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PostPosted: Fri Sep 28, 2007 3:38 pm 
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Q1: Are we sure that HRT can be used safely as estrogen receptor blockade in women with breast cancer? The research suggests that miroestrol is an estrogen mimic without estrogenic activity and yet it has been used for breast augmentation, which sounds like estrogen receptor stimulation.

I have a patient who has been on HRT for several months and doing well. She recently was diagnosed with DICS localized to the breast. Should I keep her on HRT?

Thank you,

Ronald Peters MD
http://www.healmindbody.com


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PostPosted: Fri Sep 28, 2007 3:41 pm 
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Q2: Even though this plant seems to prevent breast cancer, wouldn't it still be potentially problematic for women with estrogen sensitive breast cancer?

Thanks,
Steve Lett


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PostPosted: Fri Sep 28, 2007 3:42 pm 
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A1: Dear Doctors:
We maintain confidential research on Puresterol (Pueraria mirifica standardized extract, with >20 mg Miroestrol and Deoxymiroestrol / 100 Gms) which will be published, once our work has been validated by a mechanism of action study. Dr. Garry Gordon continues to be kept up to date with all our confidential data. He is under a non-disclosure agreement, so I will have to be the one to answer your question.

Pharmacogonosy Professor Emeritus Dr Youssef Mirhom reported, The structure of Miroestrol [having] great similarity to estriol, which is formed in human liver of non-pregnant woman from the potent estrogenic hormone estradiol-17รŸ and estrone by l6α - hydroxylation. If we look at the structure of Miroestrol we find out that it is not a steroidal hormone being a 21 carbon compound with a 6-membered D ring instead of five. The similarity is in the size of the 4- ring molecule. The aromatic A ring, the Phenolic hydroxyl group at position 3 and the oxygen function at position 18 in the form of a hydroxyl group this would correspond the apical l7 α-hydroxyl group of estradiol and Miroestrol with the presence of a 17รŸ-hydroxyl group corresponding to the 16α-hydroxyl group of estriol. This explains why Miroestrol is a unique phytoestrogen with very close similarity to estriol while being non-hormonal and even non-steroidal. This has also been confirmed by other notable researchers.

And, Miroestrol and Deoxymiroestrol are aromatics. Aromatics inhibit aromatase, essential for the conversion to estradiol.

I am unaware of research suggesting miroestrol is an estrogen mimic without estrogenic activity. In fact, in an as yet unpublished study, Puresterolยฎ (Pueraria mirifica standardized extract) has been shown to have an equivalent estrogenic effect of 19.4-30.3 ยตg of Progynova (estradiol valerate). Pharmacogonosy Professor Dr. Norman Farnsworth also stated, PM is the only plant to demonstrate a true estrogenic effect.

Good research takes time. In this respect, rumors have the advantage.

Dr. I. Sandford Schwartz (Dr. Sandy)
Bangkok


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PostPosted: Tue Oct 09, 2007 9:43 am 
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#2: This email says that PM has estrogenic activity equivalent to 20 mg or so of estradiol. I recall from your seminar that you said PM was a phytonutrients similar to estriol with no estrogenic activity.

Which is it - estrogenic or not???

Please advise and thank you.

Ronald Peters MD
http://www.healmindbody.com


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PostPosted: Tue Oct 09, 2007 9:43 am 
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#3: That answers neither of the questions asked about the estrogenic activity of H.R.T., and muddies the water about the appropriateness of this product for women with estrogen sensitive pathologies." Estrogenic activity" is an imprecise term as there are many types of estrogens, there are many downstream metabolites of the various estrogens, there are multiple estrogen receptors, and receptor populations differ from person to person. Even within the same person, in the same tissue space, polymorphisms can make one cell respond differently to steroidal hormones than its neighbor, causing one cell to become hyperplastic or dysplastic. The doctors, and the rest of us, want to know if this product is safe in relation to breast cancer, DICS and fibrocystic breast.
"Estrogen mimic without estrogenic activity" is an oxymoronic phrase. If it mimics estrogen, it has estrogenic activity. Its important for the clinician to know which estrogen transcription activities are being mimicked, whether those activities can be modulated positively or negatively by other neutraceuticals or pharmaceuticals, does this activity change with long term exposure and are other DNA modulating steroids formed when this estriol analog is metabolized. A definitive place for this product in the estrogen replacement stratosphere appears to be well undefined. It has to do much more than reduce hot flashes and build bone. I've been interested to read Gary's understandably biased reviews, but there seems to be much more work to be done before a christening.

