Steroids or pentoxifylline for alcoholic hepatitis (STOPAH): study protocol for a randomised controlled trial.

Area of Science:

• Hepatology
• Clinical Trials
• Pharmacology

Background:

• Alcoholic hepatitis is a severe form of alcohol-related liver disease with high mortality.
• Current treatment options, corticosteroids and pentoxifylline, have controversial or unconfirmed efficacy.
• Severe alcoholic hepatitis, defined by Maddrey's discriminant function ≥32, has a 28-day mortality rate of approximately 35%.

Purpose of the Study:

• To definitively evaluate the efficacy of corticosteroids and pentoxifylline in treating severe alcoholic hepatitis.
• To resolve existing controversies regarding the therapeutic benefits of these two interventions.
• To provide robust evidence for clinical practice guidelines in managing alcoholic hepatitis.

Main Methods:

• The Study of the Treatment of Alcoholic Hepatitis (STOPAH) is a multicentre, double-blind, factorial (2x2) trial.
• 1,200 patients with severe alcoholic hepatitis were randomized into four groups: placebo/placebo, placebo/prednisolone, pentoxifylline/placebo, or pentoxifylline/prednisolone.
• Primary endpoint is 28-day mortality; secondary endpoints include 90-day and 1-year mortality.

Main Results:

• Results are pending as the study aims to randomize 1,200 patients.
• The factorial design allows for parallel evaluation of two treatments.
• Sufficient statistical power is planned to determine treatment effectiveness.

Conclusions:

• The STOPAH trial is designed to be a definitive study on alcoholic hepatitis treatments.
• Eligibility criteria are based on clinical parameters, aligning with standard practice.
• The factorial design ensures efficient use of patient numbers for high statistical power.