OBJECTIVE: 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. STUDY DESIGN: 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. RESULTS: 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 = 0.572). Results were also similar for 3 of 4 and 2 of 4 Amsel's criteria and for each individual Amsel's criterion (all P-values > 0.200). Ninety-five percent confidence intervals for each endpoint were consistent with equivalence between the 2 products. There was no significant difference between the treatment groups in the incidence of treatment-emergent adverse events (P = 0.386). CONCLUSIONS: A single dose, of PHMB gynaecologic solution (Monogin) is equivalent in safety and efficacy to a 7-dose regimen of Clindamycin vaginal cream in the treatment of bacterial vaginosis. Futhermore the compliance as been reported to be higher for the single-dose treatment with PHMB than with 7-days treatment with Clindamycin.
RCT Entities:
OBJECTIVE: 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. STUDY DESIGN: 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. RESULTS: 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 = 0.572). Results were also similar for 3 of 4 and 2 of 4 Amsel's criteria and for each individual Amsel's criterion (all P-values > 0.200). Ninety-five percent confidence intervals for each endpoint were consistent with equivalence between the 2 products. There was no significant difference between the treatment groups in the incidence of treatment-emergent adverse events (P = 0.386). CONCLUSIONS: A single dose, of PHMB gynaecologic solution (Monogin) is equivalent in safety and efficacy to a 7-dose regimen of Clindamycin vaginal cream in the treatment of bacterial vaginosis. Futhermore the compliance as been reported to be higher for the single-dose treatment with PHMB than with 7-days treatment with Clindamycin.