Steroids in chronic B-hepatitis. A randomized, double-blind, multinational trial on the effect of low-dose, long-term treatment on survival. A trial group of the European Association for the Study of the Liver.

The effect of long-term, low-dose prednisolone treatment on the survival of patients with chronic B-hepatitis was studied in a randomized, double-blind multicentre trial. Twenty-two centres from 11 European countries included 99 patients in the trial. Survival analysis showed 2.9 (95% confidence limit 0.9-9) times greater mortality in the prednisolone than in the placebo group (P = 0.07). In a Cox regression analysis, correcting for the influence of other prognostic factors, the detrimental effect of prednisolone treatment was unchanged. Mortality increased significantly with age, and patients without piece-meal necrosis had 7 times higher mortality than those with this change on entry to the trial. It is concluded that long-term, low-dose prednisolone treatment is very unlikely to be beneficial, and should be considered harmful in chronic B-hepatitis, particularly in the most severe and advanced cases.