0

The full content of Annals is available to subscribers

Subscribe/Learn More  >
Articles |

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 and Author 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
Text Size: A A A

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.

Figures

Tables

References

Letters

NOTE:
Citing articles are presented as examples only. In non-demo SCM6 implementation, integration with CrossRef’s "Cited By" API will populate this tab (http://www.crossref.org/citedby.html).

Comments

Submit a Comment
Submit a Comment

Summary for Patients

Clinical Slide Sets

Terms of Use

The In the Clinic® slide sets are owned and copyrighted by the American College of Physicians (ACP). All text, graphics, trademarks, and other intellectual property incorporated into the slide sets remain the sole and exclusive property of the ACP. The slide sets may be used only by the person who downloads or purchases them and only for the purpose of presenting them during not-for-profit educational activities. Users may incorporate the entire slide set or selected individual slides into their own teaching presentations but may not alter the content of the slides in any way or remove the ACP copyright notice. Users may make print copies for use as hand-outs for the audience the user is personally addressing but may not otherwise reproduce or distribute the slides by any means or media, including but not limited to sending them as e-mail attachments, posting them on Internet or Intranet sites, publishing them in meeting proceedings, or making them available for sale or distribution in any unauthorized form, without the express written permission of the ACP. Unauthorized use of the In the Clinic slide sets will constitute copyright infringement.

Toolkit

Buy Now

to gain full access to the content and tools.

Want to Subscribe?

Learn more about subscription options

Advertisement
Related Articles
Journal Club
Related Point of Care
Topic Collections
PubMed Articles
Forgot your password?
Enter your username and email address. We'll send you a reminder to the email address on record.
(Required)
(Required)