Colchicine treatment of alcoholic cirrhosis

A randomized, placebo-controlled clinical trial of patient survival

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 J Jeffers, John Bloor, Lawrence Lumeng, Luis Marsano, Craig McClain, Girish Mishra, Brent Myers, Maria Leo & 9 others Yelena Ponomarenko, Derek Taylor, Antonio Chedid, Samuel French, Gary Kanel, Natalie Murray, Paul Pinto, Tse Ling Fong, Mike R. Sather

Research output: Contribution to journalArticle

47 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)882-890
Number of pages9
JournalGastroenterology
Volume128
Issue number4
DOIs
StatePublished - Apr 1 2005

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Alcoholic Liver Cirrhosis
Colchicine
Randomized Controlled Trials
Placebos
Survival
Fibrosis
Therapeutics
Mortality
Liver
Hepatorenal Syndrome
Biopsy
Intention to Treat Analysis
Ambulatory Care
Liver Diseases
Histology

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Colchicine treatment of alcoholic cirrhosis : A randomized, placebo-controlled clinical trial of patient survival. / Morgan, Timothy R.; Weiss, David G.; Nemchausky, Bernard; Schiff, Eugene R; Anand, Bhupinder; Simon, Francis; Kidao, Jayashri; Cecil, Bennet; Mendenhall, Charles L.; Nelson, Douglas; Lieber, Charles; Pedrosa, Marcos; Jeffers, Lennox J; Bloor, John; Lumeng, Lawrence; Marsano, Luis; McClain, Craig; Mishra, Girish; Myers, Brent; Leo, Maria; Ponomarenko, Yelena; Taylor, Derek; Chedid, Antonio; French, Samuel; Kanel, Gary; Murray, Natalie; Pinto, Paul; Fong, Tse Ling; Sather, Mike R.

In: Gastroenterology, Vol. 128, No. 4, 01.04.2005, p. 882-890.

Research output: Contribution to journalArticle

Morgan, TR, Weiss, DG, Nemchausky, B, Schiff, ER, Anand, B, Simon, F, Kidao, J, Cecil, B, Mendenhall, CL, Nelson, D, Lieber, C, Pedrosa, M, Jeffers, LJ, Bloor, J, Lumeng, L, Marsano, L, McClain, C, Mishra, G, Myers, B, Leo, M, Ponomarenko, Y, Taylor, D, Chedid, A, French, S, Kanel, G, Murray, N, Pinto, P, Fong, TL & Sather, MR 2005, 'Colchicine treatment of alcoholic cirrhosis: A randomized, placebo-controlled clinical trial of patient survival', Gastroenterology, vol. 128, no. 4, pp. 882-890. https://doi.org/10.1053/j.gastro.2005.01.057
Morgan, Timothy R. ; Weiss, David G. ; Nemchausky, Bernard ; Schiff, Eugene R ; Anand, Bhupinder ; Simon, Francis ; Kidao, Jayashri ; Cecil, Bennet ; Mendenhall, Charles L. ; Nelson, Douglas ; Lieber, Charles ; Pedrosa, Marcos ; Jeffers, Lennox J ; Bloor, John ; Lumeng, Lawrence ; Marsano, Luis ; McClain, Craig ; Mishra, Girish ; Myers, Brent ; Leo, Maria ; Ponomarenko, Yelena ; Taylor, Derek ; Chedid, Antonio ; French, Samuel ; Kanel, Gary ; Murray, Natalie ; Pinto, Paul ; Fong, Tse Ling ; Sather, Mike R. / Colchicine treatment of alcoholic cirrhosis : A randomized, placebo-controlled clinical trial of patient survival. In: Gastroenterology. 2005 ; Vol. 128, No. 4. pp. 882-890.
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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.",
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T1 - Colchicine treatment of alcoholic cirrhosis

T2 - A randomized, placebo-controlled clinical trial of patient survival

AU - Morgan, Timothy R.

AU - Weiss, David G.

AU - Nemchausky, Bernard

AU - Schiff, Eugene R

AU - Anand, Bhupinder

AU - Simon, Francis

AU - Kidao, Jayashri

AU - Cecil, Bennet

AU - Mendenhall, Charles L.

AU - Nelson, Douglas

AU - Lieber, Charles

AU - Pedrosa, Marcos

AU - Jeffers, Lennox J

AU - Bloor, John

AU - Lumeng, Lawrence

AU - Marsano, Luis

AU - McClain, Craig

AU - Mishra, Girish

AU - Myers, Brent

AU - Leo, Maria

AU - Ponomarenko, Yelena

AU - Taylor, Derek

AU - Chedid, Antonio

AU - French, Samuel

AU - Kanel, Gary

AU - Murray, Natalie

AU - Pinto, Paul

AU - Fong, Tse Ling

AU - Sather, Mike R.

PY - 2005/4/1

Y1 - 2005/4/1

N2 - 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.

AB - 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.

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