PMID: 18401974Apr 12, 2008Paper

The efficacy and safety of a single dose of polyhexamethylene biguanide gynaecologic solution versus a seven-dose regimen of vaginal clindamycin cream in patients with bacterial vaginosis

European Review for Medical and Pharmacological Sciences
M MinozziA Ferrari

Abstract

At the present the clinical treatment of choice of bacterial vaginosis (BV) is the use of systemic or local metronidazole or clindamycin. Aim of the study was to evaluate the efficacy and tolerability of a single dose of gynaecologic solution, Polyhexamethylene Biguanide (PHMB), Monogin, in the treatment of BV in comparison to a 7-days treatment with clindamycin vaginal cream. This multicenter, randomized, single-blind, parallel-group study enrolled 740 patients with BV infections. Treatment consisted of either a single intravaginal dose of PHMB or 7 daily doses of Clindamycin. Efficacy and safety were assessed 21-30 days after the start of treatment. The efficacy endpoints were Investigator Cure, Clinical Cure (a composite of all 4 Amsel's criteria and investigator Cure), Nugent Cure (Nugent score < 4), and therapeutic cure (a composite of clinical cure and Nugent Cure). Resolution of individual Amsel's criteria was also evaluated. Any adverse event of the treatment has been monitored throughout the study. No significant differences has been reported in cure rates between the PHMB and Clindamycin treatment groups in Investigator Cure (P = 0.702), Clinical Cure (P = 0.945), Nugent Cure (P = 0.788), or Therapeutic Cure (P = 0.57...Continue Reading

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