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).


METHODS
Double-blind, placebo-controlled, 12-week trial.


METHODS
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).


CONCLUSIONS
Our results demonstrated that this MVG is an effective treatment of BV.
Fiorilli
Angelo
A
Obstetric Department, Ospedale Civile di Vimercate, Presidio di Carate, Milan, Italy.
Molteni
Bruno
B
Milani
Massimo
M
D000180:Acrylic Resins / Q000008:administration & dosage*; D000282:Administration, Intravaginal; D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D005260:Female; D005782:Gels; D006801:Humans; D006863:Hydrogen-Ion Concentration; D008875:Middle Aged; D009812:Odorants; D010919:Placebos; D011145:Polyvinyls / Q000008:administration & dosage*; D011446:Prospective Studies; D014622:Vaginal Creams, Foams, and Jellies / Q000627:therapeutic use*; D019522:Vaginal Discharge; D016585:Vaginosis, Bacterial / Q000175:diagnosis / Q000188:drug therapy*
D000180:Acrylic Resins; D005782:Gels; D010919:Placebos; D011145:Polyvinyls; D014622:Vaginal Creams, Foams, and Jellies; C006912:carboxypolymethylene; C030312:calcium polycarbophil