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September, 2002, Vol. 02, Issue 09

Bye-Bye Hormone Replacement Therapy, Hello Alternative Medicine

By James P. Meschino, DC, MS

On July 9, 2002, researchers announced they were stopping the American Women's Health Initiative (WHI) trial of 16,000 women taking hormone replacement therapy (HRT). The reason was that after a little over five years of the study, there was a 26 percent increased risk of breast cancer in women taking HRT, compared with those receiving the placebo.

Women taking HRT also showed a 41 percent increased risk of stroke, and a 29 percent increased risk of myocardial infarction.

Prior to this, the Nurses' Health Study indicated that for each year a woman remained on HRT her risk of breast cancer increases by 2.3 percent. Thus, after 10 years she had a 23 percent increased risk of breast cancer, and after 20 years, a 46 percent increased risk of breast cancer compared to postmenopausal women who did not use HRT.

Adding to the alarming results of the WHI trial is the study published in the Journal of the American Medical Association (July 17, 2000 issue). This follow-up study of 44,241 former participants in the Breast Cancer Detection Demonstration Project showed that women taking estrogen replacement therapy (with no progesterone, known as unopposed estrogen) had an increased risk of ovarian cancer. For women who had used estrogen replacement for 10 to 19 years the relative risk was 1.8, which increased to 3.2 for women who used estrogen replacement therapy for 20 or more years.

These latest findings are changing the way the medical profession views the use of HRT and estrogen replacement (ERT). Doctors are now encouraged to use HRT only in cases where there is an absolute need, and ERT, which was commonly prescribed for women who had undergone hysterectomy, is no longer the treatment of choice. As the results of these findings begin to emerge in the popular media, patients themselves are voluntarily terminating their use of HRT and ERT in large numbers, and this movement is anticipated to continue at a predictable pace.

The question on the minds of consumers and practitioners is if there are natural alternatives to the use of HRT and ERT that are safe and effective in the management of menopausal symptoms. There are three clinically proven natural supplements that all practitioners should be aware of: black cohosh extract, gamma-oryzanol, and soy isoflavones.

In head-to-head studies against HRT, diazepam, and placebo, black cohosh extract (containing 2.5 percent triterpene glycoside content), has been shown to reduce hot flashes, insomnia, nervousness, anxiety, and a host of other emotional and physical menopausal symptoms. The triterpene constituents have been shown to act like the body's weakest estrogen (estriol), and serves as a precursor from which the female body can synthesize progesterone. Black cohosh extract has been widely researched and is a medically approved intervention in many European countries as a treatment for menopausal symptoms. In Germany, it has been in use for over 40 years, with no evidence of serious side effects, contraindications, or harmful interactions with other drugs.

Gamma-oryzanol is a substance derived from rice bran oil, which is a prescription drug in Japan and is used to reduce hot flashes associated with menopause, and to reduce high cholesterol and triglyceride levels in the blood stream. As heart disease is the number one killer of postmenopausal women, it is convenient that gamma-oryzanol can reduce bothersome symptoms of menopause, and help to lower risk of heart disease by reducing cholesterol and triglycerides by 12-15 percent. Recall that when people with high cholesterol lower their blood cholesterol level by one percent, there is a corresponding reduction in risk of heart disease of two to three percent. Thus, a 12 percent reduction in blood cholesterol translates into at least a 24 percent reduction in risk of heart attack and related cardiovascular events. The dosage of gamma-oryzanol required to contain menopausal symptoms and lower blood lipids is 150 mg, twice daily. Soy isoflavones have also been shown to reduce hot flashes and other menopausal symptoms, and lower cholesterol by 9-12 percent in hypercholesterolemic patients.

Soy isoflavones are also associated with a reduction in risk of breast cancer and have recently been shown, along with black cohosh triterpenes, to help support bone mineral density in postmenopausal women.

These are all attractive features for the postmenopausal woman, who is prone to heart disease, breast cancer, and osteoporosis. For this reason I recommend to postmenopausal female patients (who have no prior history of breast cancer) that they use a combination supplement product that contains all three herbal and accessory nutrients reviewed in this update, in one capsule, at the following doses:

  1. Black cohosh extract: 80 mg, twice daily (standardized to 2.5 percent triterpene glycosides);
  2. Gamma-oryzanol: 150 mg, twice per day; and
  3. Soy extract; 250 mg, twice per day (standardized to 10 percent isoflavones content).

