F.A.C.T. – Just the Facts

by Dr. Garry F. Gordon, MD, DO, MD(H)

Gordon Research Institute

Pueraria Mirifica : Nature’s Safe Alternative to Estrogen Therapy

Menopause. The onset of this phase of life is marked by a decline in the production of estrogen – a hormone that serves as a chemical messenger in the body and regulates the menstrual cycle, controls breast development, and helps maintain healthy bones and a healthy heart. From puberty to menopause, the ovaries produce estrogen. Once menopause sets in, the ovaries no longer make estrogen, and body fat becomes the primary source for estrogen.

Estrogen is a vital key to healthy aging. But when a woman’s body undergoes this important change, the accompanying symptoms can be severe enough to disrupt her life – and affect the lives of those around her. Hot flashes, night sweats, vaginal dryness and thinness, and frequent bladder infections are common complaints. Women also report chronic fatigue, weight gain, joint pains, bone loss, hair loss, insomnia, mood swings, memory loss, decreased libido, and a decrease in arousal and orgasmic response. Perimenopause also marks the beginning stages of increased risk of heart disease and osteoporosis.

Menopause is not a disease. It is a natural stage in a woman’s life, and one that should be embraced and celebrated as a freeing and wondrous time – not looked upon with disdain and fear. Over the years, prescription and various herbal remedies have come and gone. Most have proved either too ineffective or too dangerous to be worth the risk. Sadly, many women continue to suffer needlessly due to the mainstream media’s scare-tactic reporting about the serious and sometimes fatal side effects caused by hormone replacement therapy. It is true that most women will not enjoy optimal health after menopause or reach their maximum intended lifespan without hormonal support, and far too many physicians are underinformed about estrogen supplementation and the risks of heart disease and breast cancer. I am here to tell you that healthy aging and all-natural, safe, and effective hormone replacement support is possible!

In Thailand, women have been finding relief from the symptoms of menopausal change for hundreds of years. They have found this relief in preparations from the root of a flowering plant that grows in abundance in their region. That plant is Pueraria mirifica, or Thai kudzu. My good friend Dr. Sandy Schwartz relocated to Thailand some 20 years ago, and shared with me how the native people had been using Pueraria mirifica for centuries, as both a food and as a part of their traditional medicine. As I explored further, I found that the lowest rate of breast cancer in the world was in Thailand’s northern region – the only place in the world where Pueraria mirifica grows. Since that time, dozens of scientific studies have documented the beneficial and protective effects of this amazing plant.

Pueraria mirifica belongs to the same family of legumes that includes soybeans and peas, and contains a bounty of natural chemical compounds that foster good health. Most fall into a category called phytoestrogens. These naturally occurring chemical compounds have structures that are similar to estrogen. Pueraria mirifica is unique in that it is the only plant to contain a special phytoestrogen called miroestrol. Miroestrol is extraordinarily similar in structure and function to a type of estrogen called estriol. There are three types of estrogen in humans: estradiol, estrone and estriol. Of the three, estriol is the weakest. Its weakness, however, is actually its strength. Clinical trials have shown no links between estriol and cancer, and women who have taken it reported few side effects compared with those who took estradiol or estrone as hormone replacement therapies.

In her book The Wisdom of Menopause, Dr. Christiane Northrup states that Pueraria mirifica, the only kudzu variety containing miroestrol, is “hands down one of the most powerful supplements to take for menopausal symptoms. It is extremely safe and effective at relieving no fewer than twenty different conditions associated with menopause and perimenopause, including vaginal dryness, hot flashes, night sweats, depression, insomnia and irritability.” Miroesterol has adaptogenic effects on bone and vaginal tissue, while also protecting the breasts and endometrium from the adverse effects of excess estrogen. PM is also shown it to be effective in preventing osteoporosis in ovariectomized rats by increasing bone mineral density and bone mineral content. Many women are concerned and keen to prevent osteoporosis, but what is really exciting is that we have studies today proving that PM facilitates osteoblast and osteoclast reformation, effectively reversing bone loss.

