دورية أكاديمية
Efficacy of Dequalinium Chloride vs Metronidazole for the Treatment of Bacterial Vaginosis ; A Randomized Clinical Trial
| العنوان: | Efficacy of Dequalinium Chloride vs Metronidazole for the Treatment of Bacterial Vaginosis ; A Randomized Clinical Trial |
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| المؤلفون: | Raba, Grzegorz, Ďurkech, Anton, Malík, Tomáš, Bassfeld, Doerthe, Grob, Philipp, Hurtado-Chong, Anahí, Botta, Simona, Sach, Alexander, Golańska - Wróblewska, Magdalena, Paškala, Miloš, Romanek-Piva, Katarzyna, Sládičeková, Radmila, Skřivánek, Aleš, Sudek, Petr |
| المصدر: | JAMA Network Open ; volume 7, issue 5, page e248661 ; ISSN 2574-3805 |
| بيانات النشر: | American Medical Association (AMA) |
| سنة النشر: | 2024 |
| الوصف: | Importance Bacterial vaginosis (BV) is a common cause of vaginal infection. First-line treatments of BV are metronidazole and clindamycin. Due to the increase in antibiotic resistance, effective nonantibiotic treatments for BV are needed. Objective To examine whether dequalinium chloride, a broad-spectrum antiseptic, is noninferior to oral metronidazole for the treatment of BV. Design, Setting, and Participants This phase 4, multicenter, triple-blind, double-dummy, parallel, noninferiority randomized clinical trial was conducted from July 29, 2021, to August 25, 2022, with a 1-month follow-up. Participants were premenopausal women 18 years or older with BV from 11 gynecologic practices and 1 hospital in Poland, Slovakia, and the Czech. Intervention Patients were randomized to treatment with dequalinium chloride vaginal tablets (10 mg once daily for 6 days) or oral metronidazole (500 mg twice daily for 7 days). Double-dummy medication kits contained vaginal and oral tablets with placebo and active medication. Main Outcomes and Measures The main outcome was the noninferiority margin (of 15 percentage points) in the absolute difference in clinical cure rates between dequalinium chloride and metronidazole 7 to 11 days after start of treatment (visit 1). Noninferiority was met if the lower 95% CI for the difference in clinical cure rate was less than 15 percentage points at visit 1. Results A total of 147 women (mean [SD] age, 36.7 [9.0] years) were treated with dequalinium chloride (n = 72) or metronidazole (n = 75). The clinical cure rates at visit 1 were 64 of 69 (92.8%) for dequalinium chloride vs 69 of 74 (93.2%) for metronidazole in the intention-to-treat population, whereas in the per-protocol population, cure rates were 54 of 58 (93.1%) for dequalinium chloride vs 48 of 53 (90.6%) for metronidazole. The treatment differences 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 = ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| DOI: | 10.1001/jamanetworkopen.2024.8661 |
| الإتاحة: | https://doi.org/10.1001/jamanetworkopen.2024.8661Test https://jamanetwork.com/journals/jamanetworkopen/articlepdf/2818221/raba_2024_oi_240319_1713819995.30498.pdfTest |
| رقم الانضمام: | edsbas.3457976C |
| قاعدة البيانات: | BASE |
| DOI: | 10.1001/jamanetworkopen.2024.8661 |
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