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High‐dose ursodeoxycholic acid therapy for nonalcoholic steatohepatitis: a double‐blind, randomized, placebo‐controlled trial†
Abstract
UNLABELLED: In uncontrolled clinical studies, ursodeoxycholic acid (UDCA) had a beneficial effect on nonalcoholic steatohepatitis (NASH). However, a large controlled trial using UDCA (13-15 mg/kg/day) was unable to confirm these results. Accordingly, a randomized, placebo-controlled study was initiated with a high dose of UDCA (23-28 mg/kg/day). The allocation of patients and the evaluation of liver histology were performed according to a modified Brunt score and the nonalcoholic fatty liver disease activity score (NAS). With the modified Brunt score, 185 patients with histologically proven NASH were randomized [intention to treat (ITT)], and 147 were treated per protocol (PP). With the NAS, 137 patients were confirmed to have NASH, 48 had borderline NASH, and 1 did not have NASH. The treatment time was 18 months. At entry, the treatment groups were comparable. A second biopsy sample was obtained from 139 of 185 patients (NAS: 107/137). The primary criterion for evaluation was a change in the liver histology; the secondary criteria were single histological variables and liver biochemistry. Significant differences in the overall histology could not be detected between the two treatment groups with the modified Brunt score (P = 0.881) or NAS (P = 0.355). Only lobular inflammation improved significantly (P for the modified Brunt score = 0.011, P for NAS = 0.005). In subgroup analyses, significant improvements in lobular inflammation were also observed in males, younger patients up to 50 years of age, slightly overweight patients, and patients with hypertension and an increased histology score. The fibrosis score did not change (P for ITT = 0.133, P for PP = 0.140). With the exception of gamma-glutamyl transferase, UDCA did not improve laboratory data. CONCLUSION: High-dose UDCA failed to improve the overall histology in patients with NASH in comparison with placebo.
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“There are three larger, placebo-controlled trials of UDCA in MASH differing in the dose of UDCA used 373 -375 and only two of them report histological endpoints.”
From EASL-EASD-EASO Clinical Practice Guidelines on the management of metabolic dysfunction-associated steatotic liver disease (MASLD). (2024) · cites this paper as [374]
In the citing paper
“Despite several limitations and methodological differences, there is a strong indication of biochemical effi cacy (ALT reduction) and a good safety pro fi le, but no proof of histological ef fi cacy.”
From EASL-EASD-EASO Clinical Practice Guidelines on the management of metabolic dysfunction-associated steatotic liver disease (MASLD). (2024) · cites this paper as [374]
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Metadata
- Authors
- Leuschner, U. F. H., Lindenthal, B., Herrmann, G., Arnold, J. C., Rössle, M., Cordes, H., Zeuzem, S., Hein, J., & Berg, T.
- Affiliations
- Krankenhaus Sachsenhausen (DE)
- Goethe University Frankfurt (DE)
- Klinikum Ludwigsburg (DE)
- Agaplesion Diakonieklinikum Rotenburg (DE)
- University Hospital Leipzig (DE)
- Corresponding author
- Leuschner, Ulrich F. H.
- Venue
- Hepatology
- Published
- 2010-08
- Volume
- 52
- Issue
- 2
- Pages
- 472-479
- ISSN
- 0270-9139 (ISSN-L)
- OpenAlex
- W2097677758
- Cited by
- 317
- References
- 36
- Citations by year
- 2026: 9 · 2025: 7 · 2024: 13 · 2023: 14 · 2022: 15 · 2021: 29 · 2020: 17 · 2019: 25 · 2018: 15 · 2017: 21 · 2016: 20 · 2015: 25 · 2014: 23 · 2013: 25 · 2012: 25
- FWCI
- 19.31
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Hepatology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Hepatology › Liver Disease Diagnosis and Treatment
- Health Sciences › Medicine › Hepatology › Liver Diseases and Immunity
- Health Sciences › Medicine › Hepatology › Liver physiology and pathology
- Keywords
- ursodeoxycholic acid, nonalcoholic steatohepatitis, non-alcoholic fatty liver disease, liver histopathology, lobular inflammation, liver fibrosis, liver biochemistry, gamma-glutamyl transferase
- MeSH terms
- Adolescent, Adult, Aged, Double-Blind Method, Fatty Liver, Female, Humans, Male, Middle Aged, Ursodeoxycholic Acid, Young Adult
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