A double-blind randomized controlled trial of colchicine in patients with hepatitis B virus-related postnecrotic cirrhosis

Yuan Jen Wang, Shou Dong Lee, Mao Chih Hsieh, Han Chieh Lin, Fa Yauh Lee, Shyh Haw Tsay, Yang Te Tsai, Oliver Yoa Pu Hu, Ming Lu King, Kwang Juei Lo

Research output: Contribution to journalArticle

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Abstract

The preliminary results of a prospective double-blind controlled trial of colchicine in 100 patients with hepatitis B virus-related cirrhosis are reported. The patients, 94 males and 6 females, aged 32-80, were assigned to receive either 1 mg of colchicine or an identical placebo orally on a daily basis. The duration of the follow up ranged from 15 to 51 months (median 26 months). Seventy percent had histological proof of cirrhosis. On entry, 80 patients were in Child-Pugh class A, 19 were in class B, and one was in class C. Compared to the placebo group, there was no improvement in the colchicine group after a 24-month follow up in any of the biochemistry data, for example, serum albumin, alkaline phosphatase, alanine and aspartate aminotransferase, bilirubin, and prothrombin time. The difference in the cumulative survival rates at 51 months did not reach statistical significance (p=0.8) in either group. There was no histological improvement in 30 patients who were willing to undergo repeated liver biopsies. No trend toward improvement of the hepatic pressure gradient was observed in these patients. The serum levels of aminopropeptide of type III procollagen increased significantly in patients in both groups after 24 months of therapy (1.07±0.06 vs. 1.36±0.06 U/ml in the colchicine group, 0.93±0.09 vs. 1.25±0.07 U/ml in the placebo group; p<0.05). In addition, neither the clinical deterioration of cirrhosis nor death was prevented in patients receiving colchicine therapy. This report indicates that colchicine has no effect in the treatment of HBV-related postnecrotic cirrhosis.

Original languageEnglish
Pages (from-to)872-877
Number of pages6
JournalJournal of Hepatology
Volume21
Issue number5
DOIs
Publication statusPublished - Jan 1 1994
Externally publishedYes

Fingerprint

Colchicine
Hepatitis B virus
Fibrosis
Randomized Controlled Trials
Placebos
Collagen Type III
Liver
Prothrombin Time
Aspartate Aminotransferases
Alanine Transaminase
Bilirubin
Serum Albumin
Biochemistry
Alkaline Phosphatase
Therapeutics
Survival Rate
Biopsy
Pressure
Serum

Keywords

  • Cirrhosis
  • Colchicine
  • Hepatitis B virus

ASJC Scopus subject areas

  • Hepatology

Cite this

A double-blind randomized controlled trial of colchicine in patients with hepatitis B virus-related postnecrotic cirrhosis. / Wang, Yuan Jen; Lee, Shou Dong; Hsieh, Mao Chih; Lin, Han Chieh; Lee, Fa Yauh; Tsay, Shyh Haw; Tsai, Yang Te; Hu, Oliver Yoa Pu; King, Ming Lu; Lo, Kwang Juei.

In: Journal of Hepatology, Vol. 21, No. 5, 01.01.1994, p. 872-877.

Research output: Contribution to journalArticle

Wang, Yuan Jen ; Lee, Shou Dong ; Hsieh, Mao Chih ; Lin, Han Chieh ; Lee, Fa Yauh ; Tsay, Shyh Haw ; Tsai, Yang Te ; Hu, Oliver Yoa Pu ; King, Ming Lu ; Lo, Kwang Juei. / A double-blind randomized controlled trial of colchicine in patients with hepatitis B virus-related postnecrotic cirrhosis. In: Journal of Hepatology. 1994 ; Vol. 21, No. 5. pp. 872-877.
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AU - Lee, Fa Yauh

AU - Tsay, Shyh Haw

AU - Tsai, Yang Te

AU - Hu, Oliver Yoa Pu

AU - King, Ming Lu

AU - Lo, Kwang Juei

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N2 - The preliminary results of a prospective double-blind controlled trial of colchicine in 100 patients with hepatitis B virus-related cirrhosis are reported. The patients, 94 males and 6 females, aged 32-80, were assigned to receive either 1 mg of colchicine or an identical placebo orally on a daily basis. The duration of the follow up ranged from 15 to 51 months (median 26 months). Seventy percent had histological proof of cirrhosis. On entry, 80 patients were in Child-Pugh class A, 19 were in class B, and one was in class C. Compared to the placebo group, there was no improvement in the colchicine group after a 24-month follow up in any of the biochemistry data, for example, serum albumin, alkaline phosphatase, alanine and aspartate aminotransferase, bilirubin, and prothrombin time. The difference in the cumulative survival rates at 51 months did not reach statistical significance (p=0.8) in either group. There was no histological improvement in 30 patients who were willing to undergo repeated liver biopsies. No trend toward improvement of the hepatic pressure gradient was observed in these patients. The serum levels of aminopropeptide of type III procollagen increased significantly in patients in both groups after 24 months of therapy (1.07±0.06 vs. 1.36±0.06 U/ml in the colchicine group, 0.93±0.09 vs. 1.25±0.07 U/ml in the placebo group; p<0.05). In addition, neither the clinical deterioration of cirrhosis nor death was prevented in patients receiving colchicine therapy. This report indicates that colchicine has no effect in the treatment of HBV-related postnecrotic cirrhosis.

AB - The preliminary results of a prospective double-blind controlled trial of colchicine in 100 patients with hepatitis B virus-related cirrhosis are reported. The patients, 94 males and 6 females, aged 32-80, were assigned to receive either 1 mg of colchicine or an identical placebo orally on a daily basis. The duration of the follow up ranged from 15 to 51 months (median 26 months). Seventy percent had histological proof of cirrhosis. On entry, 80 patients were in Child-Pugh class A, 19 were in class B, and one was in class C. Compared to the placebo group, there was no improvement in the colchicine group after a 24-month follow up in any of the biochemistry data, for example, serum albumin, alkaline phosphatase, alanine and aspartate aminotransferase, bilirubin, and prothrombin time. The difference in the cumulative survival rates at 51 months did not reach statistical significance (p=0.8) in either group. There was no histological improvement in 30 patients who were willing to undergo repeated liver biopsies. No trend toward improvement of the hepatic pressure gradient was observed in these patients. The serum levels of aminopropeptide of type III procollagen increased significantly in patients in both groups after 24 months of therapy (1.07±0.06 vs. 1.36±0.06 U/ml in the colchicine group, 0.93±0.09 vs. 1.25±0.07 U/ml in the placebo group; p<0.05). In addition, neither the clinical deterioration of cirrhosis nor death was prevented in patients receiving colchicine therapy. This report indicates that colchicine has no effect in the treatment of HBV-related postnecrotic cirrhosis.

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KW - Hepatitis B virus

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