A comparison of dequalinium chloride vaginal tablets (Fluomizin®) and clindamycin vaginal cream in the treatment of bacterial vaginosis: a single-blind, randomized clinical trial of efficacy and safety
Ernst Rainer Weissenbacher, Gilbert Donders, Vit Unzeitig, Begoña Martinez de Tejada, Stefan Gerber, Michael Halaška, Jiří Špaček, Fluomizin Study Group, Florian Bergauer, Jan Bosteels, Josef Chovanec, Jan Danko, Piet Hinoul, Jaromír Mašata, Jan Řičánek, Luc Verguts, Ernst Rainer Weissenbacher, Gilbert Donders, Vit Unzeitig, Begoña Martinez de Tejada, Stefan Gerber, Michael Halaška, Jiří Špaček, Fluomizin Study Group, Florian Bergauer, Jan Bosteels, Josef Chovanec, Jan Danko, Piet Hinoul, Jaromír Mašata, Jan Řičánek, Luc Verguts
Abstract
Aims: To investigate if vaginal application of dequalinium chloride (DQC, Fluomizin®) is as effective as vaginal clindamycin (CLM) in the treatment of bacterial vaginosis (BV).
Methods: This was a multinational, multicenter, single-blind, randomized trial in 15 centers, including 321 women. They were randomized to either vaginal DQC tablets or vaginal CLM cream. Follow-up visits were 1 week and 1 month after treatment. Clinical cure based on Amsel's criteria was the primary outcome. Secondary outcomes were rate of treatment failures and recurrences, incidence of post-treatment vulvovaginal candidosis (VVC), lactobacillary grade (LBG), total symptom score (TSC), and safety.
Results: Cure rates with DQC (C1: 81.5%, C2: 79.5%) were as high as with CLM (C1: 78.4%, C2: 77.6%). Thus, the treatment with DQC had equal efficacy as CLM cream. A trend to less common post-treatment VVC in the DQC-treated women was observed (DQC: 2.5%, CLM: 7.7%; p = 0.06). Both treatments were well tolerated with no serious adverse events occurring.
Conclusion: Vaginal DQC has been shown to be equally effective as CLM cream, to be well tolerated with no systemic safety concerns, and is therefore a valid alternative therapy for women with BV [ClinicalTrials.gov, Med380104, NCT01125410].
Copyright © 2011 S. Karger AG, Basel.
Source: PubMed