A PLACEBO-CONTROLLED TRIAL OF PRIMARY BILIARY-CIRRHOSIS TREATMENT WITH COLCHICINE AND URSODEOXYCHOLIC ACID

Background/Aims: Ursodeoxycholic acid (UDCA) and colchicine have benef icial effects in primary biliary cirrhosis (PBC). The efficacy of colc hicine and UDCA in PBC was compared in a 2-year placebo-controlled stu dy (n = 90). Methods: Clinical events, laboratory test results, and li ver histology were recorded at the beginning and end of the trial. Res ults: There were significantly fewer dropouts for hepatic reasons with UDCA than with placebo. Pruritus was reduced by both active drugs. Co lchicine improved liver function test results only modestly, whereas U DCA significantly decreased the serum activities of aminotransferases, alkaline phosphatase, and gamma-glutamyltransferase compared with col chicine and placebo. Serum total bilirubin levels were decreased only by UDCA. Both colchicine and UDCA reduced serum cholesterol levels, an d UDCA also reduced high-density lipoprotein cholesterol levels. Furth ermore, UDCA reduced the serum levels of immunoglobulin (Ig) M and IgG , and colchicine reduced IgG levels compared with placebo. The elevate d serum level of aminoterminal propeptide of type III procollagen rema ined unchanged by colchicine or UDCA, whereas the serum level of carbo xyterminal propeptide of type I procollagen was significantly decrease d by UDCA. UDCA significantly decreased ductular proliferation compare d with colchicine or placebo. Conclusions: These data suggest that UDC A frequently is superior to colchicine and especially to placebo in th e treatment of PBC.