Successful treatment of bacterial vaginosis with a policarbophil-carbopol acidic vaginal gel: results from a randomised double-blind, placebo-controlled trial.

OBJECTIVE: We evaluated the efficacy of a mucoadhesive vaginal gel (MVG, Miphil) with acidic-buffering properties in bacterial vaginosis (BV). STUDY
DESIGN: Double-blind, placebo-controlled, 12-week trial.
SUBJECTS: A total of 45 non-pregnant women with BV were enrolled in the trial. Patients were treated with MVG 2.5 g or the corresponding placebo (P) daily for the first week and then every 3 days for the following 5 weeks (treatment phase) in a 2:1 ratio. All patients were followed for an additional 6 weeks without treatments (follow-up phase). Clinical cure was defined as absence of vaginal discharge, vaginal pH <4.5, a negative fish odour test and a Nugent score <7.
RESULTS: At week 6, 28 out of 30 women (93%) in the MVG group were clinically cured in comparison with only 1 out of 15 (6%) in the P group (P=0.0001). At week 12, 86% of MVG treated women remained cured in comparison with 8% in P group (P=0.0001). At baseline, the vaginal pH was 6.1+/-0.7 in the MVG and 5.5+/-0.7 in the P group. Vaginal pH significantly (P=0.003) decreased to 4.3+/-0.3 in the MVG group. In P group non-significant modifications of vaginal pH were observed (5.1+/-0.5).
CONCLUSION: Our results demonstrated that this MVG is an effective treatment of BV.

RCT Entities:   Population Interventions Outcomes