Open AccessAdverse Events and Nocebo Effects in Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis of Randomized Controlled Trials
Author(s) -
Christopher Ma,
Nicola Panaccione,
Tran M Nguyen,
Leonardo Guizzetti,
Claire E Parker,
Isra M. Hussein,
Niels Vande Casteele,
Reena Khanna,
Parambir S. Dulai,
Siddharth Singh,
Brian G. Feagan,
Vipul Jairath
Publication year - 2019
Publication title -
journal of crohn's and colitis
Language(s) - English
Resource type - Journals
eISSN - 1876-4479
pISSN - 1873-9946
DOI - 10.1093/ecco-jcc/jjz087
Subject(s) - medicine , adverse effect , placebo , randomized controlled trial , meta analysis , ulcerative colitis , inflammatory bowel disease , relative risk , confidence interval , crohn's disease , gastroenterology , disease , pathology , alternative medicine
Nocebo effects, adverse outcomes occurring in patients receiving inert therapy, contribute to adverse event [AE] reporting in randomized controlled trials [RCTs]. High placebo AE rates may result in inaccurate estimation of treatment-related AEs. We estimate the pooled rate of AEs in patients randomized to placebo compared to active therapy in inflammatory bowel disease [IBD] RCTs.