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Remifemin symptomatic relief, scientifically supported* Darrell Miller 8/26/06
Menopause: Disease or Condition? Darrell Miller 6/13/05
Estro-3 60 Vegetarian Capsules Darrell Miller 5/7/05



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Remifemin symptomatic relief, scientifically supported*
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Date: August 26, 2006 02:41 PM
Author: Darrell Miller (dm@vitanetonline.com)
Subject: Remifemin symptomatic relief, scientifically supported*

Remifemin

 

Symptomatic Relief, Scientifically Supported*

 

The only RemiSure black cohosh

 

Unique to Remifemin® - Exclusive standardized isopropanolic black cohosh extract, subject of over 90 scientific papers.

Proven Effective – The most clinically studies natural intervention for menopausal symptoms with over 40 years of use worldwide*

 

  • Relief from hot flashes, night sweats, mood swings, irritability, and related occasional sleeplessness*
  • Particularly in women in early stages of menopause*

 

Safe – Completely hormone free

 

  • Works naturally without plant-based estrogens that can affect breast and uterine cell growth
  • Can be used safely by women with a history of breast cancer who cannot take estrogen

 

Efficacy

STUDY DESIGN

BENEFITS

DOSAGE

REFERENCE

1. Twelve-week, randomized, multicenter, double-blind clinical trial comparing the efficacy and tolerability of Remifemin® in the treatment of climacteric complaints compared with placebo.  The primary efficacy measure was the change from baseline on the Menopause rating Scale 1.

·          Remifemin® effectively relieved menopausal symptoms, particularly in women in the early stages of menopause*

·          Most significant reduction was in hot flash occurrence*

·          Other symptoms resulting in significant reduction include: psyche (irritability and memory), and atrophy (vaginal dryness)*

·          No significant adverse effects reported

40mg qd

Osmers R, et al. Efficacy and safety of isopropanolic black cohosh extract for climacteric symptoms.  Obstet Gynecol. 2005 May; 105(5):1074-83.

2. A review of 29 randomized controlled trials of complementary and alternative therapies for menopausal symptoms.

·          Black cohosh is one of the only herbal remedies shown to be effective for menopausal symptoms, especially hot flashes*

 

Kronenberg. F. Fugh-Berman A. Complementary and alternative medicine for menopausal symptoms: a review of randomized, controlled trials. Ann Intern Med. 2002 Nov 19;137(10:805-13.

3. Four-week, pilot study, open clinical trial of menopausal women with hot flashes, including women with a history of breast cancer.

·          Remifemin® reduced mean daily hot flash frequency by 50% after 4 weeks*

·          Overall, participants reported less trouble with sleeping, less fatigue, and fewer night sweats* 

·          No participants stopped therapy because of adverse effects

40mg qd

Pockaj BA, et al. Pilot evaluation of black cohosh for the treatment of hot flashes in women.  Cancer Invest. 2004;22(4):515-21

4. Double-blind study involving the use of Remifemin® in women ages 43 to 60 with menopausal complaints lasting 6 months.

·          Majority of woman saw a 70% reduction of physical and emotional symptoms after 12 weeks, including hot flashes, night sweats, mood swings, and irritability*

·          Significant improvement was noted after 4 weeks use*

·          Remifemin® works safely and effectively to treat menopause symptoms without affecting hormone levels or vaginal cytology (pap smear)*

40mg qd

Liske J, et al. Physiological investigation of a unique extract of black cohosh (Cimicifugae racemosae rhizome): a 6-month clinical study demonstrates no systemic estrogenic effect. J Womens Health Gend Based Med. 2002 Mar; 11(2): 163-74

5. Double-blind, 6 month study in hysterectomized women under 40 with at least one ovary.

·          As effective as ESTRIOL, conjugated estrogens, or hormone combinations at decreasing physical menopausal symptoms at 4, 8, 12, and 24 weeks*

4mg dry extract bid (equivalent to 2 tablets Remifemin® bid

Lehmann-Willebrock E, Riedel HH. Clinical and endocrinologic studies of the treatment of ovarian insufficiency manifestations following hysterectomy with intact adnexa. Zentralbl Gynakol. 1988; 110(10):611-8

