Ursodeoxycholic acid therapy in primary biliary cirrhosis
David E. J. Jones, Oliver F. W. James, Margaret F. Bassendine – 1 May 1995 – Background/Aims: A double‐blind, placebo‐controlled trial of ursodeoxycholic acid (UDCA) was conducted in 180 patients with primary biliary cirrhosis (PBC) to define the efficacy and safety of UDCA. Efficacy was assessed by time to treatment failure defined as death; liver transplantation; histological progression; development of varices, ascites, or encephalopathy; doubling of total serum bilirubin levels; progression of fatigue or pruritus; drug toxicity; or voluntary withdrawal.