Corticosteroids improve short-term survival in patients with severe alcoholic hepatitis (AH): individual data analysis of the last three randomized placebo controlled double blind trials of corticosteroids in severe AH

Background/Aims: Controversy surrounding the efficacy of corticosteroids in severe alcoholic hepatitis (AH) persists. The aims of our study were: (a) to analyze individual data of patients with severe AH discriminant function (DF) greater than or equal to32 from the last three randomized controlled trials; and (b) to identify the independent prognostic factors associated with short-term survival. Methods: Individual data were collected from the three principal investigators. Survival analysis was performed at 28 days using the Kaplan-Meier method and log-rank test. The independent prognostic values were assessed by the proportional hazards regression model. Results: About 102 placebo and 113 corticosteroid patients with DF greater than or equal to32 were analyzed. At 28 days, corticosteroid patients had significantly higher survival: 84.6 +/- 3.4% vs. 65.1 +/- 4.8%, P = 0.001. In univariate analysis, corticosteroid treatment, age, DF, albumin, creatinine and encephalopathy were prognostic factors. In multivariate analysis, age(P = 0.0001), serum creatinine (P < 0.002) and corticosteroid treatment (P = 0.002) were independent prognostic variables. A more dramatic decrease of median serum bilirubin values (μmol/l) was observed at 7 and 14 days in corticosteroid patients (P < 0.05) : -76.5 vs. -35 and -105 vs. -45. Conclusions: Corticosteroids improved short-term survival of patients with severe AH. Age and serum creatinine are independent prognostic factors. Corticosteroids are recommended for patients with severe AH. (C) 2002 European Association for the Study of the Liver. Published by Elsevier Science B.V. All rights reserved.