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Int J Gynaecol Obstet. 2013 Feb;120(2):131-6. doi: 10.1016/j.ijgo.2012.08.022. Epub 2012 Dec 27.

A multicenter, double-blind, randomized, placebo-controlled study of rifaximin for the treatment of bacterial vaginosis.

Author information

1
Department of Obstetrics and Gynecology, The Regional Hospital Heilig Hart, Tienen and University Hospital Gasthuisberg, Leuven, Belgium. gilbert.donders@femicare.net

Abstract

OBJECTIVE:

To compare efficacy and tolerability between different regimens of rifaximin vaginal tablets and a placebo for treatment of bacterial vaginosis.

METHODS:

In a prospective study carried out at 13 sites in 3 European countries between August 2009 and October 2010, White, non-pregnant, premenopausal women with bacterial vaginosis were randomly assigned to receive rifaximin at 100mg for 5 days (100mg/5 days), 25mg/5 days, or 100mg/2 days, or placebo. Women were assessed at 7-10 and 28-35 days. Diagnosis and cure were based on Amsel criteria and Nugent score. Fisher exact test was used to compare cure rates.

RESULTS:

Among 114 women recruited, 103 were evaluable for drug efficacy. Therapeutic cure rate at first follow-up was higher in the rifaximin 25mg/5 days (48%, P=0.04), 100mg/2 days (36.0%), and 100mg/5 days (25.9%) groups than in the placebo group (19.0%). At second follow-up, therapeutic cure rate was 28.0%, 14.8%, and 4.0% in the respective groups versus 7.7% in the placebo group. No difference in adverse events was observed.

CONCLUSION:

Rifaximin at 25mg/5 days showed better therapeutic cure rates and maintenance of therapeutic cure after 1 month versus placebo. All treatment regimens were well tolerated. EudraCT number: 2009-011826-32.

PMID:
23273888
DOI:
10.1016/j.ijgo.2012.08.022
[Indexed for MEDLINE]
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