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.

Abstract

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].

• Authors: Ernst Rainer Weissenbacher, Gilbert Donders, Vit Unzeitig, Begoña Martinez de Tejada, Stefan Gerber, Michael Halaška, Jiří Špaček, Fluomizin Study Group
• Journal: Gynecologic and obstetric investigation (Gynecol Obstet Invest) Vol. 73 Issue 1 Pg. 8-15 ( 2012) ISSN: 1423-002X [Electronic] Switzerland
• PMID: 22205034 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2011 S. Karger AG, Basel.

Chemical References

• Vaginal Creams, Foams, and Jellies
• Clindamycin
• Dequalinium

Topics

• Adolescent
• Adult
• Candidiasis, Vulvovaginal (etiology)
• Clindamycin (administration & dosage, adverse effects)
• Dequalinium (administration & dosage, adverse effects)
• Female
• Follow-Up Studies
• Humans
• Middle Aged
• Single-Blind Method
• Treatment Outcome
• Vaginal Creams, Foams, and Jellies (administration & dosage)
• Vaginosis, Bacterial (complications, drug therapy)
• Young Adult