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Papers of the Week


2022 Sep 30


Am J Gastroenterol

Placebo Adverse Events in Non-Alcoholic Steatohepatitis Clinical Trials. A Pooled Analysis of 2,944 Participants.

Authors

Lin Tay P W, Ng C H, Lin S Y, Chin Y H, Xiao J, Lim W H, Lim S Y, Fu C E, Chan K E, Quek J, Hao Tan D J, Chew N, Syn N, Keitoku T, Tamaki N, Siddiqui M S, Noureddin M, Muthiah M, Huang DQ, Loomba R
Am J Gastroenterol. 2022 Sep 30.
PMID: 36191268.

Abstract

In the absence of an effective treatment for non-alcoholic steatohepatitis (NASH), a randomized, placebo-controlled trial (RCT) remains the current gold standard study design in NASH. As NASH is a largely asymptomatic disease, the side effects of potential therapies require careful evaluation, therefore a pooled rate of the adverse events (AEs) in placebo-treated patients serves as a useful comparator for safety. Therefore, we performed a systematic review and meta-analysis to estimate the rate of AEs among participants in the placebo arm of NASH RCTs.