 

6. Women aged 45 to 58 with menopausal complaints were studied in a double-blind, 12 week, placebo-controlled trial.

·          Remifemin® decreased physical symptoms of menopause by approximately 60% (Kupperman menopausal indeed)*

·          Daily hot flashes decreased by 86% in the Remifemin® group(from 4.9 to 0.7 per day)*

·          Emotional complaints were also dramatically reduced*

4mg dry extract bid (equivalent to 2 tablets Remifemin® bid

Stoll W. Phytopharmacon influences atrophic vaginal epithelium: Double Blind study – Cimicifuga vs. estrogenic substances. 1987.

 

Safety

STUDY DESIGN

BENEFITS

DOSAGE

REFERENCE

7. in vitro, MCF-7 cell culture model to determine estrogen-agopnist and antagonist activity of commercially available herbal menopause preparations containing red clover, soy black cohosh, or a combination of herbs.

·          Remifemin® had no effect on estrogen-sensitive cells in vitro.

·          Results suggest safety for women with a history of breast cancer who cannot take estrogen.

In Vitro(10^3-10^5 dilutions)

Bodinet C, Freudenstein J. Influence of marketed herbal menopause preparations on MCF-7 cell proliferation.  Menopause. 2004 May-Jun;11(3):281-9.

8. Six-week, in vivo investigation of Remifemin®’s ability to stimulate estrogen-receptor positive cells in an animal model

·          No estrogen stimulating effects were found.

·          Prolactin, follicle-stimulating hormone, and luteinizing hormone levels were unchanged.

0.714m 7.14 or 71.4mg/kg/day

Freudenstein J, et al. Lack of promotion of estrogen-dependent mammary gland tumors in vivo by an isopropanolic Cimicifuga racemosa extract. Cancer Res. 2002 Jun 15;62(12):3448-52.

 

 

 

9. Comprehensive review examining all published literature pertaining to pre-clinical and clinical safety of various forms of Cimicifuga racemosa, as well as FDA and World Health Organization (WHO) adverse event reporting systems, monographs, compendia, internal unpublished data from a major manufacturer, foreign literature, and historical, anecdotal report.

·          Uncontrolled reports, postmarketing surveillance, and human clinical trials of more than 2,800 patients demonstrate a low incidence of adverse events (5.4%).

·          Of the reported adverse events, 97% were minor and did not result in discontinuation of symptoms, and the only severe events were not attributed to Cimicifuga treatemtn.

·          Confirms the safety of specific Cimicifuga extracts, particularly isopropanolic preparations (Remifemin®), for use in women experiencing menopausal symptoms and as a safe alternative for women in whom estrogen therapy is contraindicated *.

Various

Low Dog T, et al. Critical evaluation of the safety of Cimicifuga racemosa in menopause symptom relief. Menopause: Journal of the North American Menopause society. 2003;10(4):299-313.

 

Relevant Reports and Guidelines

ORGANIZATION

PUBLICATION

EXCERPT OF KEY CONTENT

American Botanical Council

The ABC Clinical Guide to Herbs including a black cohosh monograph issues September 2002

“Of 10 clinical studies, including a total of 1,371 participants, nine of these studies demonstrated positive effects for menopausal symptoms.  Numerous clinical trials with varied methods and designs have been conducted on the standardized isopropanolic/ethanolic extract of black cohosh root, Remifemin®, from 1981 to the present.”

National Institute of Health

Questions and Answers About Black Cohosh and the Symptoms of Menopause issued October 2002

“Other preparations of black cohosh have been less well studied than Remifemin® …black cohosh is used primarily for hot flashes and other menopausal symptoms.  A number of studies using various designs have been conducted to determine whether black cohosh affects the menopausal symptoms… To provide more definitive evidence on the effects of black cohosh on menopausal symptoms, NCCAM is funding a 12-month, randomized placebo controlled study to determine whether treatment with black cohosh is effective in reducing the frequency and intensity of menopausal hot flashes.”

