Hepatitis

Short-term controlled studies of androgen therapy in men with alcoholic hepatitis do not provide convincing evidence of any benefit. A prospective randomised multicentre Veterans Administration study claimed a mortality benefit after 30 days of oxandrolone treatment (80 mg daily), compared with placebo in 263 men presenting with alcoholic hepatitis (Mendenhall et al. 1984). The poorly defined entry and end-point definitions have been criticised (Maddrey 1986) and the benefits, if any, appeared to be short-term. The same authors reported a further study of 271 poorly nourished men with alcoholic hepatitis randomised to treatment with oxandrolone plus high calorie food supplements compared with a group receiving placebo without dietary supplementation (Mendenhall etal. 1993). This study showed no overall survival benefit by an intention-to-treat analysis; however, subgroup analysis demonstrated a significant doubling of survival at one month, which persisted for six months in those with "moderate" but not severe malnutrition at entry. Due to the study design, the benefit of androgen therapy relative to enhanced nutrition could not be resolved. Another randomised controlled study of 19 men and 20 women with alcoholic hepatitis treated with 80 mg oxandrolone, parenteral nutrition, both or neither for 21 days demonstrated modest improvement in hepatic biochemical function but did not report other clinical end-points (Bonkovsky etal. 1991).

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