A short course of prednisolone in chronic type B hepatitis. Report of a randomized, double-blind, placebo-controlled trial

• Published in: Annals of internal medicine Vol. 104; no. 1; p. 12
• Main Authors: Hoofnagle, J H, Davis, G L, Pappas, S C, Hanson, R G, Peters, M, Avigan, M I, Waggoner, J G, Jones, E A, Seeff, L B
• Format: Journal Article
• Language: English
• Published: United States 01.01.1986
• Subjects: Adult; Alanine Transaminase - blood; DNA-Directed DNA Polymerase - blood; Double-Blind Method; Drug Administration Schedule; Drug Evaluation; Female; Hepatitis B - blood; Hepatitis B - drug therapy; Hepatitis B - pathology; Hepatitis, Chronic - blood; Hepatitis, Chronic - drug therapy; Hepatitis, Chronic - pathology; Humans; Leukocyte Count; Liver - pathology; Male; Middle Aged; Prednisolone - administration & dosage; Prednisolone - adverse effects; Prednisolone - therapeutic use; Random Allocation
• ISSN: 0003-4819
• DOI: 10.7326/0003-4819-104-1-12

Fifteen patients with chronic type B hepatitis were treated with corticosteroids in a randomized, double-blind, placebo-controlled trial lasting 28 days. Ten patients received prednisolone, 60 mg/d for 2 weeks, then 30 mg/d for another 2 weeks; 5 patients received placebo. Serum aminotransferase levels decreased significantly during prednisolone therapy but 4 to 10 weeks after abrupt withdrawal of the drug, they rebounded to levels greater than those before treatment. This exacerbation of disease lasted for several months and was prolonged and symptomatic in 3 patients. Hepatitis B virus levels did not change substantially during treatment. Follow-up examinations showed no improvement in biochemical or serologic features of the disease in any of the 15 patients; follow-up liver biopsies showed a worsening in 4 of 7 treated patients but in 0 of 5 control patients. Thus, a 28-day course of prednisolone produced no beneficial effects in patients with mild-to-moderate chronic type B hepatitis; on the contrary, such treatment may be harmful.