Male partner treatment lowers the risk of bacterial vaginosis reoccurrence

1. In this randomized controlled trial, female patients with bacterial vaginosis (BV) had lower recurrence rates when their male partner also received treatment.

2. Male partner treatment resulted in minimal side effects, including nausea, headache, metallic taste, and penile irritation.

Evidence Rating Level: 1 (Excellent)

Study Rundown: BV impacts nearly one-third of female adults worldwide and is associated with adverse obstetric and gynecologic outcomes. Past studies suggested that BV is not a sexually transmitted condition due to the ineffectiveness of treating male partners in preventing recurrence; however, these studies had notable limitations. Emerging evidence indicates that female adults with the same sexual partner are twice as likely to experience BV recurrence, and penile microbiota has been correlated with BV risk. This study investigated whether concurrent treatment of male partners with both topical clindamycin and oral metronidazole reduces BV recurrence in their female partners. The trial was halted at 12 weeks due to significantly higher recurrence in the control group (female-only treatment) compared to the partner-treatment group. Female adults in the partner-treatment group had lower recurrence rates and a longer time to recurrence. Adherence was higher among female participants than male participants, with male nonadherence primarily related to difficulties with clindamycin application rather than metronidazole intake. Most male participants reported no adverse events, though nausea, headache, vomiting, metallic taste, and penile irritation were the most common side effects. Study limitations included a higher-risk population (attendees of sexual health services), monogamous inclusion criteria, lack of adverse event data for the control group, and an open-label design. Despite these limitations, the findings support treating male partners to reduce BV recurrence.

Click here to read the study in NEJM

Relevant Reading: Bacterial Vaginosis — Time to Treat Male Partners

In-Depth [randomized controlled trial]: This randomized controlled trial evaluated the efficacy of treating male partners with topical clindamycin and oral metronidazole in reducing BV recurrence in their female partners. Recruitment involved identifying eligible female adults based on the following criteria: premenopausal, symptomatic BV, meeting diagnostic criteria based on both the Amsel criteria and Nugent score, having a regular male partner for at least eight weeks, and receiving first-line BV treatment. Eligible participants were then asked to refer their male partners. Following randomization, 81 couples were assigned to the partner-treatment group and 83 to the control group. However, only 69 couples in the partner-treatment group and 68 in the control group were included in the final analysis due to loss to follow-up or other exclusions. At 12 weeks, BV recurrence occurred in 35% of participants in the partner-treatment group (recurrence rate: 1.6 per person-year; 95% confidence interval [CI], 1.1–2.4) compared to 63% in the control group (recurrence rate: 4.2 per person-year; 95% CI, 3.2–5.7). Female adults in the partner-treatment group had a significantly longer mean time to recurrence (73.9 days) than those in the control group (54.5 days) (95% CI, 11.5–27.1; p<0.001). Overall, female adults in the partner-treatment group had a lower risk of recurrence (hazard ratio: 0.37; 95% CI, 0.22–0.61). Furthermore, those whose partners were fully adherent to treatment had the lowest recurrence rates (1.3 per person-year; 95% CI, 0.7–2.6). Among male participants, 46% reported adverse events, with nausea (14%), headache (12%), metallic taste (7%), and penile skin irritation (7%) being the most common. Overall, this study demonstrated that treating male partners effectively reduces BV recurrence in their female partners.

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