Menopause, Perimenopause and Postmenopause Part 2

Compiled by John G. Connor, M.Ac., L.Ac., Edited by Barbara Connor, M.Ac., L.Ac.

Table of Contents
1) Research on Menopause
a. Estrogen and HRT Studies
b. Phytoestrogen Studies
c. Acupuncture Studies
d. Herbal Studies
e. Progesterone Studies
2) References
1)  RESEARCH ON MENOPAUSE:

a.    Estrogen and HRT Studies
The following are the results of 12 scientific studies showing the health risks of estrogen and HRT:
 i.   As far back as 1989 a study by Bergkvist et al appeared in The New England Journal of Medicine which concluded that long term perimenopausal treatment with estrogens (or at least estradiol compounds) seems to be associated with a slightly increased risk of breast cancer, which is not prevented and may even be increased by the addition of progestins.  The relative risk was found to be 1.7 or almost twice the rate of breast cancer compared to women not using hormones.  Bergkvist’s study was the first indication that the progestogen added to HRT to protect the endometrium might be having other, sinister effects.

  ii.   A recent article published in the Journal of the American Medical Association on July 17, 2002 announced that after observing more than 16,000 women for roughly five years the authors found conclusively that the hormones in Prempro raised the risk of heart attack by 29%, stroke by 41% and breast cancer by 26%.  The federally sponsored study which was supposed to run for eight years was abruptly stopped.  The authors concluded that overall health risks exceeded benefits from use of combined estrogen plus progestin [synthetic progesterone used in HRT].

   Comments:  Prempro consists of Premarin along with synthetic progestin.  Premarin is composed of estrogenic compounds derived from the urine of pregnant mares.  These equine estrogens are not normally found in the human female body, and they are often associated with side effects such as headaches, bloating, and sore breasts.  In addition, the metabolic breakdown products of Premarin in the human female are biologically stronger and more active than the original equine estrogens.  A host of studies have shown that these breakdown products can produce DNA damage that is carcinogenic in tissue.

iii.   A study published in Journal of the American Medical Association on March 21, 2001 concluded that postmenopausal estrogen use for 10 or more years was associated with increased risk of ovarian cancer mortality that persisted up to 29 years after cessation of use.

iv.   A follow up study to the Nurses’ Health Study which appeared in The New England Journal of Medicine on June 15, 1995 noted that the risk of breast cancer was significantly increased among women who were currently using estrogen alone or estrogen plus progestin as compared with postmenopausal women who had never used hormones.

  v.   A study which appeared in Archives of Internal Medicine in Sept. 2001 concluded that regular and long-term oral contraceptive use and hormone replacement therapy are associated with an increased risk for microalbuminuria and cardiovascular disease.  (Microalbuminuria is associated with increased risk of kidney and heart disease.)

vi.   A study which appeared in the July 2001 issue of Spine concluded that postmenopausal estrogen use is associated with an increased likelihood of back pain and impaired back function in elderly white women.

 vii.   According to a study published in the British Journal of Cancer in October 1999 unopposed estrogen replacement therapy was associated with a significant increase in risk of endometrioid or clear cell epithelial ovarian tumors.

   viii.   According to an article which appeared in the Raleigh News and Observer issue of April 18, 2002 p.17A a new report called the International Position Paper on Women’s Health and Menopause casts doubt on longstanding claims that hormone replacement in postmenopausal women can prevent or treat heart disease, Alzheimer’s disease, major depression, urinary incontinence and broken bones due to osteoporosis.  Hormone therapy has well-documented drawbacks including an increased risk of blood clots and gall bladder disease and, with prolonged use, breast cancer.

ix.   Interpreting data from the Nurses’ Health Study Colditz and Rosner (2000) concluded that use of unopposed postmenopausal estrogen from ages 50-60 years increases risk of breast cancer to age 70 by 23% compared with a woman who never uses hormones.  Use of unopposed postmenopausal hormones for 10 years significantly increases the risk of breast cancer, and the addition of progestin further increases the risk.

