title: Effects of genistein on hot flushes in early postmenopausal women: a randomized, double-blind EPT- and placebo-controlled study.
abstract: OBJECTIVE
  We evaluated and compared the effects of the phytoestrogen genistein, estrogen-progestogen therapy (EPT), and placebo on hot flushes and endometrial thickness in postmenopausal women.
  
  
  METHODS
  Ninety healthy, postmenopausal women, 47 to 57 years of age, were randomly assigned to receive for 1 year continuous EPT (n = 30; 1 mg 17beta-estradiol combined with 0.5 mg norethisterone acetate), the phytoestrogen genistein (n = 30; 54 mg/day), or placebo (n = 30). Endometrial safety was evaluated by intravaginal ultrasounds at baseline, 6 and 12 months.
  
  
  RESULTS
  By comparison with placebo, daily flushes reduced significantly by a mean of 22% (95% CI: -38 to -6.2; P < 0.01) after 3 months, by a mean of 29% (95% CI: -45 to -13; P < 0.001) after 6 months, and by a mean of 24% (95% CI: -43 to -5; P < 0.01) after 12 months of genistein treatment. Flush score decreased by a mean of 53% (95% CI: -79 to -26; P < 0.001) after 3 months, by a mean of 56% (95% CI: -83 to -28; P < 0.001) after 6 months, and by a mean of 54% (95% CI: -74 to -33; P < 0.001) after 12 months of EPT, as compared with placebo. No side effect was observed on the uterus of the participants.
  
  
  CONCLUSIONS
  The present study confirms that genistein might have positive effects on hot flushes without a negative impact on endometrial thickness and suggests a future role of this phytoestrogen as a strategically therapeutic alternative in the management of postmenopausal symptoms.
authors.affiliation: Department of Clinical and Experimental Medicine and Pharmacology, School of Medicine, University of Messina, Via C.Valeria, 98125 Gazzi, Messina, Italy.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Crisafulli
authors.forename: Herbert
authors.initials: H
authors.lastname: Marini
authors.forename: Alessandra
authors.initials: A
authors.lastname: Bitto
authors.forename: Domenica
authors.initials: D
authors.lastname: Altavilla
authors.forename: Giovanni
authors.initials: G
authors.lastname: Squadrito
authors.forename: Adolfo
authors.initials: A
authors.lastname: Romeo
authors.forename: Elena B
authors.initials: EB
authors.lastname: Adamo
authors.forename: Rolando
authors.initials: R
authors.lastname: Marini
authors.forename: Rosario
authors.initials: R
authors.lastname: D'Anna
authors.forename: Francesco
authors.initials: F
authors.lastname: Corrado
authors.forename: Sebastiano
authors.initials: S
authors.lastname: Bartolone
authors.forename: Nicola
authors.initials: N
authors.lastname: Frisina
authors.forename: Francesco
authors.initials: F
authors.lastname: Squadrito
mesh_terms: D004311:Double-Blind Method; D004717:Endometrium / Q000000981:diagnostic imaging / Q000187:drug effects; D015914:Estrogen Replacement Therapy; D005260:Female; D019833:Genistein / Q000008:administration & dosage / Q000627:therapeutic use*; D019584:Hot Flashes / Q000517:prevention & control*; D006801:Humans; D008875:Middle Aged; D017698:Postmenopause / Q000187:drug effects* / Q000502:physiology; D014463:Ultrasonography
chemical_list: D019833:Genistein