The North American Menopause Society

Alternatives to Hormone Replacement Therapy: Suggestions for the North American Menopause Siciety issued July 2002

Reseach suggests that mild hot flashes can be relieved by consuming a serving of soy foods daily or taking a supplement of black cohosh.”

 

Responding to the need for alternative menopausal symptom relief*

 

Natural, Safe alternative to HRT for menopausal symptoms*

 

  • Remifemin black cohosh was as effective as HRT for menopausal symptoms*

 

Superior Manufacturing Quality

 

  • Prepared according to Good Manufacturing Practice (GMPs) which ensure delivery of a product with the highest quality and consistency
  • Convenient dosing – one 20mg tablet twice a day (one in the MORNING, one in the EVENING)
  • 100% RemiSure black cohosh – not a combination of herbs

 

VitaNet Recommends Remifemin

 

  1. Remifemin unique standardized isopropanolic extract is the most widely studied and clinically tested natural alternative treatment for relief of menopausal symptoms.
  2. Remifemin black cohosh proven effective in reducing menopause and peri-menopause symptoms, including hot flashes, right sweats, mood swings, and irritability without estrogenic effects.
  3. Used safely by millions of patients worldwide for over 40 years.  Remifemin has been proven effective and is the most clinically studied natural intervention of menopause.
  4. Remifemin doesn’t have the side effects that are experienced with hormonal drugs prescribed for the relief of menopausal symptoms.

 

Lit source: Enzymatic therapy.

*this statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treate, cure, or prevent any disease.



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Menopause: Disease or Condition?
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Date: June 13, 2005 03:44 PM
Author: Darrell Miller (dm@vitanetonline.com)
Subject: Menopause: Disease or Condition?

Menopause: Disease or Condition?

by Mary Ann Mayo & Joseph L. Mayo, MD Energy Times, September 4, 1999

It's front-page news. It's politically correct and socially acceptable. Talking about menopause is in. Suddenly it's cool to have hot flashes. Millions of women turning 50 in the next few years have catapulted the subject of menopause into high-definition prominence.

It's about time. Rarely discussed openly by women (what did your mother ever advise you?), meno-pause until recently was dismissed as "a shutting down experience characterized by hot flashes and the end of periods." Disparaging and depressing words like shrivel, atrophy, mood swings and melancholia peppered the scant scientific menopausal literature.

What a difference a few years and a very vocal, informed and assertive group of Baby Boomers make. Staggered by the burgeoning numbers of newly confrontational women who will not accept a scribbled prescription and a pat on the head as adequate treatment, health practitioners and researchers have been challenged to unravel, explain and deal with the challenges of menopause.

Not An Overnight Sensation

Menopause, researchers have discovered, is no simple, clear cut event in a woman's life. The "change of life" does not occur overnight. A woman's body may begin the transition toward menopause in her early 40s, even though her last period typically occurs around age 51. This evolutionary time before the final egg is released is called the perimenopause. Erratic monthly hormone levels produce unexpected and sometimes annoying sensations.

Even as their bodies adjust to lower levels of estrogen, progesterone and testosterone, some women don't experience typical signs of menopause until after the final period. A fortunate one-third have few or no discomforts.

Hormonal Events

According to What Your Doctor May Not Tell You About Premenopause (Warner Books) by John R. Lee, MD, Jesse Hanley, MD, and Virginia Hopkins, "The steroid hormones are intimately related to each other, each one being made from another or turned back into another depending on the needs of the body...But the hormones themselves are just part of the picture. It takes very specific combinations of vitamins, minerals and enzymes to cause the transformation of one hormone into another and then help the cell carry out the hormone's message. If you are deficient in one of the important hormone-transforming substances such as vitamin B6 or magnesium, for example, that too can throw your hormones out of balance. Thyroid and insulin problems, toxins, bad food and environmental factors, medication and liver function affect nutrient and hormone balance."

