SUMMARY The efficacy of methylprednisolone (1 g daily for three days), which is effective in reversing transplant rejection, was assessed in a randomised controlled trial of 55 patients with severe acute alcoholic hepatitis, 34 of whom had encephalopathy. The clinical progress, frequency of bleeding and sepsis, and cause of death were similar in the treatment (27 patients) and control groups (28 patients). There was no significant difference in mortality rgte between the two groups: 57% of the control group and 63% of the treatment group died during the study. Patients' survival depended on the presence or absence of the following features: encephalopathy, serum bilirubin concentration more than 340 Mmol/l, serum creatinine concentration more than 250 umol/l, and histological evidence of cirrhosis as well as severe acute alcoholic hepatitis.In addition to the direct toxic effects of alcohol, immunological mechanisms may also be involved in the pathogenesis of acute alcoholic hepatitis.' -3 Thus patients are sometimes treated with corticosteroids, although the efficacy of this approach remains uncertain. Of a total of nine studies4 -12 only three4 9 11 have shown a significant improvement in survival with corticosteriods. One of the factors responsible for the conflicting results of these previous studies may be related to the wide range in severity of alcoholic hepatitis. Therefore in this study we have included only the most severely ill patients. In previous trials only standard doses of prednisolone (up to 100 mg/day or its equivalent corticosteroid) were given, usually for a four to six week period. Apart from their anti-inflammatory effects, corticosteroids, at least in high doses, also inhibit T cell function and, as cellular immune responses to autologous and homologous liver antigens have been found in alcoholic hepatitis,'3 we have prescribed large doses of methylprednisolone for three days only, a regimen which is effective in reversing acute (cell-mediated) rejection of renal transplants. 14
Methods
PATIENTSSixty patients who had been referred from other
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