title: Nonhormonal management of postmenopausal women: effects of a red clover based isoflavones supplementation on climacteric syndrome and cardiovascular risk serum profile.
abstract: OBJECTIVE
  The aim of this prospective randomized study was to evaluate a red clover based isoflavones supplementation in the treatment of climacteric syndrome and its effects on cardiovascular risk serum profile.
  
  
  METHODS
  The study included 150 healthy postmenopausal women that were randomly assigned to receive phytoestrogens tablets, amounting in a total daily intake of 60.8 mg red clover isoflavones plus 19.2 mg soy isoflavones (n = 75), or placebo (n = 75). The authors evaluated teh following: daily number of hot flushes and Kupperman Index at baseline and after one and three months; serum total, high-density lipoprotein (HDL) and low-density lipoprotein (LDL) cholesterol, triglycerides, prothrombin time (PT), partial thromboplastin time (PTT), fibrinogen, and antithrombin III (ATIII) at baseline and after three and six months.
  
  
  RESULTS
  One hundred twenty-eight patients completed the study: 67 in the active group and 61 in the placebo group. The treatment led to a progressive significant reduction (p < 0.05) of the number of hot flushes in the active group compared to placebo already after one month, while Kupperman Index was statistically reduced after three months. No significant variation in total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, PT, PTT, fibrinogen, and ATIII were found.
  
  
  CONCLUSIONS
  The present findings suggest that a red clover based isoflavones supplementation in healthy postmenopausal women is promptly effective on climacteric syndrome, improves neurovegetative symptoms, safe on cardiovascular risk serum profile, and does not modify lipids and coagulation.
authors.affiliation: "San Leonardo" Hospital, Castellammare di Stabia, Naples, Italy. giampaolomainini@libero.it
authors.forename: G
authors.initials: G
authors.lastname: Mainini
authors.forename: M
authors.initials: M
authors.lastname: Torella
authors.forename: M C
authors.initials: MC
authors.lastname: Di Donna
authors.forename: E
authors.initials: E
authors.lastname: Esposito
authors.forename: S
authors.initials: S
authors.lastname: Ercolano
authors.forename: R
authors.initials: R
authors.lastname: Correa
authors.forename: G
authors.initials: G
authors.lastname: Cucinella
authors.forename: L
authors.initials: L
authors.lastname: Stradella
authors.forename: A
authors.initials: A
authors.lastname: Luisi
authors.forename: A
authors.initials: A
authors.lastname: Basso
authors.forename: F V
authors.initials: FV
authors.lastname: Cerreto
authors.forename: R
authors.initials: R
authors.lastname: Cicatiello
authors.forename: M
authors.initials: M
authors.lastname: Matteo
authors.forename: P
authors.initials: P
authors.lastname: De Franciscis
mesh_terms: D002318:Cardiovascular Diseases / Q000097:blood / Q000453:epidemiology*; D005260:Female; D019584:Hot Flashes / Q000188:drug therapy*; D006801:Humans; D007529:Isoflavones / Q000627:therapeutic use*; D008875:Middle Aged; D048789:Phytoestrogens / Q000008:administration & dosage* / Q000627:therapeutic use; D008517:Phytotherapy; D018570:Risk Assessment; D029921:Trifolium
chemical_list: D007529:Isoflavones; D048789:Phytoestrogens