A prospective trial of colchicine and methotrexate in the treatment of primary biliary cirrhosis

Background & Aims: The aim of this study was to determine if colchicine or methotrexate improves blood test results, symptoms, and/or liver histology in patients with primary biliary cirrhosis. Methods: Patients with histolog ically confirmed primary biliary cirrhosis whose serum alkaline phosphatase (ALP) levels were at least 2 times above normal and who were not yet candi dates for liver transplantation received colchicine or methotrexate and wer e followed up for 2 years. Results: In patients receiving colchicine (n = 4 3), mean pruritus score decreased from 1.63 to 1.12 (P = 0.04), ALP level f rom 494 to 355 U/L (P < 0.0001), and alanine aminotransferase (ALT) level f rom 79 to 61 U/L (P < 0.0001). In patients receiving methotrexate (n = 42), pruritus score decreased from 1.25 to 0.44 (P = 0.0001), ALP from 478 to 2 35 U/L (P < 0.0001), and ALT from 96 to 61 U/L (P = 0.0001). Methotrexate b ut not colchicine significantly improved liver histology (P = 0.005) and se rum immunoglobulin G levels (P = 0.0002). Methotrexate improved most blood test results more than colchicine. Serum bilirubin levels increased slightl y with each drug, and albumin levels decreased slightly. Conclusions: Both colchicine and methotrexate improved biochemical test results and symptoms in primary biliary cirrhosis, but the response to methotrexate was greater.