Colchicine treatment of alcoholic cirrhosis: a randomized, placebo-controlled clinical trial of patient survival.

Abstract

BACKGROUND & AIMS:

Colchicine improved survival and reversed cirrhosis in several small clinical trials. We compared the efficacy and safety of long-term colchicine, as compared with placebo, in patients with advanced alcoholic cirrhosis.

METHODS:

Five hundred forty-nine patients with advanced (Pugh B or C) alcoholic cirrhosis were randomized to receive either colchicine 0.6 mg twice per day (n = 274) or placebo (n = 275). Treatment lasted from 2 to 6 years. The primary outcome was all-cause mortality. Secondary outcomes were liver-related morbidity and mortality. Liver biopsy was requested prior to entry and after 24 months of treatment.

RESULTS:

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. In an intention-to-treat analysis, all-cause mortality was similar in colchicine (49%) and placebo (45%) patients (P = .371). Mortality attributed to liver disease was 32% in colchicine and 28% in placebo patients (P = .337). Fewer patients receiving colchicine developed hepatorenal syndrome. 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).

CONCLUSIONS:

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.

• Authors: Timothy R Morgan, David G Weiss, Bernard Nemchausky, Eugene R Schiff, Bhupinder Anand, Francis Simon, Jayashri Kidao, Bennet Cecil, Charles L Mendenhall, Douglas Nelson, Charles Lieber, Marcos Pedrosa, Lennox Jeffers, John Bloor, Lawrence Lumeng, Luis Marsano, Craig McClain, Girish Mishra, Brent Myers, Maria Leo, Yelena Ponomarenko, Derek Taylor, Antonio Chedid, Samuel French, Gary Kanel, Natalie Murray, Paul Pinto, Tse-Ling Fong, Mike R Sather
• Journal: Gastroenterology (Gastroenterology) Vol. 128 Issue 4 Pg. 882-90 (Apr 2005) ISSN: 0016-5085 [Print] United States
• PMID: 15825072 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, U.S. Gov't, Non-P.H.S.)

Chemical References

• Colchicine

Topics

• Colchicine (therapeutic use)
• Double-Blind Method
• Female
• Humans
• Liver (drug effects, pathology)
• Liver Cirrhosis, Alcoholic (drug therapy, epidemiology, mortality, pathology)
• Male
• Middle Aged
• Morbidity
• Survival Analysis
• Treatment Failure