Ursodeoxycholic acid for treatment of primary sclerosing cholangitis: a placebo-controlled trial
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The efficacy and safety of ursodeoxycholic acid for the treatment of primary sclerosing cholangitis were evaluated in a prospective, randomized, double–blind, placebo–controlled trial. Fourteen patients with primary sclerosing cholangitis documented by cholestatic serum enzyme pattern, liver histological appearance and endoscopic retrograde cholangiography were included in the trial. Six patients received ursodeoxycholic acid (13 to 15 mg/kg body wt/day), and eight patients received placebo. Two patients had to be withdrawn from the study, one because of UDCA–related diarrhea and the other because of worsening of the disease during placebo treatment. Patients in the ursodeoxycholic acid group improved significantly during 1 yr of treatment with respect to serum levels of bilirubin (median = - 50%), alkaline phosphatase (median = - 67%), γ–glutamyltransferase (median = - 53%), AST (median = - 54%) and ALT (median = - 36%) compared with the placebo group, but not with respect to serum levels of hydrophobic bile acids. During ursodeoxycholic acid treatment, histopathological features also improved significantly, as evaluated by multiparametric score. Expression of human leukocyte antigen class I molecules appeared to be markedly reduced on liver cells after ursodeoxycholic acid treatment. We conclude that ursodeoxycholic acid is beneficial in reducing disease activity in patients with primary sclerosing cholangitis (Hepatology 1992;16:707-714.)
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Several drugs known to affect bile homeostasis improve liver blood tests, suggesting involvement of these systems in PSC development.
“Similarly, several drugs known to affect bile homeostasis also improve liver blood tests, 13,14 suggesting an involvement of these systems in PSC development.”
From EASL Clinical Practice Guidelines on sclerosing cholangitis (2022) · cites this paper as [13]
A number of smaller pilot studies and larger RCTs demonstrated improvement of serum liver tests, except for 2 of them, but these studies were all underpowered for the identification of hard clinical outcome parameters such as death or liver transplantation.
“A number of smaller pilot studies and larger RCTs 13,80,[147][148][149][150][151][152][153][154][155][156] demonstrated improvement of serum liver tests (except for 2 of them 150,155 ), but these studies were all underpowered for the identification of”
From EASL Clinical Practice Guidelines on sclerosing cholangitis (2022) · cites this paper as [13]
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- Authors
- Beuers, U., Spengler, U., Kruis, W., Aydemir, Ü., Wiebecke, B., Heldwein, W., Weinzierl, M., Pape, G. R., Sauerbruch, T., & Paumgartner, G.
- Affiliations
- LMU Klinikum (DE)
- Ludwig-Maximilians-Universität München (DE)
- University of Cologne (DE)
- Corresponding author
- Beuers, Ulrich
- Venue
- Hepatology
- Published
- 1992-09
- Volume
- 16
- Issue
- 3
- Pages
- 707-714
- ISSN
- 0270-9139 (ISSN-L)
- OpenAlex
- W2016020580
- Cited by
- 448
- References
- 26
- Citations by year
- 2026: 4 · 2025: 9 · 2024: 9 · 2023: 10 · 2022: 8 · 2021: 5 · 2020: 5 · 2019: 9 · 2018: 10 · 2017: 15 · 2016: 8 · 2015: 12 · 2014: 14 · 2013: 12 · 2012: 18
- FWCI
- 8.20
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Hepatology (publishedVersion)
- PubMed (publishedVersion)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Pure Amsterdam UMC (submittedVersion)
- Topics
- Health Sciences › Medicine › Hepatology › Liver Diseases and Immunity
- Health Sciences › Medicine › Surgery › Pediatric Hepatobiliary Diseases and Treatments
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Inflammatory Bowel Disease
- Keywords
- ursodeoxycholic acid, primary sclerosing cholangitis, cholestatic liver disease, serum enzyme levels, liver histopathology, HLA class I expression, bile acids, disease activity
- MeSH terms
- Adolescent, Adult, Alanine Transaminase, Alkaline Phosphatase, Aspartate Aminotransferases, Chenodeoxycholic Acid, Cholic Acids, Deoxycholic Acid, Diarrhea, Double-Blind Method, Female, Humans, Liver, Male, Middle Aged, Prospective Studies, Ursodeoxycholic Acid, Cholangitis, Sclerosing, Cholic Acid
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