A double-blind randomized controlled trial of colchicine in patients with hepatitis B virus-related postnecrotic cirrhosis

Division of Gastroenterology, Veterans General Hospital-Taipei, Taiwan, R.O.C.
Journal of Hepatology (Impact Factor: 11.34). 11/1994; 21(5):872-7. DOI: 10.1016/S0168-8278(94)80252-1
Source: PubMed


The preliminary results of a prospective double-blind controlled trial of colchicine in 100 patients with hepatitis B virus-related cirrhosis 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 proof 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 follow up in any of the biochemistry data, for example, serum albumin, alkaline phosphatase, alanine and aspartate aminotransferase, bilirubin, and prothrombin time. The difference in the cumulative survival rates at 51 months did not reach statistical significance (p = 0.8) in either group. There was no histological improvement in 30 patients who were willing to undergo repeated liver biopsies. No trend toward improvement of the hepatic pressure gradient was observed in these patients. The serum levels of aminopropeptide of type III procollagen increased significantly in patients in both groups after 24 months of therapy (1.07 +/- 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 patients receiving colchicine therapy. This report indicates that colchicine has no effect in the treatment of HBV-related postnecrotic cirrhosis.

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    • "Colchicine is an anti-inflammatory agent that under some conditions suppresses collagen formation and/or stimulates collagenase. An early report on its use in patients with advanced fibrosis or cirrhosis was encouraging (Kershenobich et al., 1988) but has not been replicated, and randomized trials of patients with primary biliary cirrhosis (Kaplan et al., 1986; Kaplan et al., 1999) or chronic viral hepatitis (Wang et al., 1994) have been negative. Corticosteroids are useful for diseases that benefit from broad immunosuppression, such as autoimmune hepatitis. "
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