A PROSPECTIVE RANDOMIZED TRIAL OF COLCHICINE IN PREVENTION OF LIVER-CIRRHOSIS IN CHRONIC HEPATITIS-B PATIENTS

Background: The clinical course of chronic hepatitis B is variable. Pa tients with hepatic decompensation, bridging necrosis or an alpha-feto protein level greater than 100 ng/mL during an exacerbation of hepatit is have a high risk of developing cirrhosis, This study was conducted to evaluate the effect of colchicine in the prevention of cirrhosis in such patients. Methods: Patients with risk factor(s) were randomized to receive either colchicine 5 mg/week or no specific treatment, the e nd point being development of cirrhosis. Results: After a follow up pe riod of 4 years, the treatment group had a marked reduction in exacerb ations of acute hepatitis (32% vs. 63%/patient/year, P < 0.005). Seven out of 38 patients in the treatment group and 10 out of 27 patients i n the control group developed cirrhosis. The calculated cumulative inc idence of cirrhosis by the end of first, second, third and fourth year s in the treatment group was 8.7, 18.6, 32 and 32%, respectively, The corresponding figures in the control group were 30, 35.5, 46.3 and 73. 2%, respectively, with a P-value of 0.057. Conclusions: The results su ggest that colchicine may prevent cirrhosis in chronic hepatitis B pat ients with risk factor(s), possibly by suppressing exacerbations of he patitis through an anti-inflammatory effect.