Dequalinium Chloride Matches Metronidazole in Efficacy for Treating Bacterial Vaginosis: JAMA
Researchers have found that dequalinium chloride, a broad-spectrum antiseptic, is as effective as oral metronidazole for treating bacterial vaginosis (BV) with better tolerability and fewer adverse events. This phase 4, multicenter, triple-blind, double-dummy, noninferiority randomized clinical trial suggests that dequalinium chloride could be a promising non antibiotic treatment option for BV. This study was published in the journal JAMA Network Open by Raba G. and colleagues.
Bacterial vaginosis is a common cause of vaginal infection, with metronidazole and clindamycin being the first-line treatments. Due to rising concerns about antibiotic resistance, the need for effective non antibiotic treatments is growing. Dequalinium chloride, a broad-spectrum antiseptic, has been examined to determine if it is noninferior to oral metronidazole for treating BV.
The trial, conducted from July 29, 2021, to August 25, 2022, included 147 premenopausal women aged 18 years or older diagnosed with BV from 11 gynecologic practices and one hospital in Poland, Slovakia, and the Czech Republic. Participants were randomized to receive either dequalinium chloride vaginal tablets (10 mg once daily for six days) or oral metronidazole (500 mg twice daily for seven days). Double-dummy medication kits contained both vaginal and oral tablets with either placebo or active medication.
The main outcome was the non-inferiority margin of 15 percentage points in the absolute difference in clinical cure rates between dequalinium chloride and metronidazole 7 to 11 days after starting treatment (visit 1). Noninferiority was achieved if the lower 95% confidence interval for the difference in clinical cure rate was less than 15 percentage points.
The key findings of the study were as follows:-
• At visit 1, the clinical cure rate was 92.8% for dequalinium chloride and 93.2% for metronidazole in the intention-to-treat population.
• The treatment differences confirmed the noninferiority of dequalinium chloride, with a difference of −0.5 percentage points (95% CI, −10.8 to 9.8 percentage points; P = .002) in the intention-to-treat population and 2.5 percentage points (95% CI, −9.4 to 14.4 percentage points; P = .001) in the per-protocol population.
•Dequalinium chloride was rated as very good by 60% of patients compared to 38.9% for metronidazole.
• Three patients in the metronidazole group suspended treatment due to adverse events.
Given the similar high cure rate and improved tolerability, dequalinium chloride could be considered as a first-line treatment for BV, offering an alternative to antibiotics and helping to reduce antibiotic consumption.
The trial demonstrates that dequalinium chloride is noninferior to oral metronidazole for treating bacterial vaginosis. It provides similar efficacy with better tolerability and fewer adverse events, making it a potential first-line treatment option for BV.
Reference:
Raba, G., Ďurkech, A., Malík, T., Bassfeld, D., Grob, P., Hurtado-Chong, A., Botta, S., Sach, A., Golańska - Wróblewska, M., Paškala, M., Romanek-Piva, K., Sládičeková, R., Skřivánek, A., Sudek, P., & Fluomizin Study Group. (2024). Efficacy of dequalinium chloride vs metronidazole for the treatment of bacterial vaginosis: A randomized clinical trial. JAMA Network Open, 7(5), e248661. https://doi.org/10.1001/jamanetworkopen.2024.8661