Roby Mitchell M.D.(Dr Fitt)


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PostPosted: Tue Oct 09, 2007 9:45 am 
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#4: Dear Doctor,

I concur; there is always a need for more and more information. We have additional studies to identify the mechanism(s) of action of PM at a university in Scotland. There seems to be more than one mechanism of action.
I am fortunate to receive prepublication drafts of other researchers and I share them with Dr. Garry Gordon. In just the last month, 4 additional articles were published on PM, all demonstrating absolute safety, even at extremely high dosing.
One presented, but as yet unpublished study reports - "P. mirifica had no effect on proliferation of normal endometrial epithelial cells and human endometrial cancer cell lines".
In another, we had the direct opportunity to view ER-positive (T47-D, MCF-7, and ZR-75-1) and ER-negative (MDA-MB-157, MDA-MB-231, and SK-Br-3), in the author's laboratory. It was reported at Emory University School of Medicine by Dr. Sayan Sawatsri, Dr. Neil Sidell, et al. "Dose response studies demonstrate that PM inhibited the growth of the sensitive (ER+) cell lines with potency. These findings suggest that there is "cross-talk" between the PM and estrogen signaling pathways such that PM can directly inhibit estrogen-dependent events. Using a reporter gene construct (EREV-tk-Luc) containing a canonical estrogen response element that will transiently transfected into T47-D cells, It is believed the inhibition of promoter activity by PM is directly mediated by blocking the activity through the ERE. Taken together, these findings indicate that PM possesses potent anti-estrogen properties that may, at least partly, account for their anti-proliferative effects on ER+ breast cancer cells. The data suggests a novel mechanism of action that might bypass some of the limitations of conventional anti-estrogen therapy. In conclusion, Pueraria mirifica is a prototype, constitutes a new class of low toxicity natural SERMs with demonstrated anti-tumor activity in in-vitro and in vivo models cancer cell lines directly, having been treated using standardized PM extract."

In support of this, a recently published study in the Journal of Agricultural and Food Chemistry 2007, 55, 4371-4381 reports "These results clearly show that C. genistoides*methanol extracts display phytoestrogenic activity and act predominantly via ERรŸ."
*C. genistoides is a South African plant also exhibiting estrogenic activity.

Dr. Sandy


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PostPosted: Tue Oct 09, 2007 9:46 am 
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#5: So what did you mean by "estrogen equivalent effect.....(estradiol valerate)".That makes me think epithelial hyperplasia. What was the "estrogenic effect"? Also, is this ER beta blockade inhibiting production of acetylcholine in the brain and modulation of Th1 helper cells? How should we be thinking about using PM? The name ,H.R.T., and Gary's writings suggests that it is a replacement for bio-identical estrogens. You describe it as a SERM. Are those human cell lines being tested? It does sound like an intriguing product.
Roby Mitchell M.D.(Dr Fitt)
Tahoma Clinic


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PostPosted: Tue Oct 09, 2007 9:47 am 
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#6: Dear Doctor,

