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

Abstract

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.

• Authors: Angelo Fiorilli, Bruno Molteni, Massimo Milani
• Journal: European journal of obstetrics, gynecology, and reproductive biology (Eur J Obstet Gynecol Reprod Biol) Vol. 120 Issue 2 Pg. 202-5 (Jun 01 2005) ISSN: 0301-2115 [Print] Ireland
• PMID: 15925053 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial)

Chemical References

• Acrylic Resins
• Gels
• Placebos
• Polyvinyls
• Vaginal Creams, Foams, and Jellies
• carboxypolymethylene
• calcium polycarbophil

Topics

• Acrylic Resins (administration & dosage)
• Administration, Intravaginal
• Adult
• Aged
• Double-Blind Method
• Female
• Gels
• Humans
• Hydrogen-Ion Concentration
• Middle Aged
• Odorants
• Placebos
• Polyvinyls (administration & dosage)
• Prospective Studies
• Vaginal Creams, Foams, and Jellies (therapeutic use)
• Vaginal Discharge
• Vaginosis, Bacterial (diagnosis, drug therapy)