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Ten‐year combination treatment with colchicine and ursodeoxycholic acid for primary biliary cirrhosis: a double‐blind, placebo‐controlled trial on symptomatic patients
Author(s) -
Battezzati P. M.,
Zuin M.,
Crosignani A.,
Allocca M.,
Invernizzi P.,
Selmi C.,
Villa E.,
Podda M.
Publication year - 2001
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1046/j.1365-2036.2001.01018.x
Subject(s) - medicine , ursodeoxycholic acid , primary biliary cirrhosis , gastroenterology , placebo , colchicine , liver transplantation , jaundice , hepatocellular carcinoma , incidence (geometry) , cirrhosis , surgery , transplantation , pathology , alternative medicine , optics , physics
Background: Combined medical treatment may provide further benefit to primary biliary cirrhosis (PBC) patients administered ursodeoxycholic acid (UDCA). Aim: To evaluate the long‐term effects of colchicine and UDCA in symptomatic 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 study comparing UDCA and colchicine (U + C) versus UDCA and placebo (U + P). Outcome measures were death or liver transplantation; incidence of clinically relevant events; clinical and quantitative variables retaining prognostic information. Results: Mean follow‐up was 7 ± 3 years. One patient was lost, three withdrew because of jaundice (U + P); two patients stopped colchicine but remained on UDCA. Eleven patients (two for liver‐unrelated reasons, U + P) and six patients (U + C) died, three and two patients, respectively, were transplanted (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 complications in nine patients from each group (difference, 1; CI, −5 to 6). Trends of serum bilirubin, Mayo score, antipyrine clearance were similar among treatment groups. Conclusions: In cirrhotic PBC patients, colchicine does not offer additional benefits to UDCA. In this population, UDCA does not obviate disease progression.