Evidence map›Paper›PMID 24914504›Full record

Trial reportAmerican journal of therapeutics

Prospective Clinical Trial of Rifaximin Therapy for Patients With Primary Sclerosing Cholangitis.

James H Tabibian, Andrea Gossard, Mounif El-Youssef, John E Eaton, Jan Petz, Roberta Jorgensen, Felicity B Enders, Anilga Tabibian, Keith D Lindor

Registry-linked trialOpen access · greenAbstract readClinical Trial
In one paragraph

Trial report in American journal of therapeutics. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01695174 (A Pilot Study of Xifaxan in Patients With Primary Sclerosing Cholangitis), which is not on this map. Cited by 31 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 4 pooled it
2.4field-weighted citation impact, top 10% of its field
1 · What the graph read from 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.

2 · The registry

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.

NCT01695174 phase1completednot on this map

A Pilot Study of Xifaxan in Patients With Primary Sclerosing Cholangitis

TypeinterventionalSponsorMayo ClinicRan2012 to 2014Enrolled16ConditionsPrimary Sclerosing Cholangitis (PSC)ArmsXifaxan
3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 4 syntheses or guidelines pooled it, 79 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. [Guidelines on the diagnosis and management of primary sclerosing cholangitis (2021)].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2022
    Guideline
  4. Pooled it
  5. Review
  6. Gut-directed therapeutics in inflammatory bowel disease.Current opinion in gastroenterology · 2025
    Review
  7. Review
  8. Article
  9. Current Therapeutics in Primary Sclerosing Cholangitis.Journal of clinical and translational hepatology · 2023
    Review
  10. Review
  11. Review
  12. The microbiota and the gut-liver axis in primary sclerosing cholangitis.Nature reviews. Gastroenterology & hepatology · 2023
    Review
  13. Review
  14. [Emphasis on the treatment of biliary liver disease].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2022
    Article
  15. Review
  16. Review
  17. Review
  18. Review
  19. Review
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 2 institutions in 1 country.

James H Tabibian1Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN; 2Center for Clinical and Translational Sciences, Mayo Graduate School, Rochester, MN; 3Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN; 4Department of Psychiatry and Psychology, Mayo Clinic, Rochester, MN; and 5College of Health Solutions, Arizona State University, Phoenix, AZ.
Andrea Gossard
Mounif El-Youssef
John E Eaton
Jan Petz
Roberta Jorgensen
Felicity B Enders
Anilga Tabibian
Keith D Lindor
Mayo Clinic in Arizona · USMayo Clinic · US

Funding

MULTIDISCRIPLINARY TRAINING IN DIGESTIVE DISEASEST32DK007198 · NIDDK · MAYO CLINIC ROCHESTER · PI Harmeet Malhi · 1986 to 2026
$8.9M
NIDDK NIH HHS T32 DK007198
6 · The paper itself

Abstract

Primary sclerosing cholangitis (PSC) is a rare, chronic, cholestatic liver disease in which emerging data suggest that oral antibiotics may offer therapeutic effects. We enrolled patients with PSC in a 12-week, open-label pilot study to investigate the efficacy and safety of 550 mg of oral rifaximin twice daily. The primary end point was serum alkaline phosphatase (ALK) at 12 weeks. Secondary end points included (1) serum bilirubin, gamma-glutamyl transpeptidase, and Mayo PSC risk score; (2) fatigue impact scale, chronic liver disease questionnaire, and short form health survey (SF-36) scores; and (3) adverse effects (AEs). Analyses were performed with nonparametric tests. Sixteen patients were enrolled, among whom the median age was 40 years; 13 (81%) were male, 13 had inflammatory bowel disease, and baseline ALK was 342 IU/mL (interquartile range, 275-520 IU/mL). After 12 weeks of treatment, there were no significant changes in ALK (median increase of 0.9% to 345 IU/mL; P = 0.47) or any of the secondary biochemical end points (all P > 0.05). Similarly, there were no significant changes in fatigue impact scale, chronic liver disease questionnaire, or SF-36 scores (all P > 0.05). Three patients withdrew from the study due to AEs; 4 others reported mild AEs but completed the study. In conclusion, although some antibiotics may have promise in treating PSC, oral rifaximin, based on the results herein, seems inefficacious for this indication. Future studies are needed to understand how the antimicrobial spectra and other properties of antibiotics might determine their utility in treating PSC.

Indexed as

AdultAlkaline PhosphataseAnti-Infective AgentsBilirubinCholangitis, SclerosingFatigueFemalegamma-GlutamyltransferaseHumansMalePilot ProjectsProspective StudiesPruritusRifamycinsRifaximinSurveys and QuestionnairesAlkaline PhosphataseAnti-Infective AgentsBilirubingamma-GlutamyltransferaseRifamycinsRifaximin

Identifiers

PMID24914504
PMCPMC4261045
OpenAlexW2018878564

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.