Ursodeoxycholic acid treatment in patients with primary biliary cirrhosis. A Swedish multicentre, double-blind, randomized controlled study

Scand J Gastroenterol. 1997 Feb;32(2):179-86. doi: 10.3109/00365529709000190.


Background: Ursodeoxycholic acid (UDCA) has been shown to improve serum levels of liver enzymes and bilirubin in primary biliary cirrhosis (PBC). However, it is still uncertain whether UDCA treatment also improves symptoms, liver histology, and survival without liver transplantation.

Methods: We randomized 116 patients with PBC to receive 0.5 g UDCA (n = 60) or placebo (n = 56) daily for 2 years. During the next 2 years, 80% of the UDCA-treated patients and 65% of the placebo-treated patients continued to take UDCA.

Results: UDCA improved serum enzyme values but not survival, symptoms, serum bilirubin levels, or liver histology. There was no significant difference in response between initially symptomatic and asymptomatic patients.

Conclusions: UDCA in a dosage 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.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Bile Acids and Salts / metabolism
  • Blood Chemical Analysis
  • Cholagogues and Choleretics / administration & dosage
  • Cholagogues and Choleretics / therapeutic use*
  • Double-Blind Method
  • Drug Administration Schedule
  • Female
  • Humans
  • Liver Cirrhosis, Biliary / blood
  • Liver Cirrhosis, Biliary / drug therapy*
  • Liver Cirrhosis, Biliary / pathology
  • Liver Function Tests
  • Male
  • Middle Aged
  • Survival Rate
  • Ursodeoxycholic Acid / administration & dosage
  • Ursodeoxycholic Acid / therapeutic use*


  • Bile Acids and Salts
  • Cholagogues and Choleretics
  • Ursodeoxycholic Acid