Convincing questioning physicians using statistically significant data that we generate, is most enjoyable. Not being able to share with you all the data we have, is sometimes difficult.
Attached is a study, to be published next month, sent to me without a seal of confidentiality. The other, sent as an abstract, I'm still waiting receipt of the full study, sent by the author.
They can better explain the neuro effect you're asking about.
The estrogenic effect was measured against estradiol valerate as a marker, for calculation, using a known. Its action is that of an adaptogenic herb.
As to the SERM question, NIH registered human cell lines were used.
In the 4th attached paper, and will be a Phase II published shortly, PM's effects were measured, using the climacteric scale as an HRT in perimenopausal women.
As for Garry's suggesting PM is a replacement for Bio-identical hormones; so is Jonathan Wright, this week at the Bio-identical Hormone seminar in Chicago.
Being a true adaptogen, modulating the ERs, classifying its actions as a one or the other, is taking the short view. In the study of cancer cell lines, we have indications supporting 4 different mechanisms of action, all expressing inhibition. Intriguing product?... You ain't seen nothin' yet.
Remember your Latin... mirifica means miracle maker.

Sandy

Neuroprotective effects of Pueraria mirifica on ischemic-induced neuronal death S. Lapanantasin, R. Chindewa, P. Chaovipoch and S. Chongthammakun Department of Anatomy, Faculty of Science, Mahidol University, Bangkok, Thailand Journal of Neurochemistry, 88 (Suppl. 1)

Cerebral ischemia is a common cause of hemiplegia. The extent of neuronal death after ischemia leads to the more disability of patient. There is a large body of evidence from animal studies showing that sexsteroids modulate brain damage during cerebral ischemia. Although estrogen (E2) has been widely shown to be neuro- and vasoprotective, the cellular and molecular mechanisms remain unknown. However, it was claimed to have an adverse effect of causing breast or ovarian cancer. Phytoestrogen (PE), a plant-derived molecule possessing estrogenic-liked activity, is an interesting alternative therapy. Pueraria mirifica (PM) is a native herb of Thailand, which contains PE. The major estrogenic compounds found in PM are miroestrol and deoxymiroestrol. The aim of this study is to examine the neuroprotective effects of PM on ischemic-induced neuronal death. The N18 cell ine and the primary rat cortical neuronal cells were challenged in oxygen-glucose deprivation (OGD) as an in vitro ischemic condition, either pretreated or posttreated with PM or E2. The number of viable neurons were measured by MTTassay. Our data suggest that pretreatment with either E2 or PM promote higher number of neuronal survival, although at different degree, in cortical neuron and N18 after OGD. Post-treatments with either E2 or PM showed neuroprotective effects against OGD in cortical neurons. However, the mechanisms of the neuroprotective effects of PM remain for further studies.


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PostPosted: Fri Nov 16, 2007 10:56 am 
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C1: the new data on P.M. looks exciting. But so have all newly launched designer drugs... until the truth about them comes out.. look at black cohosh and kava..

no SERMs have ever been shown to reduce all-cause mortality let alone all major chronic degenerative diseases, in fact SERMs reportedly double the already high (65%) incidence/severity of stress incontinence in women around 65yrs of age.

The only miracle "drugs" for chronic primary prevention are indeed all as old as evolution:
*appropriate metformin - the natural galega extract (aet 1922) which reduces all major chronic degenerative diseases by almost half, and all-cause mortality by about 40%, and new diabees by almost half; *and fish oil - which reduces all major diseases by almost half and all mortality by about 20%.
* and appropriate BID human systemic HRT does as well in men and women, with negligible adversity.
*and appropriate combo of vits, minerals, biologicals and herbs - for which stats are harder to come by.
The landmark McMaster Supermouse trial of multisupplemnts of Lemon & Rollo (2002-2005) may be as close as we wll ever come to proof - but
they muddied that brilliant longterm trial by including DHEA.

