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
Collaborateur⸱rice⸱s
Fluomizin Study Group
Contributeur⸱rice⸱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
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].
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 21:23
Dernière modification de la notice
20/08/2019 14:15