A C Ford1, P Moayyedi. 1. Department of Academic Medicine, St. James's University Hospital, Leeds, UK. alexf12399@yahoo.com
Abstract
BACKGROUND: Irritable bowel syndrome (IBS) is a functional disorder of the gastrointestinal tract with a significant placebo response. AIM: To conduct a systematic review and meta-analysis examining the magnitude of placebo response rate in treatment trials for IBS. METHODS: MEDLINE, EMBASE and the Cochrane central register of controlled trials were searched to identify randomized controlled trials (RCTs) comparing pharmacological therapies with placebo in adult IBS patients. Studies reported either global assessment of IBS symptom cure or improvement or abdominal pain cure or improvement. Data were extracted as intention-to-treat analyses with drop-outs assumed to be treatment failures and pooled using a random-effects model. Proportion of placebo patients experiencing symptom improvement or resolution was reported with a 95% confidence interval (CI). Effect of trial characteristics on magnitude of placebo response was examined. RESULTS: In all, 73 RCTs were eligible, including 8364 patients with IBS allocated to placebo. Pooled placebo response rate across all RCTs was 37.5% (95% CI 34.4-40.6%). Rates were higher in European RCTs, RCTs that used physician-reported outcomes and RCTs using shorter duration of therapy. CONCLUSIONS: Placebo response rates across RCTs of pharmacological therapies in IBS were high. Future research should identify patient characteristics predicting placebo response.
BACKGROUND:Irritable bowel syndrome (IBS) is a functional disorder of the gastrointestinal tract with a significant placebo response. AIM: To conduct a systematic review and meta-analysis examining the magnitude of placebo response rate in treatment trials for IBS. METHODS: MEDLINE, EMBASE and the Cochrane central register of controlled trials were searched to identify randomized controlled trials (RCTs) comparing pharmacological therapies with placebo in adult IBSpatients. Studies reported either global assessment of IBS symptom cure or improvement or abdominal pain cure or improvement. Data were extracted as intention-to-treat analyses with drop-outs assumed to be treatment failures and pooled using a random-effects model. Proportion of placebo patients experiencing symptom improvement or resolution was reported with a 95% confidence interval (CI). Effect of trial characteristics on magnitude of placebo response was examined. RESULTS: In all, 73 RCTs were eligible, including 8364 patients with IBS allocated to placebo. Pooled placebo response rate across all RCTs was 37.5% (95% CI 34.4-40.6%). Rates were higher in European RCTs, RCTs that used physician-reported outcomes and RCTs using shorter duration of therapy. CONCLUSIONS: Placebo response rates across RCTs of pharmacological therapies in IBS were high. Future research should identify patient characteristics predicting placebo response.
Authors: Jeffrey M Lackner; James Jaccard; Laurie Keefer; Darren M Brenner; Rebecca S Firth; Gregory D Gudleski; Frank A Hamilton; Leonard A Katz; Susan S Krasner; Chang-Xing Ma; Christopher D Radziwon; Michael D Sitrin Journal: Gastroenterology Date: 2018-04-25 Impact factor: 22.682
Authors: Paul Enck; Sibylle Klosterhalfen; Katja Weimer; Björn Horing; Stephan Zipfel Journal: Philos Trans R Soc Lond B Biol Sci Date: 2011-06-27 Impact factor: 6.237