The New England journal of medicine · 2025
Male-Partner Treatment to Prevent Recurrence of Bacterial Vaginosis.
Клиническое исследование III фазыСтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Vodstrcil Lenka A, Plummer Erica L, Fairley Christopher K, Hocking Jane S, Law Matthew G, Petoumenos Kathy, Bateson Deborah, Murray Gerald L, Donovan Basil, Chow Eric P F, Chen Marcus Y, Kaldor John, Bradshaw Catriona S, StepUp Team
Аннотация
BACKGROUND: Bacterial vaginosis affects one third of reproductive-aged women, and recurrence is common. Evidence of sexual exchange of bacterial vaginosis-associated organisms between partners suggests that male-partner treatment may increase the likelihood of cure.
METHODS: This open-label, randomized, controlled trial involved couples in which a woman had bacterial vaginosis and was in a monogamous relationship with a male partner. In the partner-treatment group, the woman received first-line recommended antimicrobial agents and the male partner received oral and topical antimicrobial treatment (metronidazole 400-mg tablets and 2% clindamycin cream applied to penile skin, both twice daily for 7 days). In the control group, the woman received first-line treatment and the male partner received no treatment (standard care). The primary outcome was recurrence of bacterial vaginosis within 12 weeks.
RESULTS: A total of 81 couples were assigned to the partner-treatment group, and 83 couples were assigned to the control group. The trial was stopped by the data and safety monitoring board after 150 couples had completed the 12-week follow-up period because treatment of the woman only was inferior to treatment of both the woman and her male partner. In the modified intention-to-treat population, recurrence occurred in 24 of 69 women (35%) in the partner-treatment group (recurrence rate, 1.6 per person-year; 95% confidence interval [CI], 1.1 to 2.4) and in 43 of 68 women (63%) in the control group (recurrence rate, 4.2 per person-year; 95% CI, 3.2 to 5.7), which corresponded to an absolute risk difference of -2.6 recurrences per person-year (95% CI, -4.0 to -1.2; P<0.001). Adverse events in treated men included nausea, headache, and metallic taste.
CONCLUSIONS: The addition of combined oral and topical antimicrobial therapy for male partners to treatment of women for bacterial vaginosis resulted in a lower rate of recurrence of bacterial vaginosis within 12 weeks than standard care. (Funded by the National Health and Medical Research Council of Australia; StepUp Australian New Zealand Clinical Trials Registry number, ACTRN12619000196145.).
METHODS: This open-label, randomized, controlled trial involved couples in which a woman had bacterial vaginosis and was in a monogamous relationship with a male partner. In the partner-treatment group, the woman received first-line recommended antimicrobial agents and the male partner received oral and topical antimicrobial treatment (metronidazole 400-mg tablets and 2% clindamycin cream applied to penile skin, both twice daily for 7 days). In the control group, the woman received first-line treatment and the male partner received no treatment (standard care). The primary outcome was recurrence of bacterial vaginosis within 12 weeks.
RESULTS: A total of 81 couples were assigned to the partner-treatment group, and 83 couples were assigned to the control group. The trial was stopped by the data and safety monitoring board after 150 couples had completed the 12-week follow-up period because treatment of the woman only was inferior to treatment of both the woman and her male partner. In the modified intention-to-treat population, recurrence occurred in 24 of 69 women (35%) in the partner-treatment group (recurrence rate, 1.6 per person-year; 95% confidence interval [CI], 1.1 to 2.4) and in 43 of 68 women (63%) in the control group (recurrence rate, 4.2 per person-year; 95% CI, 3.2 to 5.7), which corresponded to an absolute risk difference of -2.6 recurrences per person-year (95% CI, -4.0 to -1.2; P<0.001). Adverse events in treated men included nausea, headache, and metallic taste.
CONCLUSIONS: The addition of combined oral and topical antimicrobial therapy for male partners to treatment of women for bacterial vaginosis resulted in a lower rate of recurrence of bacterial vaginosis within 12 weeks than standard care. (Funded by the National Health and Medical Research Council of Australia; StepUp Australian New Zealand Clinical Trials Registry number, ACTRN12619000196145.).