A placebo-controlled trial of primary biliary cirrhosis treatment with colchicine and ursodeoxycholic acid.
OBJECTIVE
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.
Vuoristo
M
M
Second Department of Medicine, University of Helsinki, Finland.
Färkkilä
M
M
Karvonen
A L
AL
Leino
R
R
Lehtola
J
J
Mäkinen
J
J
Mattila
J
J
Friman
C
C
Seppälä
K
K
Tuominen
J
J
D000410:Alanine Transaminase / Q000097:blood; D000469:Alkaline Phosphatase / Q000097:blood; D001219:Aspartate Aminotransferases / Q000097:blood; D001663:Bilirubin / Q000097:blood; D002784:Cholesterol / Q000097:blood; D003078:Colchicine / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005387:Finland; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood; D007075:Immunoglobulin M / Q000097:blood; D008099:Liver / Q000187:drug effects / Q000473:pathology; D008105:Liver Cirrhosis, Biliary / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D008111:Liver Function Tests; D008297:Male; D008875:Middle Aged; D011347:Procollagen / Q000097:blood; D014580:Ursodeoxycholic Acid / Q000627:therapeutic use*; D005723:gamma-Glutamyltransferase / Q000097:blood
D007074:Immunoglobulin G; D007075:Immunoglobulin M; D011347:Procollagen; D014580:Ursodeoxycholic Acid; D002784:Cholesterol; D005723:gamma-Glutamyltransferase; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase; D000469:Alkaline Phosphatase; D001663:Bilirubin; D003078:Colchicine