MRI Quantification of Placebo Effect in Nonalcoholic Steatohepatitis Clinical Trials.

ABSTRACT: Background Several early-phase clinical trials for the treatment of nonalcoholic steatohepatitis (NASH) use liver fat content as measured with the MRI-derived proton density fat fraction (PDFF) for a primary outcome. These trials have shown relative reductions in liver fat content with placebo treatment alone, a phenomenon termed "the placebo effect." This phenomenon confounds the results and limits generalizability to future trials. Purpose To quantify the effect of placebo treatment on change in the absolute PDFF value and to identify variables associated with this observed change. Materials and Methods This is a secondary analysis of prospectively collected data from seven early phase clinical trials that included participants with a diagnosis of NASH based on MRI and/or liver biopsy wh

SUBMITTER: Nedrud MA 

PROVIDER: S-EPMC9968769 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature