Ursodeoxycholic acid and prednisolone versus ursodeoxycholic acid and placebo in the treatment of early stages of primary biliary cirrhosis
Abstract
Background Ursodeoxycholic acid probably is not able to cure primary biliary cirrhosis. Therefore in this study ursodeoxycholic acid was administered together with prednisolone, since monotherapy with glucocorticoids has been shown to have some positive effects. Methods Thirty patients with primary biliary cirrhosis (stages I-III) were entered into the study. Fifteen were treated with ursodeoxycholic acid 10 mg.kg-1.day-1 and placebo (group A), 15 with ursodeoxycholic acid and 10 mg prednisolone (group B) for 9 months. Apart from the usual laboratory examinations, liver biopsies were taken from 29 patients before and after therapy. Results Liver enzymes decreased significantly compared to the initial values in both groups (p < 0.001), but in group B cholestasis-indicating enzymes and the immunoglobulins G and A improved more rapidly. Between both groups the differences for AP, GGT, IgG, IgA and gamma-globulins were significant (p < 0.05), but only for short terms. In group B, liver histology improved significantly (p < 0.003), which correlated with the decrease of IgG. Ursodeoxycholic acid became the predominant bile acid in the serum. Toxic bile acids did not increase. Bone densitometry revealed a slight deterioration of preexisting osteoporosis in one patient. Conclusions Although combination therapy with ursodeoxycholic acid and prednisolone was not superior to monotherapy with ursodeoxycholic acid with regard to liver function tests, it had a highly beneficial influence on liver histology. In our previous trials with monotherapy histology remained unchanged. An early decrease in IgG during combination therapy seems to be an indicator of an amelioration of liver histology.
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UDCA administration in cystic fibrosis-associated liver disease and early-stage primary biliary cirrhosis reported modest improvements in liver function.
“In 1994 and 1996, two studies evaluated the administration of ursodeoxycholic acid (UDCA), a hydrophilic secondary bile acid, in patients with cystic fibrosis–associated liver disease (200) and early-stage primary biliary cirrhosis (201), respectively, reporting modest improvements in liver function.”
From Strategies to promote liver fibrosis amelioration with involvement of restorative macrophages (2026) · cites this paper as [201]
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- Authors
- Leuschner, M., Güldütuna, S., You, T., Hübner, K., Bhatti, S., & Leuschner, U.
- Affiliations
- Goethe University Frankfurt (DE)
- Corresponding author
- Leuschner, Ulrich
- Venue
- Journal of Hepatology
- Publisher
- Elsevier BV
- Published
- 1996-07
- Volume
- 25
- Issue
- 1
- Pages
- 49-57
- ISSN
- 0168-8278 (ISSN-L)
- OpenAlex
- W2012146760
- Cited by
- 119
- References
- 33
- Citations by year
- 2026: 1 · 2025: 3 · 2024: 3 · 2020: 2 · 2019: 4 · 2018: 1 · 2017: 5 · 2016: 3 · 2015: 5 · 2014: 6 · 2013: 1 · 2012: 5
- FWCI
- 2.98
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Hepatology (publishedVersion)
- PubMed (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
- primary biliary cirrhosis, ursodeoxycholic acid, prednisolone, combination therapy, glucocorticoids, liver histopathology, IgG, cholestasis, serum bile acids, osteoporosis, early-stage disease
- MeSH terms
- Adult, Aged, Double-Blind Method, Drug Therapy, Combination, Female, Humans, Immunoglobulin G, Liver, Liver Cirrhosis, Biliary, Male, Middle Aged, Prednisolone, Prospective Studies, Ursodeoxycholic Acid
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