title: 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.
authors.affiliation: Department of Epidemiology, University of Washington, Seattle, WA 98104, USA. jbalkus@u.washington.edu
authors.forename: Jennifer E
authors.initials: JE
authors.lastname: Balkus
authors.forename: Walter
authors.initials: W
authors.lastname: Jaoko
authors.forename: Kishorchandra
authors.initials: K
authors.lastname: Mandaliya
authors.forename: Barbra A
authors.initials: BA
authors.lastname: Richardson
authors.forename: Linnet
authors.initials: L
authors.lastname: Masese
authors.forename: Ruth
authors.initials: R
authors.lastname: Gitau
authors.forename: James
authors.initials: J
authors.lastname: Kiarie
authors.forename: Jeanne
authors.initials: J
authors.lastname: Marrazzo
authors.forename: Carey
authors.initials: C
authors.lastname: Farquhar
authors.forename: R Scott
authors.initials: RS
authors.lastname: McClelland
mesh_terms: D000293:Adolescent; D000328:Adult; D000890:Anti-Infective Agents / Q000008:administration & dosage; D000935:Antifungal Agents / Q000008:administration & dosage; D015331:Cohort Studies; D005260:Female; D015725:Fluconazole / Q000008:administration & dosage; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D007630:Kenya / Q000453:epidemiology; D007778:Lactobacillus / Q000187:drug effects* / Q000254:growth & development; D008795:Metronidazole / Q000008:administration & dosage; D016016:Proportional Hazards Models; D011446:Prospective Studies; D012307:Risk Factors; D011477:Sex Work / Q000706:statistics & numerical data*; D016896:Treatment Outcome; D014621:Vagina / Q000187:drug effects* / Q000382:microbiology; D016585:Vaginosis, Bacterial / Q000188:drug therapy* / Q000453:epidemiology / Q000517:prevention & control; D055815:Young Adult
chemical_list: D000890:Anti-Infective Agents; D000935:Antifungal Agents; D008795:Metronidazole; D015725:Fluconazole