The scientific evidence to support the concurrent use of these natural agents is as follows:
Black Cohosh: The most widely used and thoroughly studied natural supplement for the management of menopausal symptoms is the herbal agent black cohosh (cimifuga racemosa), which must be standardized to 2.5 percent triterpene content.
- hot flashes
- profuse sweating
- heart palpitations
- nervousness or irritability
- sleep disturbances
- depressive moods
Only seven percent of patients reported mild transitory stomach complaints.6,22,30
A second study (controlled) 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 Premarin (C.E.E.) and Valium (diazepam) using the Kupperman Menopausal Index (KMI).
The KMI is one of the most utilized assessments in clinical studies of menopause. This quantitative assessment of menopausal symptoms is achieved by grading of severity: Severe is rated 3; moderate is rated 2; mild is rated 1; and symptoms not present are rated 0. After grading each symptom, the total score is achieved by adding all of the symptom scores together.
Symptoms assessed are:
- depressive moods
- feelings of vertigo
- heart palpitations
- hot flashes
- joint pain
- loss of concentration
- nervousness or irritability
- profuse sweating
- sleep disturbances31
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 (KMI 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 following 110 women. The black cohosh group demonstrated significant improvement in menopausal symptoms and blood hormone measurements. In addition to relieving hot flashes, it 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, it 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 bloodstream. Black cohosh extract has also been shown to inhibit the oversecretion of leutinizing hormone (LH), providing proof of its estrogen-like properties.28,32
Remarkably, the triterpene saponins, unique to black cohosh, have 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 and maintaining libido and psychological well-being.4 The dosage proven beneficial in the treatment of menopausal symptoms is 40 or 80 mg, taken twice per day (standardized grade containing 2.5 percent triterpene glycoside content).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 (SERM), which preferentially stimulates a beta estrogen receptor 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 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 the rate of cell division of breast and endometrial cells in the presence of the body's own estrogen; an effect 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 antioxidant protection against free radicals; the slowing of cellular proliferation; reducing the synthesis of estrone hormone by inhibiting the estrogen synthase (aromatase) enzyme in fat tissue; increasing the detoxification of potentially harmful chemicals and hormones; and competing with the body's more powerful estrogen for attachment and stimulation of estrogen receptors on the breast, and other tissues expressing estrogen receptors.
Soy isoflavones have also been shown to support bone mineral density in postmenopausal women, and help keep cholesterol levels within a safer range, as mentioned earlier.14
- 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 (profuse sweating or mood changes) result indirectly 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 the follicle-stimulating hormone (FSH) and LH by the pituitary, contributing to the onset of hot flashes and related symptoms. Clinical trials reveal that 67-85 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 formulation. As these three nutrients work synergistically, recommending a combination formula of this nature gives patients the best possible opportunity to control their symptoms and improve their state of well-being, without having to rely on HRT.
Not all cases respond to the use of natural supplementation. However, studies suggest that the majority of patients report extremely positive results. To summarize the doses and standardized grades of each nutrient, the following guide should prove helpful:
- black cohosh extract - 80 mg, twice per day (standardized to 2.5 percent triterpene content);
- soy extract - 250 mg (yielding 25 mg of soy isoflavones), twice per day; and
- gamma-oryzanol - 150 mg, twice per day.
This combination of nutrients can be used safely by low-risk menopausal women as a viable alternative to HRT (monitoring of bone density and blood lipids should be performed 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 Women taking HRT may want to use a combination formula such as this for general nutrient support to acquire important isoflavones and related phytoestrogens.
Due to bothersome side-effects and fear of breast cancer, less than 20 percent of North American postmenopausal women were currently using estrogen replacement therapy prior to this most recent report in July 2002.4 It is anticipated that many users will choose to quit HRT or be advised to do so by their physicians, based upon the latest findings of the WHI trial.1
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 the risk of breast cancer. As such, some concerned doctors have been prescribing lower doses of estrogen in combination with 200 mg of natural progesterone, over the past several years, 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 toward 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 on 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:
- 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 lifetimes (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 contraindica-tions to estrogen replacement therapy; and
- as a dietary adjunct to estrogen replacement therapy or the birth control pill, in order to help lessen overstimu-lation of breast and uterine tissues.
By age 50, all women should have a bone mineral density test to determine their bone status. If osteoporosis is not present, most women can simply follow the lifestyle program outlined in this review. If there has already been significant bone loss, the attending physician may wish to consider the use of biphosphonate drugs, which have been shown to slow the loss of calcium from bone, or the use of raloxifen or other SERMs, such as tamoxifen. All postmenopausal women should have their bone density tracked periodically to monitor the effectiveness of the programs to which they are subscribing, through lifestyle and natural substances or the use of conventional drugs. Bloodwork, 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 to manage menopausal symptoms and prevent heart disease in postmenopausal women 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 proven to be safe and effective. With a person turning 50 years of age every seven seconds, there is a tremendous need for allied health practitioners to disseminate credible wellness information that can enhance the quality of people's lives and help individuals avoid illness. And science has shown that such conditions can be prevented, postponed or safely and effectively managed. This information should enable health care professionals interested in wellness management 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, common in the postmenopausal stage of life.
(Editor's note: References to this article are on line at www.chiroweb.com/archives/20/24/10.html.)
Toronto, Ontario, Canada
Click here for more information about James P. Meschino, DC, MS.