title: Lack of effect of colchicine in alcoholic cirrhosis: final results of a double blind randomized trial.
abstract: BACKGROUND
  Colchicine, an inhibitor of collagen synthesis, has been suggested as potentially beneficial in cirrhosis.
  
  
  OBJECTIVE
  This long-term, randomized, double blind, placebo controlled trial was conducted in order to evaluate the efficacy of colchicine in alcoholic cirrhosis.
  
  
  METHODS
  Ambulatory patients with biopsy proven alcoholic cirrhosis, presenting from 1989 to 1997, with no exclusion criteria (e.g. Child-Pugh C, bilirubin > 10 mg/dl and gastrointestinal bleeding in the previous 15 days), were randomized to receive orally, 5 days/week, 1 mg/day of colchicine or placebo.
  
  
  METHODS
  Results were analysed on an intention to treat basis, for survival, incidence of complications, biochemical liver tests and safety.
  
  
  RESULTS
  Twenty-nine patients received colchicine and 26 placebo; characteristics of both groups were similar. The median follow-up was 40.6 (1.4-126.3) months in the colchicine versus 42.4 (5.7-118.2) months in the placebo group (NS). No significant side effects were reported. During follow-up, there were no significant differences in compliance and alcohol abstinence (86% vs 85%). Overall survival was not statistically different (P = 0.38). Cumulative 3-year survival rates were 74.9% in the colchicine versus 91.4% in placebo group (NS). The annual incidence rate of complications was similar with colchicine or placebo: gastrointestinal bleeding, 1.5% vs 1.2%; ascites, 3.7% vs 3.7%; and encephalopathy, 1.0% vs 0.9%. The comparison of changes in biochemical parameters between groups did not show any significant difference.
  
  
  CONCLUSIONS
  Although well tolerated, colchicine does not appear to overcome the progression and natural history of long-established alcoholic cirrhosis.
authors.affiliation: Department of Medicine 2, University Hospital of Santa Maria, Lisbon Medical School, Avenida Prof. Egas Moriz, 1669 Lisbon, Portugal. hlcortezpinto@netcabo.pt
authors.forename: Helena
authors.initials: H
authors.lastname: Cortez-Pinto
authors.forename: Paula
authors.initials: P
authors.lastname: Alexandrino
authors.forename: Maria E
authors.initials: ME
authors.lastname: Camilo
authors.forename: António
authors.initials: A
authors.lastname: Gouveia-Oliveira
authors.forename: Paula M
authors.initials: PM
authors.lastname: Santos
authors.forename: Manuel M
authors.initials: MM
authors.lastname: Alves
authors.forename: Miguel C
authors.initials: MC
authors.lastname: Moura
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D003078:Colchicine / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008104:Liver Cirrhosis, Alcoholic / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016019:Survival Analysis; D017211:Treatment Failure
chemical_list: D003078:Colchicine