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.