These facts have been long demonstrated.

we wish that Gary's optimism is justified, that MP truly proves to be a safer alternative than appropriate BID human systemic HRT. It will be the first giant breakthrough for postmenopausal women since Masters & Grody's 1st landmark RCT of appropriate BID HRT in 1953.

http://www.Womentowomen.com

Hormone replacement therapy
Talking about bio-identical hormone replacement therapy with your doctor by Dixie Mills, MD & Marcy Holmes, NP, Certified Menopause Clinician

Over the past months we’ve been inundated with calls, faxes and e-mails from women desperately seeking information and help in finding a local specialist who prescribes bio-identical hormones. We appreciate that it can be very frustrating finding and getting what you want but we applaud you for trying - we feel this is a certain way to bring about change in the medical system.
This recent surge of interest has been sparked in part by Suzanne Somers’s books, Ageless and The Sexy Years, in which she tells the story of her personal discovery of bio-identical hormone therapy. While bio-identical hormones have been around for a long time – we’ve used them for almost 20 years - most practitioners have little or no experience with the kind of individualized approach that Suzanne Somers writes about in her books.
It has been our experience that women know that something is not right, that their periods are irregular or have stopped, but they do not want a œquick fix. Women want to œprocess- talk about these changes with a healthcare provider. Many of these women turn first to their current doctor, asking œCan you prescribe bio-identical hormones for me? Here’s our practical advice on how to prepare to talk with your local doctor about the many ways to get bio-identical hormone replacement therapy, and what to do to support your system naturally as well as get the best results on the lowest doses.
Women can be best prepared to discuss their hormonal and life changes with a healthcare provider by understanding three basic things:
Know where your doctor is coming from.
Know yourself, your history and your health philosophy.
Know what you are asking for.
Know where your doctor is coming from
Our goal is for you to have a health provider who will want to partner and work with you to find the best possible means to help you through this challenging period in your life.
Most women have a primary care doctor or gynecologist whom they see for regular Pap tests. Often this is the place to start, or if not with that person, someone else in the group practice may be specializing in menopause. However, if you are new to an area or know you want someone new, we encourage you to call around to find a practitioner who is familiar with bio-identical hormones. Asking friends, calling local offices, checking out local newspapers, and searching the internet or the Yellow Pages for alternative health and holistic health can oftentimes lead you to a surprising resource. You may well find that nurse practitioners have more experience with bio-identical hormone therapy due to their interest in preventative health.
Remember that all health providers, doctors or nurse practitioners, are human. They have spent many years learning to be experts in their field and even more years practicing their expertise and they like to feel that they are good at what they do. They went into medicine to help people, but today, unfortunately, most are overstressed by managed care rules and financial considerations and having to work in factory-like conditions. He or she probably did not get much training in sex hormones (female or male) in medical school or residency programs. (Only in the last five years have women’s health programs in hospitals even been started.) Moreover, the headlines and drug companies have bombarded your doctor with conflicting arguments that synthetic hormones are just as good as bio-identical hormone replacement therapy, that their trademarked hormones are the most trustworthy because they’ve been so thoroughly tested, and that women have no good alternative for the relief of symptoms of menopause. All these arguments are untrue, but they are the doctrine doctors have heard over and over.
When you are ready to call for your appointment, specifically request an appointment for a "hormone consultation." With all the recent news and released studies on hormones, doctors are certainly expecting these calls. If the office doesn’t know what you are talking about or doesn’t offer one, that should be a signal that you need to try elsewhere. Ask for at least a 15“minute or 30“minute appointment. This should be the sole focus of your visit, and you deserve to have your œhormone consultation comfortably dressed in your clothes in an office instead of in a œjohnnie on an exam table. If you have not had a check-up or breast and pelvic exam in the last year, be sure to schedule that after the consultation or on another day if necessary. This type of focused consultation appointment assures that you can say what you want to say and not be rushed.
Know yourself and your history
Doctors are taught to first ask for a patient’s œchief complaint, then to ask more details about it and take a history - when, what, how, where, etc. Unfortunately, with managed care time constraints, a full discussion often fails to take place. We advise women to be prepared with a list of their symptoms, what worries them the most, what they have tried, what seems to have worked in the past, and what they would like to change.

