title: Randomized Trial of Periodic Presumptive Treatment With High-Dose Intravaginal Metronidazole and Miconazole to Prevent Vaginal Infections in HIV-negative Women.
abstract: BACKGROUND
  Vaginal infections are common, frequently recur, and may increase women's risk for sexually transmitted infections (STIs). We tested the efficacy of a novel regimen to prevent recurrent vaginal infections.
  
  
  METHODS
  Human immunodeficiency virus (HIV)-negative women 18-45 years old with 1 or more vaginal infections, including bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), or Trichomonas vaginalis (TV), were randomly assigned to receive vaginal suppositories containing metronidazole 750 mg plus miconazole 200 mg or matching placebo for 5 consecutive nights each month for 12 months. Primary endpoints, evaluated every 2 months, were BV (Gram stain) and VVC (positive wet mount and culture).
  
  
  RESULTS
  Participants (N = 234) were randomly assigned to the intervention (N = 118) or placebo (N = 116) arm. Two hundred seventeen (93%) women completed an end-of-study evaluation. The intervention reduced the proportion of visits with BV compared to placebo (21.2% vs 32.5%; relative risk [RR] 0.65, 95% confidence interval [CI] .48-.87). In contrast, the proportion of visits with VVC was similar in the intervention (10.4%) versus placebo (11.3%) arms (RR 0.92, 95% CI .62-1.37).
  
  
  CONCLUSIONS
  Monthly treatment with intravaginal metronidazole plus miconazole reduced the proportion of visits with BV during 12 months of follow-up. Further study will be important to determine whether this intervention can reduce women's risk of STIs.
authors.affiliation: Department of Medicine Department of Epidemiology Department of Global Health, University of Washington Institute of Tropical and Infectious Diseases.
authors.forename: R Scott
authors.initials: RS
authors.lastname: McClelland
authors.affiliation: Department of Global Health, University of Washington Department of Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.
authors.forename: Jennifer E
authors.initials: JE
authors.lastname: Balkus
authors.affiliation: Department of Biostatistics, University of Arkansas for Medical Sciences, Little Rock.
authors.forename: Jeannette
authors.initials: J
authors.lastname: Lee
authors.affiliation: Kenya AIDS Vaccine Initiative, University of Nairobi.
authors.forename: Omu
authors.initials: O
authors.lastname: Anzala
authors.affiliation: Institute of Tropical and Infectious Diseases.
authors.forename: Joshua
authors.initials: J
authors.lastname: Kimani
authors.affiliation: Division of Infectious Diseases, University of Alabama at Birmingham.
authors.forename: Jane
authors.initials: J
authors.lastname: Schwebke
authors.affiliation: FHI360, Durham, North Carolina.
authors.forename: Vivian
authors.initials: V
authors.lastname: Bragg
authors.affiliation: Department of Biostatistics, University of Arkansas for Medical Sciences, Little Rock.
authors.forename: Shelly
authors.initials: S
authors.lastname: Lensing
authors.affiliation: Embil Pharmaceutical Company, Istanbul, Turkey.
authors.forename: Lale
authors.initials: L
authors.lastname: Kavak
mesh_terms: D000293:Adolescent; D000328:Adult; D000890:Anti-Infective Agents / Q000008:administration & dosage*; D002181:Candidiasis, Vulvovaginal / Q000517:prevention & control*; D018890:Chemoprevention / Q000379:methods; D005260:Female; D006801:Humans; D008795:Metronidazole / Q000008:administration & dosage*; D008825:Miconazole / Q000008:administration & dosage*; D008875:Middle Aged; D010919:Placebos / Q000008:administration & dosage; D065129:Pre-Exposure Prophylaxis / Q000379:methods*; D016896:Treatment Outcome; D014247:Trichomonas Vaginitis / Q000517:prevention & control*; D016585:Vaginosis, Bacterial / Q000517:prevention & control*; D055815:Young Adult
chemical_list: D000890:Anti-Infective Agents; D010919:Placebos; D008795:Metronidazole; D008825:Miconazole
keywords: Trichomonas vaginalis; bacterial vaginosis; metronidazole; miconazole; periodic presumptive treatment; vulvovaginal candidiasis