Treatment of chronic active hepatitis. An analysis of three controlled trials

Three controlled trials from different parts of the world are analysed. In two trials, one of which was open and did not use placebo, prednisolone was found to reduce mortality significantly. In the third trial the patients received either placebo, azathioprine, prednisone or a combination of azathioprine and prednisone. Once again prednisone appeared to be of value. The trials are criticised in their design and it is suggested that in future trials one must take into account strict clinical parameters, define the reason for exclusion and attempt true randomization with placebo control. The only patients who appear to benefit markedly from corticosteroids are those with the characteristic picture of chronic active hepatitis who are symptomatic, who are HBsAg negative and who have severe histological abnormalities of the liver biopsies. In such cases the benefit of corticosteroids outweighs their potential toxicity.