Abstract
BackgroundAlcoholic hepatitis is the most florid presentation of alcohol-related liver disease. In its severe form, defined by a Maddrey’s discriminant function (DF) ≥32, the 28-day mortality rate is approximately 35%. A number of potential treatments have been subjected to clinical trials, of which two, corticosteroids and pentoxifylline, may have therapeutic benefit. The role of corticosteroids is controversial as trial results have been inconsistent, whereas the role of pentoxifylline requires confirmation as only one previous placebo-controlled trial has been published.Methods/designSTOPAH is a multicentre, double-blind, factorial (2 × 2) trial in which patients are randomised to one of four groups:1. Group A: placebo / placebo2. Group B: placebo / prednisolone3. Group C: pentoxifylline / placebo4. Group D: pentoxifylline / prednisoloneThe trial aims to randomise 1,200 patients with severe alcoholic hepatitis, in order to provide sufficient power to determine whether either of the two interventions is effective. The primary endpoint of the study is mortality at 28 days, with secondary endpoints being mortality at 90 days and 1 year.DiscussionSTOPAH aims to be a definitive study to resolve controversy around the existing treatments for alcoholic hepatitis. Eligibility criteria are based on clinical parameters rather than liver biopsy, which are aligned with standard clinical practice in most hospitals. The use of a factorial design will allow two treatments to be evaluated in parallel, with efficient use of patient numbers to achieve high statistical power.Trial registrationEudraCT reference number: 2009-013897-42ISRCTN reference number: ISRCTN88782125
Highlights
Alcoholic hepatitis is the most florid presentation of alcohol-related liver disease
One study has compared prednisolone with pentoxifylline and suggested a survival benefit with pentoxifylline at 3 months (85.3% compared to 64.7%; P=0.04)
The primary objective of this study is to determine whether corticosteroids or pentoxifylline reduce the mortality associated with severe alcoholic hepatitis at 28 days, 90 days and 1 year
Summary
Alcoholic hepatitis is the most florid presentation of alcohol-related liver disease. A recent review of the burden of liver disease in Europe confirms the prominence of alcohol as the most important cause of cirrhosis and liver-related mortality in Europe. While many patients presenting with alcoholic liver disease will have cirrhosis, as many as 60% will have evidence of an alcohol-related hepatitis [6]. Alcoholic hepatitis is the most florid manifestation of alcohol-related liver disease, but is potentially reversible. The short-term mortality of alcoholic hepatitis is high among those with indicators of severe disease. The 28-day mortality of patients who have a Glasgow Alcoholic Hepatitis Score (GAHS) ≥9 is approximately 60% [10]. Despite the increasing prevalence and the severity of this disease, there is no consistency in its management
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