The most important reproductive hormones include:

Estrogen: the female hormone produced by the ovaries from puberty through menopause to regulate the menstrual cycle and prepare the uterus for pregnancy. Manufacture drops significantly during menopause. Estradiol is a chemically active and efficient form of estrogen that binds to many tissues including the uterus, breasts, ovaries, brain and heart through specific estrogen receptors that allow it to enter those cells, stimulating many chemical reactions. ESTRIOL and estrone are additional forms of estrogen.

Progesterone: also produced by the ovaries, it causes tissues to grow and thicken, particularly during pregnancy, when it protects and nurtures the fetus. Secretion ceases during menopause.

Testosterone: Women produce about one-twentieth of what men do, but require it to support sex drive. About half of all women quit secreting testosterone during menopause.

Estrogen's Wide Reach

Since estrogen alone influences more than 400 actions on the body, chiefly stimulating cell growth, the effects of its fluctuations can be far-reaching and extremely varied: hot (and cold) flashes, erratic periods, dry skin (including the vaginal area), unpredictable moods, fuzzy thinking, forgetfulness, fatigue, low libido, insomnia and joint and muscle pain.

Young women may experience premature menopause, which can occur gradually, as a matter of course, or abruptly with hysterectomy (even when the ovaries remain) or as a result of chemotherapy. Under such conditions symptoms can be severe.

In the 1940s doctors reasoned that if most discomforts were caused by diminishing estrogen (its interactive role with progesterone and testosterone were underestimated), replacing it would provide relief. When unchecked estrogen use resulted in high rates of uterine cancer, physicians quickly began adding progesterone to their estrogen regimens and the problem appeared solved.

For the average woman, however, hormone replacement therapy (HRT) became suspect and controversial, especially when a link appeared between extended use of HRT (from five to 10 years) and an increase in breast and endometrial cancers (Journal of Clinical Pharmacology 37, 1997). The result: Women have drawn a line in the sand between themselves and their doctors.

Resolving The Impasse

Since hormone replacement reduces the risk of major maladies like heart disease, osteoporosis, Alzheimer's, colon cancer and diabetes that would otherwise significantly rise as reproductive hormone levels decrease, most doctors recommend hormone replacement shortly before or as soon as periods stop. Hormone replacement also alleviates the discomforts of menopause.

But only half of all women fill their HRT prescriptions and, of those who do, half quit within a year. Some are simply indifferent to their heightened medical risks. Some are indeed aware but remain unconvinced of the safety of HRT. Others complain of side effects such as bloating, headaches or drowsiness.

Women's resistance to wholesale HRT has challenged researchers to provide more secure protection from the diseases to which they become vulnerable during menopause, as well as its discomforts. If the conventional medical practitioners do not hear exactly what modern women want, the complementary medicine community does. Turning to centuries-old botanicals, they have validated and compounded them with new technology. Their effectiveness depends on various factors including the synergistic interaction of several herbs, specific preparation, the correct plant part and dosage, harvesting and manufacturing techniques.

Research demonstrates that plant hormones (phytoestrogens) protect against stronger potentially carcinogenic forms of estrogen while safely providing a hormone effect. Other herbs act more like tonics, zipping up the body's overall function.

Help From Herbs

Clinical trials and scientific processing techniques have resulted in plant-based supplements like soy and other botanicals that replicate the form and function of a woman's own estrogen.

The complementary community also can take credit for pushing the conventional medical community to look beyond estrogen to progesterone in postmenopausal health.

Natural soy or Mexican yam derived progesterone is formulated by pharmacologists in creams or gels that prevent estrogen-induced overgrowth of the uterine lining (a factor in uterine cancer), protect against heart disease and osteoporosis and reduce hot flashes (Fertility and Sterility 69, 1998: 96-101).

A quarter of the women who take the popularly prescribed synthetic progesterone report increased tension, fatigue and anxiety; natural versions have fewer side effects.

These "quasi-medicines," as Tori Hudson, a leading naturopathic doctor and professor at the National College of Naturopathic Medicine, Portland, Oregon, calls them, are considered "stronger than a botanical but weaker than a medicine." (Hudson is author of Gynecology and Naturopathic Medicine: A Treatment Manual.)

