Double-blind controlled trial of prednisolone therapy in patients with severe acute alcoholic hepatitis and spontaneous encephalopathy.

Twenty-eight patients entered a double-blind controlled trial to evaluate the efficacy of prednisolone treatment in severe acute alcoholic hepatitis accompanied by encephalopathy. Fifty-three percent (8 of 15) given prednisolone and 54% (7 of 13) given placebo died during the study. The mean duration of hospitalization was 66 days for the prednisolone-treated group and 56 days for those treated with placebo. Prednisolone treatment produced no important beneficial effect on any of the hepatic biochemical tests. The outcome in any particular case was directly related to the development of specific lethal complications (renal failure, injection, and gastrointestinal bleeding) rather than to the treatment employed. We were unable to show any beneficial effect of prednisolone treatment on morbidity or mortality in patients with severe acute alcoholic hepatitis and encephalopathy.