title: Effect of ultra-low-dose estriol and lactobacilli vaginal tablets (Gynoflor®) on inflammatory and infectious markers of the vaginal ecosystem in postmenopausal women with breast cancer on aromatase inhibitors.
abstract: This study was a detailed microscopic analysis of the changes of vaginal microflora characteristics after application of 0.03 mg estriol-lactobacilli combination on the vaginal ecosystem in postmenopausal breast cancer (BC) survivors on aromatase inhibitors (AI) with severe atrophic vaginitis. A total of 16 BC women on AI applied daily one vaginal tablet of Gynoflor® for 28 days followed by a maintenance therapy of three tablets weekly for 8 weeks. During four follow up visits a smear from the upper lateral vaginal wall was analysed by phase contrast microscopy at 400 times magnification in order to classify the lactobacillary grades(LBG), bacterial vaginosis (BV), aerobic vaginitis (AV), vulvovaginal candidosis (VVC), proportional number of leukocytes and evidence of parabasal cells and epitheliolysis. LBG improved from 81% LBG-III at entry to 88% LBG-I&IIa after 2 weeks of initial therapy, which further improved upon follow up (p < 0.001). Whereas BV was a rare event, AV was frequent and substantially improved during treatment (p < 0.01). While at entry most patients had moderate or severe AV, after maintenance therapy no patient except one had AV. The number of leukocytes dropped dramatically from a score of 1.78 ± 0.70 to 1.06 ± 0.25 which was consistent till the end of the study (p < 0.01). Parabasal cells dropped from a score of 3.4 ± 0.64 at entry to 1.3 ± 0.60 at the final visit (p trend < 0.01). Starting from a low rate of Candida colonisation of 2/14 (14%), a sudden rise to 7/16 (44%) occurred after 2 weeks, to return back to base levels at subsequent visits. The vaginal use of ultra-low dose estriol and lactobacilli results in rapid and enduring improvement of all markers of the vaginal microflora and epithelial vaginal cell quality in women with breast cancer on AI with dyspareunia. Candida may develop soon after its use, but rapidly disappears again upon their prolonged use. Due to its excellent safety profiles and clinical efficacy we recommend this product as first choice in women on AI with severe dyspareunia.
authors.affiliation: Department of Obstetrics and Gynecology, University Antwerp, Antwerp, Belgium. gilbert.donders@femicare.net.|Femicare vzw, Clinical Research for Women, Gasthuismolenstraat 31, 3300, Tienen, Belgium. gilbert.donders@femicare.net.
authors.forename: G
authors.initials: G
authors.lastname: Donders
authors.affiliation: Femicare vzw, Clinical Research for Women, Gasthuismolenstraat 31, 3300, Tienen, Belgium.
authors.forename: G
authors.initials: G
authors.lastname: Bellen
authors.affiliation: Department of Obstetrics and Gynecology, Gasthuisberg Hospital, University Leuven, Leuven, Belgium.
authors.forename: P
authors.initials: P
authors.lastname: Neven
authors.affiliation: Medinova AG, Zurich, Switzerland.
authors.forename: P
authors.initials: P
authors.lastname: Grob
authors.affiliation: Medinova AG, Zurich, Switzerland.
authors.forename: V
authors.initials: V
authors.lastname: Prasauskas
authors.affiliation: Department of Obstetrics and Gynecology, University Medical Center Regensburg, Regensburg, Germany.
authors.forename: S
authors.initials: S
authors.lastname: Buchholz
authors.affiliation: Department of Obstetrics and Gynecology, University Medical Center Regensburg, Regensburg, Germany.
authors.forename: O
authors.initials: O
authors.lastname: Ortmann
mesh_terms: D000282:Administration, Intravaginal; D000328:Adult; D047072:Aromatase Inhibitors / Q000009:adverse effects*; D015415:Biomarkers / Q000097:blood; D001943:Breast Neoplasms / Q000188:drug therapy*; D002175:Candida / Q000648:ultrastructure; D002181:Candidiasis, Vulvovaginal / Q000188:drug therapy*; D003141:Communicable Diseases / Q000188:drug therapy*; D017753:Ecosystem; D004964:Estriol / Q000008:administration & dosage* / Q000493:pharmacokinetics; D005260:Female; D006801:Humans; D007249:Inflammation / Q000188:drug therapy*; D007779:Lactobacillus acidophilus / Q000648:ultrastructure; D008875:Middle Aged; D017698:Postmenopause; D013607:Tablets; D014621:Vagina / Q000187:drug effects / Q000382:microbiology; D014622:Vaginal Creams, Foams, and Jellies; D016585:Vaginosis, Bacterial / Q000188:drug therapy* / Q000382:microbiology
chemical_list: D047072:Aromatase Inhibitors; D015415:Biomarkers; D013607:Tablets; D014622:Vaginal Creams, Foams, and Jellies; D004964:Estriol