x.   In a population-based case-control study by Purdie et al (1999) the authors found that unopposed estrogen replacement therapy was associated with a significant increase in risk of endometrioid or clear cell epithelial ovarian tumors.

xi.   In a case-control study by Scalori et al (2002) the authors conducted a study designed to shed light on the role of female hormones, including oral contraceptives, in the etiology of focal nodular hyperplasia of the liver. They discovered that there was a trend in risk with duration which was statistically significantly.  Their study confirmed previous clinical observations and provided a quantitative estimate of the association between the use of oral contraceptives and focal nodular hyperplasia of the liver.

  xii.   In an experiment conducted by Hyder et al (2001) it was demonstrated that progestins stimulate VEGF (vascular endothelial growth factor) mRNA levels and raises the possibility that anti-progestins may be useful to inhibit proliferation and metastasis in some human breast cancers by blocking VEGF production.  Tumor expansion is dependent on angiogenesis, which is regulated by peptide growth factors of which VEGF is one of the most selective and potent.

b.   Phytoestrogen Studies    
The following are the results of 14 scientific studies showing the health benefits of phytoestrogens:
   i.   In order to more fully explore the basis for the different clinical outcomes that have found that estrogens used in HRT regimens may increase the risk of developing breast cancer, whereas high consumption of plant-derived phytoestrogens, particularly soybean isoflavones, are associated with a low incidence of breast cancer An et al (2001) demonstrated that estrogen 17beta-estradiol effectively triggers the transcriptional activation and repression pathways with both estrogen receptors (ERs) ERalpha and ERbeta.  In contrast, soybean isoflavones (genistein, daidzein and biochanin A) are ERbeta-selective agonists of transcriptional repression and activation at physiological levels.

 ii.   In a review of the literature a study published in Clinical Endocrinology & Metabolism in 1998 concluded that phytoestrogens exhibit physiological effects in humans, mild estrogenic changes occur in postmenopausal women and benefits are seen regarding hypercholesterolemia.

  iii.   According to a study published in Biochemical Pharmacology in July 2000 the authors have shown that dietary supplementation with soy-derived isoflavones reduced the in vitro oxidation susceptibility of low-density lipoprotein (LDL).  They feel that lipophylic phytoestrogen derivatives could be incorporated into LDLs, increasing their oxidation resistance and antiproliferative efficacy ex vivo, both of which are, in theory, antiatherogenic effects.  The authors observed that there is a great interest in isoflavone phytoestrogens such as genistein and daidzein as lower rates of chronic diseases including coronary heart disease have been associated with high dietary intake of soy-containing foods.

iv.   According to a review of the scientific literature by Seidl and Stewart (1998) they concluded that “in available controlled studies, the strongest data support phytoestrogens for their role in diminishing menopausal symptoms related to estrogen deficiency and for possible protective effects on bones and the cardiovascular system.”

v.   To find out why a high dietary intake of soy-containing foods lowers rates of chronic diseases, including coronary heart disease, Tikkanen and Adlercreutz (2000) conducted a meta analysis.  The authors concluded that lipophylic phytoestrogen derivatives could be incorporated into LDL (“bad”) cholesterol, increasing their oxidative resistance and antiproliferative efficacy ex vivo, both of which are, in theory, antiatherogenic effects.

vi.   A review of over 600 articles by Murkies et al (1998) concluded that phytoestrogens exhibit physiological effects in humans, that mild estrogenic changes occur in postmenopausal women and benefits are seen regarding hypercholesterolemia.

  vii.   In a review of the in vitro and in vivo data Polkowski and Mazurek (2000) concluded that at the cellular level, genistein induces apoptosis and differentiation in cancer cells, inhibits cell proliferation, modulates cell cycling, exerts antioxidant effects, inhibits angiogenesis and suppresses osteoclast and lymphocyte functions.  Additionally, genistein health beneficial effects have been shown in osteoporosis, cardiovascular diseases and menopause.

