title: Soy isoflavones and melatonin for the relief of climacteric symptoms: a multicenter, double-blind, randomized study.
abstract: OBJECTIVE
  To evaluate the effect of soy isoflavones and melatonin in relieving menopausal symptoms.
  
  
  METHODS
  Double-blind, multicenter, randomized trial performed according to a 2 x 2 factorial design. Treatment groups: (1) soy isoflavones+melatonin; (2) soy isoflavones alone; (3) melatonin alone; (4) placebo. 80 mg of soy isoflavones, 3 mg of pure melatonin or placebo were supplemented to participants for 3 months. Severity of menopausal symptoms was recorded at baseline and after 3 months using the Greene Climacteric Scale.
  
  
  RESULTS
  388 consecutive women were screened: not eligible 98, refused informed consent 28. Randomized 262 and analyzed 232; twelve women withdrew because of adverse events. Median percent differences between basal and final scores were 39% in the isoflavones + melatonin group, 38% in the isoflavones alone group, 26% in the melatonin alone group and 38% in the placebo group. Placebo response was much higher than planned, making it meaningless to perform any statistical test. With regard to somatic and vasomotor symptoms, outcome was similar among the four groups, whereas improvement of psychological symptoms was higher in the isoflavones+melatonin group than in the other three.
  
  
  CONCLUSIONS
  Present data do not show any advantage of isoflavones or melatonin over placebo for the relief of menopausal symptoms. However, the effect in psychological symptoms in the isoflavones + melatonin group should be further investigated.
authors.affiliation: Endocrinology Unit, Hormone Research Laboratory, National Cancer Institute, Via Venezian 1, 20133 Milan, Italy. secreto@istitutotumori.it
authors.forename: Giorgio
authors.initials: G
authors.lastname: Secreto
authors.forename: Luigi Mario
authors.initials: LM
authors.lastname: Chiechi
authors.forename: Andrea
authors.initials: A
authors.lastname: Amadori
authors.forename: Rosalba
authors.initials: R
authors.lastname: Miceli
authors.forename: Elisabetta
authors.initials: E
authors.lastname: Venturelli
authors.forename: Teresa
authors.initials: T
authors.lastname: Valerio
authors.forename: Ettore
authors.initials: E
authors.lastname: Marubini
mesh_terms: D000328:Adult; D000368:Aged; D000975:Antioxidants / Q000009:adverse effects / Q000627:therapeutic use*; D002979:Climacteric / Q000187:drug effects* / Q000523:psychology; D004311:Double-Blind Method; D005260:Female; D019584:Hot Flashes / Q000188:drug therapy; D006801:Humans; D007529:Isoflavones / Q000009:adverse effects / Q000627:therapeutic use*; D008550:Melatonin / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D010349:Patient Compliance; D013025:Glycine max / Q000737:chemistry; D016896:Treatment Outcome
chemical_list: D000975:Antioxidants; D007529:Isoflavones; D008550:Melatonin