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Menopause: Evidence-Based Management Using Natural Therapies By James Meschino, DC, MS, ND In recent years, many women across North America have been reluctant to rely upon hormone replacement therapy (HRT) to reduce menopausal symptoms, due primarily to concerns about the potential risk of breast cancer. In fact, only about 20 percent of women who are given a prescription for HRT actually follow through and take it faithfully. A growing number of postmenopausal women have sought out the use of herbal remedies as an alternative to HRT, as reflected by the rapid growth in supplement sales during the past decade. Interest in natural therapies to control menopausal symptoms is expected to escalate due to two recent alarming reports, which confirm previous suggestions that HRT increases the risk of breast cancer and unopposed estrogen (usually given to women who have undergone a hysterectomy) substantially increases the risk of ovarian cancer.1,2 On July 9, 2002, researchers announced that they were stopping the American Women’s Health Initiative (WHI) trial of 16,000 women taking HRT. Results showed that after 5.2 years, there was a 26 percent increased risk of breast cancer in the women using HRT than in women receiving the placebo. Women taking HRT also showed a 41 percent increased risk of stroke and a 29 percent increased risk of heart attack (myocardial infarction) compared to women receiving the placebo. Prior to this, many doctors promoted HRT to reduce the risk of heart disease in postmenopausal women. However, the findings of the WHI trial provide unequivocal evidence that, in fact, HRT greatly increases the risk of both heart attack and stroke in this population.1,3 More bad news regarding estrogen replacement therapy appeared in the July 17th, 2002, issue of JAMA. In a follow-up study of 44,241 former participants in the Breast Cancer Detection Demonstration Project, researchers discovered that the use of estrogen replacement therapy (without concurrent use of progesterone) increased risk of ovarian cancer. There was a relative risk of 1.8 in women who used estrogen replacement therapy for 10 to 19 years and a 3.2 relative risk in women using estrogen replacement therapy for 20 or more years.2 Previous data from the Nurses’ Health Study demonstrated that for each year a woman remained on HRT, her risk of developing breast cancer increased by 2.3 percent. Thus, a postmenopausal woman taking HRT for 10 years had a 23 percent increased risk of developing breast cancer, compared to women who were non-users of HRT. After 20 years of HRT use, a woman’s risk of developing breast cancer would be 46 percent greater than a women who never used HRT.37-39 As the results of these studies get reported by the popular media, a growing number of women are giving up HRT in favor of credible alternative means to optimize their feeling of well-being, reduce hot flashes, maintain an active sex life and a healthy appearance, and reduce their risk of osteoporosis, heart disease and other degenerative conditions.1 In order to help patients arrive at a prudent course of action, health practitioners should be informed about the current research status of various natural interventions that have a proven and safe record in the management of menopausal complaints and health conditions affecting menopausal women. In today’s world, women live one-third of their lives in the postmenopausal years. Helping women maximize their quality of life and life span should be the intent of any nutrition, supplementation or lifestyle recommendations, which should be customized to an individual’s needs. In addition to controlling hot flashes and other menopausal symptoms, there are three major health concerns that must also be factored into the decision-making process. It is well-established that postmenopausal women are at increased risk for breast cancer, osteoporosis and heart disease. Here are the facts: Heart disease is the number-one killer of postmenopausal women Osteoporosis affects one in four women by age 50 Breast cancer incidence rates have increased by 40 percent in the last 50 years, with one in every 403 women afflicted between ages 50 and 59; one in 266 women afflicted between ages 60 and 69; and one in 220 women afflicted at age 70 and over.4 Heart Disease After menopause, women become less able to clear cholesterol from their bloodstream. During the pre-menopausal stage of life, high-circulating estrogen levels increase the production of LDL-cholesterol receptors, which enable cells to extract LDL-cholesterol (low-density lipoprotein cholesterol, which is known to increase risk of heart attack and stroke) from the bloodstream and