Once just a promising plant that Asian women whispered about, Pueraria mirifica is now refined and formulated to the highest standards and is called Puresterol. Approved as a food supplement by the FDA, Puresterol is available from Longevity Plus LLC as H.R.T. Plus (Herbal Remedy from Thailand). H.R.T. Plus has been documented in extensive research to safely eliminate all menopause related symptoms while actually providing anticancer protections for the breast and other tissues. It is a SERM-beta (selective estrogen receptor modulator of the beta receptor) and provides favorable effects throughout the entire body. It protects against bone loss, depression, insomnia, hot flashes, vaginal dryness, and loss of memory. In my experience, there is no comparison between the minimal effects of traditional botanicals such as black cohosh, red clover or soy, and the dramatic benefits I have seen in my patients receiving Puresterol in H.R.T Plus.

With ever increasing numbers of women searching for safe, alternative, organic, and holistic remedies and approaches to breast and hormonal health and longevity, Puresterol is the perfect fit.

Here is a discussion on the safety and efficacy of bioidentical hormone replacement and breast cancer risk by F.A.C.T. forum participants (names and responses redacted to protect member confidentiality):

Q: What are people’s thoughts on bioidentical estrogen use in a woman who has recent history of breast cancer?

I know it is obvious: no estrogen replacement yet I have three patients now who have read Suzanne Somers’s books, saying that her doctor has researched this and says that post breast cancer patients do better with estrogen, even if their tumors were ER+, and that they have decreased risk of reoccurrence, even with bioidentical estrogens

This still seems crazy to me. ~RZ

A1: It’s not crazy when one understands that low iodine may play a role in dysplastic breast cancer cells; iodine also plays a role in clearing estrogen from breast tissue in activating enzymes. Although I’ve not read Suzanne Somers’s most recent book, my clients have referred to the information in it.

Looking at estrogen only as the primary cause for breast cancer does not seem to be the most comprehensive way to look at this disease once one understands the biochemistry of the breast tissue. I’ve picked up good information on this at conferences on measuring human hormones and on iodine as well as the current research on both. The problem is that in conventional medical practice we only know to focus on the “ER+” tissue and not the bigger picture. Keeping one’s milieu on the alkaline side (avoid sugar, have adequate minerals to activate enzymes, detoxify heavy metals/other toxins, etc.) helps cells not become dysplastic as well.

“What Your Doctor May Not Tell You About Breast Cancer” by Drs. Lee and Zava, “Breast Cancer and Iodine” by Dr. David Derry are a couple good books to start one out. Also, attending ZRT Laboratory’s conferences ( http: www.salivatest.com ) have helped me a lot over the years as well in learning from various physician speakers. I also see positive changes in breast thermograms when women balance their steroid hormones, normalize iodine levels, etc. ~CW

A2: It is not crazy. When you replace estrogen in a patient with breast cancer you should use only Estriol (bio-identical) which has never been implicated in cancer of the breast not Estradiol or Estrone ( which have been implicated). Even though Suzanne Somers has some good information it is not without fault. I have Patients with history of breast cancer who are on the Estriol and I believe that they are at decreased risk of reoccurrence. Using the word Estrogen is misleading. ~FP

A3: Dear RZ,

Hot topic! Some very important points to remember about hormones…. First, all hormones are not the same. Second, each case is different. Third, look at the big picture, not just one factor. Allow me to explain. Hormones produced by the body are the natural ones that nature intended for the body. They have a certain biological activity. Let’s say for arguments sake, they have an activity level of “x”. In a perfect world where even our genetic predispositions are moderated correctly with nutrients and no pollution, disease (like breast cancer) would be rare. In today’s world, women are exposed to xenoestrogens, synthetic estrogens (BCP, HRT), and animal estrogens (natural and synthetic) from our diet. All this overlies a woman’s natural estrogens produced by her own ovaries. Considering all these hormones must be processed through the liver and or stored in adipose cells, the load can be great. The biological activity of synthetics and oxidized exogenous estrogens is much greater than “x” and I believe is largely responsible for the detrimental estrogen overload diseases like breast cancer, fibroids, PMS, etc…..Since bioidentical hormones attempt to emulate natural estrogen more closely than the other types, there is likely a moderating effect happening in the body. To improve on this, phytoestrogens are an even better strategy. Phytoestrogens(from plants) have less biological activity than the above, but can still occupy estrogen receptors with about 1/400th the strength. The beauty of this is that the more powerful and hazardous estrogen forms are displaced, allowing them to be unbound and free to be eliminated via the liver. In a very toxic and estrogen overloaded individual, even bioid hormones are probably having a moderating effect. Think about it. Case history will uncover the prescription hormones taken in the past or at least the high dairy consuming vegetarians. Beware the plastic water bottles. Remember that cheese is a highly concentrated source of oxidized hormones. No matter what product you choose to add in a breast cancer survivor’s protocol, look at her ability to get the bad hormones out. Hope this helps.

