Randomized trial of chlorambucil for primary biliary cirrhosis

Jay H. Hoofnagle, Gary L. Davis, Daniel F. Schafer, Marion Peters, Mark I. Avigan, S. Chris Pappas, Reginald G. Hanson, Gerald Y. Minuk, Geoffrey M. Dusheiko, Gregory Campbell, Roderick N.M. MacSween, E. Anthony Jones

Research output: Contribution to journalArticle

105 Citations (Scopus)

Abstract

Twenty-four patients with primary biliary cirrhosis were entered into a prospective, randomized trial of chlorambucil therapy. Thirteen patients received chlorambucil (0.5-4 mg/day) and 11 patients received no therapy; all have been followed for 2-6 yr (mean, 4.1 yr). Two control but no treated patients died. Average serum bilirubin, serum aspartate aminotransferase activities, and albumin levels improved or remained unchanged in treated patients but worsened in controls. Serum alkaline phosphatase levels did not change in either group. Immunoglobulin M levels decreased and became normal in all treated patients but in only 3 control patients. Liver biopsy histology revealed an improvement in inflammatory cell infiltrate in treated patients in comparison with controls, but no significant change in degree of fibrosis or the histologic stage of disease. Side effects of therapy included bone marrow suppression necessitating discontinuation of the drug in 4 patients. These findings indicate that chlorambucil therapy may retard the progression of primary biliary cirrhosis. Whether such therapy will ultimately decrease morbidity and improve survival in this disease can only be demonstrated by large-scale, placebo-controlled trials.

Original languageEnglish (US)
Pages (from-to)1327-1334
Number of pages8
JournalGastroenterology
Volume91
Issue number6
DOIs
StatePublished - Dec 1986

Fingerprint

Chlorambucil
Biliary Liver Cirrhosis
Serum
Therapeutics
Aspartate Aminotransferases
Bilirubin
Alkaline Phosphatase
Immunoglobulin M
Albumins
Histology
Fibrosis
Bone Marrow
Placebos
Morbidity
Biopsy

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

Cite this

Hoofnagle, J. H., Davis, G. L., Schafer, D. F., Peters, M., Avigan, M. I., Pappas, S. C., ... Jones, E. A. (1986). Randomized trial of chlorambucil for primary biliary cirrhosis. Gastroenterology, 91(6), 1327-1334. https://doi.org/10.1016/0016-5085(86)90183-6

Randomized trial of chlorambucil for primary biliary cirrhosis. / Hoofnagle, Jay H.; Davis, Gary L.; Schafer, Daniel F.; Peters, Marion; Avigan, Mark I.; Pappas, S. Chris; Hanson, Reginald G.; Minuk, Gerald Y.; Dusheiko, Geoffrey M.; Campbell, Gregory; MacSween, Roderick N.M.; Jones, E. Anthony.

In: Gastroenterology, Vol. 91, No. 6, 12.1986, p. 1327-1334.

Research output: Contribution to journalArticle

Hoofnagle, JH, Davis, GL, Schafer, DF, Peters, M, Avigan, MI, Pappas, SC, Hanson, RG, Minuk, GY, Dusheiko, GM, Campbell, G, MacSween, RNM & Jones, EA 1986, 'Randomized trial of chlorambucil for primary biliary cirrhosis', Gastroenterology, vol. 91, no. 6, pp. 1327-1334. https://doi.org/10.1016/0016-5085(86)90183-6
Hoofnagle JH, Davis GL, Schafer DF, Peters M, Avigan MI, Pappas SC et al. Randomized trial of chlorambucil for primary biliary cirrhosis. Gastroenterology. 1986 Dec;91(6):1327-1334. https://doi.org/10.1016/0016-5085(86)90183-6
Hoofnagle, Jay H. ; Davis, Gary L. ; Schafer, Daniel F. ; Peters, Marion ; Avigan, Mark I. ; Pappas, S. Chris ; Hanson, Reginald G. ; Minuk, Gerald Y. ; Dusheiko, Geoffrey M. ; Campbell, Gregory ; MacSween, Roderick N.M. ; Jones, E. Anthony. / Randomized trial of chlorambucil for primary biliary cirrhosis. In: Gastroenterology. 1986 ; Vol. 91, No. 6. pp. 1327-1334.
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