use it for various purposes. In menopause, there is a 90 percent drop-off in circulating estrogen levels, which appears to reduce the ability of cells to produce LDL-cholesterol receptors. As a result, there is a strong tendency for cholesterol to accumulate in the bloodstream, stick to the walls of the arteries and cause narrowing of coronary blood vessels and heart attacks.4 Since a high-saturated fat diet is the main culprit in raising LDL-cholesterol levels, postmenopausal women should adjust their diet to lower their saturated fat intake in order to keep their blood cholesterol levels below 200 mg per dL. Results from the Framingham Heart Study suggest individuals should ingest no more than 10 to 28 gm per day of saturated fat, based upon the presence of other risk factors such as family history, diabetes, smoking, high blood pressure, etc. This implies that the use of animal protein foods should consist of chicken, turkey, Cornish hen and fish. All milk and yogurt products should be nonfat or lowfat varieties. No cheese above 3-percent milk fat should be consumed. Butter, ice cream, whipping cream, regular chocolate products, items containing coconut or palm oil, and deep-fried products of all types should be avoided.5 Increasing soluble, dietary fiber intake can also reduce blood cholesterol levels by dragging cholesterol out of the body, as well as bile acids, which can serve as precursors (building blocks) to the synthesis of cholesterol in the liver. Soluble fiber is found in most fruits and vegetables, oat bran, psyllium-husk fiber, ground flaxseeds, and beans and peas.6 Remaining physically fit and near an ideal weight is also an important lifestyle factor in preventing cardiovascular disease in the postmenopausal years.7,8 It should also be noted that soy products and soy extract supplements are known to reduce blood cholesterol levels by 9-12 percent in patients with high cholesterol levels. 9 The same is true for a supplement known as gamma-oryzanol, which is derived from rice bran oil.10,11 Both soy extract and gamma-oryzanol have been shown to reduce hot flashes and other menopausal symptoms and are excellent alternative therapies to the use of HRT in postmenopausal women. Gamma-oryzanol is an approved drug for the management of menopausal symptoms in Japan, where the research on this natural agent has been performed.12 It is very convenient that soy extract and gamma-oryzanol can help reduce menopausal symptoms and cholesterol levels, and in the case of soy isoflavones, help maintain bone mineral density.13-15 Osteoporosis The decline in estrogen levels that accompanies the menopausal years also permits calcium to leak out of bone into the bloodstream, where it will eventually become filtered by the kidney and exit the body in the urine. This, of course, leads to osteoporosis, which increases risk of fractures. Osteoporosis is reaching epidemic proportions in our society, largely due to insufficient calcium intake and accumulation in bone (especially between ages 11 and 24) and loss of calcium from bone during the menopausal years.16,17 It should be noted that Canadian statistics indicate that complications from osteoporotic hip fractures (e.g., the development of pneumonia) result in more deaths each year than the combined mortality rate from breast and ovarian cancers.18 The lifestyle recipe to prevent osteoporosis during the menopausal years is as follows: Ingest 1500 mg per day of calcium if not taking HRT. This can be through a combination of calcium from diet and supplements (note that calcium carbonate and calcium citrate are absorbed equally as well if taken with meals). As calcium carbonate is less expensive, it represents a more cost-effective intervention for patients. However, if the patient has had a previous history of kidney stones, calcium citrate may be preferred due to its greater solubility.16 Supplement with 600 to 1000 IU of vitamin D. For general health reasons, women should consider taking a high potency multiple vitamin and mineral, which normally includes 400 IU of vitamin D. Studies show that postmenopausal women ingesting an additional 200 to 400 IU of vitamin D per day may reduce their risk of hip fractures by approximately 50 percent. A high potency multiple vitamin and mineral (including extra anti-oxidant protection and a B-50 complex) contains other nutrients important to bone health (calcium zinc, magnesium, copper), as well as providing comprehensive micronutrient support for other aspects of health optimization. As we age, our kidneys reduce their ability to convert 25-hydroxyvitamin D to 1,25-dihydroxyvitamin D, which is twice as powerful a form of vitamin D. However, studies indicate that by increasing blood