Deleterious Effect of Prednisolone in HBsAg-positive Chronic Active Hepatitis

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Abstract
To study the efficacy of corticosteroids in chronic active hepatitis (CAH) positive for hepatitis B surface antigen (HBsAg), we pair-randomized 51 patients to receive either 15 to 20 mg of prednisolone per day or a placebo. After initial remission, the maintenance dosage of prednisolone was 10 mg per day, and the patients were prospectively followed for up to 3 1/2 years. Prednisolone decreased serum bilirubin (P<0.05) and globulin (P<0.01) at three months; it delayed other biochemical remission occurring after the second month of medication (P<0.001); it hastened biochemical relapse (P<0.0001); and it increased the frequency of complications (P<0.0001) and the death rate (P<0.01). We conclude that prednisolone has an overall harmful effect in patients with HBsAg-positive CAH. (N Engl J Med. 1981; 304:380–6.)