A triple blinded, randomized, placebo-controlled clinical trial to evaluate the efficacy and safety of oral vancomycin in primary sclerosing cholangitis: A pilot study

Rahimpour, S. and Nasiri-Toosi, M. and Khalili, H. and Daryani, N.E. and Taromlou, M.K.N. and Azizi, Z. (2016) A triple blinded, randomized, placebo-controlled clinical trial to evaluate the efficacy and safety of oral vancomycin in primary sclerosing cholangitis: A pilot study. Journal of Gastrointestinal and Liver Diseases, 25 (4). pp. 457-464.

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Abstract

Background & Aim: Recent studies have suggested the therapeutic effect of antimicrobial agents on primary sclerosing cholangitis (PSC). Therefore, we aimed to evaluate the efficacy of oral vancomycin in patients with PSC. Method: A triple blinded, randomized, placebo-controlled trial was performed on 29 patients (2015-2016) in the Imam Khomeini Hospital, Tehran, Iran (NCT02605213). Patients were divided into two groups by simple randomization method: placebo 11 (37.9)/vancomycin 18 (62.1) and were treated with oral vancomycin (125 mg, four times a day) for 12 weeks. All patients in both groups simultaneously underwent treatment with ursodeoxycholic acid (UDCA, 300 mg, three times a day) before and during the study. Patients� laboratory data and clinical symptoms were recorded at the beginning, first and third month after starting treatment, and the response to treatment was analyzed. Results: 29 patients with a mean age of 36.27±10.60 years were included in the study. Primary endpoints were accomplished in the vancomycin group showing a significant decline in the mean level of PSC Mayo risk score (decrease rate 3rd month - baseline = -322.03, p=0.026) during follow up time. Moreover, the analysis of the level of alkaline phosphatase (ALP) in the vancomycin group showed a significant decrease in the third month of treatment as compared to its level in the first month (mean difference 3rd month -1st month = -142.92, Decrease rate= -18.24, p=0.02). Among secondary endpoints, erythrocyte sedimentation rate (p=0.005), gamma-glutamyl transpeptidase (p=0.02) and patients� symptoms including fatigue, pruritus, diarrhea and anorexia showed a significant decrease in the vancomycin group. Conclusion: This study demonstrated an acceptable efficacy of vancomycin in the treatment of PSC. © 2016, Romanian Society of Gastroenterology. All rights reserved.

Item Type: Article
Additional Information: cited By 9
Depositing User: eprints admin
Date Deposited: 16 Jul 2018 07:13
Last Modified: 16 Jul 2018 07:13
URI: http://eprints.iums.ac.ir/id/eprint/2920

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