Liu 2010.
Methods | Design: Parallel
Blinding: Yes Attempt to confirm patient blinding?: No Dropouts/withdrawals: No [There were no dropouts] Total duration: 4 weeks treatment followed by an evaluation, no follow up reported Type of analysis reported: Not reported |
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Participants | Setting: Outpatient of digestion medicine and inpatient of the department of internal medicine in Hebei Provincial Hospital of TCM, China Mean age (+/‐ Standard Deviation or Range): 45.75 (7.91) years for acupuncture plus Chinese medicine group, 46.16 (8.13) years for bifidobacteria group, 45.71 (7.89) years for Chinese medicine group, 46.08 (8.07) years for acupuncture group Men/Women (number/number): 118/182 Acupuncture/Geshanxiaoyao Decoction: 61/89, Bifidobacterium: 19/31, Geshanxiaoyao Decoction: 17/33, Acupuncture: 21/29 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: 24.56 (3.10) months for acupuncture plus Chinese medicine group, 23.79 (2.92) months for bifidobacteria group, 24.37 (2.84) months for Chinese medicine group, 25.13 (2.89) months for acupuncture group Diagnosis of IBS required for eligibility?: Rome III criteria for diarrhea‐predominant irritable bowel syndrome and criteria of diarrhea caused by stagnation of the liver‐Qi attacking the spleen and spleen stomach deficiency (Guide for clinical trials of new drugs of Chinese medicine) Evaluation to rule out organic gastrointestinal disease: Not reported Predominant symptoms or stool patterns of participants: The study only recruited patient with diarrhea‐predominant IBS Hospital inpatients? Yes, but the number of inpatients was not reported. Were people with a history of acupuncture treatment excluded? Not stated |
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Interventions | ELECTRO‐ACUPUNCTURE PLUS CHINESE MEDICINE
Number allocated to acupuncture: 150
Style of acupuncture: Chinese
Points selection: Fixed formula
Points stimulated: 3 fixed bilateral acupoints including LV 3, SP 6 and HT 3
Description of acupuncturist qualifications: Not stated Total length of treatment period (weeks): 4 Number of sessions target (mean): 28 ‐‐ All the authors of Chinese language trials did not specify whether they treated patients in the weekend. We assume patients were treated on weekends, because the authors described that the treatment was 7 times a week Times per week: 7 Number of points used (mean): 3 (bilateral 6) Insertion depth: Not reported Was De Qi reportedly sought?: [Yes] Duration (minutes): [15 min] Method of stimulation: [Manipulation and Electro‐acupuncture] Chinese medicine: Formula name: Geshan Xiaoyao Fang Ingredients and preparation: auriculate swallowwort root 15 g, Chinese thorowax 12 g, root of herbaceous peony 20 g, Chinese angelica root 12 g, the rhizome of large‐headed atractylodes 10 g, Tuckahoe 15 g, cortex albiziae 20 g, Flos Albiziae 12 g, caulis polygoni multiflor 20 g. The above herbs were decocted into 300 ml and divided into 2 bags with 150 ml/bag. Total length of treatment period: 4 weeks Number of sessions target (mean): 28 days per week: 7 Times per day: 2 (medicine were taken at 9 am and 9 pm) Dosage: 150 ml / time CONTROL GROUP A INTERVENTION: Bifidobacteria (Product name: Li Zhu Chang Le). This product is a Bifidobacterium longum composition. Number allocated to control group A: 50 Total length of treatment period: 4weeks Number of sessions target (mean): 28 days per week: 7 Times per day: 2 Dosage: 1 pill / time CONTROL GROUP B: Chinese medicine alone Number allocated to control group B: 50 Formula name: Geshan Xiaoyao Fang (as described above) Total length of treatment period: 4 weeks Number of sessions target (mean): 28 days per week: 7 Times per day: 2 (medicine were taken at 9 am and 9 pm) Dosage: 150ml / time CONTROL GROUP C: Electro‐Acupuncture alone Number allocated to control group C: 50 Style of acupuncture: Chinese Points selection: Fixed formula Points stimulated: 3 fixed bilateral acupoints including LV 3, SP 6 and HT 3 Description of acupuncturist qualifications: Not reportedTotal length of treatment period (weeks): 4 Number of sessions target (mean): 28 Times per week: 7 Number of points used (mean): 3 (bilateral 6) Insertion depth: Not reported Was De Qi reportedly sought? [Yes] Duration (minutes): [15 min] Method of stimulation: [Manipulation and Electro‐acupuncture] Any co‐interventions in all groups?: Not reported |
