxibustion was not reported in the article. The information was provided by the 3rd author Chu JM, in a telephone survey on July 26, 2011) CONTROL GROUP A INTERVENTION: trimebutine maleate (product name: Niweifu) Number allocated to control group A: 32 Total length of treatment period: ˜4 weeks (30 days) Number of sessions target (mean): 30 days per week: 7 Times per day: 3 Dosage: 100mg / time Any co‐interventions in all groups? Not reported |
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Outcomes | Symptom severity: 1. Overall abdominal symptom scale. 2. Symptom improvement(3‐point scoring system) at end of treatment: 1) markedly effective 2) effective 3) no effect. The evaluation of symptom improvement was based on an intestinal symptoms scale. 1) markedly effective: the decrease of intestinal symptom scale > 80%, 2) effective: the decrease of intestinal symptom scale is between 50% and 80%; 3) no effect: the decrease of intestinal symptom scale < 50% or worsening symptoms. Measured as number of responders for both groups Quality of life: Not assessed Time points of symptom measurement: The Overall abdominal symptom scale (mean and SD)were reported at baseline, 4 weeks (30 days) and 2 months follow up The numbers of responders for symptom improvement were reported at 4 weeks Author's conclusion: “Moxibustion in dog days could improve the symptom of diarrhea‐predominant IBS patients” Additional outcomes reported in the trial but not extracted: The Bristol score (mean and SD) were reported at baseline, 4 weeks (30 days) and 2 months follow up (Table 2). [the evaluators were blind to the participant assignment] Adverse effects: Not reported |
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Notes | Funding sources: [No funding] Information in square brackets was provided by the second author Bao YH, in a telephone survey onJuly 22, 2011 We dichotomized improved, effective and no effect into the 2 categories of improved or not improved according to the methods section of the review |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | [Referred to a random number table] |
Allocation concealment (selection bias) | Low risk | [We used sequentially numbered, opaque, sealed envelopes] |
Blinding (performance bias and detection bias) All outcomes | High risk | [The evaluators were blind to the participant assignment] |
Incomplete outcome data (attrition bias) Short term | Low risk | "4 participants in acupuncture group withdrew and 1 participant in trimebutine mleate group withdrew during the treatment." There is no information about the missing outcome data |
Selective reporting (reporting bias) | Low risk | This trial reported outcomes for overall abdominal symptom scale and the number of responders at the completion of the 30 days treatment period, together with results for each outcome measured according to the observational targets |
Other bias | Unclear risk | Although ITT analysis was not reported, there were few drop‐outs, so the degree of "missingness" would be unlikely to affect the estimate of the treatment effect in this trial The two treatment groups were comparable at baseline in terms of the variables Bristol scale and overall abdominal symptom scale. The two treatment groups were also comparable at baseline in terms of demographic characteristics and duration of IBS |