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.

Détails

ID Serval
serval:BIB_5CD4F136619A
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Institution
Titre
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.
Périodique
Gynecologic and Obstetric Investigation
Auteur(s)
Weissenbacher E.R., Donders G., Unzeitig V., Martinez de Tejada B., Gerber S., Halaška M., Špaček J.
Collaborateur(s)
Fluomizin Study Group
Contributeur(s)
Bergauer F., Bosteels J., Chovanec J., Danko J., Hinoul P., Mašata£££Jaromír£££ J. , Řičánek J., Verguts L.
ISSN
1423-002X (Electronic)
ISSN-L
0378-7346
Statut éditorial
Publié
Date de publication
2012
Volume
73
Numéro
1
Pages
8-15
Langue
anglais
Notes
Publication types: Comparative Study ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Résumé
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].
Mots-clé
Adolescent, Adult, Candidiasis, Vulvovaginal/etiology, Clindamycin/administration & dosage, Clindamycin/adverse effects, Dequalinium/administration & dosage, Dequalinium/adverse effects, Female, Follow-Up Studies, Humans, Middle Aged, Single-Blind Method, Treatment Outcome, Vaginal Creams, Foams, and Jellies/administration & dosage, Vaginosis, Bacterial/complications, Vaginosis, Bacterial/drug therapy, Young Adult
Pubmed
Web of science
Open Access
Oui
Création de la notice
17/02/2012 22:23
Dernière modification de la notice
20/08/2019 15:15
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