Sincerely ~TM

A4: Dear Doctor,

I hate beating the same drum about Pm. We are now completing a Pm study on the mechanism of action as to ER beta expression in the UK, which has already demonstrated no potential cancer proliferation on MCF-7 cancer cell lines. This confirms the studies that have preceded it. Our study should be ready for publishing sometime next year. If you would go to www.puresterol.com you will find many of the published articles, with a link to GordonResearch.com where additional studies can be found. There you will find a Phase I, Phase II and Phase III study; showing Pm alone is as beneficial as Premarin and Premarin with progesterone. In addition, there are articles on Pm’s beneficial effects on circulation, bone density and cognition.

A new article, published this month in a rather obscure journal, tested a material identified Pueraria mirifica Graph Ex Benth. There is no such species. It’s actually identified as Pueraria candolii Graph Ex Benth and this species is among 12 other Pueraria sub-species erroneously being sold in the market as Pm. It was shown to act in a very similar manner to estradiol, with all the negative implications, which Pueraria candolii, var mirifica Airy Shaw et Suvat has no such negative actions. ~SS

A5: Refer to the very thoughtful article recent published on FACT regarding this issue. I forget the doc’s name but it was a 3-4 page article that explored estrogen replacement and breast cancer. You should read that. ~RW

A6: If breast cancer occurred because of estrogen, my 13 year old daughter would have it now that she has started her periods. Luckily most in this group get “it” the it being that cancer is multifactorial and the fact that some MD (most likely) decided that because a tumor has markers associated with estrogen, doesn’t mean it was caused by it. I have a friend who had breast cancer at 35 and they didn’t do a hysterectomy because she was still producing estrogen. It is a huge risk from a legal standpoint, but most likely estrogen has very little to do with breast cancer other than most br. cancer is in women who have high estrogen levels comparatively. the hard part is figuring out what is the real problem. ~JB

A7: My experience with this is that the use of DIM really makes a difference. It changes the estrone metabolites to be more protective, and can reduce the risk of future incidence of breast cancer, even if no exogenous estradiol is used. I have given estradiol to my women patients who have had breast cancer, using it topically only, along with good opposition of progesterone, taken orally. Oral administration of progesterone produces better sleep. It’s a GABA effect. Check labs often. Genova also has a test to check Estrogen Metabolites which can be checked before and after using DIM for a few months. I keep everyone on it for prevention regardless of the test results.

I also give Calcium d’glucarate to women who have had breast cancer that are going to use bio-identical HRT. Dose is 500 mg. bid. DIM dose is 100-200 mg. qd. DIM is also found to be good for preventing colon, lung, ovarian Ca in women, and colon, lung, breast and prostate Ca in men, and is a must for anyone with any of these cancers in my experience. High lignan flax is a 3rd very good protectant. Hope this is helpful. ~MM

A8: Dear RZ,

Sure, prescribing ERT after breast cancer is highly dangerous to prescribers, due to massive vested interests against what is appropriate and cheap, and to hysteria and disinformation from the WHI, MWS, EPIC and other misguided studies. It has taken over 5 years for “authorities” in USA – the WHI, AMCOG, NAMS- to recant their untenable beliefs and prejudices from the WHI, admit that the International Menopause Society www.IMSociety.org and the Nurses’ Study were right all along, that there is no reason to avoid appropriate HT, or stop it at 60 years.

