Controversies in clinical trials for alcoholic hepatitis

Sarah R. Lieber, John P. Rice, Michael R. Lucey, Ramon Bataller

Research output: Contribution to journalShort surveypeer-review

10 Scopus citations

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 briefly describes the current state of affairs in AH therapy and examines the practical and ethical challenges of conducting controlled trials in patients with severe AH. While prednisolone is considered standard of care in severe AH, this recommendation remains controversial given the marginal benefits and questionable long-term safety of steroids. Placebo-controlled trials without steroids may be necessary and ethically justified in certain populations with AH who have not been adequately investigated. Ultimately, we suggest that the field will advance with the development of a plausible animal model of true AH, a consensus on a composite clinical endpoint that does not rely solely on mortality, as well as the adoption of the NIAAA Alcoholic Hepatitis Consortia recommendations regarding standard definitions and when to request a liver biopsy prior to study entry.

Original languageEnglish (US)
Pages (from-to)586-592
Number of pages7
JournalJournal of Hepatology
Volume68
Issue number3
DOIs
StatePublished - Mar 2018
Externally publishedYes

Keywords

  • Alcohol use disorder
  • Alcoholic liver disease
  • Ethics of placebo-controlled trials
  • Prednisolone

ASJC Scopus subject areas

  • Hepatology

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