A review is made of the literature regarding the present status of ursodeoxycholic acid in the treatment of primary biliary cirrhosis, focusing on the difficulties encountered in establishing the efficacy of this and any other therapy in the management of the disease. It is concluded that further studies or, at least, an updated meta-analysis including the final data emerging from the multicentre, long-term, randomised, double-blind, controlled trials currently under way are needed to establish the clinical importance of ursodeoxycholic acid as a therapeutic agent in primary biliary cirrhosis.