Abstract | BACKGROUND: AIMS: 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 (AEs). 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). AEs 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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Authors | J H Tabibian, E Weeding, R A Jorgensen, J L Petz, J C Keach, J A Talwalkar, K D Lindor |
Journal | Alimentary pharmacology & therapeutics
(Aliment Pharmacol Ther)
Vol. 37
Issue 6
Pg. 604-12
(Mar 2013)
ISSN: 1365-2036 [Electronic] England |
PMID | 23384404
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | © 2013 Blackwell Publishing Ltd. |
Chemical References |
- Anti-Bacterial Agents
- Biomarkers
- Metronidazole
- Vancomycin
- Bilirubin
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Topics |
- Adult
- Aged
- Anti-Bacterial Agents
(adverse effects, therapeutic use)
- Bilirubin
- Biomarkers
- Cholangitis, Sclerosing
(drug therapy)
- Dose-Response Relationship, Drug
- Double-Blind Method
- Female
- Humans
- Male
- Metronidazole
(adverse effects, therapeutic use)
- Middle Aged
- Pilot Projects
- Vancomycin
(adverse effects, therapeutic use)
- Young Adult
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