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Clinical effects of a proprietary combination isoflavone nutritional supplement in menopausal women: a pilot trial.
Altern Ther Health Med. 2005 Sep-Oct; 11(5):60-5.AT

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.

PURPOSE

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+Show Affiliations

Lukaczer D
Metagenics Inc, Functional Medicine Research Center, Gig Harbor, WA, USA.
Darland G
No affiliation info available
Tripp M
No affiliation info available
Liska D
No affiliation info available
Lerman RH
No affiliation info available
Schiltz B
No affiliation info available
Bland JS
No affiliation info available

MeSH

AdultBreast NeoplasmsCardiovascular DiseasesDietary SupplementsFeeding BehaviorFemaleHot FlashesHumansIsoflavonesMenopauseMiddle AgedPhytoestrogensPhytotherapyPilot ProjectsPlant ExtractsQuality of LifeSurveys and QuestionnairesTime FactorsTreatment OutcomeTrifolium

Pub Type(s)

Clinical Trial
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16189949

Citation

Lukaczer, Daniel, et al. "Clinical Effects of a Proprietary Combination Isoflavone Nutritional Supplement in Menopausal Women: a Pilot Trial." Alternative Therapies in Health and Medicine, vol. 11, no. 5, 2005, pp. 60-5.
Lukaczer D, Darland G, Tripp M, et al. Clinical effects of a proprietary combination isoflavone nutritional supplement in menopausal women: a pilot trial. Altern Ther Health Med. 2005;11(5):60-5.
Lukaczer, D., Darland, G., Tripp, M., Liska, D., Lerman, R. H., Schiltz, B., & Bland, J. S. (2005). Clinical effects of a proprietary combination isoflavone nutritional supplement in menopausal women: a pilot trial. Alternative Therapies in Health and Medicine, 11(5), 60-5.
Lukaczer D, et al. Clinical Effects of a Proprietary Combination Isoflavone Nutritional Supplement in Menopausal Women: a Pilot Trial. Altern Ther Health Med. 2005 Sep-Oct;11(5):60-5. PubMed PMID: 16189949.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Clinical effects of a proprietary combination isoflavone nutritional supplement in menopausal women: a pilot trial. AU - Lukaczer,Daniel, AU - Darland,Gary, AU - Tripp,Matthew, AU - Liska,DeAnn, AU - Lerman,Robert H, AU - Schiltz,Barbara, AU - Bland,Jeffrey S, PY - 2005/9/30/pubmed PY - 2005/11/16/medline PY - 2005/9/30/entrez SP - 60 EP - 5 JF - Alternative therapies in health and medicine JO - Altern Ther Health Med VL - 11 IS - 5 N2 - 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. PURPOSE: 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. SN - 1078-6791 UR - https://www.unboundmedicine.com/medline/citation/16189949/Clinical_effects_of_a_proprietary_combination_isoflavone_nutritional_supplement_in_menopausal_women:_a_pilot_trial_ DB - PRIME DP - Unbound Medicine ER -