title: The effectiveness of live lactobacilli in combination with low dose oestriol (Gynoflor) to restore the vaginal flora after treatment of vaginal infections.
abstract: OBJECTIVE
  To evaluate the effectiveness of live lactobacilli in combination with low dose oestriol for restoration of the vaginal flora after anti-infective treatment.
  
  
  METHODS
  The study was designed as a single centre, randomised, placebo-controlled, double-blind clinical trial.
  
  
  METHODS
  University Hospital.
  
  
  METHODS
  Three hundred and sixty women out of 1750 were randomised.
  
  
  METHODS
  Three hundred and sixty women with the complaints of vaginal infections (bacterial vaginosis, candidiasis, trichomoniasis or fluor vaginalis) were randomly assigned two to seven days after the end of the anti-infective therapy, to therapy with live lactobacilli in combination with low dose oestriol (study group, n= 240) or placebo (n= 120). The follow up visits occurred three to seven days and four to six weeks after the end of the restoration therapy.
  
  
  METHODS
  The Normal Flora Index (NFI), which consists of numbers of lactobacilli, pathogenic microorganisms, leucocytes and vaginal pH, was used as the primary outcome of the study. Secondary outcomes included the total symptoms score, the degree of purity of the vaginal flora and the global assessment of the treatment by the investigator and the women.
  
  
  RESULTS
  During restoration therapy, the NFI increased significantly more in the study group than in the control group in both first and second control visits (P= 0.002 and P= 0.006, respectively). The degree of purity of the vaginal flora also increased significantly more in the study group compared with the control group (P < 0.0001 and P= 0.001, respectively). No serious adverse event was reported during restoration therapy.
  
  
  CONCLUSIONS
  Restoration of the vaginal flora can be significantly enhanced by the administration of live lactobacilli in combination with low dose oestriol.
authors.affiliation: Department of Obstetrics and Gynecology, Ege University Faculty of Medicine, Izmir 35100, Turkey.
authors.forename: Erdinc
authors.initials: E
authors.lastname: Ozkinay
authors.forename: Mustafa Cosan
authors.initials: MC
authors.lastname: Terek
authors.forename: Murat
authors.initials: M
authors.lastname: Yayci
authors.forename: Renato
authors.initials: R
authors.lastname: Kaiser
authors.forename: Philipp
authors.initials: P
authors.lastname: Grob
authors.forename: Gungor
authors.initials: G
authors.lastname: Tuncay
mesh_terms: D000282:Administration, Intravaginal; D000293:Adolescent; D000328:Adult; D000368:Aged; D000890:Anti-Infective Agents / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D003141:Communicable Diseases / Q000628:therapy*; D004311:Double-Blind Method; D004964:Estriol / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D007778:Lactobacillus; D008875:Middle Aged; D010865:Pilot Projects; D013607:Tablets; D016896:Treatment Outcome; D014621:Vagina / Q000382:microbiology*; D014623:Vaginal Diseases / Q000628:therapy*
chemical_list: D000890:Anti-Infective Agents; D013607:Tablets; D004964:Estriol