Here is a sample script -
First, provide your chief complaint and symptoms:
Hello, Dr. Jones, I am Mary Smith and I am now 52 years old. I have been having irregular periods for the last year with some heavy bleeding. My last period was 3 months ago. I have a job I love but it is very demanding. My youngest child has just started college. I am having trouble sleeping at night, waking up with hot sweats, and not remembering things as well as in the past.

Then provide your current medical issues and medications:
I am otherwise very healthy and take no prescription medications. I take a multivitamin with calcium when I remember. I try to walk a couple times a week and not eat junk food, but I find I am gaining weight.

Then give your past history and family history:
I get regular mammograms and do not have a family history of breast or ovarian cancer. Both my parents are still alive. Other than having my gallbladder out about 10 years ago, I have never been in the hospital. I have never smoked and have a few drinks a month.

Then sum up with what you are looking for:
I want to continue living with the quality of life I had, but I’m concerned that I may be perimenopausal and need some help in getting what I had back. I have heard about bio-identical hormones and am very interested in them. Can you help me?
You obviously will want to revise this script with your own personal story. You may want to write it out and copy it for your provider or send it prior to your meeting. You can start out writing as much as you need to, but your doctor will appreciate if you keep your summary short and succinct, ideally less than a page. You will want to be assertive and honest - this is your life and this time is a wise investment. It will also be important to be able to talk openly - if a nonexistent libido is a problem you will need to bring up your sex life.
Remember YOU are the expert on your body and its symptoms, needs and feelings, although you may not understand them at this point. If you get the sense that your provider is not listening, or telling you that there are no choices and that you just have to endure or grin and bear it, we would urge you to end the appointment, excuse yourself and find someone else.
Know what you are asking for
There is still a great deal of confusion about bio-identical hormones. Let’s try to clear that up. You can take a look at our article on the fundamentals of bio-identical hormones here.
The key points:
What is the difference between hormones: Bio-identical hormones are made in a laboratory, usually from the components of plants, to match exactly the formula that your body produces and has been used to. In contrast, synthetic hormones are designed by drug companies and are foreign to the human body, unique in ways so they can be patented. The formula has been altered in a small way - if you remember your basic biochemistry class - an H or OH or C has been switched on the basic steroid ring. Scientists did not realize that some of the changes which they originally thought were insignificant would not be - we all remember the DES story.

We are just now realizing that Provera - a synthetic, non bio-identical progesterone - may be the œbad actor in increasing the rate of breast cancer. Premarin, the most commonly prescribed estrogen replacement therapy (ERT), is natural to a horse, being derived from pregnant mares™ urine (hence the name œPremarin). But equine estrogen is not bio-identical to a woman’s. Prempro is the combination of Premarin and Provera: we haven’t recommended it for many years, and since the WHI studies in 2002 most conventional doctors don’t either. (See our 2007 press release for an update on its œsafety.) Other estrogens on the market, like Ogen, are made from plants but not in the same formula as a woman’s.

Human estrogen is found in three forms, called estrone (E1), estradiol (E2), and estriol (E3), all of which can be custom“compounded as bio-identical ERT. Of these three, only estradiol is available in brand name form - because the pharmaceutical companies have developed and patented various unique delivery methods for it.
What is usually available: Many doctors have knowledge of other hormone replacement products besides Premarin, but they may not be aware of which brands fall under the category of bio-identical. In regular pharmacies there are brand name, standard-dosage bio-identical products sold in many strengths: estradiol in the form of Estrace, Estraderm, Estrasorb, Climara, Vivelle or Femring; and bio-identical progesterone, sold only under one brand name, Prometrium. A significant percentage of doctors are familiar with these brand name products, and again, they are also natural and bio-identical - the doctors just may not call them that. They come in various forms and doses, including pills, vaginal creams, vaginal rings, and adhesive patches. Many women do very well on them, on daily, weekly, monthly or otherwise cyclical regimes. They only replace estradiol and progesterone, but these are the two main hormones that need replacement.

