The Posttrial Effect of Oral Periodic Presumptive Treatment for Vaginal Infections on the Incidence of Bacterial Vaginosis and Lactobacillus Colonization

Abstract

Background We previously demonstrated a decrease in bacterial vaginosis (BV) and an increase in Lactobacillus colonization among randomized controlled trial (RCT) participants who received monthly oral periodic presumptive treatment (PPT) [2g metronidazole + 150mg fluconazole]. Post-trial data were analyzed to test the hypothesis that the treatment effect would persist following completion of one year of PPT. Methods Data were obtained from women who completed all 12 RCT visits and attended ≥1 post-trial visit within 120 days following completion of the RCT. We used Andersen-Gill proportional hazards models to estimate the post-trial effect of the intervention on the incidence of BV by Gram stain and detection of Lactobacillus species by culture. Results The analysis included 165 subjects (83 active and 82 placebo). The post-trial incidence of BV was 260 per 100 person-years in the intervention arm versus 358 per 100 person-years in the placebo arm (hazard ratio [HR]=0.76; 95% confidence interval [CI]: 0.51–1.12). The post-trial incidence of Lactobacillus colonization was 180 per 100 person-years in the intervention arm versus 127 per 100 person-years in the placebo arm (HR=1.42; 95% CI: 0.85–2.71). Conclusions Despite a decrease in BV and an increase in Lactobacillus colonization during the RCT, the effect of PPT was not sustained at the same level following cessation of the intervention. New interventions that reduce BV recurrence and promote Lactobacillus colonization without the need for ongoing treatment are needed.

Behavioural and medical predictors of bacterial vaginosis recurrence among female sex workers: longitudinal analysis from a randomized controlled trial

“…In summary, from this longitudinal analysis of data from a randomized clinical trial, we report a relatively high rate of RBV, though lower than in some previous studies [24,25], among FSWs HIV seronegative at baseline. Some common risk factors for a single BV episode were associated with RBV while others were not.…”

“…The first study, which was a secondary analysis focusing on the placebo group only, found a BV incidence rate of 361/100 person-years over the trial period [24]. The second study evaluated the post-trial effect of the PPT (first 120 days post-trial) and found RBV incidence of 260/100 person-years (95% CI=199-340) and 358/100 person-years (95% CI=286-448) for the intervention and placebo groups, respectively [25]. The RBV incidence of 253/100 person-years in the present study is somewhat lower than the three others, though only significantly for the two results reported from the placebo group (whether in- or post-trial).…”

The Barrier to HIV Transmission Provided by Genital Tract Lactobacillus Colonization

“…Treatment of women with antibiotics can temporarily suppress BV organisms, but this does not substantially aid in long-term Lactobacillus colonization. 32 Several of the biologic factors that can disrupt or prevent colonization by Lactobacillus are known. For example, a study by Cherpes et al 22 followed 773 women over a year and found that occurrence of BV was associated with a number of factors including smoking, vaginal intercourse, receptive anal sex before vaginal intercourse, sex with an uncircumcised male partner, and lack of vaginal H 2 O 2 -producing lactobacilli.…”

Bacterial Vaginosis and Sexually Transmitted Diseases: Relationship and Management

“…Human papilloma virus (HPV), human immunodeficiency virus (HIV), human herpes simplex virus (HSV), and PID infections/acquisition seem to be more frequent in women affected by BV [32,[111][112][113][114][115][116][117][118][119][120][121].…”

“…The fact that treatment for BV asymptomatic nonpregnant women is not currently recommended [118,[120][121][122];…”