Weissenbacher, Ernst Rainer; Donders, Gilbert; Unzeitig, Vit; de Tejada, Begona Martinez; Gerber, Stefan; Halaska, Michael; Spacek, Jiri (2012): A Comparison of Dequalinium Chloride Vaginal Tablets (Fluomizin (R)) and Clindamycin Vaginal Cream in the Treatment of Bacterial Vaginosis: A Single-Blind, Randomized Clinical Trial of Efficacy and Safety. In: Gynecologic and Obstetric Investigation, Nr. 1: S. 8-15




Aims: To investigate if vaginal application of dequalinium chloride (DQC, Fluomizin (R)) 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 (Cl: 81.5%, C2: 79.5%) were as high as with CLM (Cl: 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 (C) 2011 S. Karger AG, Basel