Emerging data suggest that oral antibiotics may have therapeutic effects in primary sclerosing cholangitis, but published studies are limited.
Dr Tabibian and colleagues investigated the safety and efficacy of oral vancomycin and metronidazole in patients with primary sclerosing cholangitis.
The team randomized 35 patients with primary sclerosing cholangitis in a double-blind manner into 4 groups.
Groups 1 and 2 included patients receiving vancomycin 125 mg or 250 mg 4 times per day, respectively.
Groups 3 and 4 received metronidazole 250 mg or 500 mg 3 times per day for 12 weeks, respectively.
The primary endpoint was decrease in alkaline phosphatase at 12 weeks.
The doctors noted that secondary end points included serum bilirubin and Mayo primary sclerosing cholangitis risk score, pruritus, and adverse effects.
Nonparametric tests were used for analysis.
The researchers examined that the primary endpoint was reached in the low-dose and high-dose vancomycin groups, with 2 patients in the former experiencing alkaline phosphatase normalization.
|Pruritus decreased significantly in the high-dose metronidazole group|
|Alimentary Pharmacology & Therapeutics|
Bilirubin decreased significantly in the low-dose metronidazole group, and trended towards significance in the low-dose vancomycin group.
The doctors reported that the Mayo primary sclerosing cholangitis risk score decreased significantly in the low-dose vancomycin and low-dose metronidazole group.
Pruritus decreased significantly in the high-dose metronidazole group.
Adverse events led to medication discontinuation in 6 patients, 4 of whom were receiving metronidazole.
Dr Tabibian's team concluded, "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."