 viii.   In a case control study on phytoestrogens and beast cancer in postmenopausal women Murkies et al (2000) concluded that their findings were in keeping with the increasing observational data demonstrating a protective effect from phytoestrogens on breast cancer risk.

 ix.   In a cross-sectional study Goodman-Gruen and Kritz-Silverstein (2001) found a protective role for dietary soy intake against cardiovascular disease in postmenopausal women.

  x.   Dixon and Ferreira (2002) found that ingestion of dietary genistein has been linked, through epidemiological and animal model studies, with a range of potential health beneficial effects.  These include chemoprevention of breast and prostate cancers, cardiovascular disease and post-menopausal ailments.

xi.   A review of the literature by Carusi (2000) concluded that controlled trials have shown a reduction in postmenopausal hot flashes when subject’s diets were supplemented with soy.  Furthermore, dietary supplementation also appears to lower total and LDL (“bad”) cholesterol in hypercholesterolemic subjects.

 xii.   A review of the main studies on the subject by Arena et al (2002) concluded that a diet rich in isoflavones is associated with a reduced incidence of vasomotor episodes; the average supplement of genistein is approximately 50 mg/day.  After supplementing the diet with phytoestrogens, studies show a reduction in total cholesterol and LDL fraction.  This is accompanied by an increase in BMD (Bone mineral density) after taking 90mg of isoflavones for 6 months.  Isoflavones may reduce the risk of developing breast cancer.  The data examined confirm the excellent clinical efficacy of supplementing the diet with soy extracts, particularly genistein which is indicated to alleviate both the short-term symptoms of menopause and the long-term effects, although the latter finding requires further substantiation. [Hot flashes are an example of a “vasomotor episode”].

   xiii.   In a review of the literature by Vincent and Fitzpatrick (2000) of the Mayo Clinic they state that in October 1999, the US Food and Drug Administration authorized the use of food labels of health claims associated with soy protein and the reduced risk of coronary heart disease.  Several studies have indicated that a total daily intake of 25 g of soy protein paired with a low-fat diet resulted in clinically important reductions of total cholesterol and LDL cholesterol levels.  To date, no adverse effects of short- or long-term use of soy proteins are known in humans.

xiv.   According to a review of the literature by Setchell and Cassidy (1999) the found that soy protein-containing isoflavones were found to reduce tumor formation significantly in a dose-dependent manner.  These animal studies are supported by numerous in vitro studies that have shown that daidzein and genistein can inhibit cell growth.  More recently, genistein has been found to augment transforming growth factor-β, an essential growth factor that inhibits the cell cycle and therefore progression of cell growth.  Like flavonoids, the isoflavones possess antioxidant activity, which offers further potential protective actions for phytoestrogens.

c.    Acupuncture Studies   
The following are the results of some scientific studies showing the health benefits of acupuncture for menopausal symptoms:   
 i.   In a study undertaken by Dong et al (2001) it was determined that acupuncture is shown to be effective in relieving vasomotor and physical disturbances of menopausal women with effects lasting at least up to 3 months after termination of treatment.  Acupuncture may be a useful treatment alternative for women who are unable or do not want to receive hormone replacement therapy.

 ii.   In a study by Kraft and Coulon (1999) the authors concluded that acupuncture with a standardized combination of acupuncture points according to Chinese syndrome can transitorily reduce postmenopausal complaints, but does not alter blood pressure or serum lipids at the same time.

 iii.   In a pilot study conducted by Porzio et al (2002) it was concluded that acupuncture seems to be safe and effective for the treatment of menopausal symptoms in women with previous breast cancer taking tamoxifen.

 iv.   According to a study on the effects of acupuncture on ovariectomized mice conducted by Toriizuka et al (1999) it was concluded that acupuncture could improve the memory loss and decrease of immune responses accompanying aging and/or menopause, and that it may play an important role in the medical care of the elderly.

