A prospective trial of colchicine and methotrexate in the treatment of primary biliary cirrhosis.
OBJECTIVE
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 histologically confirmed primary biliary cirrhosis whose serum alkaline phosphatase (ALP) levels were at least 2 times above normal and who were not yet candidates for liver transplantation received colchicine or methotrexate and were followed up for 2 years.


RESULTS
In patients receiving colchicine (n = 43), mean pruritus score decreased from 1.63 to 1.12 (P = 0.04), ALP level from 494 to 355 U/L (P < 0.0001), and alanine aminotransferase (ALT) level from 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 235 U/L (P < 0.0001), and ALT from 96 to 61 U/L (P = 0.0001). Methotrexate but not colchicine significantly improved liver histology (P = 0.005) and serum immunoglobulin G levels (P = 0.0002). Methotrexate improved most blood test results more than colchicine. Serum bilirubin levels increased slightly 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.
Kaplan
M M
MM
Division of Gastroenterology, Department of Medicine, New England Medical Center and Tufts University School of Medicine, Boston, Massachusetts, USA. marshall.kaplan@es.nemc.org
Schmid
C
C
Provenzale
D
D
Sharma
A
A
Dickstein
G
G
McKusick
A
A
D000410:Alanine Transaminase / Q000097:blood; D000469:Alkaline Phosphatase / Q000097:blood; D001663:Bilirubin / Q000097:blood; D003078:Colchicine / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood; D008099:Liver / Q000187:drug effects / Q000473:pathology; D008105:Liver Cirrhosis, Biliary / Q000097:blood / Q000188:drug therapy*; D008297:Male; D008727:Methotrexate / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D011446:Prospective Studies; D011537:Pruritus / Q000188:drug therapy; D012709:Serum Albumin / Q000032:analysis
D007074:Immunoglobulin G; D012709:Serum Albumin; D000410:Alanine Transaminase; D000469:Alkaline Phosphatase; D001663:Bilirubin; D003078:Colchicine; D008727:Methotrexate