Randomised clinical trial: vancomycin or metronidazole in patients with primary sclerosing cholangitis - a pilot study
Open accessAbstract
Summary: Background: Emerging data suggest that oral antibiotics may have therapeutic effects in primary sclerosing cholangitis ( PSC ), but published studies are limited. Aims: To investigate the safety and efficacy of oral vancomycin and metronidazole in patients with PSC . Methods: Thirty‐five patients with PSC were randomised in a double‐blind manner into four groups: vancomycin 125 mg or 250 mg four times/day, or metronidazole 250 mg or 500 mg three times/day for 12 weeks. The primary endpoint was decrease in alkaline phosphatase ( ALK ) at 12 weeks. Secondary end points included serum bilirubin and Mayo PSC risk score; pruritus; and adverse effects ( AE s). Nonparametric tests were used for analysis. Results: The primary endpoint was reached in the low‐dose (−43% change in ALK , P = 0.03) and high‐dose (−40%, P = 0.02) vancomycin groups, with two patients in the former experiencing ALK normalisation. Bilirubin decreased significantly in the low‐dose metronidazole group (−20%, P = 0.03) and trended towards significance in the low‐dose vancomycin group (−33%, P = 0.06). Mayo PSC risk score decreased significantly in the low‐dose vancomycin (−0.55, P = 0.02) and low‐dose metronidazole group (−0.16, P = 0.03). Pruritus decreased significantly in the high‐dose metronidazole group (−3.4, P = 0.03). AE s led to medication discontinuation in six patients, four of whom were receiving metronidazole. Conclusions: Both vancomycin and metronidazole demonstrated efficacy; however, only patients in the vancomycin groups reached the primary endpoint, and with less adverse effects. Larger, longer‐term studies are needed to further examine the safety and efficacy of antibiotics as a potential treatment for patients with primary sclerosing cholangitis ( clinicaltrials.gov NCT01085760 ).
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Proof-of-concept trials show an impact from antibiotics on liver blood tests in PSC.
“Proof-ofconcept trials show an impact from antibiotics on liver blood tests, 9,10”
From EASL Clinical Practice Guidelines on sclerosing cholangitis (2022) · cites this paper as [10]
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- Authors
- Tabibian, J. H., Weeding, E., Jorgensen, R. A., Petz, J. L., Keach, J. C., Talwalkar, J. A., & Lindor, K. D.
- Affiliations
- Mayo Clinic (US)
- Arizona State University (US)
- Corresponding author
- Lindor, K. D.
- Venue
- Alimentary Pharmacology & Therapeutics
- Publisher
- Wiley
- Published
- 2013-02-05
- Volume
- 37
- Issue
- 6
- Pages
- 604-612
- ISSN
- 0269-2813 (ISSN-L)
- 1365-2036
- OpenAlex
- W2028005970
- Cited by
- 267
- References
- 51
- Citations by year
- 2026: 13 · 2025: 11 · 2024: 22 · 2023: 22 · 2022: 12 · 2021: 26 · 2020: 21 · 2019: 23 · 2018: 28 · 2017: 28 · 2016: 22 · 2015: 13 · 2014: 17 · 2013: 6 · 2012: 2
- FWCI
- 12.06
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Alimentary Pharmacology & Therapeutics (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Hepatology › Liver Diseases and Immunity
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Inflammatory Bowel Disease
- Health Sciences › Medicine › Surgery › Pediatric Hepatobiliary Diseases and Treatments
- Keywords
- primary sclerosing cholangitis, vancomycin, metronidazole, oral antibiotics, alkaline phosphatase, serum bilirubin, pruritus, adverse effects, drug dosing
- MeSH terms
- Adult, Aged, Anti-Bacterial Agents, Bilirubin, Dose-Response Relationship, Drug, Double-Blind Method, Female, Humans, Male, Metronidazole, Middle Aged, Pilot Projects, Vancomycin, Cholangitis, Sclerosing, Biomarkers, Young Adult
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