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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 63-69 |
| Number of pages | 7 |
| Journal | Current Hepatology Reports |
| Volume | 19 |
| Issue number | 1 |
| DOIs | |
| State | Published - Mar 2020 |
Keywords
- Magnetic resonance imaging–estimated proton density fat fraction
- Magnetic resonance spectroscopy
- Nonalcoholic fatty liver disease
- Nonalcoholic fatty liver disease activity score
- Nonalcoholic steatohepatitis
- Placebo effect
ASJC Scopus subject areas
- Hepatology