levels of 25-hydroxyvitamin D, through the intake of vitamin D supplements (600-1000 IU per day), a postmenopausal women can compensate for the drop-off in 1,25-hydroxyvitamin D synthesis and thereby significantly reduce her risk of osteoporotic fractures.19,20 Perform weight-bearing and/or resisted exercises four to seven times per week. Weight-bearing exercise, such as walking or jogging, and weight-training exercises place increased stress on the spine and femurs, which respond by holding their calcium in bone to help withstand the physical stresses acting on the bone structures. Some studies reveal that postmenopausal women can increase their bone density without using HRT by simply ingesting more calcium and performing a series of five weight-training exercises, twice per week.21 Supplement with a product that contains black cohosh and soy isoflavones. As will be discussed later, standardized black cohosh and soy extract have been shown to reduce menopausal symptoms. Evidence shows that they can also help to preserve bone mineral density via their estrogenic effects on bone receptors.22,23 Breast Cancer It is well-documented that women who are overweight during the postmenopausal years have approximately a three times greater risk of developing breast cancer.24-26 This is likely due to the fact that as fat mass increases, there is a greater conversion of androstenedione to estrone within the stromal tissue of adipose tissue. High-circulating estrone (one of three types of estrogens made by the female body) hormone levels are associated with increased risk of breast cancer, as estrone is known to increase the cell division rate of breast cells. In turn, this leads to a greater chance of genetic mutations that may be cancerous. This is exactly the same mechanism through which HRT has been shown to increase breast cancer risk. Thus, postmenopausal women would be well-advised to attain and maintain an ideal body weight and a body mass index below 25 (24.87).24 Avoiding the use of HRT is emerging as a significant strategy upon which to help prevent breast cancer in postmenopausal women. The best alternative approaches include a combination of black cohosh, soy isoflavones and gamma-oryzanol, as each of these natural interventions has been shown to reduce menopausal complaints. Furthermore, their use in human populations over many years suggests that they do not increase risk of breast cancer. In Japan, where soy isoflavone intake is customarily between 50 and 75 mg per day, breast cancer incidence is 75 percent lower than in the US.14 Recent experimental studies involving black cohosh have shown that it exerts an anti-proliferative effect on breast cells and human breast cancer cell lines, which is consistent with a reduced risk of breast cancer.27 Therefore, the use of black cohosh, soy isoflavones and gamma-oryzanol can be considered safe and effective alternatives to the use of HRT in women without a previous history of breast cancer.12,14,28 In patients with a previous history of breast cancer, the jury is still out as to whether or not these natural agents should be used. However, in a recent survey, women with a previous history of breast cancer were 7.4 times more likely to use alternative treatments for menopause symptoms than were women with no such history. Soy products, herbal remedies (including black cohosh and gamma-oryzanol) and vitamin E were the most common alternatives to HRT.29 In addition to these devastating statistics, the decline in estrogen and progesterone production triggers a broad range of physical, psychological and aging-related signs and symptoms that can significantly interfere with a woman’s feeling of well-being.4 Although underutilized by medical doctors in this part of the world, substantial evidence from European and Asian studies provides convincing support that the herbal agent known as black cohosh, along with soy extract and gamma-oryzanol, can significantly reduce menopausal symptoms, help support bone density, reduce high cholesterol, prevent atrophy and dryness of vaginal tissues, and improve a woman’s feeling of well-being and vitality. The scientific evidence to support the concurrent use of these natural agents is as follows: Dietary Supplements in the Management of Menopausal Symptoms Black cohosh: The most widely used and thoroughly studied natural supplement for the management of menopausal symptoms is the herbal agent known as black cohosh (Cimifuga racemosa), which must be standardized to 2.5 percent triterpene content. Four major human studies have demonstrated the ability of black cohosh to help manage menopausal signs and symptoms. In the first study (an open study), 80 percent of 629 female patients experienced