A placebo-controlled trial of primary biliary cirrhosis treatment with colchicine and ursodeoxycholic acid

Gastroenterology. 1995 May;108(5):1470-8. doi: 10.1016/0016-5085(95)90696-7.

Abstract

Background/aims: Ursodeoxycholic acid (UDCA) and colchicine have beneficial effects in primary biliary cirrhosis (PBC). The efficacy of colchicine and UDCA in PBC was compared in a 2-year placebo-controlled study (n = 90).

Methods: Clinical events, laboratory test results, and liver histology were recorded at the beginning and end of the trial.

Results: There were significantly fewer dropouts for hepatic reasons with UDCA than with placebo. Pruritus was reduced by both active drugs. Colchicine improved liver function test results only modestly, whereas UDCA significantly decreased the serum activities of aminotransferases, alkaline phosphatase, and gamma-glutamyltransferase compared with colchicine and placebo. Serum total bilirubin levels were decreased only by UDCA. Both colchicine and UDCA reduced serum cholesterol levels, and UDCA also reduced high-density lipoprotein cholesterol levels. Furthermore, UDCA reduced the serum levels of immunoglobulin (Ig) M and IgG, and colchicine reduced IgG levels compared with placebo. The elevated serum level of aminoterminal propeptide of type III procollagen remained unchanged by colchicine or UDCA, whereas the serum level of carboxyterminal propeptide of type I procollagen was significantly decreased by UDCA. UDCA significantly decreased ductular proliferation compared with colchicine or placebo.

Conclusions: These data suggest that UDCA frequently is superior to colchicine and especially to placebo in the treatment of PBC.

Publication types

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

MeSH terms

  • Alanine Transaminase / blood
  • Alkaline Phosphatase / blood
  • Aspartate Aminotransferases / blood
  • Bilirubin / blood
  • Cholesterol / blood
  • Colchicine / therapeutic use*
  • Double-Blind Method
  • Female
  • Finland
  • Humans
  • Immunoglobulin G / blood
  • Immunoglobulin M / blood
  • Liver / drug effects
  • Liver / pathology
  • Liver Cirrhosis, Biliary / blood
  • Liver Cirrhosis, Biliary / drug therapy*
  • Liver Cirrhosis, Biliary / pathology
  • Liver Function Tests
  • Male
  • Middle Aged
  • Procollagen / blood
  • Ursodeoxycholic Acid / therapeutic use*
  • gamma-Glutamyltransferase / blood

Substances

  • Immunoglobulin G
  • Immunoglobulin M
  • Procollagen
  • Ursodeoxycholic Acid
  • Cholesterol
  • gamma-Glutamyltransferase
  • Aspartate Aminotransferases
  • Alanine Transaminase
  • Alkaline Phosphatase
  • Bilirubin
  • Colchicine