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Multicentre Randomized Placebo-controlled Trial of Ursodeoxycholic Acid with or Without Colchicine in Symptomatic Primary Biliary Cirrhosis by P. L. Almasio; A. Floreani; M. Chiaramonte; G. Provenzano; P. Battezzati; A. Crosignani; M. Podda; L. Todros; F. Rosina; G. Saccoccio; F. Manenti; G. Ballardini; F. P. Bianchi; P. J. Scheuer; S. E. Davies; A. Craxì is a Medicine article available to read on EtoBox.

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## Aim: To establish the efficacy of combination therapy with ursodeoxycholic acid (UDCA) and colchicine in patients with symptomatic primary biliary cirrhosis (PBC), defined by the presence of liver cirrhosis, pruritus or bilirubin exceeding 2 mg/mL. ## Methods: A total of 90 patients were randomly assigned to ursodeoxycholic acid 500 mg/daily plus placebo (UDCA group, __n__=44), or ursodeoxycholic acid at the same dosage plus colchicine, 1 mg/daily (UDCA/C group, __n__=46). The two groups were comparable for age, sex, stage of disease, severity of pruritus, bilirubin, and Mayo score. All patients underwent clinical, ultrasonographic, and biochemical examinations at entry and then every 6 months up to 3 years of follow‐up. Patients with cirrhosis underwent endoscopy every 12 months. In a sub‐group of patients without cirrhosis, who consented, liver biopsy was repeated at the end of the study. ## Results: The number of treatment failures (i.e. dead, orthotopic liver transplantation (OLT), complications of cirrhosis, doubling of bilirubin, untreatable pruritus) was 11 (25%) in the UDCA group and four (9%) in the UDCA/C group (__P__ < 0.05). No significant differences were observed i

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Author

P. L. Almasio; A. Floreani; M. Chiaramonte; G. Provenzano; P. Battezzati; A. Crosignani; M. Podda; L. Todros; F. Rosina; G. Saccoccio; F. Manenti; G. Ballardini; F. P. Bianchi; P. J. Scheuer; S. E. Davies; A. Craxì

Publisher

John Wiley and Sons; Blackwell Publishing; Wiley (Blackwell Publishing); Blackwell Publishing Inc.; Wiley; Research Square (ISSN 0269-2813)

Published

2000

Language

EN

Field

Medicine (Health Sciences)