Trial reportHepatology (Baltimore, Md.)2009
High-dose ursodeoxycholic acid for the treatment of primary sclerosing cholangitis.
Trial report in Hepatology (Baltimore, Md.), 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00059202 (Multicentered Randomized Trial of High-dose Urso in Primary Sclerosing Cholangitis), which is not on this map. Cited by 249 papers, 12 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Multicentered Randomized Trial of High-dose Urso in Primary Sclerosing Cholangitis
Who cites it
249 citing papers in PubMed, 12 syntheses or guidelines pooled it, 710 citations in OpenAlex.
- Management of paediatric ulcerative colitis, part 1: Ambulatory care-An updated evidence-based consensus guideline from the European Society of Paediatric Gastroenterology, Hepatology and Nutrition and the European Crohn's and Colitis Organisation.Journal of pediatric gastroenterology and nutrition · 2025Guideline
- British Society of Gastroenterology guidelines for diagnosis and management of autoimmune hepatitis.Gut · 2025Guideline
- Primary sclerosing cholangitis in children with inflammatory bowel disease: An ESPGHAN position paper from the Hepatology Committee and the IBD Porto group.Journal of pediatric gastroenterology and nutrition · 2025Guideline
- Efficacy and safety of ursodeoxycholic acid in children with cholestasis: A systematic review and meta-analysis.PloS one · 2023Pooled it
- [Guidelines on the diagnosis and management of primary sclerosing cholangitis (2021)].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2022Guideline
- Effect of ursodeoxycholic acid on liver markers: A systematic review and meta-analysis of randomized placebo-controlled clinical trials.British journal of clinical pharmacology · 2020Pooled it
- Consensus guidelines: best practices for detection, assessment and management of suspected acute drug-induced liver injury occurring during clinical trials in adults with chronic cholestatic liver disease.Alimentary pharmacology & therapeutics · 2020Guideline
- Guideline
- Clinical guidelines for primary sclerosing cholangitis 2017.Journal of gastroenterology · 2018Guideline
- Pooled it
- ACG Clinical Guideline: Primary Sclerosing Cholangitis.The American journal of gastroenterology · 2015Guideline
- Ursodiol and colorectal cancer or dysplasia risk in primary sclerosing cholangitis and inflammatory bowel disease: a meta-analysis.Digestive diseases and sciences · 2013Pooled it
- Fenofibrate in primary sclerosing cholangitis; a randomized, double-blind, placebo-controlled trial.Pharmacology research & perspectives · 2022Trial
- Ursodeoxycholic acid prevention on cholestasis associated with total parenteral nutrition in preterm infants: a randomized trial.World journal of pediatrics : WJP · 2022Trial
- A randomized, placebo-controlled, phase II study of obeticholic acid for primary sclerosing cholangitis.Journal of hepatology · 2020Trial
- Pharmacokinetics, Safety, and Tolerability of Orally Administered Ursodeoxycholic Acid in Patients With Parkinson's Disease-A Pilot Study.Journal of clinical pharmacology · 2020Trial
- The Nonsteroidal Farnesoid X Receptor Agonist Cilofexor (GS-9674) Improves Markers of Cholestasis and Liver Injury in Patients With Primary Sclerosing Cholangitis.Hepatology (Baltimore, Md.) · 2019Trial
- Efficacy and safety of curcumin in primary sclerosing cholangitis: an open label pilot study.Scandinavian journal of gastroenterology · 2019Trial
- Trial
- The longstanding issue of the benefit of ursodeoxycholic acid in primary sclerosing cholangitis: a long-term population-based study.Journal of gastroenterology · 2026Article
189 more citing papers are in PubMed but not listed here.
Corrections and comments
- Commented on by
Authors and funding
20 authors at 9 institutions in 2 countries.
Funding
Abstract
unlabelledPrevious controlled trials are inconclusive regarding the efficacy of ursodeoxycholic acid (UDCA) for treating primary sclerosing cholangitis (PSC). One hundred fifty adult patients with PSC were enrolled in a long-term, randomized, double-blind controlled trial of high-dose UDCA (28-30 mg/kg/day) versus placebo. Liver biopsy and cholangiography were performed before randomization and after 5 years. The primary outcome measures were development of cirrhosis, varices, cholangiocarcinoma, liver transplantation, or death. The study was terminated after 6 years due to futility. At enrollment, the UDCA (n = 76) and placebo (n = 74) groups were similar with respect to sex, age, duration of disease, serum aspartate aminotransferase and alkaline phosphatase levels, liver histology, and Mayo risk score. During therapy, aspartate aminotransferase and alkaline phosphatase levels decreased more in the UDCA group than the placebo group (P < 0.01), but improvements in liver tests were not associated with decreased endpoints. By the end of the study, 30 patients in the UDCA group (39%) versus 19 patients in the placebo group (26%) had reached one of the pre-established clinical endpoints. After adjustment for baseline stratification characteristics, the risk of a primary endpoint was 2.3 times greater for patients on UDCA than for those on placebo (P < 0.01) and 2.1 times greater for death, transplantation, or minimal listing criteria (P = 0.038). Serious adverse events were more common in the UDCA group than the placebo group (63% versus 37% [P < 0.01]).
conclusionLong-term, high-dose UDCA therapy is associated with improvement in serum liver tests in PSC but does not improve survival and was associated with higher rates of serious adverse events.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.