A RANDOMIZED TRIAL COMPARING COLCHICINE AND URSODEOXYCHOLIC ACID COMBINATION TO URSODEOXYCHOLIC ACID IN PRIMARY BILIARY-CIRRHOSIS

The efficacy of colchicine combined with ursodeoxy-cholic acid (UDCA) and UDCA alone in the treatment of patients with nonadvanced primary b iliary cirrhosis (PBC) was evaluated in a 2-year controlled study, Sev enty-four patients with PBC who had been treated previously with UDCA (at least 8 months) but still had ab normal Liver test results, especi ally elevated alkaline phosphatase activity, were randomized to be adm inistered colchicine (1 mg/d, 5 days per week) (n = 37) or a placebo ( n = 37), In addition, the patients were treated with UDCA (13-15 mg . kg(-1) . day(-1)). The patients underwent clinical examination and liv er tests every 6 months and upper endoscopy and liver biopsy at entry and at 2 years. Procollagen type III aminoterminal peptide (PIIINP), h yaluronic acid, and sulfobromophthalein (BSP) elimination kinetics wer e determined at entry and after 2 years, After 2 years of treatment, r elative to UDCA, colchicine combined with UDCA did not significantly i mprove symptoms, laboratory findings (serum bilirubin level, alkaline phosphatase and alanine transaminase [ALT] activities, immunoglobulin [Ig] M level), serum markers of fibrosis, or histological features, ex cept lobular inflammation, Colchicine did tend to slightly reduce the progression of esophageal varices; however, the difference was not sig nificant, BSP elimination kinetics (45-minute retention percentage) wa s significantly improved when treated with colchicine, During the 2-ye ar study, the only clinical complications were variceal bleeding in on e patient administered colchicine and two administered the placebo. Tw o patients died from nonliver causes, One severe adverse effect (perip heral neuromyopathy) was observed in a colchicine-treated patient, In conclusion, this study suggests that colchicine appears to provide a s light advantage relative to UDCA alone in patients with nonadvanced PB C.