 v.   In a study done using two types of acupuncture on perimenopausal women Wyon et al (1994) found that the frequency of hot flushes decreased significantly by more than 50% in both groups.  In the electroacupuncture treated group it remained decreased, whereas in the superficial needle position treated group it increased slightly again over the three months after treatment.

  vi.   A study done by Aso et al (1976) demonstrated that acupuncture stimulation might affect female endocrine function.

d.   Herbal Studies  
The following are the results of some studies on the use of  herbs for treatment of menopausal symptoms:   
 
 i.   According to Liu et al ((2001) methanol extracts of red clover, chasteberry and hops showed significant competitive binding to estrogen receptors alpha (ER alpha) and beta (ER beta).  Chasteberry also stimulated PR (progesterone receptor) induction. Dong quai and licorice showed only weak ER binding and PR and pS2 (presenelin-2) m RNA induction.  Black cohosh showed no activity in any of the above in vitro assays.  [It should not be a surprise that black cohosh showed no activity in the above in vitro assays because black cohosh is not a phytoestrogen — it contains triterpenes which have steroid-like actions via its response on LH (luteinizing hormone).  pS2 is a marker of breast tissue proliferation.  However, for the results of this experiment to be useful we need to know at what time of the cycle this measurement took place, because breast tissue shouldproliferate for the first 15 days of the cycle.  It is only in the last 15 days of the cycle when a woman does not need proliferation.]

 ii.   In an article reviewing the literature Dharmananda (1999) reported on a study using the Chinese herbal “Rehmannia Six Formula” (Liu Wei Di Huang Wan) in women with menopause of recent onset.  The authors of the study noted that the treatment resulted in decline of serum FSH and LH by half, and increase of estradiol of 20%.  Estrogen receptors in peripheral leukocytes more than doubled.  The authors suggested that this formula benefited menopausal women by regulating both hormone levels and hormone receptors.  Another study reported that the use of Rehmannia Six Formula with regard to menopausal syndrome not only relieved the symptoms and ailments of the patients but also brought back the normal balance of their female sex hormones, i.e., it increased the serum estrogen level while lowering the high FSH and LH levels.

 iii.   In an article on herbs and their effects on cancer Dharmananda (1999) concludes that most of the concern related to estrogen levels and herbs is currently focused on women who have a diagnosis of breast cancer (even if it is fully in remission) or ovarian cancer.  In these cases, Chinese herbs cannot be advocated as part of the therapeutic regime.  The same restriction would apply to other herbs that are not classified as Chinese, and also to men with prostate cancer who are concerned about the adverse impact of testosterone on cancer development (certain testosterone metabolites stimulate growth of prostate cancer cells). 

iv.   According to an article by Kass-Annese (2000) the author observed that although there has been limited clinical research of herbal and homeopathic alternative therapies for menopause, when taken according to directions and if no contraindications exist, they have the potential for being extremely effective and safe options.

 v.   In a double-blind placebo controlled study undertaken by Clifton-Bligh et al (2001) to evaluate the effects of a red clover preparation (Rimostil) containing genistein, daidzein, formononetin and biochanin it was found that this combination was associated with a significant increase in HDL (“good”) cholesterol, a significant fall in apolipoprotein B and a significant increase in the bone mineral density of the proximal radius and ulna after 6 months of treatment. [Apolipoprotein B is a “bad” protein involved in Alzheimers and arteriosclerosis formation.  Genistein is present in only very, very small amounts in red clover compared to the amount of genistein in soybeans.]

e.    Progesterone Studies    
i.   
According to Dennerstein, et al (1985) in a double blind crossover trial using oral micronized progesterone for PMS symptoms the authors   found an appreciably beneficial effect of progesterone over placebo for mood and some physical symptoms and it was identifiable after both one and two months of treatment.
 
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