title: A randomized trial of prednisolone in patients with severe alcoholic hepatitis.
abstract: 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.
authors.affiliation: Service d'Hépatologie, Hôpital Beaujon, Clichy, France.
authors.forename: M J
authors.initials: MJ
authors.lastname: Ramond
authors.forename: T
authors.initials: T
authors.lastname: Poynard
authors.forename: B
authors.initials: B
authors.lastname: Rueff
authors.forename: P
authors.initials: P
authors.lastname: Mathurin
authors.forename: C
authors.initials: C
authors.lastname: Théodore
authors.forename: J C
authors.initials: JC
authors.lastname: Chaput
authors.forename: J P
authors.initials: JP
authors.lastname: Benhamou
mesh_terms: D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006501:Hepatic Encephalopathy / Q000188:drug therapy; D006519:Hepatitis, Alcoholic / Q000188:drug therapy* / Q000401:mortality; D006801:Humans; D008297:Male; D015201:Meta-Analysis as Topic; D008875:Middle Aged; D011239:Prednisolone / Q000627:therapeutic use*; D015996:Survival Rate
chemical_list: D011239:Prednisolone