According to Hudson, the amount of estrogen and progesterone in these supplements is much less than medical hormone replacement but equally efficacious in relieving menopausal problems and protecting the heart and bones.

According to a study led by Harry K. Genant, PhD, of the University of California, San Francisco, "low-dose" plant estrogen derived from soy and yam, supplemented with calcium, prevents bone loss without such side effects as increased vaginal bleeding and endometrial hypoplasia, abnormal uterine cell growth that could be a precursor to endometrial cancer (Archives of Internal Medicine 157, 1997: 2609-2615).

These herbal products, including natural progesterone and estrogen in the form of the weaker ESTRIOL or estrone, may block the effect of the stronger and potentially DNA-damaging estradiol.

Soy in its myriad dietary and supplemental forms provides a rich source of isoflavones and phytosterols, both known to supply a mild estrogenic effect that can stimulate repair of the vaginal walls (Journal of the National Cancer Institute 83, 1991: 541-46).

To enhance vaginal moisture, try the herb cimicifuga racemosa, the extract of black cohosh that, in capsule form, builds up vaginal mucosa (Therapeuticum 1, 1987: 23-31). Traditional Chinese herbal formulas containing roots of rehmannia and dong quai have long been reputed to promote vaginal moisture.

Clinical research in Germany also confirms the usefulness of black cohosh in preventing hot flashes and sweating, as well as relieving nervousness, achiness and depressed moods caused by suppressed hormone levels. It works on the hypothalamus (the body's thermostat, appetite and blood pressure monitor), pituitary gland and estrogen receptors. Green tea is steeped with polyphenols, mainly flavonoids, that exert a massive antioxidant influence against allergens, viruses and carcinogens. The risks of estrogen-related cancers such as breast cancer are particularly lowered by these flavonoids, as these substances head directly to the breast's estrogen receptors. About three cups a day exert an impressive anti-inflammatory, antiallergenic, antiviral and anticarcinogenic effect.

Other phytoestrogen-rich botanicals, according to Susun Weed's Menopausal Years: The Wise Woman Way (Ash Tree Publishing), include motherwort and lactobacillus acidophilus to combat vaginal dryness; hops and nettles for sleep disturbances; witch hazel and shepherd's purse for heavy bleeding; motherwort and chasteberry for mood swings; dandelion and red clover for hot flashes.

Our Need For Supplements

Adding micronutrients at midlife to correct and counter a lifetime of poor diet and other habits is a step toward preventing the further development of the degenerative diseases to which we become vulnerable. At the very minimum, you should take:

a multivitamin/mineral supplement vitamin E calcium

Your multivitamin/mineral should contain vitamins A, B complex, C, D, E, calcium, magnesium, potassium, copper and zinc. Look for a wide variety of antioxidants that safeguard you from free radical damage, believed to promote heart disease and cancer, as well as contribute to the aging process.

Also on the list: mixed carotenoids such as lycopene, alpha carotene and vitamin C; and folic acid to help regulate cell division and support the health of gums, red blood cells, the gastrointestinal tract and the immune system.

Studies indicate a deficiency of folic acid (folate) in 30% of coronary heart disease, blood vessel disease and strokes; lack of folate is thought to be a serious risk factor for heart disease (OB.GYN News, July 15, 1997, page 28).

Extra vitamin E is believed to protect against breast cancer and bolster immune strength in people 65 and older (Journal of the American Medical Association 277, 1997: 1380-86). It helps relieve vaginal dryness, breast cysts and thyroid problems and, more recently, hit the headlines as an aid in reducing the effects of Alzheimer's and heart disease. It is suspected to reduce the thickening of the carotid arterial walls and may prevent the oxidation of LDL (bad) cholesterol, which contributes to the formation of plaque in arteries.

Selenium also has been identified as an assistant in halting cancer (JAMA 276, 1996: 1957-63).

