A study of oral nutritional support with oxandrolone in... : Hepatology (original) (raw)

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A study of oral nutritional support with oxandrolone in malnourished patients with alcoholic hepatitis: Results of a department of veterans affairs cooperative study

Mendenhall, Charles L. M.D., Ph.D.*, 1; Moritz, Thomas E.2; Roselle, Gary A.1; Morgan, Timothy R.3; Nemchausky, Bernard A.2; Tamburro, Carlo H.4; Schiff, Eugene R.5; McClain, Craig J.6; Marsano, Luis S.6; Allen, John I.7; Samanta, Arun8; Weesner, Robert E.1; Henderson, William2; Gartside, Peter1; Chen, Thomas S.8; French, Samuel W.9; Chedid, Antonio2 Veterans affairs cooperative study group 275

1_Department of Veterans Affairs Medical Centers: Cincinnati, Ohio 45220_

2_Department of Veterans Affairs Medical Centers: Hines, Illinois 60141_

3_Department of Veterans Affairs Medical Centers: Long Beach, California 90822_

4_Department of Veterans Affairs Medical Centers: Louisville, Kentucky 40292_

5_Department of Veterans Affairs Medical Centers: Miami, Florida 33125_

6_Department of Veterans Affairs Medical Centers: Lexington, Kentucky 50511_

7_Department of Veterans Affairs Medical Centers: Minneapolis, Minnesota 55147_

8_Department of Veterans Affairs Medical Centers: East Orange, New Jersey 07019_

9_Harbor-UCLA Medical Center, Torrance, California 90509_

*Address reprint requests to: Department of Veterans Affairs, Medical Center (151F), 3200 Vine Street, Cincinnati, OH 45220

†Authorship listing is based on manuscript preparation, data analyses, patient enrollment and study participation.

Abstract

A Veterans Affairs cooperative study involving 273 male patients was performed to evaluate efficacy of oxandrolone in combination with an enteral food supplement in severe alcoholic hepatitis. All patients had some degree of protein calorie malnutrition. On an intention-to-treat basis, only minimal changes in mortality were observed. However, in patients with moderate malnutrition mortality on active treatment at 1 mo was 9.4% compared with 20.9% in patients receiving placebo. This beneficial effect was maintained so that after 6 mo on active treatment 79.7% of patients were still alive, compared with 62.7% of placebo-treated patients (p = 0.037). Improvements in both the severity of the liver injury (p = 0.03) and malnutrition (p = 0.05) also occurred. No significant improvement was observed with severe malnutrition. To better determine the effect on therapeutic efficacy, we compared results with those from a nearly identical population (cooperative study 119) treated with oxandrolone but not given the food supplement. Patients were stratified according to their caloric intake (greater than 2,500 kcal/day was considered adequate to supply energy needs and promote anabolism). For patients with moderate malnutrition and adequate caloric intake, oxandrolone treatment reduced 6-mo mortality (4% active treatment vs. 28% placebo [p = 0.002]). For patients with moderate malnutrition and inadequate calorie intake, oxandrolone had no effect on mortality (30% active treatment vs. 33% placebo). In cases of severe malnutrition, oxandrolone had no effect on survival. However, adequate caloric intake was associated with 19% mortality, whereas patients with inadequate intake exhibited 51% mortality (p = 0.0001). These results indicate that nutritional status should be evaluated in patients with alcoholic hepatitis. When malnutrition is present, vigorous nutrition therapy should be provided, and in patients with moderate malnutrition oxandrolone should be added to the regimen. (Hepatology 1993;17:564-576.)