title: Effects of a soy-based dietary supplement compared with low-dose hormone therapy on the urogenital system: a randomized, double-blind, controlled clinical trial.
abstract: OBJECTIVE
  This study aims to compare the effects of a soy-based dietary supplement, low-dose hormone therapy (HT), and placebo on the urogenital system in postmenopausal women.
  
  
  METHODS
  In this double-blind, randomized, placebo-controlled trial, 60 healthy postmenopausal women aged 40 to 60 years (mean time since menopause, 4.1 y) were randomized into three groups: a soy dietary supplement group (90 mg of isoflavone), a low-dose HT group (1 mg of estradiol plus 0.5 mg of norethisterone), and a placebo group. Urinary, vaginal, and sexual complaints were evaluated using the urogenital subscale of the Menopause Rating Scale. Vaginal maturation value was calculated. Transvaginal sonography was performed to evaluate endometrial thickness. Genital bleeding pattern was assessed. Statistical analysis was performed using χ(2) test, Fisher's exact test, paired Student's t test, Kruskal-Wallis test, Kruskal-Wallis nonparametric test, and analysis of variance. For intergroup comparisons, Kruskal-Wallis nonparametric test (followed by Mann-Whitney U test) was used.
  
  
  RESULTS
  Vaginal dryness improved significantly in the soy and HT groups (P = 0.04). Urinary and sexual symptoms did not change with treatment in the three groups. After 16 weeks of treatment, there was a significant increase in maturation value only in the HT group (P < 0.01). Vaginal pH decreased only in this group (P < 0.01). There were no statistically significant differences in endometrial thickness between the three groups, and the adverse effects evaluated were similar.
  
  
  CONCLUSIONS
  This study shows that a soy-based dietary supplement used for 16 weeks fails to exert estrogenic action on the urogenital tract but improves vaginal dryness.
authors.affiliation: From the 1Department of Obstetrics and Gynecology, State University of Campinas (Universidade Estadual de Campinas), Campinas, São Paulo, Brazil; and 2Department of Pathology, Federal University of São Paulo (Universidade Federal de São Paulo), São Paulo, São Paulo, Brazil.
authors.forename: Lucio O
authors.initials: LO
authors.lastname: Carmignani
authors.forename: Adriana Orcesi
authors.initials: AO
authors.lastname: Pedro
authors.forename: Eliana B
authors.initials: EB
authors.lastname: Montemor
authors.forename: Victor A
authors.initials: VA
authors.lastname: Arias
authors.forename: Lucia H
authors.initials: LH
authors.lastname: Costa-Paiva
authors.forename: Aarão M
authors.initials: AM
authors.lastname: Pinto-Neto
mesh_terms: D000328:Adult; D019587:Dietary Supplements; D004311:Double-Blind Method; D004958:Estradiol / Q000494:pharmacology*; D015914:Estrogen Replacement Therapy / Q000379:methods; D005260:Female; D006801:Humans; D007529:Isoflavones / Q000494:pharmacology*; D008875:Middle Aged; D009640:Norethindrone / Q000494:pharmacology*; D008517:Phytotherapy; D017698:Postmenopause / Q000187:drug effects* / Q000502:physiology; D030262:Soybean Proteins / Q000494:pharmacology*; D014463:Ultrasonography; D014566:Urogenital System / Q000000981:diagnostic imaging / Q000187:drug effects*; D014623:Vaginal Diseases / Q000188:drug therapy
chemical_list: D007529:Isoflavones; D030262:Soybean Proteins; D004958:Estradiol; D009640:Norethindrone