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Papers of the Week

Papers: 24 Dec 2022 - 30 Dec 2022

2022 Dec 22

Am J Gastroenterol

Examining the Nocebo Effect in Trials of Neuromodulators for Use in Disorders of Gut-Brain Interaction.


Glissen Brown JR, Sanayei A, Proctor S, Flanagan R, Ballou S, Bain PA, Nee J
Am J Gastroenterol. 2022 Dec 22.
PMID: 36563308.


Nocebo effects are thought to influence the rate of reported adverse events (AEs) and subject withdrawal in both the treatment and placebo groups of randomized clinical trials (RCTs). Neuromodulators are commonly prescribed to treat disorders of gut-brain interaction (DGBIs), but adherence to these medications is often limited by side effects such as headache, dry mouth, fatigue, and altered bowel habits. We performed a systematic review and meta-analysis to assess the proportion and risk difference of patients who experienced side effects leading to withdrawal in the placebo arm versus the treatment arm of RCTs of neuromodulators for DGBIs. We also sought to estimate the risk of developing any AE in the placebo arm of these studies as well as the rate of specific individual adverse events.