{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,30]],"date-time":"2026-10-30T02:03:46Z","timestamp":1793325826074,"version":"4.5.0"},"reference-count":58,"publisher":"American Medical Association (AMA)","issue":"5","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Netw Open"],"abstract":"\n Importance<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n To examine whether dequalinium chloride, a broad-spectrum antiseptic, is noninferior to oral metronidazole for the treatment of BV.<\/jats:p>\n <\/jats:sec>\n \n Design, Setting, and Participants<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Intervention<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Main Outcomes and Measures<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n A total of 147 women (mean [SD] age, 36.7 [9.0] years) were treated with dequalinium chloride (n\u2009=\u200972) or metronidazole (n\u2009=\u200975). 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 \u22120.5 percentage points (95% CI, \u221210.8 to 9.8 percentage points;\n P<\/jats:italic>\n \u2009=\u2009.002) in the intention-to-treat population and 2.5 percentage points (95% CI, \u22129.4 to 14.4 percentage points;\n P<\/jats:italic>\n \u2009=\u2009.001) in the per-protocol population confirmed the noninferiority of dequalinium chloride. The tolerability of dequalinium chloride was rated as very good by 30 of 50 patients (60.0%) but only by 21 of 54 (38.9%) for metronidazole. Three patients in the metronidazole group suspended treatment due to an adverse event.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions and Relevance<\/jats:title>\n This randomized clinical trial showed that dequalinium chloride was not inferior to metronidazole for the treatment of BV. Dequalinium chloride had a similarly high cure rate but with better tolerability and fewer adverse events. With a similar efficacy to metronidazole and clindamycin, dequalinium chloride warrants consideration as first-line treatment for BV to help reduce antibiotic consumption.<\/jats:p>\n <\/jats:sec>\n \n Trial Registration<\/jats:title>\n \n EudraCT:\n 2020-002489-15<\/jats:ext-link>\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jamanetworkopen.2024.8661","type":"journal-article","created":{"date-parts":[[2024,5,2]],"date-time":"2024-05-02T11:33:06Z","timestamp":1714649586000},"page":"e248661","source":"Crossref","is-referenced-by-count":19,"title":["Efficacy of Dequalinium Chloride vs Metronidazole for the Treatment of Bacterial Vaginosis"],"prefix":"10.1001","volume":"7","author":[{"given":"Grzegorz","family":"Raba","sequence":"first","affiliation":[{"name":"Prywatny Gabinet Gynekologiczno, Zurawica, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anton","family":"\u010eurkech","sequence":"additional","affiliation":[{"name":"Gynedur s.r.o., Dubnica nad 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