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
| Autor: | Ernst Rainer, Weissenbacher, Gilbert, Donders, Vit, Unzeitig, Begoña, Martinez de Tejada, Stefan, Gerber, Michael, Halaška, Jiří, Špaček, Luc, Verguts |
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| Rok vydání: | 2011 |
| Předmět: |
Adult
medicine.medical_specialty Adolescent law.invention Young Adult Randomized controlled trial law Internal medicine Vaginal Tablets medicine Humans Single-Blind Method Candidiasis Vulvovaginal Pregnancy ddc:618 Candidiasis Vulvovaginal/etiology business.industry Clindamycin Incidence (epidemiology) Clindamycin/administration & dosage/adverse effects Obstetrics and Gynecology Vaginosis Bacterial Dequalinium/administration & dosage/adverse effects Middle Aged medicine.disease Surgery Treatment Outcome Vaginal Creams Foams and Jellies/administration & dosage Dequalinium Reproductive Medicine Vaginosis Bacterial/complications/drug therapy Dequalinium chloride Vaginal Creams Foams and Jellies Female Single blind Bacterial vaginosis business Follow-Up Studies medicine.drug |
| Zdroj: | Gynecologic and Obstetric Investigation, Vol. 73, No 1 (2012) pp. 8-15 |
| ISSN: | 1423-002X 0378-7346 |
| Popis: | 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]. |
| Databáze: | OpenAIRE |
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