Abstract
Objective:Assess efficacy of intermittent intravaginal metronidazole gel treatment in reducing frequency of bacterial vaginosis (BV).Design:Randomized, double-masked, placebo-controlled phase 3 trial.Setting:Postnatal and family planning clinics of the Queen Elizabeth Central Hospital and two health centers in Blantyre, Malawi.Participants:Nonpregnant HIV-uninfected and -infected women.Intervention:Intravaginal metronidazole treatment and placebo gels provided at baseline and every 3 mo for 1 y.Outcome measures:Primary: Cross-sectional and longitudinal comparisons of BV frequency at baseline, 1 mo after product dispensation (post-treatment evaluation [PTE]), and every quarterly visit. Secondary: Effect of treatment on BV clearance and recurrence.Results:Baseline: 842 HIV-uninfected and 844 HIV-infected women were enrolled. The frequency of BV at baseline in treatment and placebo arms, respectively, was 45.9% and 46.8% among HIV-uninfected women, and 60.5% and 56.9% among HIV-infected women. Primary outcomes: At the PTEs the prevalence of BV was consistently lower in treatment than placebo arms irrespective of HIV status. The differences were statistically significant mainly in HIV-uninfected women. Prevalence of BV was also reduced over time in both treatment and placebo arms. In a multivariable analysis that controlled for other covariates, the effect of intravaginal metronidazole treatment gel compared with placebo was not substantial: adjusted relative risk (RR) 0.90, 95% confidence interval (CI) 0.83–0.97 in HIV-uninfected women and adjusted RR 0.95, 95% CI 0.89–1.01 in HIV-infected women. Secondary outcomes: Intravaginal metronidazole treatment gel significantly increased BV clearance (adjusted hazard ratio [HR] 1.34, 95% CI 1.07–1.67 among HIV-uninfected women and adjusted HR 1.29, 95% CI 1.06–1.58 among HIV-infected women) but was not associated with decreased BV recurrence. Safety: No serious adverse events were related to use of intravaginal gels.Conclusion:Intermittent microbicide treatment with intravaginal gels is an innovative approach that can reduce the frequency of vaginal infections such as BV.
Highlights
Bacterial vaginosis (BV) is the most common vaginal infection, and its impact on the health of women is substantial [1,2,3,4]
Generalized estimating equation log binomial models based on relative risk ratio assessed longitudinal associations of treatment with BV after controlling for other covariates measured at multiple visits to account for repeated visit correlation of these repeated observations
We examined the effect of intravaginal metronidazole gel treatment on BV recurrence among 381 HIV-uninfected and 409 HIV-infected women who had BV at baseline and cleared BV
Summary
Bacterial vaginosis (BV) is the most common vaginal infection, and its impact on the health of women is substantial [1,2,3,4]. Bacterial vaginosis (BV) results from a change in the normal balance of bacteria in the vaginal tract, and is very common In pregnant women, it is associated with poorer outcomes in pregnancy, and is linked with HIV transmission ( it is not certain that BV increases the chance of getting HIV—just because these two occur together it does not necessarily follow that one causes the other). The primary outcome for the trial was the proportion of women with BV at each quarterly follow-up visit, and the researchers intended to compare this outcome between treatment arms at each visit and to look at the overall changes over time among women receiving either metronidazole or placebo, looking separately at HIV-infected and HIV-uninfected women
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