improvement of physical and psychological symptoms, associated with menopause, within six to eight weeks of treatment. Significant improvement was noted in the following symptoms: Hot flashes Profuse sweating Headache Vertigo Heart palpitations Tinnitus Nervousness/Irritability Sleep disturbances Depressive moods Only 7 percent of patients reported mild transitory stomach complaints.6,22,30 A second study (a controlled study) compared the effects of black cohosh to estrogen replacement therapy (0.625 mg C.E.E.) or diazepam (2 mg) for 12 weeks. Black cohosh outperformed both the estrogen replacement Premarin and diazepam using the Kupperman Menopausal Index.31 This quantitative assessment of menopausal symptoms is achieved by grading severity. The third study (double-blind) compared the effects of black cohosh to estrogen replacement therapy (0.625 mg C.E.E.) or a placebo for 12 weeks. In this study, black cohosh produced better results in controlling menopausal symptoms (on the Kupperman Menopausal Index and the Hamilton Anxiety Test) and produced greater improvement in the vaginal lining than estrogen or the placebo. In the black cohosh group, the number of hot flashes per day dropped from an average of five to less than one. In the estrogen group, this number dropped from five to 3.5 hot flashes per day, on average.28 In a fourth study (double-blind), black cohosh was compared to a placebo in a study of 110 women. The black cohosh group demonstrated significant improvement in menopausal symptoms and blood hormone measurements. In addition to relieving hot flashes, it once again produced impressive age-reversal results on the vaginal lining as confirmed by vaginal smear analysis. Since 1956, over 1.5 million menopausal women in Germany have used black cohosh extract with noted success and without significant side effects. Physiologically, black cohosh extract appears to mimic the effects of estriol, which is a form of estrogen made by the body. Estriol is a weaker form of estrogen than estrone or estradiol, and is not associated with an increased risk of reproductive cancers. Like other forms of estrogen, estriol helps to maintain bone density and aids cholesterol removal from the blood stream. Black cohosh extract has also been shown to inhibit the over-secretion of leutinizing hormone.28,32 Remarkably, the triterpene saponins, unique to black cohosh, has also been shown to serve as a precursor (building block) for the synthesis of progesterone in the body.33 As there is a 66 percent decline in progesterone levels at menopause, black cohosh supplementation may help to preserve progesterone balance, which is important to preserving bone health, libido and psychological well-being.4 The most beneficial dosage is 40 or 80 mg, taken twice per day.28 Soy Isoflavones: Soy extract, yielding a minimum of 50 mg of soy isoflavones, has been shown to reduce hot flashes and other menopausal symptoms in various clinical trials.14,34,36 Some studies show up to a 40 percent reduction in hot flashes with the use of soy isoflavone products.14 Soy isoflavones also possess phytoestrogen activity (plant-based estrogen). Like the triterpene saponins found in black cohosh, soy isoflavones are a type of “selective estrogen receptor modulator,” which preferentially stimulates beta-estrogen receptors on reproductive and other tissues. In turn, this provides weak estrogenic support to reproductive tissue and bones, without overstimulating breast and endometrial cells, as may happen with HRT. HRT stimulates the alpha-receptors on breast tissue, which increases their rate of cell division and the likelihood of developing cancerous mutations. Stimulation of the beta-receptors by soy isoflavones and black cohosh triterpenes has been shown to slow down the rate of cell division of breast and endometrial cells in the presence of the body’s own estrogen. This is associated with a decreased risk of reproductive cancers.35 Investigation into the biological actions of soy isoflavones suggests that they provide a number of additional protective effects. These include anti-oxidant protection against free radicals; slowing of cellular proliferation; reduction of estrone hormone synthesis by inhibiting the estrogen synthase (aromatase) enzyme in fat tissue; increasing the detoxification of potentially harmful chemicals and hormones; and competition with the body’s more powerful estrogen for attachment and stimulation of estrogen receptors on the breast and other tissues expressing estrogen receptors. Gamma-oryzanol: Supplementation with gamma-oryzanol (150 mg, twice per day) has been shown to reduce the secretion of leutinizing hormone (LH) by the pituitary gland and promote endorphin release by the