DQC in BV
Trial question
Is dequalinium chloride noninferior to metronidazole in women with bacterial vaginosis?
Study design
Multi-center
Double blinded
RCT
Population
147 female patients.
Inclusion criteria: adult premenopausal women with bacterial vaginosis.
Key exclusion criteria: uterine bleeding or vaginal bleeding of unknown origin; ulcerations or erosions of the vaginal mucosa or cervix; candidiasis; aerobic vaginitis; STIs; severe systemic diseases; hypersensitivity to the study medications; pregnancy.
Interventions
N=72 dequalinium chloride (vaginal tablets of 10 mg once daily for 6 days).
N=75 metronidazole (oral dose of 500 mg BID for 7 days).
Primary outcome
Rate of clinical cure rate at visit 1 (7-11 days after start of treatment)
92.8%
93.2%
93.2 %
69.9 %
46.6 %
23.3 %
0.0 %
Dequalinium
chloride
Metronidazole
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in the rate of clinical cure rate at visit 1 (7-11 days after start of treatment) (92.8% vs. 93.2%; ARD -0.5, 95% CI -10.8 to 9.8).
Secondary outcomes
No significant difference in the rate of clinical cure rate at visit 2 (20-40 days after start of treatment) (79.7% vs. 87.3%; ARD -7.6, 95% CI -20.1 to 4.8).
No significant difference in bacteriologic cure rate at visit 2 (40.6% vs. 53.5%; ARD -12.9, 95% CI -29.3 to 3.4).
No significant difference in standard Amsel criteria cure rate at visit 2 (88.4% vs. 94.4%; ARD -6, 95% CI -16.2 to 4.3).
Safety outcomes
No significant difference in adverse events.
Significant difference in very good tolerability of treatment (60.0% vs. 38.9%).
Conclusion
In adult premenopausal women with bacterial vaginosis, dequalinium chloride was noninferior to metronidazole with respect to the rate of clinical cure rate at visit 1 (7-11 days after start of treatment).
Reference
Grzegorz Raba, Anton Durkech, Tomáš Malík et al. Efficacy of Dequalinium Chloride vs Metronidazole for the Treatment of Bacterial Vaginosis: A Randomized Clinical Trial. JAMA Netw Open. 2024 May 1;7(5):e248661.
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