Colchicine treatment of alcoholic cirrhosis: a randomized, placebo-controlled clinical trial of patient survival.
OBJECTIVE
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.
Morgan
Timothy R
TR
VA Long Beach Healthcare Systems, Long Beach, CA 90822, USA. timothy.morgan@med.va.gov
Weiss
David G
DG
Nemchausky
Bernard
B
Schiff
Eugene R
ER
Anand
Bhupinder
B
Simon
Francis
F
Kidao
Jayashri
J
Cecil
Bennet
B
Mendenhall
Charles L
CL
Nelson
Douglas
D
Lieber
Charles
C
Pedrosa
Marcos
M
Jeffers
Lennox
L
Bloor
John
J
Lumeng
Lawrence
L
Marsano
Luis
L
McClain
Craig
C
Mishra
Girish
G
Myers
Brent
B
Leo
Maria
M
Ponomarenko
Yelena
Y
Taylor
Derek
D
Chedid
Antonio
A
French
Samuel
S
Kanel
Gary
G
Murray
Natalie
N
Pinto
Paul
P
Fong
Tse-Ling
TL
Sather
Mike R
MR
D003078:Colchicine / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008099:Liver / Q000187:drug effects / Q000473:pathology; D008104:Liver Cirrhosis, Alcoholic / Q000188:drug therapy* / Q000453:epidemiology / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009017:Morbidity; D016019:Survival Analysis; D017211:Treatment Failure
D003078:Colchicine