Randomised clinical trial: vancomycin or metronidazole in patients with primary sclerosing cholangitis ‐ a pilot study

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...

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Bibliographic Details
Published in:Alimentary pharmacology & therapeutics 2013-03, Vol.37 (6), p.604-612
Main Authors: Tabibian, J. H., Weeding, E., Jorgensen, R. A., Petz, J. L., Keach, J. C., Talwalkar, J. A., Lindor, K. D.
Format: Article
Language:English
Subjects:
Adult
Aged
Anti-Bacterial Agents - adverse effects
Anti-Bacterial Agents - therapeutic use
Bilirubin
Biological and medical sciences
Biomarkers
Cholangitis, Sclerosing - drug therapy
Digestive system
Dose-Response Relationship, Drug
Double-Blind Method
Female
Gastroenterology. Liver. Pancreas. Abdomen
Humans
Liver. Biliary tract. Portal circulation. Exocrine pancreas
Male
Medical sciences
Metronidazole - adverse effects
Metronidazole - therapeutic use
Middle Aged
Other diseases. Semiology
Pharmacology. Drug treatments
Pilot Projects
Vancomycin - adverse effects
Vancomycin - therapeutic use
Young Adult
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Summary: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 (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).
ISSN:0269-2813
1365-2036
DOI:10.1111/apt.12232