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Red clover isoflavones are safe and well tolerated in women with a family history of breast cancer.
Menopause Int 2008; 14(1):6-12MI

Abstract

OBJECTIVE

To assess the safety and tolerability of a standardized 40 mg red clover isoflavone dietary supplement (Promensil, Novogen) in women with a family history of breast cancer to evaluate the feasibility of using the supplement for prevention of breast cancer in healthy women.

STUDY DESIGN

Healthy women aged 35-70 years (n = 401) with at least one first-degree relative with breast cancer received red clover isoflavones or placebo for three years in a randomized, double-blind, placebo-controlled pilot trial. Participants were assessed clinically and blood samples taken for biochemical analysis every six months. In addition, study participants underwent mammography, bone density and transvaginal ultrasound (postmenopausal women only) once per year.

RESULTS

No significant differences in breast density, endometrial thickness, serum cholesterol, follicle stimulating hormone levels and bone mineral density were detected between those taking red clover isoflavones and placebo. In postmenopausal women, some significant differences in bone marker levels were seen between active and placebo groups, at six months and at 12 months. The adverse event profile was similar across all red clover isoflavone and placebo groups.

CONCLUSION

This three-year study supports the growing body of evidence that treatment with red clover isoflavones is safe and well tolerated in healthy women. Supplements containing red clover isoflavones did not adversely affect breast density, skeletal strength or cardiovascular status. In postmenopausal women, endometrial status was not adversely affected. The adverse event profile was similar between red clover isoflavones, and placebo and endocrine status did not differ.

Authors+Show Affiliations

Breast Unit, Parkside Oncology Clinic, Wimbledon, London, UK. trevorpowles@aol.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18380954

Citation

Powles, Trevor J., et al. "Red Clover Isoflavones Are Safe and Well Tolerated in Women With a Family History of Breast Cancer." Menopause International, vol. 14, no. 1, 2008, pp. 6-12.
Powles TJ, Howell A, Evans DG, et al. Red clover isoflavones are safe and well tolerated in women with a family history of breast cancer. Menopause Int. 2008;14(1):6-12.
Powles, T. J., Howell, A., Evans, D. G., McCloskey, E. V., Ashley, S., Greenhalgh, R., ... Tidy, A. (2008). Red clover isoflavones are safe and well tolerated in women with a family history of breast cancer. Menopause International, 14(1), pp. 6-12. doi:10.1258/mi.2007.007033.
Powles TJ, et al. Red Clover Isoflavones Are Safe and Well Tolerated in Women With a Family History of Breast Cancer. Menopause Int. 2008;14(1):6-12. PubMed PMID: 18380954.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Red clover isoflavones are safe and well tolerated in women with a family history of breast cancer. AU - Powles,Trevor J, AU - Howell,Anthony, AU - Evans,D Gareth, AU - McCloskey,Eugene V, AU - Ashley,Sue, AU - Greenhalgh,Rosemary, AU - Affen,Jenny, AU - Flook,Lesley Ann, AU - Tidy,Alwynne, PY - 2008/4/3/pubmed PY - 2008/7/18/medline PY - 2008/4/3/entrez SP - 6 EP - 12 JF - Menopause international JO - Menopause Int VL - 14 IS - 1 N2 - OBJECTIVE: To assess the safety and tolerability of a standardized 40 mg red clover isoflavone dietary supplement (Promensil, Novogen) in women with a family history of breast cancer to evaluate the feasibility of using the supplement for prevention of breast cancer in healthy women. STUDY DESIGN: Healthy women aged 35-70 years (n = 401) with at least one first-degree relative with breast cancer received red clover isoflavones or placebo for three years in a randomized, double-blind, placebo-controlled pilot trial. Participants were assessed clinically and blood samples taken for biochemical analysis every six months. In addition, study participants underwent mammography, bone density and transvaginal ultrasound (postmenopausal women only) once per year. RESULTS: No significant differences in breast density, endometrial thickness, serum cholesterol, follicle stimulating hormone levels and bone mineral density were detected between those taking red clover isoflavones and placebo. In postmenopausal women, some significant differences in bone marker levels were seen between active and placebo groups, at six months and at 12 months. The adverse event profile was similar across all red clover isoflavone and placebo groups. CONCLUSION: This three-year study supports the growing body of evidence that treatment with red clover isoflavones is safe and well tolerated in healthy women. Supplements containing red clover isoflavones did not adversely affect breast density, skeletal strength or cardiovascular status. In postmenopausal women, endometrial status was not adversely affected. The adverse event profile was similar between red clover isoflavones, and placebo and endocrine status did not differ. SN - 1754-0453 UR - https://www.unboundmedicine.com/medline/citation/18380954/Red_clover_isoflavones_are_safe_and_well_tolerated_in_women_with_a_family_history_of_breast_cancer_ L2 - http://www.diseaseinfosearch.org/result/960 DB - PRIME DP - Unbound Medicine ER -