Robert L. Carithers Jr., MD; H. Franklin Herlong, MD; Anna Mae Diehl, MD; Ellen W. Shaw, MD; Burton Combes, MD; Harold J. Fallon, MD; Willis C. Maddrey, MD
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.
Robert L. Carithers, H. Franklin Herlong, Anna Mae Diehl, Ellen W. Shaw, Burton Combes, Harold J. Fallon, et al. Methylprednisolone Therapy in Patients with Severe Alcoholic Hepatitis: A Randomized Multicenter Trial. Ann Intern Med. 1989;110:685–690. doi: 10.7326/0003-4819-110-9-685
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Published: Ann Intern Med. 1989;110(9):685-690.
Gastroenterology/Hepatology, Liver Disease, Tobacco, Alcohol, and Other Substance Abuse.
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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