Mm. Kaplan et al., A prospective trial of colchicine and methotrexate in the treatment of primary biliary cirrhosis, GASTROENTY, 117(5), 1999, pp. 1173-1180
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.