Lieber, S, Rice J, Lucey MA, Bataller R. “Controversies in clinical trials for alcoholic hepatitis.” Journal of Hepatology 2017 (in press). https://doi.org/10.1016/j.jhep.2017.09.013
ABSTRACT: Alcoholic hepatitis (AH) is the most severe form of alcoholic liver disease, contributing to significant morbidity and mortality. Yet, the only available therapies that improve survival are corticosteroids and liver transplantation with no new drugs successfully developed for decades. This article describes briefly the current state of affairs in AH therapy and examines the practical and ethical challenges to conducting controlled trials in patients with severe AH. While prednisolone is considered to be standard of care in severe AH, this recommendation remains controversial given the marginal benefits and questionable longterm safety of steroids. Placebo controlled trials without steroids may be necessary and ethically justified in certain populations of AH who have not been adequately investigated. Ultimately, we suggest the field will advance with the development of a plausible animal model of true AH, a consensus on a composite clinical end-point that does not rely solely on mortality for use in future RCTs, and the adoption of the recommendations of the NIAAA Alcoholic Hepatitis Consortia regarding standard definitions and when to require a liver biopsy prior to study entry.
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