A DOUBLE-BLIND RANDOMIZED CONTROLLED TRIAL OF COLCHICINE IN PATIENTS WITH HEPATITIS-B VIRUS-RELATED POSTNECROTIC CIRRHOSIS

The preliminary results of a prospective double-blind controlled trial of colchicine in 100 patients with hepatitis B virus-related cirrhosi s are reported. The patients, 94 males and 6 females, aged 32-80, were assigned to receive either 1 mg of colchicine or an identical placebo orally on a daily basis. The duration of the follow up ranged from 15 to 51 months (median 26 months). Seventy percent had histological pro of of cirrhosis. On entry, 80 patients were in Child-Pugh class A, 19 were in class B, and one was in class C. Compared to the placebo group , there was no improvement in the colchicine group after a 24-month fo llow up in any of the biochemistry data, for example, serum albumin, a lkaline phosphatase, alanine and aspartate aminotransferase, bilirubin , and prothrombin time. The difference in the cumulative survival rate s at 51 months did not reach statistical significance (p=0.8) in eithe r group. There was no histological improvement in 30 patients who were willing to undergo repeated liver biopsies. No trend toward improveme nt of the hepatic pressure gradient was observed in these patients. Th e serum levels of aminopropeptide of type III procollagen increased si gnificantly in patients in both groups after 24 months of therapy (1.0 7+/-0.06 vs. 1.36+/-0.06 U/ml in the colchicine group, 0.93+/-0.09 vs. 1.25+/-0.07 U/ml in the placebo group; p<0.05). In addition, neither the clinical deterioration of cirrhosis nor death was prevented in pat ients receiving colchicine therapy. This report indicates that colchic ine has no effect in the treatment of HBV-related postnecrotic cirrhos is. (C) Journal of Hepatology.