A randomized trial of prednisolone in patients with severe alcoholic hepatitis

N Engl J Med. 1992 Feb 20;326(8):507-12. doi: 10.1056/NEJM199202203260802.


Background: Controlled trials have yielded inconsistent results with regard to the efficacy of corticosteroids in the treatment of alcoholic hepatitis. Three meta-analyses suggest that they may be effective in patients with encephalopathy who have severe liver disease.

Methods: We conducted a randomized, double-blind trial comparing 28 days of prednisolone treatment (40 mg per day) with placebo in 61 patients with biopsy-proved alcoholic hepatitis and either spontaneous hepatic encephalopathy (n = 19) or a discriminant-function value higher than 32. The discriminant function used was as follows: 4.6 (prothrombin time-control time [in seconds]) + serum bilirubin (in micromoles per liter)/17. Fifty-seven of the patients had evidence of cirrhosis on biopsy. The primary end point was death within two months.

Results: One patient was lost to follow-up after 56 days. Treatment was discontinued in two patients because of drug toxicity. By the 66th day after randomization, 16 of 29 placebo recipients had died (mean [+/- SE] survival, 45 +/- 8 percent), as compared with 4 of 32 prednisolone recipients (survival, 88 +/- 5 percent) (log-rank test, 10.9; P = 0.001). The survival advantage for prednisolone persisted after stratification according to center and the presence of encephalopathy, and after adjustment for prognostic factors in a proportional-hazards model.

Conclusions: Treatment with prednisolone improves the short-term survival of patients with severe biopsy-proved alcoholic hepatitis.

Publication types

  • Clinical Trial
  • Meta-Analysis
  • Randomized Controlled Trial

MeSH terms

  • Double-Blind Method
  • Female
  • Follow-Up Studies
  • Hepatic Encephalopathy / drug therapy
  • Hepatitis, Alcoholic / drug therapy*
  • Hepatitis, Alcoholic / mortality
  • Humans
  • Male
  • Meta-Analysis as Topic
  • Middle Aged
  • Prednisolone / therapeutic use*
  • Survival Rate


  • Prednisolone