Metronidazole and ursodeoxycholic acid for primary sclerosing cholangitis: a randomized placebo-controlled trial
Open accessAbstract
No effective medical therapy is currently available for primary sclerosing cholangitis (PSC). Ursodeoxycholic acid (UDCA) improves liver enzymes, but its effect on liver histology is controversial. Metronidazole (MTZ) prevents PSC–like liver damage in animal models and reduces intestinal permeability. We recruited 80 patients with PSC into a randomized placebo–controlled study to evaluate the effect of UDCA and MTZ (UDCA/MTZ) compared with UDCA/placebo on the progression of PSC. Patients (41 UDCA/placebo and 39 UDCA/MTZ) were followed every third month. Assessment of liver function test, histological stage and grade, and cholangiography (via ERCP) at baseline showed no differences between the groups. After 36 months, serum aminotransferases γ–glutamyltransferase, and alkaline phosphatase (ALP) decreased markedly in both groups, serum ALP more significantly in the UDCA/MTZ group (-337 ± 54 U/L, P < .05) compared with the UDCA/placebo group. The New Mayo Risk Score decreased markedly only in the UDCA/MTZ group (-0.50 ± 0.13, P < .01). The number of patients with improvement of stage ( P < .05) and grade ( P < .05) was higher in the combination group. ERCP findings showed no progression or improvement in 77% and 68% of patients on UDCA/MTZ and UDCA/placebo, respectively. In conclusion , combining MTZ with UDCA in PSC improved serum ALP levels and New Mayo Risk Score, but no statistically significant effect on disease progression as assessed via liver histology or ERCP was seen. Long–term studies using a higher dose of UDCA combined with MTZ in larger patient populations are indicated. (Hepatology 2004;40:1379-1386.)
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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 [9]
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References 44 · Cited by 218
Research works printed but not linked: 2
- Vierling JM. Hepatobiliary complications of ulcerative colitis and Crohn's disease. In: Zakim D, Boyer TD, eds. Hepatology. A Textbook of Liver Disease. Volume 2. 4th ed. Philadelphia, PA: Saunders, 2003;1221-1272.
- Mahadevan U, Bass NM. Sclerosing cholangitis and recurrent pyogenic cholangitis. In: Feldman M, Friedman LS, Sleisenger MH, eds. Sleisenger & Fordtran's Gastrointestinal and Liver Disease. Volume 1. 7th ed. Phil- adelphia, PA: Saunders, 2002:1131-1152.
- Authors
- Färkkilä, M., Karvonen, A., Nurmi, H., Nuutinen, H., Taavitsainen, M., Pikkarainen, P., & Kärkkäinen, P.
- Affiliations
- Helsinki University Hospital (FI)
- Tampere University (FI)
- Turku University Hospital (FI)
- Corresponding author
- Färkkilä, Martti
- ORCID
- Färkkilä, Martti
- Venue
- Hepatology
- Published
- 2004-12
- Volume
- 40
- Issue
- 6
- Pages
- 1379-1386
- ISSN
- 0270-9139 (ISSN-L)
- OpenAlex
- W1993535010
- Cited by
- 218
- References
- 44
- Citations by year
- 2026: 7 · 2025: 6 · 2024: 13 · 2023: 11 · 2022: 8 · 2021: 15 · 2020: 12 · 2019: 15 · 2018: 15 · 2017: 17 · 2016: 13 · 2015: 13 · 2014: 11 · 2013: 12 · 2012: 8
- FWCI
- 2.85
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Hepatology (publishedVersion)
- PubMed (publishedVersion)
- Työväentutkimus Vuosikirja (submittedVersion, other-oa)
- Funders
- Mary and Georg C. Ehrnrooth Foundation
- Orion Pharma, Finland (metronidazole, Trikozol)
- Leiras Finland (ursodeoxycholic acid, Adursal)
- Topics
- Health Sciences › Medicine › Hepatology › Liver Diseases and Immunity
- Health Sciences › Medicine › Surgery › Pediatric Hepatobiliary Diseases and Treatments
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Inflammatory Bowel Disease
- Keywords
- primary sclerosing cholangitis, metronidazole, ursodeoxycholic acid, combination therapy, disease progression, liver histopathology, serum alkaline phosphatase, liver enzymes, cholangiography, intestinal permeability
- MeSH terms
- Adult, Anti-Infective Agents, Cholagogues and Choleretics, Cholangiopancreatography, Endoscopic Retrograde, Drug Therapy, Combination, Female, Humans, Liver, Male, Metronidazole, Placebos, Ursodeoxycholic Acid, Cholangitis, Sclerosing, Treatment Outcome
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