The Omegas To The Rescue

Essential fatty acids found in cold water fish, flaxseed, primrose and borage oils and many nuts and seeds are essential for the body's production of prostaglandin, biochemicals which regulate hormone synthesis, and numerous physiological responses including muscle contraction, vascular dilation and the shedding of the uterine lining. They influence hormonal balance, reduce dryness and relieve hot flashes.

In addition, the lignans in whole flaxseed behave like estrogen and act aggressively against breast cancer, according to rat and human studies at the University of Toronto (Nutr Cancer 26, 1996: 159-65).

Research has demonstrated that these omega-3 and omega-6 fatty acids can reverse the cancer-causing effects of radiation and other carcinogens (Journal of the National Cancer Institute 74, 1985: 1145-50). Deficiencies may cause swelling, increased blood clotting, breast pain, hot flashes, uterine and menstrual cramps and constipation. Fatigue, lack of endurance dry skin and hair and frequent colds may signal EFA shortage. Plus, fatty fish oils, along with vitamin D and lactose, help absorption of calcium, so vital for maintaining bone mass.

In addition, studies show that the natural substance Coenzyme A may help menopausal women reduce cholesterol and increase fat utilization (Med Hyp 1995; 44, 403, 405). Some researchers belive Coenzyme A plays a major role in helping women deal with stress while strengthening immunity.

Still Suffering?

Can't shake those menopausal woes? Menopause imposters may be imposing on you: The risk of thyroid disease, unrelenting stress, PMS, adrenal burnout, poor gastrointestinal health and hypoglycemia all increase at midlife. Menopause is a handy hook on which to hang every misery, ache and pain but it may only mimic the distress of other ailments. For this reason every midlife woman should have a good medical exam with appropriate tests to determine her baseline state of health. Only with proper analysis can you and your health practitioner hit on an accurate diagnosis and satisfying course of therapy.

And if menopause is truly the issue, you have plenty of company. No woman escapes it. No woman dies from it. It is not a disease but a reminder that one-third of life remains to be lived. Menopausal Baby Boomers can anticipate tapping into creative energy apart from procreation. If not new careers, new interests await. An altered internal balance empowers a menopausal woman to direct, perhaps for the first time, her experience of life. She has come of age-yet again. Gone is the confusion, uncertainty, or dictates of a hormone driven life: This time wisdom and experience direct her. There is no need to yearn for youth or cower at the conventional covenant of old age. Menopause is the clarion call to reframe, reevaluate and reclaim.

Mary Ann Mayo and Joseph L. Mayo, MD, are authors of The Menopause Manager (Revell) and executive editors of Health Opportunities for Women (HOW). Telephone number 877-547-5499 for more information.



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Estro-3 60 Vegetarian Capsules
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Date: May 07, 2005 10:30 AM
Author: Darrell Miller (dm@vitanetonline.com)
Subject: Estro-3 60 Vegetarian Capsules

Estro-3 Dietary Supplement to help restore Balance Naturalls. More and more women rely on plant derived phytoestrogens as a natural way to help support a woman's transition. The Solaray® brand is proud to introduce a highly advanced and innovative proprietary blend of licorice, pomegranate, and hops with a Guaranteed Potency(GP) amount of phytoESTRIOL, phytostrone, and phytoestrodiol three phytoestrogens that are naturally occuring.

Trust in the Power of Three!

Most plant estrogens (Phytoestrogen) products contain genistein and daidzein. Estro-3 dietary supplement provides three sources of novel phytoestrogens-- phytoESTRIOL, phytoestrone, and phytoestradiol.

Support herbs

  • Butcher's Broom is an herb that has been used traditionally to provide nutritive support for healthy, normal blood circulation.
  • Indole-3-carbinol is a sulfur-based compound from cruciferous vegetables that breaks down into metabolites that may play a beneficial role in supporting estrogen metabolism down various pathways and may play a support role in normal, healthy cell function.
  • Nattokinase is a fibrinolitic enzyme produced from natto, a traditional japanese cheese-like substance made from fermented soybean, that may help provide nutritive support of normal blood flow.
  • Estro-3 balance estrogen naturally




    Darrell -- VitaNet ® VitaNet ® Staff

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