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Summaries for Patients are a service provided by Annals to help patients better understand the complicated and often mystifying language of modern medicine.
Many women who are looking for "natural" ways to promote bone health use phytoestrogens. Phytoestrogens are naturally occurring estrogen analogues, which are found in soy products. Genistein is a phytoestrogen that is a common ingredient of products marketed to promote bone health. Typically, however, the level of genistein in these products is too low to be effective. Also, the effectiveness of phytoestrogens such as genistein has not been carefully studied.
SUMMARIES FOR PATIENTS
Effects of the Phytoestrogen Genistein on Bone Health in Postmenopausal Women
19 June 2007 | Volume 146 Issue 12 | Page I-34
Summaries for Patients are presented for informational purposes only. These summaries are not a substitute for advice from your own medical provider. If you have questions about this material, or need medical advice about your own health or situation, please contact your physician. The summaries may be reproduced for not-for-profit educational purposes only. Any other uses must be approved by the American College of Physicians.
The summary below is from the full report titled "Effects of the Phytoestrogen Genistein on Bone Metabolism in Osteopenic Postmenopausal Women. A Randomized Trial." It is in the 19 June 2007 issue of Annals of Internal Medicine (volume 146, pages 839-847). The authors are H. Marini, L. Minutoli, F. Polito, A. Bitto, D. Altavilla, M. Atteritano, A. Gaudio, S. Mazzaferro, A. Frisina, N. Frisina, C. Lubrano, M. Bonaiuto, R. D'Anna, M.L. Cannata, F. Corrado, E.B. Adamo, S. Wilson, and F. Squadrito.
What is the problem and what is known about it so far?
As people age, their bones become less dense and bone fractures occur more easily. Estrogen helps to maintain bone health in younger women, but after about 30 years of age, estrogen levels begin to decrease and then fall sharply after menopause. Estrogen replacement therapy is effective at maintaining bone, but because of its side effects, it is no longer recommended for this purpose.
Why did the researchers do this particular study?
To find out whether genistein improves bone health in postmenopausal women with osteopenia.
Who was studied?
389 postmenopausal women with osteopenia who were otherwise healthy.
How was the study done?
The researchers assigned patients to take 2 pills that contained a total of 54 mg of genistein or a placebo pill daily for 24 months. Both pills contained vitamin D3 and calcium, which are necessary for healthy bones. The placebo pills contained no other active ingredients. The researchers measured bone density and performed several blood tests to see whether bone breakdown and formation occurred after 24 months. Because estrogens can make the lining of the uterus thicker and can lead to cancer, the researchers used ultrasound tests to measure the thickness of the lining of the uterus to see whether genistein also caused this side effect.
What did the researchers find?
After 24 months, women who took genistein had a greater increase in bone mineral density than the women who took the placebo. In addition, bone markers were more favorable in women taking genistein than in women taking placebo. Gastrointestinal side effects were more common among women taking genistein than in women taking placebo. The thickness of the lining of the uterus did not change in either group, suggesting that genistein may be safe to use in terms of uterine health.
What were the limitations of the study?
The study had too few participants and was too short to determine whether genistein reduces fractures and whether side effects might become more of a problem when genistein is used for longer than 24 months.
What are the implications of the study?
The phytoestrogen genistein, when taken with vitamin D3 and calcium, has favorable effects on bone health compared with vitamin D3 and calcium alone.
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  H. Marini, A. Bitto, D. Altavilla, B. P. Burnett, F. Polito, V. Di Stefano, L. Minutoli, M. Atteritano, R. M. Levy, R. D'Anna, et al. Breast Safety and Efficacy of Genistein Aglycone for Postmenopausal Bone Loss: A Follow-Up Study J. Clin. Endocrinol. Metab., December 1, 2008; 93(12): 4787 - 4796. [Abstract] [Full Text] [PDF]
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 C. W. Xiao Health Effects of Soy Protein and Isoflavones in Humans J. Nutr., June 1, 2008; 138(6): 1244S - 1249S. [Abstract] [Full Text] [PDF]
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 R. Lehman Evidently... Evid. Based Med., October 1, 2007; 12(5): 135 - 135. [Full Text] [PDF]
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Other articles noted Evid. Based Med., October 1, 2007; 12(5): 159 - 160. [Full Text] [PDF]
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 Soy phytoestrogen genistein increases bone mineral density in postmenopausal women BMJ, August 11, 2007; 335(7614): 299 - 299. [Abstract] [Full Text] [PDF]
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 Preventing Osteoporosis: Got Soy? Journal Watch Women's Health, July 19, 2007; 2007(719): 3 - 3. [Full Text]
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