CoChat
Sign Up
Cited by 338Liver Disease Diagnosis and TreatmentLiver Diseases and ImmunityLiver physiology and pathology

The DOI matches its Crossref record; 58 of the 58 references it cites were found in a registry or an index.

A randomized controlled trial of high-dose ursodesoxycholic acid for nonalcoholic steatohepatitis

Ratziu, Vlad, de Ledinghen, Victor, Oberti, Fréderic, Mathurin, Philippe, Wartelle-Bladou, Claire, Renou, Christophe, Sogni, Philippe, Maynard, Marianne, Larrey, Dominique, Serfaty, Lawrence, Bonnefont-Rousselot, Dominique, Bastard, Jean-Philippe, Rivière, Marc, Spénard, Jean·2011·Journal of Hepatology
DOI 10.1016/j.jhep.2010.08.030
Open this paper in CoChat — free account

Abstract

Background & aims Nonalcoholic steatohepatitis (NASH) is a prevalent liver disease associated with increased morbidity and mortality. Ursodeoxycholic acid (UDCA) may have antioxidant, anti-inflammatory, and antifibrotic properties and may reduce liver injury in NASH. To date, no studies have assessed the efficacy and safety of high-dose UDCA (HD-UDCA) in patients with NASH.Methods We conducted a 12-month, randomized, double-blind, placebo-controlled multicenter trial to evaluate the efficacy and safety of HD-UDCA (28-35 mg/kg per day) in 126 patients with biopsy-proven NASH and elevated alanine aminotransferase (ALT) levels. The primary study end point was reduction in ALT levels from baseline in patients treated with HD-UDCA compared with placebo. Secondary study end points were the proportion of patients with ALT normalization, relative reduction in the scores of serum markers of fibrosis and hepatic inflammation, and safety and tolerability.Results HD-UDCA significantly reduced mean ALT levels -28.3% from baseline after 12 months compared with -1.6% with placebo (p<0.001). At the end of the trial, ALT levels normalized (≤35 IU/L) in 24.5% of patients treated with HD-UDCA and in 4.8% of patients who received placebo (p=0.003). Both results were not accounted for by changes in weight during the trial. HD-UDCA significantly reduced the FibroTest® serum fibrosis marker (p<0.001) compared with placebo. HD-UDCA also significantly improved markers of glycemic control and insulin resistance. There were no safety issues in this population.Conclusions Treatment with HD-UDCA was safe, improved aminotransferase levels, serum fibrosis markers, and selected metabolic parameters. Studies with histologic end points are warranted.

Overview

Integrity signals

Registry

Crossref · 10.1016/j.jhep.2010.08.030

Cites

58 of 58 references verified0 citation errors · 0 not checkable

Statistics

Recomputing p-values needs the paper’s full text.

Verification

Claims the paper makes

This paper’s full text isn’t openly available, so its claims and self-check weren’t run. The registry and citation checks still apply.

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

Citations

Cites

Flagged first, then by citations

Show all 58 references

Research works printed but not linked: 1

  1. Kobak, 2002, Fat-laden hepatocytes are more prone to cellular necrosis than apoptosis when exposed to hydrophobic bile acids, Gastroenterology, 122, A642

Cited by

Sorted by citations

Related

See all

Metadata

Authors
Ratziu, V., de Ledinghen, V., Oberti, F., Mathurin, P., Wartelle-Bladou, C., Renou, C., Sogni, P., Maynard, M., Larrey, D., Serfaty, L., Bonnefont-Rousselot, D., Bastard, J.-P., Rivière, M., & Spénard, J.
Affiliations
  • Inserm (FR)
  • Centre Hospitalier Universitaire d'Angers (FR)
  • Hôpital Claude Huriez (FR)
  • Hôpital Cochin (FR)
  • Hospices Civils de Lyon (FR)
  • Centre Hospitalier Universitaire de Montpellier (FR)
  • Hôpital Saint-Antoine (FR)
  • Assistance Publique – Hôpitaux de Paris (FR)
  • Université de Montréal (CA)
Corresponding author
Ratziu, Vlad
ORCID
Venue
Journal of Hepatology
Publisher
Elsevier BV
Published
2011-05
Volume
54
Issue
5
Pages
1011-1019
ISSN
0168-8278 (ISSN-L)
DOI
10.1016/j.jhep.2010.08.030
OpenAlex
W2078519195
Cited by
338
References
58
Citations by year
2026: 10 · 2025: 20 · 2024: 24 · 2023: 21 · 2022: 18 · 2021: 26 · 2020: 13 · 2019: 25 · 2018: 14 · 2017: 18 · 2016: 18 · 2015: 32 · 2014: 22 · 2013: 33 · 2012: 33
FWCI
17.68
Type
journal article
Language
en
Open access
closed
Licence
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations
  • Journal of Hepatology (publishedVersion)
  • PubMed (publishedVersion)
  • HAL (submittedVersion)
Funders
Axcan Pharma Inc
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
nonalcoholic steatohepatitis, ursodeoxycholic acid, alanine aminotransferase normalization, liver fibrosis, liver inflammation, insulin resistance, glycemic control, FibroTest, bile acid therapy
MeSH terms
Adult, Blood Glucose, Cholagogues and Choleretics, Dose-Response Relationship, Drug, Fatty Liver, Female, Follow-Up Studies, Glycated Hemoglobin, Humans, Insulin, Insulin Resistance, Male, Middle Aged, Ursodeoxycholic Acid, Treatment Outcome, Non-alcoholic Fatty Liver Disease

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review