Colchicine improved survival and reversed cirrhosis in several small clinical trials.
Dr Morgan and colleagues compared the efficacy and safety of long-term colchicine, as compared with placebo, in patients with advanced alcoholic cirrhosis.
The researchers randomized 549 patients with advanced (Pugh B or C) alcoholic cirrhosis to receive either colchicine 0.6 mg twice per day (n = 274) or placebo (n = 275).
Treatment lasted from 2 to 6 years and the primary outcome was all-cause mortality.
Secondary outcomes were liver-related morbidity and mortality.
The researchers requested liver biopsy prior to entry and after 24 months of treatment.
| Mortality attributed to liver disease was 32% in colchicine and 28% in placebo patients|
The research team reported that attendance at scheduled clinic visits and adherence with study medication were similar in colchicine and placebo groups.
Alcohol intake was less than 1 drink per day in 69% of patients.
The investigators showed with an intention-to-treat analysis, that all-cause mortality was similar in colchicines with 49% and placebo with 45% of patients.
The researchers found that mortality attributed to liver disease was 32% in colchicine and 28% in placebo patients.
The team observed that fewer patients receiving colchicine developed hepatorenal syndrome.
In addition, the researchers noted that in 54 patients with repeat liver biopsies after 24 or more months of treatment, cirrhosis improved to septal fibrosis in 7 patients (3 colchicine, 4 placebo) and to portal fibrosis in 1 patient (colchicine).
Dr Morgan's team concludes, “ In patients with advanced alcoholic cirrhosis, colchicine does not reduce overall or liver-specific mortality.”
“Liver histology improves to septal fibrosis in a minority of patients after 24 months of treatment, with similar rates of improvement in patients receiving placebo and colchicine.”
“Colchicine is not recommended for patients with advanced alcoholic cirrhosis.”