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Current Hepatology Reports
Published in: Current Hepatology Reports 1/2020

01-03-2020 | Magnetic Resonance Imaging | Fatty Liver Disease (V Ajmera, Section Editor)

Accounting for the Placebo Effect and Optimizing Outcomes in Clinical Trials of Nonalcoholic Steatohepatitis (NASH)

Authors: Nabil Noureddin, Ma Ai Thanda Han, Naim Alkhouri, Mazen Noureddin

Published in: Current Hepatology Reports | Issue 1/2020

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Abstract

Purpose of Review

Understand the placebo effect and optimize the design of nonalcoholic fatty liver disease (NAFLD) clinical trials.

Recent Findings

The placebo effect on histologic outcomes and liver fat on MRI-based imaging has been assessed in a systematic review and meta-analysis, and three phase 3 studies have been reported. The placebo effect on improvement in the main histologic outcome was present in ~ 25% of the patients. The placebo effect on components of the NAFLD activity index in trials using the magnetic resonance imaging proton density fat fraction and magnetic resonance spectroscopy as outcomes also was reported. In this review, we discuss factors that led to placebo effects in the reported studies and suggest measures to ameliorate the effects in future NASH trials.

Summary

The significant placebo response in NASH clinical trials is evidence that investigators should consider this effect in estimating sample size and designing future clinical trials.
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Metadata
Title
Accounting for the Placebo Effect and Optimizing Outcomes in Clinical Trials of Nonalcoholic Steatohepatitis (NASH)
Authors
Nabil Noureddin
Ma Ai Thanda Han
Naim Alkhouri
Mazen Noureddin
Publication date
01-03-2020
Publisher
Springer US
Published in
Current Hepatology Reports / Issue 1/2020
Electronic ISSN: 2195-9595
DOI
https://doi.org/10.1007/s11901-020-00505-1

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