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.
OBJECTIVE
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.


CONCLUSIONS
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].
Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, LMU München Grosshadern, Munich, Germany. ernst-rainer.weissenbacher@med.uni-muenchen.de
Ernst Rainer
ER
Weissenbacher
Gilbert
G
Donders
Vit
V
Unzeitig
Begoña
B
Martinez de Tejada
Stefan
S
Gerber
Michael
M
Halaška
Jiří
J
Špaček
D000293:Adolescent; D000328:Adult; D002181:Candidiasis, Vulvovaginal / Q000209:etiology; D002981:Clindamycin / Q000008:administration & dosage* / Q000009:adverse effects; D003868:Dequalinium / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D016037:Single-Blind Method; D016896:Treatment Outcome; D014622:Vaginal Creams, Foams, and Jellies / Q000008:administration & dosage; D016585:Vaginosis, Bacterial / Q000150:complications / Q000188:drug therapy*; D055815:Young Adult
D014622:Vaginal Creams, Foams, and Jellies; D002981:Clindamycin; D003868:Dequalinium