title: Colchicine treatment of alcoholic cirrhosis: a randomized, placebo-controlled clinical trial of patient survival.
abstract: 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.
authors.affiliation: VA Long Beach Healthcare Systems, Long Beach, CA 90822, USA. timothy.morgan@med.va.gov
authors.forename: Timothy R
authors.initials: TR
authors.lastname: Morgan
authors.forename: David G
authors.initials: DG
authors.lastname: Weiss
authors.forename: Bernard
authors.initials: B
authors.lastname: Nemchausky
authors.forename: Eugene R
authors.initials: ER
authors.lastname: Schiff
authors.forename: Bhupinder
authors.initials: B
authors.lastname: Anand
authors.forename: Francis
authors.initials: F
authors.lastname: Simon
authors.forename: Jayashri
authors.initials: J
authors.lastname: Kidao
authors.forename: Bennet
authors.initials: B
authors.lastname: Cecil
authors.forename: Charles L
authors.initials: CL
authors.lastname: Mendenhall
authors.forename: Douglas
authors.initials: D
authors.lastname: Nelson
authors.forename: Charles
authors.initials: C
authors.lastname: Lieber
authors.forename: Marcos
authors.initials: M
authors.lastname: Pedrosa
authors.forename: Lennox
authors.initials: L
authors.lastname: Jeffers
authors.forename: John
authors.initials: J
authors.lastname: Bloor
authors.forename: Lawrence
authors.initials: L
authors.lastname: Lumeng
authors.forename: Luis
authors.initials: L
authors.lastname: Marsano
authors.forename: Craig
authors.initials: C
authors.lastname: McClain
authors.forename: Girish
authors.initials: G
authors.lastname: Mishra
authors.forename: Brent
authors.initials: B
authors.lastname: Myers
authors.forename: Maria
authors.initials: M
authors.lastname: Leo
authors.forename: Yelena
authors.initials: Y
authors.lastname: Ponomarenko
authors.forename: Derek
authors.initials: D
authors.lastname: Taylor
authors.forename: Antonio
authors.initials: A
authors.lastname: Chedid
authors.forename: Samuel
authors.initials: S
authors.lastname: French
authors.forename: Gary
authors.initials: G
authors.lastname: Kanel
authors.forename: Natalie
authors.initials: N
authors.lastname: Murray
authors.forename: Paul
authors.initials: P
authors.lastname: Pinto
authors.forename: Tse-Ling
authors.initials: TL
authors.lastname: Fong
authors.forename: Mike R
authors.initials: MR
authors.lastname: Sather
mesh_terms: 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
chemical_list: D003078:Colchicine