No company has yet put bio-identical estradiol and progesterone into one combined product, so if you still have a uterus, two prescriptions are usually needed (e.g., an estradiol patch worn weekly and a Prometrium pill taken nightly or cyclically). If you have had a hysterectomy, you may need prescription estradiol, and low“dose, over-the-counter progesterone cream complements this nicely. (Even post hysterectomy, your body needs both these hormones to achieve hormonal balance.) This is a great simple way to start, and your doctor should be happy to help you with this.

Custom-compounded bio-identical hormones, as described in Suzanne Somers’s books, are another option. In this approach, a practitioner usually does a hormone test, such as a comprehensive female hormone panel, to measure your existing hormone levels. Based on the results of the panel, your practitioner will then prescribe a hormone supplement for you that includes several hormones matched to your individual needs - either separately or all combined. The hormones usually include estradiol and progesterone, but they may also include a combination of other estrogens, testosterone, and/or DHEA.

Unfortunately, very few physicians have any experience with the testing or prescribing of compounded formulas, or with the follow-up necessary to tailor things to your individual response. But we are finding that more providers are willing to learn as they are hearing about compounding over and over from their patients.
In a perfect world, every woman would be familiar with her own ideal hormone balance by having had it tested at various times in her life. Maybe our daughters will have baseline hormone testing available to them as a standard of care. But for now we can work with blood tests to monitor our current hormone levels. Our favorite is a hormone panel provided in a kit from Genova Diagnostics. Other labs can also draw hormone levels with a doctor’s prescription. Very few physicians have been trained in interpreting these lab values - we’ve been told they are too variable to be reliable - but again, the science of hormone testing is changing and new standards are being established. And having a baseline is important. How often to continue to test and tweak your prescription is something that you and your provider will have to determine as you proceed, based on your unique response. We have found that some women do well on one dose for several years and others need to change dosages every three months. Changes in lifestyle or life situation can obviously create hormonal changes and necessitate changes in your prescription.
You may be one of the many women frustrated with their medical care. Many women who call us have significant symptoms but were told by their doctors that they are œnormal or that œthere is nothing we can do; these women turn to us because they don’t want the altered HRT or antidepressants they are offered. If you are already convinced you can’t get what you want in your local area, again we invite you call us at the Personal Program or at our medical practice. We cannot offer individual referrals but suggest you contact Woman’s International Pharmacy - longtime compounding specialists - and request their referral list for your area (1-800-279-5708). Note that this is simply a list of practitioners, not a rating of their experience or ability. Christine Conrad’s organization, the Natural Woman Institute, also provides a database of physicians and pharmacies by area; however, we do not have personal knowledge of the listings.
You are always welcome to be treated at Women to Woman’s medical practice, in person or via phone consultations. We have been using compound bio-identical hormones for nearly 20 years, and offer advanced hormone testing and replacement options. Note that phone consultations and compounded formulations are not usually covered by health insurance. We won’t replace your local practitioner (unless you can get to our clinic in person), but we can help you via phone with everything that affects your hormonal balance. In that way we can complement the regular care you get from your local practitioner.
Feeling your best usually takes more than just the right prescription. In our practice, we recommend trying the most natural, least invasive steps first to create a foundation of health and hormonal balance, gradually adding remedies if and when needed. That foundation usually includes good dietary habits to avoid processed foods and simple carbohydrates, regular exercise, multivitamins and minerals, essential fatty acids, and good day-to-day self-care measures. The earlier you can start this approach, the better!
You can try to create the balance and support on your own, or consider our help. In our Personal Program, we use a universally appropriate foundation of support for health and hormonal balance with pharmaceutical“grade nutritional supplements that include essential fatty acids, a comprehensive dietary guide, and Herbal Equilibrium our exclusive Multibotanical supports estrogen, testosterone and progesterone balance, the key hormones influx during menopause and perimenopause. Our Personal Program also offers optional consultations with our Nurse“Educators for individual support and guidance if needed. If that extra support doesn’t bring you relief from your symptoms, you can consider adding hormones prescribed by your doctor. It is very important that you continue to support your foundation for health and hormonal balance even if you do choose to go on HRT of any kind.
Unless you’re sure your doctor already knows about bio-identical hormones, it may be helpful to take the following reference list to him or her:
Hargrove, J.T., & Osteen, K.G. 1995. An alternative method of hormone replacement therapy using the natural sex steroids. Infertility & Reproductive Medicine Clinics of North America, 6 (4), 653“674.
Hargrove, J.T., et al. 1989. Menopausal hormone replacement therapy with continuous oral micronized estradiol and progesterone. Obstetrics & Gynecology, 73 (4), 606“612.
Woman’s International Pharmacy also provides an information packet for women and their physicians.
Some additional books with useful information:
Natural Woman, Natural Menopause, by Laux and Conrad The Wisdom of Menopause, by Dr. Christiane Northrup The Sexy Years, by Suzanne Somers


