[Show abstract][Hide abstract] 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 5days (100mg/5days), 25mg/5days, or 100mg/2days, or placebo. Women were assessed at 7-10 and 28-35days. 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/5days (48%, P=0.04), 100mg/2days (36.0%), and 100mg/5days (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/5days showed better therapeutic cure rates and maintenance of therapeutic cure after 1month versus placebo. All treatment regimens were well tolerated. EudraCT number: 2009-011826-32.
International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics 12/2012; 120(2). DOI:10.1016/j.ijgo.2012.08.022 · 1.56 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Bacterial vaginosis (BV) is a common vaginal disorder characterized by an alteration of the vaginal bacterial morphotypes, associated with sexually transmitted infections and adverse pregnancy outcomes. The purpose of the present study was to evaluate the impact of different doses of rifaximin vaginal tablets (100 mg/day for 5 days, 25 mg/day for 5 days, and 100 mg/day for 2 days) on the vaginal microbiota of 102 European patients with BV enrolled in a multicenter, double-blind, randomized, placebo-controlled study. An integrated molecular approach based on quantitative PCR (qPCR) and PCR-denaturing gradient gel electrophoresis (PCR-DGGE) was used to investigate the effects of vaginal tablets containing the antibiotic. An increase in members of the genus Lactobacillus and a decrease in the BV-related bacterial groups after the antibiotic treatment were demonstrated by qPCR. PCR-DGGE profiles confirmed the capability of rifaximin to modulate the composition of the vaginal microbial communities and to reduce their complexity. This molecular analysis supported the clinical observation that rifaximin at 25 mg/day for 5 days represents an effective treatment to be used in future pivotal studies for the treatment of BV.