Xue 2009.
Methods | Design: Parallel
Blinding: No Attempt to confirm patient blinding?: No Dropouts/withdrawals: Not reported in the article. [3/103 withdrew from the acupuncture group, 5/105 withdrew from the sulfasalazine group] Total duration: 23 to 49 days treatment followed by an evaluation, no follow up reported. (“A course of treatment included 10 sessions (days) acupuncture and there was a break of 3 days between two courses. Participants were administrated totally 2 to 4 courses”) Type of analysis reported: Not specified |
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Participants | Setting: Outpatient and inpatient in Gansu Provincial Tumor Hospital and Gansu Provincial Hospital of Traditional Chinese Medicine, China Mean age (+/‐ Standard Deviation or Range): 37.77 (9.70) years for acupuncture group, 38.40 (9.65) years for sulfasalazine group Men/Women (number/number): 99/101 Acu/Moxa: 48/52, Medication: 51/49 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: 5.17 (3.19) months for acupuncture group, 5.12 (3.66) years for sulfasalazine group Diagnosis of IBS required for eligibility?: Rome II criteria Evaluation to rule out organic gastrointestinal disease: type‐B ultrasonic, endoscopy, colonoscopy to exclude other digestive disease Predominant symptoms or stool patterns of participants: Not reported 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: 103 [210 participants were randomly assigned to two groups, 105 for both groups originally, which was different with that documented in article (i.e. 100 participants). During the trial, 3 withdrew in acupuncture group, 5 withdrew in sulfasalazine group. To reach an equal sample size in both groups, two participants who should have been assigned to acupuncture group were not recruited]
Style of acupuncture: Chinese
Points selection: Fixed
Points stimulated: Six fixed acupoints including ST 25, CV 8, ST 36, PC 6, LI 4 and LV 3
Description of acupuncturist qualifications: Not reported Total length of treatment period (weeks): 23 to 49 days (“A course of treatment included 10 sessions (days) acupuncture and there was a break of 3 days between two courses. Participants were administrated totally 2 to 4 courses.”) Number of sessions target (mean): 20 to 40 Times per week: 7 Number of points used (mean): 6 fixed acupoints, 5 of which are bilateral 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: Moxibustion was administrated on CV 8 for 5 min CONTROL GROUP A INTERVENTION: Sulfasalazine (Company: Shanghai Sanwei Pharmaceutical Co., Ltd) Number allocated to control group A: 105 (as described above) Total length of treatment period: 20 to 40 days Medication – Sulfasalazine (SASP), 10mg/kg, once daily, course of 10 days, total 2 to 4 courses Number of sessions target (mean): 20 to 40 Days per week: 7 Times per day: 1 Dosage: 10 mg/kg Any co‐interventions in all groups? Not reported |
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Outcomes | Symptom severity: Overall IBS symptom (3‐point scoring system) at end of treatment: 1) cured 2) improved 3) no effect. The outcome was measured as responder rates for both groups, but there’s no clear description of the evaluation basis or procedure Quality of life: Not assessed Time points of symptom measurement: The responder rates of overall IBS symptom were reported at the end of treatment (23 to 49 days) for both groups Author's conclusion: "Evident Acupuncture treatment effect on patients with IBS." (Abstract) Additional outcomes reported in the trial but not extracted: The SOD, MDA and NO in patient plasma were reported at baseline and end of treatment.. The evaluators who asked the patients the symptom score questions were blind to the participant assignment Adverse effects: Not reported. |
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Notes | [The number of participants assigned to either group was originally 105, which was different from that documented in the article (i.e., the article stated that 100 participants were assigned to each group), but the investigator could not describe clearly the method used to ensure exactly the same number of participants assigned to either treatment group. During the trial, 3 withdrew in acupuncture group, 5 withdrew in sulfasalazine group, leaving 102 in the acupuncture group and 100 in the sulfasalazine group. To reach an equal sample size in both groups, 2 participants who were assigned to the acupuncture group were not included in the analysis. So finally, there were 100 participants analyzed in the acupuncture group and 100 participants analyzed in the sulfasalazine group] Funding sources: Natural science foundation of Gansu Province, China (Grant No. 3ZS041 ‐ A25 ‐ 071) Information in square brackets was provided by one of the study personnel Kou Suotang, in telephone surveys on July 25 and 28, 2011 We dichotomized cured, improved 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 | [We referred to a random number table] |
Allocation concealment (selection bias) | Unclear 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 | [The number of participants assigned to either group was originally 105, which was different with that documented in article (i.e. 100 participants). During the trial, 3 withdrew in acupuncture group, 5 withdrew in sulfasalazine group. To reach an equal sample size in both groups, 2 participants who should be assigned to acupuncture group were finally not been recruited. So finally, there were 103 participants assigned to acupuncture group and 105 participants assigned to sulfasalazine group] |
Selective reporting (reporting bias) | Low risk | This trial reported outcomes for overall IBS symptom at the completion of the treatment period, together with results of SOD, MDA and NO in patients’ plasma before and after treatment according to the Observation item and methods section |
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 groups were comparable at baseline |