A STUDY OF ORAL NUTRITIONAL SUPPORT WITH OXANDROLONE IN MALNOURISHED PATIENTS WITH ALCOHOLIC HEPATITIS - RESULTS OF A DEPARTMENT-OF-VETERANS-AFFAIRS COOPERATIVE STUDY

A Veterans Affairs cooperative study involving 273 male patients was p erformed to evaluate efficacy of oxandrolone in combination with an en teral 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 pa tients with moderate malnutrition mortality on active treatment at 1 m o was 9.4% compared with 20.9% in patients receiving placebo. This ben eficial effect was maintained so that after 6 mo on active treatment 7 9.7% of patients were still alive, compared with 62.7% of placebo-trea ted patients (p = 0.037). Improvements in both the severity of the liv er injury (p = 0.03) and malnutrition (p = 0.05) also occurred. No sig nificant 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) trea ted 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 anaboli sm). For patients with moderate malnutrition and adequate caloric inta ke, 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 malnutritio n, oxandrolone had no effect on survival. However, adequate caloric in take was associated with 19% mortality, whereas patients with inadequa te intake exhibited 51% mortality (p = 0.0001). These results indicate that nutritional status should be evaluated in patients with alcoholi c hepatitis. When malnutrition is present, vigorous nutrition therapy should be provided, and in patients with moderate malnutrition oxandro lone should be added to the regimen.