Ursodeoxycholic Acid Treatment in Patients with Primary Biliary Cirrhosis: A Swedish Multicentre, Double-Blind, Randomized Controlled Study

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 ran...

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Bibliographic Details
Published in:Scandinavian journal of gastroenterology 1997, Vol.32 (2), p.179-186
Main Authors: Eriksson, L. S., Olsson, R., Glauman, H., Prytz, H., Befrits, R., Rydén, B. O., Einarsson, K., Lindgren, S., Wallerstedt, S., Wedén, M.
Format: Article
Language:English
Subjects:
Bile acids
Bile Acids and Salts - metabolism
Biological and medical sciences
Blood Chemical Analysis
Cholagogues and Choleretics - administration & dosage
Cholagogues and Choleretics - therapeutic use
Digestive system
Double-Blind Method
Drug Administration Schedule
Female
histology
Humans
Liver Cirrhosis, Biliary - blood
Liver Cirrhosis, Biliary - drug therapy
Liver Cirrhosis, Biliary - pathology
Liver Function Tests
Male
Medical sciences
Middle Aged
Pharmacology. Drug treatments
primary biliary cirrhosis
Survival Rate
Ursodeoxycholic acid
Ursodeoxycholic Acid - administration & dosage
Ursodeoxycholic Acid - therapeutic use
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Summary: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.
ISSN:0036-5521
1502-7708
DOI:10.3109/00365529709000190