Methylprednisolone therapy in patients with severe alcoholic hepatitis. A randomized multicenter trial

Ann Intern Med. 1989 May 1;110(9):685-90. doi: 10.7326/0003-4819-110-9-685.


Study objective: To determine the efficacy of a corticosteroid in reducing the short-term mortality of patients with severe alcoholic hepatitis.

Design: Randomized, double-blind, placebo-controlled multicenter trial.

Setting: Four university teaching hospitals.

Patients: We enrolled 66 patients with alcoholic hepatitis and either spontaneous hepatic encephalopathy or a discriminant function value greater than 32, calculated using the formula: 4.6 (prothrombin time - control time) + serum bilirubin [in mumol/L]/17.1. Fifty-nine patients (89%) completed the study. Two patients withdrew from the trial. The other 64 patients were hospitalized for the duration of the trial; however, treatment was discontinued in 5 patients because of potential drug toxicity.

Interventions: Patients were randomly assigned to receive either methylprednisolone (32 mg) or placebo within 7 days of admission. Treatment was given for 28 days. The doses were then tapered over 2 weeks and discontinued.

Measurements and main results: The endpoint of the study was death. Of the 31 recipients of placebo, 11 (35%) died within 28 days of randomization compared with 2 (6%) of the 35 patients given methylprednisolone (P = 0.006). The 95% CI for the difference in mortality was 12% to 70%. In the patients with spontaneous hepatic encephalopathy at entry, 9 of 19 recipients of placebo died (47%) compared with 1 (7%) of the 14 patients given methylprednisolone (P = 0.02). The 95% CI for the difference in mortality was 14% to 66%. The Cox proportional hazards regression model showed the advantage of methylprednisolone over placebo after adjustment for other potentially important prognostic variables (P = 0.004).

Conclusions: Methylprednisolone therapy decreases short-term mortality in patients with severe alcoholic hepatitis manifested either by spontaneous hepatic encephalopathy or a markedly elevated discriminant function value.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adult
  • Aged
  • Bilirubin / blood
  • Clinical Trials as Topic
  • Data Interpretation, Statistical
  • Double-Blind Method
  • Female
  • Hepatic Encephalopathy / drug therapy
  • Hepatitis, Alcoholic / blood
  • Hepatitis, Alcoholic / drug therapy*
  • Hepatitis, Alcoholic / mortality
  • Humans
  • Male
  • Methylprednisolone / adverse effects
  • Methylprednisolone / therapeutic use*
  • Middle Aged
  • Multicenter Studies as Topic
  • Prognosis
  • Prothrombin Time
  • Random Allocation


  • Bilirubin
  • Methylprednisolone