title: The effect of synthetic genistein on menopause symptom management in healthy postmenopausal women: a multi-center, randomized, placebo-controlled study.
abstract: OBJECTIVE
  To evaluate the efficacy of synthetic genistein for reducing the frequency and severity of hot flushes.
  
  
  METHODS
  A 12 week randomized double-blind, placebo-controlled study in which 84 postmenopausal women received placebo or a single 30 mg dose of synthetic genistein. Outcome measures primary: percentage change in the number of daily hot flushes from pre-treatment to week 12. Secondary: duration and severity of daily hot flushes, Greene Climacteric Scale score, serum follicle stimulating hormone (FSH), 17β-estradiol and endometrial thickness.
  
  
  RESULTS
  Genistein supplemented subjects completing at least 4 weeks on trial (n=40) demonstrated a 51% reduction (9.4-4.7/day) in the number of hot flushes by week 12 compared to a 27% reduction in the placebo group (9.9-7.1/day) (p=0.026). Subjects in the genistein group also reported significantly fewer hot flushes per day (p=0.010) and a decrease in total duration of hot flushes per day (p=0.009) at week 12 versus placebo. Subjects on genistein (n=32) completing 12 weeks on trial demonstrated a 51% reduction (9.7-4.7/day) in the number of hot flushes by week 12 (p=0.049) compared to 30% reduction in the placebo group (9.8-7.0/day) and had fewer hot flushes per day and a decrease in total duration of hot flushes per day at week 12 compared to placebo (p=0.020 and p=0.017, respectively). There were no differences between groups in Greene Climacteric Scale, FSH, 17β-estradiol, endometrial thickness or adverse events.
  
  
  CONCLUSIONS
  The current study provides the first evidence that a single daily dose of 30 mg of synthetic genistein reduces hot flush frequency and duration.
authors.affiliation: Contract Research Services Division, KGK Synergize Inc., London, ON, Canada. mevans@kgksynergize.com
authors.forename: Malkanthi
authors.initials: M
authors.lastname: Evans
authors.forename: James G
authors.initials: JG
authors.lastname: Elliott
authors.forename: Prachi
authors.initials: P
authors.lastname: Sharma
authors.forename: Robert
authors.initials: R
authors.lastname: Berman
authors.forename: Najla
authors.initials: N
authors.lastname: Guthrie
mesh_terms: D004311:Double-Blind Method; D045166:Estradiol Congeners / Q000627:therapeutic use*; D005260:Female; D019833:Genistein / Q000627:therapeutic use*; D019584:Hot Flashes / Q000188:drug therapy* / Q000209:etiology; D006801:Humans; D008875:Middle Aged; D017698:Postmenopause; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D045166:Estradiol Congeners; D019833:Genistein