BACKGROUND: The evidence on the effectiveness of acupuncture for irritable bowel syndrome (IBS) is inconclusive. However, many patients with IBS are self referring for acupuncture, therefore it is of interest to know whether acupuncture is effective or not. The aim of this study was to establish variability in the primary outcome measure to enable a sample size to be calculated for a full scale trial, and to explore feasibility and design criteria. METHODS: A pragmatic randomised controlled trial compared 10 sessions of acupuncture plus usual GP care with usual GP care alone. Thirty patients were recruited from four GP databases in Birmingham, UK, and randomised one-to-two to acupuncture or usual care alone. The primary outcome was the IBS Symptom Severity Score (SSS) at three months (maximum score 500). Analysis was by intention-to-treat, and multiple imputation was used for missing data. RESULTS: From the databases, 189 patients with IBS were identified, of whom 30 were eligible and consented to randomisation. At three months, a statistically and clinically significant difference between groups of 138 points (SD 90) in favour of acupuncture was observed on the IBS SSS (95% CI: 66 to 210; P=0.001) using multiple imputation. For a full scale trial, we estimate that a sample size of 108 patients per arm is required, based on a minimum clinically significant change of 50 points, drawn from a primary care population of 140 000. CONCLUSIONS: We established the feasibility of a full scale trial, successfully recruiting patients and calculating the sample size required. The results of our pilot analysis suggest that more definitive research into acupuncture for IBS is merited. A pragmatic trial design will not be able to distinguish between acupuncture specific effects and placebo effects; however, it is the design of choice to determine cost effectiveness.
RCT Entities:
BACKGROUND: The evidence on the effectiveness of acupuncture for irritable bowel syndrome (IBS) is inconclusive. However, many patients with IBS are self referring for acupuncture, therefore it is of interest to know whether acupuncture is effective or not. The aim of this study was to establish variability in the primary outcome measure to enable a sample size to be calculated for a full scale trial, and to explore feasibility and design criteria. METHODS: A pragmatic randomised controlled trial compared 10 sessions of acupuncture plus usual GP care with usual GP care alone. Thirty patients were recruited from four GP databases in Birmingham, UK, and randomised one-to-two to acupuncture or usual care alone. The primary outcome was the IBS Symptom Severity Score (SSS) at three months (maximum score 500). Analysis was by intention-to-treat, and multiple imputation was used for missing data. RESULTS: From the databases, 189 patients with IBS were identified, of whom 30 were eligible and consented to randomisation. At three months, a statistically and clinically significant difference between groups of 138 points (SD 90) in favour of acupuncture was observed on the IBS SSS (95% CI: 66 to 210; P=0.001) using multiple imputation. For a full scale trial, we estimate that a sample size of 108 patients per arm is required, based on a minimum clinically significant change of 50 points, drawn from a primary care population of 140 000. CONCLUSIONS: We established the feasibility of a full scale trial, successfully recruiting patients and calculating the sample size required. The results of our pilot analysis suggest that more definitive research into acupuncture for IBS is merited. A pragmatic trial design will not be able to distinguish between acupuncture specific effects and placebo effects; however, it is the design of choice to determine cost effectiveness.
Authors: Eric Manheimer; Ke Cheng; L Susan Wieland; Li Shih Min; Xueyong Shen; Brian M Berman; Lixing Lao Journal: Cochrane Database Syst Rev Date: 2012-05-16
Authors: Hugh MacPherson; Martin Bland; Karen Bloor; Helen Cox; David Geddes; Arthur Kang'ombe; Julie Reynolds; Eugena Stamuli; Tracey Stuardi; Helen Tilbrook; David Torgerson; Peter Whorwell Journal: BMC Gastroenterol Date: 2010-06-17 Impact factor: 3.067
Authors: Eric Manheimer; L Susan Wieland; Ke Cheng; Shih Min Li; Xueyong Shen; Brian M Berman; Lixing Lao Journal: Am J Gastroenterol Date: 2012-04-10 Impact factor: 10.864
Authors: Hugh MacPherson; Douglas G Altman; Richard Hammerschlag; Li Youping; Wu Taixiang; Adrian White; David Moher Journal: PLoS Med Date: 2010-06-08 Impact factor: 11.069