A new approach for the treatment of bacterial vaginosis: use of polyhexamethylene biguanide. A prospective, randomized study.
BACKGROUND
Bacterial vaginosis (BV) is the most common vulvovaginal infection and represents the 35% of all the infections occurring in women in the reproductive age. It is well recognised that serious forms of BV can induce several complications among women undergoing gynaecologic or obstetric surgery, having pelvic inflammatory diseases, temporary or absolute infertility, miscarriage and abortion. At present, the clinical treatment of choice of BV is the use of systemic or local (gel or cream) metronidazole and clindamycin, though systemic use has some limitations due to side-effects and contraindications. Polyhexamethylene biguanide (PHMB) is a new bi-biguanide compound having a broad spectrum activity and low toxicity, that have been successfully utilized in ophthalmology and dentistry. Aim of this study was to evaluate the efficacy and tolerability of a single-dose vaginal administration of a PHMB vaginal gel in the treatment of BV in comparison to clindamycin vaginal cream.


METHODS
One-hundred and ten patients affected by BV were treated with PHMB vaginal gel in single administration or clindamycin vaginal cream 1 daily administration for 7 days.


RESULTS
We demonstrated the therapeutic efficacy of mono-dose administration of a vaginal solution containing PHMB in BV treatment; this efficacy is similar to the one shown in antibiotic therapy. Furthermore, this product was well tolerated by all treated patients.


CONCLUSIONS
Mono-dose PHMB treatment should be regarded as the therapy of choice for BV, using clindamycin and metronidazole only for relapses treatment.
Gerli
S
S
Centre of Reproductive and Perinatal Medicine, Department of Gynecological, Obstetrical and Pediatric Sciences, Policlinico Monteluce, University of Perugia, Italy.
Rossetti
D
D
Di Renzo
G C
GC
D000282:Administration, Intravaginal; D000293:Adolescent; D000328:Adult; D001645:Biguanides / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000627:therapeutic use*; D002981:Clindamycin / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000627:therapeutic use; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D010349:Patient Compliance; D011446:Prospective Studies; D015163:Superinfection / Q000150:complications / Q000453:epidemiology; D013997:Time Factors; D016896:Treatment Outcome; D014622:Vaginal Creams, Foams, and Jellies / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D016585:Vaginosis, Bacterial / Q000150:complications / Q000188:drug therapy* / Q000453:epidemiology
D001645:Biguanides; D014622:Vaginal Creams, Foams, and Jellies; C031233:polihexanide; D002981:Clindamycin