But the use of appropriate HRT has always done vast good, and rarely significant harm, eg in the WHI ERT-only trial 2004 master paper, in women in their fifties on “appropriate” ET for >6yrs, the incidence of both BRCA and all major disease, and mortality, fell by 1/3. Ditto with conservative estrogen-progestin dose for 9 years in such women in the Oulu trial by Heikinnen ea 2006. Ditto in the NBCCT (Bernard Fisher in the 1990s). Because of phobias, myths and vested interests, further meaningful trials of the best appropriate HRT ie bioidentical human hormones (as is gold standard in all of endocrinology including testosterone replacement in men) in women after breast cancer is unlikely -who will fund these?

But ethical practitioners have a duty to practice evidence-based medicine that is best for their patients- including where necessary appropriate HT. It takes a martyr, a death wish, to put the interests of patients first and risk prosecution for advising appropriate balanced HRT in cancer patients. Certainly no sensible surgeon or oncologist dare publically support such heresy, because the best HRT prevention cannot avoid some cancers and early deaths (albeit far fewer) occurring- and they are the ones who may have to do further surgery/ oncology therapy.

Remember that “Authorities” in Vienna murdered Dr Semmelweiss for doing and preaching what was right (history says they strangled him); and USA “Authorities” mercilessly persecuted nuclear advisor Richard Barlow, nurse Margaret Sanger, Drs Jonathan Wright and Guylaine Lanctot for doing what was right. Boldness be your friend. Read Illich’ Medical Nemesis, Elaine Feuer’s The FDA’s War against Patients, Dr James le Fanu’s The Rise and Fall of Modern Medicines, John le Carre’s The Constant Gardner, McTaggart’s What Doctors Don’t Tell You; Naomi Klein’s Shock Doctrine- Disaster Capitalism; Al Gore’s The Assault on Reason; and Levine +Scott-Clarke’s The Pakistan Deception.

It is now common cause that the main trigger for activating dormant breast cancer nests is progestin: in the premarin-only arm of the WHI (2004), there was 28% lower incidence of invasive BRCA in the women aged 50-69 at start (and 44% less CHD, 36% fewer deaths in the women starting under age 60y); so the feared major ADVERSE endpoints after HRT – athero/thrombosis, and breast cancer- are largely related to progestin, age of onset of HT, and dose.

Prof Fred Naftolin of NYU- former head of ObGyn and then professor in Biology at Yale has a (not the) final word below: don’t quibble over the type or route of estrogen, or what has/ has not been “proven” by big medium-term trials. It is easy to see the wood and the trees. Only oral estrogen has been proven (in >5year trials) to do wonders in reducing morbidity and mortality long-term, even from breast cancer (in the WHI 2004 paper on solo oral conjugated equine estrogen CEE when started appropriately from menopause; the 1990s Breast and Colon Cancer trial- Dr Bernard Fisher ea; and the Oulu trial 2006 with oral estradiol +- synthetic progestin). Similarly, physiological systemic testosterone replacement has shown if anything an antiproliferative effect on breast tissue in trials in both women (Zhou & Dimitrikakis); other primates (Clarkson; Zhou & Dimitrikakis); and rodents (von Schultz).

The landmark Wake University primate trials (Clarkson ea 1995-2007) show the CVD benefits of early postmenopausal (but not late) systemic estradiol plus progesterone, and oral CEE but not synthetic progestin; but adverse effect of oral CEE on breast proliferation. Significant medium – and long-term benefit has not yet been shown for a single plant-sourced phyto-estrogen in controlled trials in postmenopausal women- and who is going to fund such a trial since both kava and black cohosh have killed when used for menopause symptoms.

The current KEEPS trial under way (Harman, Naftolin ea) will soon show what balance of benefit and harm there is between 450mcg a day oral premarin or 50mcg a day estradiol patch or placebo, (with or without parenteral progesterone) in young postmenopausal women. This trial, in women well under 60yrs, albeit (in comparison with the WHI) small and only for 5 years, will to a great extent largely resolve the unwarrantedly acrimonious secondary debate over oral vs parenteral and human bioidentical vs oral xenohormone ie horse estrogen. Unlike the obvious difference (seldom subtle) between good and bad, there are many good alternative routes to Rome or health, the differences being mostly superficial – like between man and woman.

