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Cited by 54Liver Diseases and ImmunityPediatric Hepatobiliary Diseases and TreatmentsDrug Transport and Resistance Mechanisms

The DOI matches its Crossref record; 32 of the 32 references it cites were found in a registry or an index.

The Canadian Multicenter Double‐blind Randomized Controlled Trial of ursodeoxycholic acid in primary biliary cirrhosis

Heathcote, Jenny E., Cauch-Dudek, Karen, Walker, Valery, Bailey, Robert J., Blendis, Laurence M., Ghent, Cameron N., Michieletti, Pina, Minuk, Gerald Y., Pappas, Chris S., Scully, Linda J., Steinbrecher, Urs P., Sutherland, Lloyd R., Williams, Noel C., Witt-Sullivan, Helga, Worobetz, Lawrence J., Milner, Ruth A., Wanless, Ian R.·1994·Hepatology
DOI 10.1002/hep.1840190512
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Abstract

Ursodeoxycholic acid, a dihydroxyl bile acid normally present in human beings in minimal amounts, becomes incorporated into the bile salt pool when taken orally. In cholestasis, bile acids are retained in the liver and are hepatotoxic. Ursodeoxycholic acid is the least-known hepatotoxic bile acid, has choleretic properties and is reported to benefit patients with chronic cholestasis. In a nationwide Canadian controlled trial, 222 patients with primary biliary cirrhosis were treated with ursodeoxycholic acid (14 mg/kg/body wt/day) or placebo for 24 mo. Only patients with a diagnosis confirmed by liver biopsy and serum positive for antimitochondrial antibodies were enrolled; 88% were symptomatic on entry. The primary outcome measure was percent change in total serum bilirubin from baseline to final follow-up. Treated patients (111) and controls (111) were comparable with regard to age, gender, biochemical parameters and liver histological condition. Although treatment was not associated with any improvement in symptoms, ursodeoxycholic acid therapy caused the bilirubin to fall significantly within the first 3 mo of therapy (p<0.001). Significant falls in serum alkaline phosphatase, aminotransferases, cholesterol and IgM levels were also noted in the treated group. Improvement in some histological features was observed but there was no difference between the groups in the number of patients who reached the endpoints of death or liver transplantation. Ursodeoxycholic acid, given to patients with primary biliary cirrhosis, leads to an improvement in serum markers of cholestasis. A larger sample size is needed to determine whether ursodeoxycholic acid therapy has a beneficial effect on the survival of patients with primary biliary cirrhosis. (Hepatology 1994;19:1149-1156.)

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Crossref · 10.1002/hep.1840190512

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Research works printed but not linked: 5

  1. Epstein, 1985, J Hepatol, 1, s49
  2. David, 1985, Z Gastroenterol, 23, 420
  3. , . Immunoglobulin quantitation. In: , , , , eds. Manual of clinical laboratory immunology. Washington, D.C.: American Society for Microbiology, 1992: 71–83.
  4. Zanninelli, 1993, Hepatology, 18, 139a
  5. Hockerstedt, 1990, Transplant Proc, 22, 1499

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Metadata

Authors
Heathcote, J. E., Cauch-Dudek, K., Walker, V., Bailey, R. J., Blendis, L. M., Ghent, C. N., Michieletti, P., Minuk, G. Y., Pappas, C. S., Scully, L. J., Steinbrecher, U. P., Sutherland, L. R., Williams, N. C., Witt-Sullivan, H., Worobetz, L. J., Milner, R. A., & Wanless, I. R.
Affiliations
  • University of Toronto (CA)
  • University of Alberta (CA)
  • Western University (CA)
  • University of Manitoba (CA)
  • University of Ottawa (CA)
  • University of British Columbia (CA)
  • University of Calgary (CA)
  • University of Saskatchewan (CA)
Venue
Hepatology
Publisher
Ovid Technologies (Wolters Kluwer Health)
Published
1994-05
Volume
19
Issue
5
Pages
1149-1156
ISSN
0270-9139 (ISSN-L)
DOI
10.1002/hep.1840190512
OpenAlex
W7214189001
Cited by
2
References
32
Citations by year
2026: 1
FWCI
0.28
Type
journal article
Language
en
Open access
closed
Licence
doi.wiley.com/10.1002/tdm_license_1.1 (tdm, 7793 d)
Locations
Hepatology (publishedVersion)
Topics
  • Health Sciences › Medicine › Hepatology › Liver Diseases and Immunity
  • Health Sciences › Medicine › Surgery › Pediatric Hepatobiliary Diseases and Treatments
  • Health Sciences › Medicine › Oncology › Drug Transport and Resistance Mechanisms
Keywords
ursodeoxycholic acid, primary biliary cirrhosis, cholestasis, serum bilirubin, antimitochondrial antibodies, alkaline phosphatase, transaminases, liver histopathology, liver transplantation, survival, bile acids, hepatotoxicity

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