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) ≥32 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 ≥ 32 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/1) 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.