Bacterial vaginosis: A randomized controlled trial to prevent recurrence

Background. Bacterial vaginosis (BV) is associated with significant obstetric and gynecologic morbidity and with HIV acquisition. BV recurs frequently despite treatment with appropriate medication. Hypothesizing possible sexual transference of the anaerobic bacteria associated with BV, we sought to evaluate in a randomized controlled trial (RCT) the efficacy of a 62% ethyl alcohol in emollient gel by male partners of women diagnosed with BV in reducing post treatment recurrence.; Methods. Among 223 couples attending or referred to a sexually transmitted disease referral center in Nairobi, Kenya in whom the woman was confirmed to have BV as defined by a vaginal Gram stain Nugent score of over 6, we randomized 115 to the intervention and 108 to the control arm. Male partners in couples assigned to the intervention arm were instructed to use the 62% ethyl alcohol in emollient gel before and after sexual intercourse and to have a bath daily. All couples, including those in the control group, were provided with counseling for STI reduction, treated using syndromic management, and provided with condoms. The women were followed up for up to a maximum of 3 months post enrollment with repeat vaginal Gram stain evaluations at every visit and a lactobacilli culture obtained at the 2 month visit.; Results. In the intent to treat analysis, there was no difference in the recurrence of BV in the two arms (Hazard ratio of 1.31 (95% CI 0.96-1.79). A comparison of bacterial morphotypes in vaginal specimens obtained at one and two months showed a trend towards fewer lactobacillus morphotypes (p=0.08) and more mobiluncus morphotypes (p=0.06) in the intervention arm at one month but not at the two month visit (p=0.14 and p=0.33). At the two month follow up visit, cultures for any lactobacilli or for H2O2 producing lactobacilli did not differ between women in the two study arms (p=0:81 and 0.32 respectively).; Conclusions. The use of the 62% ethyl alcohol by male partners did not reduce persistence or early recurrence of BV among women treated with metronidazole. The effect of the ethyl alcohol gel on lactobacilli and/or mobiluncus morphotypic bacteria warrants further investigation.