hypothalamus. Hot flashes and other menopausal symptoms indirectly result from the oversecretion of LH, which is attempting to initiate the start of another ovulatory cycle. The lack of response by the immature egg cells in the ovaries at the outset of menopause results in oversecretion of follicle-stimulating hormone (FSH) and LH by the pituitary. Clinical trials reveal that 67 to 85 percent of women treated with gamma-oryzanol have experienced a significant reduction in menopausal symptoms.12 As noted previously, gamma-oryzanol, supplemented at the above-noted dosage, is also known to reduce high cholesterol by up to 12 percent.10,11,15 Summary of Daily Dosage It is now possible to find combination supplement products that provide all three nutrients (black cohosh, soy isoflavones and gamma-oryzanol) in a single product formulation. As these three nutrients work synergistically, recommending a combination formula of this nature gives the patient the best possible opportunity to control their symptoms and improve their state of well-being without having to rely on HRT. This combination of nutrients can be used safely by low-risk menopausal women as a viable alternative to HRT (bone density and blood lipids should be monitored periodically), and by women who have contraindications to estrogen replacement therapy (fibrocystic breast disease, endometriosis, uterine fibroids, liver or gallbladder disease, pancreatitis, or unexplained uterine bleeding).12,14,28 It should be noted however, that several studies using lower doses of estrogen (0.33 mg vs 0.625 or 1.25 mg, as occurs in standard HRT preparations) have provided some evidence that lower doses of estrogen may be beneficial in preventing osteoporosis without increasing risk of breast cancer. As such, some concerned doctors have been prescribing lower doses of estrogen in combination with 200 mg of natural progesterone, in light of previous evidence linking standard HRT doses with an increased risk of breast cancer. More study is required to know if these lower doses are safe, but they may represent a viable alternative for the time being for women who absolutely need this type of intervention.40 Through proper guidance directed towards nutrition, exercise and supplementation, practitioners can greatly influence a woman’s quality of life and health-risk profile during the menopausal years. Many of the proven principles of natural menopausal management have been largely overlooked by traditional medicine and thus, it is incumbent upon more holistic practitioners to enlighten their female patients in regards to these matters, particularly in light of the recent negative outcomes associated with HRT. From my experience, the combination of black cohosh, soy isoflavones and gamma-oryzanol, as outlined above can be used for the following conditions and concerns: As a natural alternative to estrogen replacement or HRT for postmenopausal women who demonstrate normal bone density and cholesterol levels As an important source of phytoestrones and phytonutrients for women of all ages to help reduce the risk of female-related diseases throughout their lifetime (cut the dosage in half for premenopausal women and teenagers) As a supplement for women with PMS, fibroids, endometriosis and fibrocystic breast disease As an alternative treatment for postmenopausal women with contraindications to estrogen replacement therapy As a dietary adjunct to estrogen replacement therapy or the birth-control pill, in order to help tone down the overstimulation effect of these drugs on breast and uterine tissues. Final Comments By age 50, all women should have a bone-mineral density test to determine their bone status. If osteoporosis is not present, then most women can simply follow the lifestyle program outlined in this review. If there has already been significant bone loss, then the attending physician may wish to consider the use of biphosphonate drugs, which slow the loss of calcium from bone, or the use of raloxifen or tamoxifen. The point is that all postmenopausal women should have their bone density tracked periodically Blood work to determine fasting cholesterol and triglyceride levels and other biomarkers of cardiovascular disease should also be included as part of regular screening. What is now clear, however, is that the use of HRT has fallen out of favor even in the most traditional medical circles. Patients are seeking the help of knowledgeable professionals who are able to guide them to evidence-based natural interventions that are proven to be safe and effective. With a baby boomer turning 50 years of age every seven seconds, there is tremendous need for allied health practitioners to disseminate credible wellness information