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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; 2 g metronidazole + 150 mg fluconazole). Posttrial data were analyzed to test the hypothesis that the treatment effect would persist after completion of 1 year of PPT.
METHODS
Data were obtained from women who completed all 12 RCT visits and attended ≥ 1 posttrial visit within 120 days after completion of the RCT. We used Andersen-Gill proportional hazards models to estimate the posttrial 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 posttrial 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 = 0.76; 95% confidence interval, 0.51-1.12). The posttrial incidence of Lactobacillus colonization was 180 per 100 person-years in the intervention arm versus 127 per 100 person-years in the placebo arm (hazard ratio = 1.42; 95% confidence interval, 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 after cessation of the intervention. New interventions that reduce BV recurrence and promote Lactobacillus colonization without the need for ongoing treatment are needed.

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    • Authors

    Balkus JE, Jaoko W, Mandaliya K, Richardson BA, Masese L, Gitau R, Kiarie J, Marrazzo J, Farquhar C, McClelland RS

    Institution

    Department of Epidemiology, University of Washington, Seattle, WA 98104, USA. jbalkus@u.washington.edu

    Source

    Sexually transmitted diseases 39:5 2012 May pg 361-5

    MeSH

    Adolescent
    Adult
    Anti-Infective Agents
    Antifungal Agents
    Cohort Studies
    Female
    Fluconazole
    Humans
    Incidence
    Kenya
    Lactobacillus
    Metronidazole
    Proportional Hazards Models
    Prospective Studies
    Prostitution
    Risk Factors
    Treatment Outcome
    Vagina
    Vaginosis, Bacterial
    Young Adult

    Pub Type(s)

    Journal Article
    Research Support, N.I.H., Extramural
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    22504600