Ten-year combination treatment with colchicine and ursodeoxycholic acid for primary biliary cirrhosis: a double-blind, placebo-controlled trial on symptomatic patients

Background: Combined medical treatment may provide further benefit to prima ry biliary cirrhosis (PBC) patients administered ursodeoxycholic acid (UDCA ). Aim: To evaluate the long-term effects of colchicine and UDCA in symptomati c PBC patients. Patients/methods: We extended up to 10 years the double-blind treatment of 44 symptomatic PBC patients originally included in a 3-year multicentre stu dy comparing UDCA and colchicine (U + C) versus UDCA and placebo (U + P). O utcome measures were death or liver transplantation; incidence of clinicall y relevant events; clinical and quantitative variables retaining prognostic information. Results: Mean follow-up was 7 +/- 3 years. One patient was lost, three with drew because of jaundice (U + P); two patients stopped colchicine but remai ned on UDCA. Eleven patients (two for liver-unrelated reasons, U + P) and s ix patients (U + C) died, three and two patients, respectively, were transp lanted (incidence rate difference, five cases per 100 patient-years; 95% CI , -1 to 11). Hepatocellular carcinoma developed in one (U + P) and four (U + C) patients (difference, -2; CI, -5 to 1), portal hypertension complicati ons in nine patients from each group (difference, 1; CI, -5 to 6). Trends o f serum bilirubin, Mayo score, antipyrine clearance were similar among trea tment groups. Conclusions: In cirrhotic PBC patients, colchicine does not offer additiona l benefits to UDCA. In this population, UDCA does not obviate disease progr ession.