It is common cause that the main trigger for activating dormant breast cancer nests is progestin, so in the premarin-only arm of the WHI, there was 28% lower incidence of invasive BRCA in the women aged 50-69 at start (and 44% less CHD in the women starting under age 60y;) so breast cancer after HRT is very much age dependent. .

This benefit has not yet been shown for a single plant-sourced or synthetic estrogen- and who is going to fund it since the 1950 trial of synthetic estrogen (diethylstilbestrol) is still causing increased breast cancer in the women who received it (and vaginal cancer in their daughters, and infertility in their grandchildren). ~NB

A9: Dear RZ,

I agree with your sentiments. However, so-called “bioidenticals” have no magical differences from their natural or synthetic counterparts, except they often suffer from lack of quality control and scientifically investigated regimens. Estrogen has an enviable record in treatment of the post-BRCA subject. Their prognosis is ~ the same as being one clinical stage lower. Replacement hormones should not be used in women with active BRCA; rather the hormones should be part of an integrated program of treatment of the post-BRCA subject.

Regards ~FN

A10: I don’t have the answer, but here is some additional information. At the last ACAM meeting, Dr. Drisko (who’s running the U Kansas IV vit C trials) mentioned that she had a patient with breast cancer (I don’t recall the ER status) whose cancer took off suddenly and admitted that she convinced another doctor to give her bioidentical estrogen (maybe just estriol). I heard of a paper in the 1970s (?) published in JAMA called something like “Estriol: the forgotten estrogen” that mentioned in a footnote that someone gave estriol to some women with breast cancer and it went away. Finally, there are a few studies and meta-analyses about estrogen replacement after breast cancer and the risk of recurrence, which seem to lean toward no increased risk of recurrence after a successfully treated cancer (again no word on ER status), however this is after the cancer is gone. So, while there may be a little data showing it’s OK, there’s also some data saying it isn’t. I’d be awfully careful and make sure the patient is fully informed about all her options and the lack of data. Remember that if she gets a relapse of gets worse, even if she was totally the one pushing for it, if she can’t testify then the family left behind may seek a legal settlement. I hate to bring up scare stuff like that, but that’s where we’re living. ~MS

References

Tiyasatkulkovit W, Malaivijitnond S, Charoenphandhu N, et al. Pueraria mirifica extract and puerarin enhance proliferation and expression of alkaline phosphatase and type I collagen in primary baboon osteoblasts. Phytomedicine. 2014;21:1498–1503.

Chansakaow S, Ishikawa T, Sekine K. Isoflavonoids from Pueraria mirifica and their estrogenic activity. Planta Med. 2000;66:572–575.

Potee A. An ancient Thai “miracle” herb reveal itself to be a real-life fountain of youth [online article]. Health Sciences Institute. September 2007;12(3).

Chandeying V, Lamlertkittikul S. Challenges in the conduct of Thai herbal scientific study: efficacy and safety of phytoestrogen, Pueraria mirifica (Kwao Keur Kao), phase I, in the alleviation of climacteric symptoms in perimenopausal women. J Med Assoc Thai. 2007;90(7):1274–1280.

Manonai J, Chittacharoen A, Theppisai U, Teppisai H. Effect of Pueraria Mirifica on vaginal health. Menopause. 2007;14(5).

Ritchie M, Young R . Protocol for assessment of mechanism of action of Pueraria Mirifica on the alpha and beta receptor of a selected breast cancer cell line. Napier University. August 4, 2007.

The F.A.C.T. group, or “Forum for Anti-aging and Chelation Therapies,” originated as a way to help doctors learn about and facilitate the use of the latest alternative therapies and nutritional supplement protocols in managing their patients. Over the years, F.A.C.T. has grown to a membership of over 4000 practitioners from 68 countries around the world. F.A.C.T. membership is free to qualified practitioners, and as members, they can discreetly consult on and discuss cases with one another, learn about new treatments and protocols, share their success stories, and gain access to an extensive catalog of information gathered from 55 years of ongoing research, conferences, and lectures on the latest developments in natural and alternative health. For more information about the F.A.C.T. group and how to apply for free membership, visit the Gordon Research Institute website at www.gordonresearch.com.