A controlled trial of colchicine in primary biliary cirrhosis. Trial design and preliminary report.
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.
Warnes
T W
TW
University Department of Gastroenterology, Manchester Royal Infirmary, U.K.
Smith
A
A
Lee
F I
FI
Haboubi
N Y
NY
Johnson
P J
PJ
Hunt
L
L
D001663:Bilirubin / Q000097:blood; D003078:Colchicine / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007136:Immunoglobulins / Q000032:analysis; D008105:Liver Cirrhosis, Biliary / Q000188:drug therapy* / Q000276:immunology / Q000473:pathology; D012709:Serum Albumin / Q000032:analysis; D012712:Serum Globulins / Q000032:analysis
D007136:Immunoglobulins; D012709:Serum Albumin; D012712:Serum Globulins; D001663:Bilirubin; D003078:Colchicine