A controlled trial of colchicine in primary biliary cirrhosis. Trial design and preliminary report.

Abstract

Colchicine (1 mg/day), or an identical placebo, was given to 64 patients with primary biliary cirrhosis in a double-blind controlled trial. Due to a novel, pair-matched trial design, the two groups were exceptionally well matched at entry. In comparison with placebo, colchicine produced a beneficial effect on serum albumin and bilirubin levels at 3 months in patients who had abnormal liver function (bilirubin greater than 20 mumol/l) at entry: (albumin, P = 0.047; bilirubin, P = 0.022). In patients with normal liver function at entry (bilirubin less than 20 mumol/l), beneficial effects were noted on total globulin levels at 3 months (P = 0.013) and on immunoglobulin G levels at 3 and 6 months (P = 0.044 and 0.001, respectively). At 18 months, survival estimate in the colchicine and placebo groups were 84% and 69%, respectively. The difference did not reach significance. Colchicine produced an early improvement in liver function and immunoglobulin levels. Few serious side effects were encountered, and colchicine clearly merits long-term study in the treatment of primary biliary cirrhosis.

• Authors: T W Warnes, A Smith, F I Lee, N Y Haboubi, P J Johnson, L Hunt
• Journal: Journal of hepatology (J Hepatol) Vol. 5 Issue 1 Pg. 1-7 (Aug 1987) ISSN: 0168-8278 [Print] Netherlands
• PMID: 3655305 (Publication Type: Clinical Trial, Controlled Clinical Trial, Journal Article, Randomized Controlled Trial)

Chemical References

• Immunoglobulins
• Serum Albumin
• Serum Globulins
• Bilirubin
• Colchicine

Topics

• Bilirubin (blood)
• Colchicine (adverse effects, therapeutic use)
• Humans
• Immunoglobulins (analysis)
• Liver Cirrhosis, Biliary (drug therapy, immunology, pathology)
• Serum Albumin (analysis)
• Serum Globulins (analysis)