URSODEOXYCHOLIC ACID TREATMENT IN PATIENTS WITH PRIMARY BILIARY-CIRRHOSIS - A SWEDISH MULTICENTER, DOUBLE-BLIND, RANDOMIZED CONTROLLED-STUDY

Background: Ursodeoxycholic acid (UDCA) has been shown to improve seru m levels of liver enzymes and bilirubin in primary biliary cirrhosis ( PBC). However, it is still uncertain whether UDCA treatment also impro ves symptoms, liver histology, and survival without liver transplantat ion. Methods: We randomized 116 patients with PBC to receive 0.5 g UDC A (n = 60) or placebo (n = 56) daily for 2 years. During the next 2 ye ars, 80% of the UDCA-treated patients and 65% of the placebo-treated p atients continued to rake UDCA. Results: UDCA improved serum enzyme va lues but not survival, symptoms, serum bilirubin levels, or liver hist ology. There was no significant difference in response between initial ly symptomatic and asymptomatic patients. Conclusions: UDCA in a dosag e of 7.7 mg/kg body weight is of little benefit in PBC. This does not exclude the possibility that larger doses have beneficial effects.