title: Steroid therapy in severe viral hepatitis. A double-blind, randomized trial of methyl-prednisolone versus placebo.
abstract: The efficacy of corticosteroid therapy in severe viral hepatitis has never been demonstrated in a controlled clinical trial. For this reason, patients with severe viral hepatitis were randomly assigned to methyl-prednisolone or placebo treatment groups. The two groups were comparable in clinical findings, laboratory results and the presence of bridging necrosis on liver biopsy. Seven of the 14 patients assigned to methyl-prednisolone and two of the 15 assigned to placebo died during the 16-week study period. Although the apparent excess mortality in the steroid-treated patients is not quite statistically significant (P = 0.08), the trend persists when only patients positive for hepatitis B surface antigen (P = 0.04) are analyzed separately. Methyl-prednisolone does not enhance survival in patients with severe viral hepatitis, and it may be detrimental.
mesh_terms: D000208:Acute Disease; D000328:Adult; D001706:Biopsy; D002986:Clinical Trials as Topic; D004341:Drug Evaluation; D005260:Female; D005500:Follow-Up Studies; D006506:Hepatitis A / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D006511:Hepatitis B Antigens; D006801:Humans; D007258:Informed Consent; D008099:Liver / Q000473:pathology / Q000503:physiopathology; D008103:Liver Cirrhosis / Q000473:pathology; D008111:Liver Function Tests; D008297:Male; D008775:Methylprednisolone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D009336:Necrosis; D010919:Placebos; D011446:Prospective Studies
chemical_list: D006511:Hepatitis B Antigens; D010919:Placebos; D008775:Methylprednisolone