The dangers of HRT and ERT will likely prompt a flurry of questions about the use of safe, and natural alternatives to these drugs. Health care practitioners will be called upon to help postmenopausal patients make informed decisions about the management of menopause, anti-aging and disease prevention strategies, based upon the existing scientific evidence. It is vital that patients be made aware of the evidence-based research in this area, which should help to avoid their reliance upon less effective or ineffective dietary supplements in the management of their menopausal years.

Black Cohosh References

  • Stolze H. An alternative to treat menopausal complaints. Gyne 1982; 3:1416.
  • Warnecke G: Influencing menopausal symptoms with a phytotherapeutic agent. Med Welt 1985;36:871-4.
  • Stoll W. Phytopharmacon influences atrophic vaginal epithelium. Double-blind study: Cimicifuga vs. estrogenic substances. Therapeuticum 1987;1:23-31.
  • Schildge E. Essay on the treatment of premenstrual and menopausal mood swings and depressive states. Rigelh Biol Umsch 1964;18(2):18-22.
  • Bruker A. Essay on the phytotherapy of hormonal disorders in women. Med Welt 1960;44:2331-3.
  • Murray M. Remifemin:Answers to some common questions. AM J Natural Med April 1997;4(3).
  • Gorlich N. Treatment of ovarian disorders in general practice. Arztl Prax 1962;14:1742-3.
  • Gamma-Oryzanol References
  • Murase Y, et al. Clinical studies of oral administration of gamma-oryzanol on climacteric complaints and its syndrome. Obstet Gynecol Prac 1963;(12):147-149.
  • Ishihara M. Effect of gamma-oryzanol on serum lipid peroxide levels and climacteric disturbances. Asia Oceania J Obstet Gynecol 1984;(10):317.
  • Yoshino G, et al. Effects of gamma-oryzanol on hyperlipidemic subjects. Curr Ther Res 1989;(45):543-552.
  • Yoshino G, et al. Effects of gamma-oryzanol and probucol on hyperlipidemia. Curr Ther Res 1989;(45):975-982.

Soy References

  • Murkies AL, et al. Dietary flour supplementation decreases postmenopausal hot flashes: effect of soy and wheat. Maturitas 1995;(21):189-195.
  • Albertzazzi P, et al. The effect of dietary soy supplementation on hot flashes. Obstet Gynecol 1998;(91):6-11.
  • Cassidy A, et al. Biological effects of a diet of soy protein rich in isoflavones on the menstrual cycle of pre-menopausal women. Am J Clin Nutr 1994;(60):333-340.
  • Valente M, et al. Effects of 1-year treatment with ipriflavone on bone in postmenopausal women with low bone mass. Calcif Tissue Int 1994; 54:377-80.
  • Tsuda M, et al. The effect of ipriflavone on bone resorption in tissue culture. J Bone Miner Res 1986;1:207-11.
  • Patter SM, et al. Soy protein and isoflavones: their effects on blood lipids and bone density in postmenopausal women. Am J Clin Nutr 1998:68 (suppl) 137-9.
  • Dalais FS, et al. Dietary soy supplementation increases vaginal cytology maturation index and bone mineral content in post menopausal women Am J Clin Nutr 1998;68 (suppl) 1519 (abstr).
  • Anderson JW, et al. Meta-analysis of the effects of soy protein intake on serum lipids. N Engl J Med 1995;333:276-82.
  • Messina M. Legumes and Soybeans: overview of their nutritional profiles and health effects. Am J Clin Nutr 1999 vol 70 (suppl);439-50.

Estrogen Replacement Therapy and Breast Cancer References

  • Colditz GA. Relationship between estrogen levels, use of hormone replacement therapy and breast cancer. J Nat'l Cancer Inst 1998;90;11:814-823.
  • Health after 50. John Hopkins Medical Newsletter 6-7 Nov. 1999;11(9).
  • Simone B. Cancer and Nutrition. Avery Publishing Group, Inc., 1992:219-23. Use of combination hormone replacement therapy in light of recent data from the Women's Health Initiative. Medscape Women's Health eJournal Posted 07-12-2002.
  • Barclay L. Estrogen therapy, but NOT estrogen-progestin, linked to ovarian cancer. JAMA 2002;288:334-341:368-36.

Click here for previous articles by James P. Meschino, DC, MS.


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