Colchicine for alcoholic and non-alcoholic liver fibrosis and cirrhosis.
BACKGROUND
The majority of liver fibrosis and liver cirrhosis cases in the Western World is caused by alcohol and hepatotoxic viruses. Colchicine is an anti-inflammatory and anti-fibrotic medication. Several randomised clinical trials have addressed the question whether colchicine has any efficacy in patients with alcoholic as well as non-alcoholic fibrosis and cirrhosis.


OBJECTIVE
The objectives were to assess the efficacy of colchicine on mortality, clinical symptoms and complications, liver biochemistry, liver fibrosis markers, liver histology, alcohol consumption, quality of life, and health economics in patients with alcoholic and non-alcoholic fibrosis or cirrhosis, excluding primary biliary cirrhosis and other rarer forms of fibrosis/cirrhosis. Also adverse events were assessed.


METHODS
The Cochrane Hepato-Biliary Group Controlled Trials Register, The Cochrane Library, MEDLINE, and full text searches were combined.


METHODS
Only randomised clinical trials were included studying patients with alcoholic fibrosis, alcoholic hepatitis and/or alcoholic cirrhosis as well as patients with viral induced or cryptogenic fibrosis and/or cirrhosis according to the diagnostic work-up of the individual trial. Interventions encompassed peroral colchicine at any dose versus placebo or no intervention. The trials could be double-blind, single-blind or unblinded. The trials could be unpublished or published and no language limitations were applied.


METHODS
All analyses were performed according to the intention-to-treat method. The statistical package (RevMan and MetaView) provided by the Cochrane Collaboration was used. The methodological quality of the randomised clinical trials was evaluated by the Jadad-scale.


RESULTS
Combining the results of 14 randomised clinical trials including 1150 patients demonstrated no significant effects of colchicine on mortality (Peto odds ratio (OR) 0.90, 95% confidence interval (CI) 0.63 to 1.29), liver related mortality (OR 1.05, 95% CI 0.61 to 1.80), complications (OR 1.01, 95% CI 0.63 to 1.62), liver biochemistry, liver histology, and alcohol consumption (OR 1.02, 95% CI 0.58 to 1.79). Colchicine was associated with a significantly increased risk of adverse events (OR 4.92, 95% CI 2.66 to 9.10; P< 0.001).


CONCLUSIONS
Colchicine should not be used for alcoholic, viral, or cryptogenic liver fibrosis or liver cirrhosis outside randomised trials.
Rambaldi
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Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital, H:S Rigshopitalet, Blegdamsvej 9, Dep. 77.01., Copenhagen, Denmark, DK-2100. arambaldi@hotmail.com
Gluud
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D003078:Colchicine / Q000627:therapeutic use*; D006801:Humans; D008103:Liver Cirrhosis / Q000188:drug therapy* / Q000401:mortality; D008104:Liver Cirrhosis, Alcoholic / Q000188:drug therapy / Q000401:mortality; D016032:Randomized Controlled Trials as Topic
D003078:Colchicine