that can enhance the quality of people’s lives and help them avoid illness and other maladies. The information contained in this report should enable health care professionals to provide scientifically sound advice to their female clients in regards to the natural management of menopausal symptoms and the prevention of serious and often life-threatening health conditions. For more information on this or other related topics, visit Dr. Meschino’s website at www.renaisante.com. References Kaunitz AM. Use of combination hormone replacement therapy in light of recent data From the Women’s Health Initiative. Medscape Women’s Health eJournal, Jul 12, 2002. Barclay L. Estrogen therapy, but not estrogen-progestin, linked to ovarian cancer. JAMA 2002;288:334-41, 368-9. “British Scientists Say HRT Trial Should Continue.” Reuters Health Information, 2002. Colgan M. Hormonal Health. Vancouver, BC, Canada: Apple Publishing, 1996. Castelli WP, Griffin GC. How to help patients cut down on saturated fat. Postgrad Med 1988;84(3):44-56. Masley SC. Dietary methods to reduce LDL levels. Am Fam Physician 1998;57(6):1299-1306. Pate RR, et al. Physical activity and public health. JAMA 1995;273(5):402-7. Kannel WB, et al. Effect of weight on cardiovascular disease. Am J Clin Nutr 1996;63(suppl):419-22. 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. Yoshino G, et al. Effects of gamma-oryzanol on hyperlipidemic subjects. Curr Ther Res 1989;45(4):543-52. Yoshino, G et al. Effects of gamma-oryzanol and probucol on hyperlipidemia. Curr Ther Res 1989;45(6):975-82. Murase Y, et al. Clinical studies of oral administration of gamma-oryzanol on climacteric complaints and its syndrome. Obstet Gynecol Prac 1963;12:147-9. 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;70(suppl):439-50. Ishihara M. Effect of gamma-oryzanol on serum lipid peroxide levels and climacteric disturbances. Asia Oceania J Obstet Gynecol 1984;10):317. NIH Consensus Conference. Optimal calcium intake. NIH Consensus Development Panel on Optimal Calcium Intake. JAMA Dec 28, 1994;272(24):1942-8. Dawson-Hughes B. Calcium supplementation and bone loss: a review of controlled clinical trials. Am J Clin Nutr 1991;54(Supplement):274-80. Osteoporosis Society of Canada. Clinical practice guidelines for the diagnosis and management of osteoporosis. CMAJ 1996;155:1113-33. Supplementation with vitamin D3 and calcium prevents hip fractures in elderly women. Nutr-Rev June 1993;51(6):183-5. Dawson-Hughes B, et al. Rates of bone loss in postmenopausal women randomly assigned to one of two dosages of vitamin D. Am J Clin Nutr 1995;61(5):1140-5. Nelson ME, et al. Effects of high-intensity strength training on multiple risk factors for osteoporotic fractures. JAMA 1994;272(24):1909-14. Stolze H. An alternative to treat menopausal complaints. Gynecologie 1982;3:14-16. Albertzazzi P et al. The effect of dietary soy supplementation on hot flashes. Obstet Gynecol 1998;91(1):6-11. Toniolo PG, et al. A prospective study of endogenous estrogens and breast cancer in postmenopausal women. JNCI 1995;87(3):190-9. Lew EA, et al. The American Cancer Society Study: Variations in mortality by weight among 750,000 men and women. J Chronic Dis 1979;32:563-76. Tannenbaum A. The relationship of body weight to cancer incidence Arch Pathol 1940;30:509. Dixon-Shanies D, Shaikh N. Growth inhibition of human breast cancer cells by herbs and phytoestrogens. Oncol Rep 1999;6(6):1383-7. Murray M. Remifemin: Answers to some common questions. Am J Natural Med 1997;4(3). Many U.S. breast cancer survivors use alternatives to HRT. J Pain Symptom Manage 2002;23:501-9. 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. Gorlich N. Treatment of ovarian disorders in general practice. Arztl Prax 1962;14:1742-3. Limon L. Use of alternative medicine in women’s health. American Pharmaceutical Association Annual Meeting, 2000. Murkies AL, et al. Dietary flour supplementation decreases post-menopausal hot flashes: effect of soy and wheat. Maturitas 1995;21:189-95. Durand N, Marmoreo J: Isoflavones and menopause. The Medical Post Q & A Supplement Oct, 3. 2000: page Q1. 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(3):333-40. Colditz GA. Relationship between estrogen levels, use of hormone replacement therapy and breast cancer. JNCI 1998;90(11):814-23. Health after 50. Johns Hopkins Medical Newsletter 1999;11(9):6-7. Simone B. Cancer and Nutrition. New York: Avery Publishing Group Inc., 1992:219-23. Brinton LA. Menopausal estrogen use and risk of breast cancer. Cancer 1981;47(10):2517-22. About the Author: Dr. James Meschino practices in Toronto, Ontario. He can be contacted via his Web site: www.renaisante.com.

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