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

Publication ,  Journal Article
Carithers, RL; Herlong, HF; Diehl, AM; Shaw, EW; Combes, B; Fallon, HJ; Maddrey, WC
Published in: Ann Intern Med
May 1, 1989

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.

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Published In

Ann Intern Med

DOI

ISSN

0003-4819

Publication Date

May 1, 1989

Volume

110

Issue

9

Start / End Page

685 / 690

Location

United States

Related Subject Headings

  • Random Allocation
  • Prothrombin Time
  • Prognosis
  • Multicenter Studies as Topic
  • Middle Aged
  • Methylprednisolone
  • Male
  • Humans
  • Hepatitis, Alcoholic
  • Hepatic Encephalopathy
 

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Carithers, R. L., Herlong, H. F., Diehl, A. M., Shaw, E. W., Combes, B., Fallon, H. J., & Maddrey, W. C. (1989). Methylprednisolone therapy in patients with severe alcoholic hepatitis. A randomized multicenter trial. Ann Intern Med, 110(9), 685–690. https://doi.org/10.7326/0003-4819-110-9-685
Carithers, R. L., H. F. Herlong, A. M. Diehl, E. W. Shaw, B. Combes, H. J. Fallon, and W. C. Maddrey. “Methylprednisolone therapy in patients with severe alcoholic hepatitis. A randomized multicenter trial.Ann Intern Med 110, no. 9 (May 1, 1989): 685–90. https://doi.org/10.7326/0003-4819-110-9-685.
Carithers RL, Herlong HF, Diehl AM, Shaw EW, Combes B, Fallon HJ, et al. Methylprednisolone therapy in patients with severe alcoholic hepatitis. A randomized multicenter trial. Ann Intern Med. 1989 May 1;110(9):685–90.
Carithers, R. L., et al. “Methylprednisolone therapy in patients with severe alcoholic hepatitis. A randomized multicenter trial.Ann Intern Med, vol. 110, no. 9, May 1989, pp. 685–90. Pubmed, doi:10.7326/0003-4819-110-9-685.
Carithers RL, Herlong HF, Diehl AM, Shaw EW, Combes B, Fallon HJ, Maddrey WC. Methylprednisolone therapy in patients with severe alcoholic hepatitis. A randomized multicenter trial. Ann Intern Med. 1989 May 1;110(9):685–690.

Published In

Ann Intern Med

DOI

ISSN

0003-4819

Publication Date

May 1, 1989

Volume

110

Issue

9

Start / End Page

685 / 690

Location

United States

Related Subject Headings

  • Random Allocation
  • Prothrombin Time
  • Prognosis
  • Multicenter Studies as Topic
  • Middle Aged
  • Methylprednisolone
  • Male
  • Humans
  • Hepatitis, Alcoholic
  • Hepatic Encephalopathy