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Outcomes | Symptom severity: Curative effect for Clinical IBS symptom (4‐point scoring system) referring to the Guide for clinical trials of new drugs of Chinese medicine at end of treatment: 1) cured 2) improved 3) effective 4) no effect. 1) cured: the symptom and signs almost disappeared. The symptom scale decreased by > = 95% 2) markedly effective: the symptom and signs obviously improved. The symptom scale decreased by > = 70% 3) effective: the symptom and signs improved. The symptom scale decreased by > = 30% 4) no effect: the symptom and signs did not improved or aggravated. The symptom scale decreased by = < 30% Computation formula: (symptom score before treatment ‐ symptom score after treatment) / symptom score before treatment * 100% Quality of life: "Index of curative effect for quality of life: The IBS‐QOL questionnaire was used. The questionnaire items includes emotional state, mental status, sleep state, whether get up early, energy situation, physical condition, appetite and diet, influence to the social role and work. The score for every item ranged from highest 100 to lowest 0. Trial only reported IBS‐QOL scores (mean and SD) for each item, not the total score before and after 4 weeks treatment, so quality of life was not extracted for this trial Time points of symptom measurement: The curative effect for Clinical IBS symptom were reported after 4 weeks treatment. The IBS‐QOL scores (mean and SD) for each item were reported before and after 4 weeks treatment. Author's conclusion: “Geshan Xiaoyao Fang combined with acupuncture could improve the IBS‐QOL of IBS patients.” (Extracted from Liu QQ 2010 trial). “Geshan Xiaoyao Fang combined with acupuncture had good curative effect for diarrhea‐predominant IBS” (Extracted from Wang ZK 2010a trial). "Electro‐acupuncture treatment of diarrhea‐predominant irritable bowel syndrome is safe and effective, it is worth for further research and promotion." Additional outcomes reported in the trial but not extracted: The Clinical IBS symptom scores for each item such as diarrhea, abdomen ache/distention, borborygmus, lack of appetite, tire and asthenia, fatigue and not wanting talk were reported before and after 4 weeks treatment Adverse effects: "The results of routine blood, urine and stool test did not significantly change before and after treatment, which suggested there’s no obvious toxic side effect in treatment group and control groups.” |
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Notes | Funding sources: Hebei provincial sci‐tech support plan (No. 072761825) Reason for identical numbers assigned to the two groups: [We did not use any specific method to ensure the same number of participants assigned to the two groups. It might be a coincidence] Information in square brackets was provided by one of the first authors, Liu QQ, in a telephone survey onJuly 29, 2011 and by the other first author Wang ZK, in a telephone survey on September 26, 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. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | [Random number table method was used. We assigned 300 participants into a treatment group (150 participants) and 3 control groups, 50 participants in each] |
Allocation concealment (selection bias) | High risk | [The allocation procedure was open. We did not use any method to conceal the allocation] |
Blinding (performance bias and detection bias) All outcomes | High risk | [The evaluators were not blind to the participant assignment] |
Incomplete outcome data (attrition bias) Short term | Unclear risk | [There were no dropouts in the study]. We scored this as unclear because it is unlikely that there would be zero drop‐outs in a 4 week trial of 300 participants |
Selective reporting (reporting bias) | Low risk | This trial reported outcomes for clinical IBS symptoms at the completion of the 4 week treatment period, together with results for each outcome measured based on the "Observational targets" section in both Liu 2010 and Wang 2010a articles |
Other bias | Unclear risk | Although ITT analysis was not reported, there were reportedly no drop‐outs, although this does not seem plausible, as described above “The two groups were comparable at baseline in terms of sex, age, disease duration (P > 0.05)” There are no P values reported for the comparison of symptom score or IBS‐QOL score among 4 groups at baseline, but the groups appeared comparable at baseline |