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 Post subject: Pueraria Mirifica Study
PostPosted: Sat Jan 05, 2008 10:25 am 
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Q: Dear Gary,
as you take a well-earned Xmas break,

your attached paper on pueraria (on this email from you below ) from an unpublished Sayan Sawatsri study is problematic in today's otherwise excellent email dedicated entirely to saliva testosterone measurement, and tribulus as a natural male testosterone promoter. .

Where does the unsourced paper come from that you attach? - Pueraria Mirifica Promotes Fibroblasts in Normal Breast Cells and Inhibits Estrogen-Dependent Breast Cancer Cells Sayan Sawatsri 1,Bundit Juntayanee1,Suwicha Jitpatima2, Prasert Boonnao1, Chuchat Kampoo N Ayuttaya3, Surapote Wongyai4and Neil Sidell5

The only website Google brings up for any Sayan Sawatsri study is the almost illiterate Thai (Govt?) http://www.puremiracleherbs.com/index.php?lay=show&ac=article&Id=329301&Ntype=1 which also offers no scientific validity; and Colonel Sawatsri's congress abstract below on PM and Alzheimer's;

and the FDA 2002 response to the US PM registration also raised many relevat queries about PM..
http://www.fda.gov/ohrms/DOCKETS/dockets/95s0316/95s-0316-rpt0149-01-vol107.pdf.

So while both approriate testosterone, and PM, reduce the risks of breast cancer, and offer multisystem benefits for women, why promote the bust-expanding PM when women are already mostly seriously overweight with dangerously heavy breasts? and when appropriate permanent physiological systemic combination of human BID HRT (bi-est, testosterone and progesterone) gives ideal longterm protection post menopause?

best wishes for many more years of leading us, neil burman


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 Post subject: Pueraria Mirifica Study
PostPosted: Thu Feb 14, 2008 11:06 am 
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A: Dear Dr. Burman,

The paper was presented at a meeting of the OB/GYN Department of Duke University and remains unpublished, as it's part of a larger study, being completed by Dr. Sayan.
The inclusion of the action on normal breast tissue was done, as PM's recent exploitation as a breast enhancing herb, is better known than its relief of HRT action.
Dr. Sayan was trying to establish an action, which he thought was due to collagen building. More recent tests have shown that PM inhibits collaginase, as the mechanism of action.
Further, according to Dr. Youssef Mirhom, the structure of "Miroestrol" has great similarity to estriol, which is formed in human liver of non-pregnant woman from the potent estrogenic hormone estradiol-17? and estrone by l6? - hydroxylation. If we look at the structure of Miroestrol we find out that it is not a steroidal hormone being a 21 carbon compound with a 6-membered D ring instead of five. The similarity is in the size of the 4-ring molecule. The aromatic A ring, the Phenolic hydroxyl group at position 3 and the oxygen function at position 18 in the form of a รŸ-hydroxyl group this would correspond the apical l7 รŸ-hydroxyl group of estradiol and Miroestrol with the presence of a 17a-hydroxyl group corresponding to the 16a-hydroxyl group of estriol.
This explains why Miroestrol is a unique phytoestrogen with very close similarity to estriol while being non-hormonal and even non-steroidal Estriol is produced in the third trimester and throughout lactation, hence the action on the breasts is similar.
The stated action on the breast size decreases with age, and after 40, the action is to firm, rather than enlarge. This data is found in the attached unpublished paper.

