title: Clinical effects of a proprietary combination isoflavone nutritional supplement in menopausal women: a pilot trial.
abstract: BACKGROUND
  As they reach menopause, a majority of women living in Westernized countries experience climacteric symptoms. Hormone replacement therapy (HRT) has been used to remediate these symptoms. Recent studies, however, have suggested that HRT may increase the risk of developing breast cancer and cardiovascular disease (CVD). Therefore, many women are looking for alternative treatment options.
  
  
  OBJECTIVE
  This trial was a pilot study to assess the effect of a nutritional supplement containing isoflavones from kudzu and red clover, along with other targeted nutrients on menopausal symptoms and markers of breast cancer and CVD risk. Twenty-five menopausal women suffering from severe hot flushes and night sweats completed a 12-week intervention using this combination isoflavone nutritional supplement.
  
  
  RESULTS
  We observed a 46% decrease in reported hot flushes, from an average of 9.7 to 5.2 per day. Quality of life, as assessed by the standardized Greene Questionnaire, showed similar improvement. Two markers of CVD risk, the ratio of total cholesterol to high-density lipoprotein (HDL) cholesterol and homocysteine, showed modest improvement. A proposed marker of breast cancer risk, the ratio of 2-hydroxyestrone to 16 alpha-hydroxyestrone, also showed a statistically significant improvement.
  
  
  CONCLUSIONS
  The results of this pilot trial suggests that this combination isoflavone nutritional supplement may significantly relieve the most troubling symptoms of menopause, as well as confer some chemopreventive and cardioprotective benefits.
authors.affiliation: Metagenics Inc, Functional Medicine Research Center, Gig Harbor, WA, USA.
authors.forename: Daniel
authors.initials: D
authors.lastname: Lukaczer
authors.forename: Gary
authors.initials: G
authors.lastname: Darland
authors.forename: Matthew
authors.initials: M
authors.lastname: Tripp
authors.forename: DeAnn
authors.initials: D
authors.lastname: Liska
authors.forename: Robert H
authors.initials: RH
authors.lastname: Lerman
authors.forename: Barbara
authors.initials: B
authors.lastname: Schiltz
authors.forename: Jeffrey S
authors.initials: JS
authors.lastname: Bland
mesh_terms: D000328:Adult; D001943:Breast Neoplasms / Q000517:prevention & control; D002318:Cardiovascular Diseases / Q000517:prevention & control; D019587:Dietary Supplements; D005247:Feeding Behavior; D005260:Female; D019584:Hot Flashes / Q000188:drug therapy* / Q000517:prevention & control; D006801:Humans; D007529:Isoflavones / Q000008:administration & dosage*; D008593:Menopause / Q000187:drug effects*; D008875:Middle Aged; D048789:Phytoestrogens / Q000008:administration & dosage*; D008517:Phytotherapy; D010865:Pilot Projects; D010936:Plant Extracts / Q000008:administration & dosage; D011788:Quality of Life; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D029921:Trifolium
chemical_list: D007529:Isoflavones; D048789:Phytoestrogens; D010936:Plant Extracts