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Methylprednisolone Therapy in Patients with Severe Alcoholic Hepatitis: A Randomized Multicenter Trial

Robert L. Carithers Jr., MD; H. Franklin Herlong, MD; Anna Mae Diehl, MD; Ellen W. Shaw, MD; Burton Combes, MD; Harold J. Fallon, MD; and Willis C. Maddrey, MD
[+] Article, Author, and Disclosure Information

Grant Support: Supported by a research grant from the National Institute of Alcohol Abuse and Alcoholism (AA04093).

Request for Reprints: Willis C. Maddrey, MD, Thomas Jefferson University, Department of Medicine, 1025 Walnut Street, Philadelphia, PA 19107.

Current Author Addresses: Drs. Carithers and Fallon. Department of Internal Medicine, Medical College of Virginia, Box 663, Richmond, VA 23298-0663.

Dr. Herlong: Division of Gastroenterology, School of Medicine, The Johns Hopkins University, Baltimore, MD 21205.

Dr. Diehl: Veterans Administration Hospital, Washington, DC.

Dr. Shaw: Veterans Administration Hospital, Wilmington, Delaware.

Dr. Combes: Department of Internal Medicine, Liver Unit, University of Texas, Southwestern Medical Center at Dallas, Dallas, TX 75235.

Dr. Maddrey: Department of Medicine, Thomas Jefferson University, 1025 Walnut Street, Philadelphia, PA 19107.

©1989 American College of PhysiciansAmerican College of Physicians

Ann Intern Med. 1989;110(9):685-690. doi:10.7326/0003-4819-110-9-685
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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 µmol/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 (prednisolone 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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