We followed up a group of patients with
primary biliary cirrhosis who participated in a 4-yr prospective, double-blind controlled trial of
colchicine therapy for 4 additional years. All were placed on open label
colchicine (0.6 mg twice daily) after the trial was concluded. Of the original group of 28 patients treated with
colchicine, 8 died and 5 received transplants (3 of the 5 died). Of the original placebo control group eight patients died and six received transplants (1 of the 6 died). Surviving patients on long-term
colchicine therapy (mean period = 8.1 yr, range = 5.3 to 9.1) showed reduction of mean serum
alkaline phosphatase from 5.1 times the upper limit of normal values to 1.9 times (p less than 0.01). Mean ALT fell from 1.8 to 1.2 times the upper limit of normal (p = 0.05), and mean serum total
bilirubin remained stable (1.6 mg/dl vs. 1.5 mg/dl). Major complications of
cirrhosis developed in four patients in the
colchicine group and five patients in the original control group. The only side effect of
colchicine was
diarrhea, which was noted in three patients. The
diarrhea resolved with reduction in the dose of
colchicine.
Colchicine is a safe and inexpensive
drug for the long-term treatment of
primary biliary cirrhosis. The biochemical parameters of disease activity (
alkaline phosphatase and ALT) remain improved after long-term follow-up, and
bilirubin values remain stable. However, complications of
cirrhosis, deaths and
transplantations were not prevented. The clinical usefulness of
colchicine in the treatment of
primary biliary cirrhosis seems to be limited.