Dr. I. Sandford Schwartz
Bangkok


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PostPosted: Wed Jul 16, 2008 7:42 am 
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C1:
your attached paper on pueraria (on this email from you below ) from an unpublished Sayan Sawatsri study is problematic in today's otherwise excellent email dedicated entirely to saliva testosterone measurement, and tribulus as a natural male testosterone promoter. .

Where does the unsourced paper come from that you attach? - Pueraria Mirifica Promotes Fibroblasts in Normal Breast Cells and Inhibits Estrogen-Dependent Breast Cancer Cells

Sayan Sawatsri 1,Bundit Juntayanee1,Suwicha Jitpatima2, Prasert Boonnao1, Chuchat Kampoo N Ayuttaya3, Surapote Wongyai4and Neil Sidell5

The only website Google brings up for any Sayan Sawatsri study is the almost illiterate Thai (Govt?) http://www.puremiracleherbs.com/index.php?lay=show&ac=article&Id=329301&Ntype=1 which also offers no scientific validity; and Colonel Sawatsri's congress abstract below on PM and Alzheimer's; and the FDA 2002 response to the US PM registration also raised many relevat queries about PM..
http://www.fda.gov/ohrms/DOCKETS/dockets/95s0316/95s-0316-rpt0149-01-vol107.pdf.

So while both approriate testosterone, and PM, reduce the risks of breast cancer, and offer multisystem benefits for women, why promote the bust-expanding PM when women are already mostly seriously overweight with dangerously heavy breasts? and when appropriate permanent physiological systemic combination of human BID HRT (bi-est, testosterone and progesterone) gives ideal longterm protection post menopause?

best wishes for many more years of leading us, neil burman
J Med Assoc Thai Vol. 87 Suppl. 3 2004 S271

Development of Pueraria Mirifica (Thai Herb) for ERT and Inhibits Neurotoxic in Alzheimerโ€™s Model in Vitro

Sayan Sawatsri*, Wanphen Yamkunthong*, Neil Sidell**

* Phramongkutklao Hospital and College of Medicine, Bangkok, Thailand

** Emory University School of Medicine, GYN-OB Dept., Research Div., Atlanta, GA, USA

Background: Pueraria mirifica (PM) or White Klao Keur (Thai herb) has long been used as a rejuvenator during aging.

This herb contains a variety of phytoestrogens that possess estrogenic activity. In vitro, animal, and epidemiological studies have suggested that estrogen can decrease the risk of developing Alzheimerโ€™s disease. Interestingly, the estrogenic effect of PM has been shown to prevent the deleterious effects of certain neurotoxic agents (e.g. glutamate, H2O2, and betaamyloid/25-35) in AD model systems. The mechanism (s) responsible for prevention of neuronal cell death by PM is presently unknown.

Objectives: The current study investigated the neurotrophic and neuroprotective action of the complex formulation of phytoestrogens from a standardized PM extract compared with 17beta-estradiol in an in vitro AD model.

Methods: Crude PM was extracted by ethanol and standardized by HPLC (standardized PM). The ability of standardized PM to inhibit cell death was evaluated in the LA-N5 human neuroblastoma cell line cultured in estrogen deprived medium either alone, or with the neurotoxic agents, 0.2 mM glutamate, 20 uM H2O2, or 8 ug/ml beta-amyloid/25-33. Morphologic and biochemical analyses were conducted on the cultures to compare the neurotrophic/neuroprotective properties of the standardized PM with that of 17beta-estradiol. Using MTT for determining the percentage of cells viability. Co-treatment of the cells with the known antiestrogenic compound ICI 164,384, was used to assess the specificity of standardized PM as acting through the estrogen-dependent signaling pathway.

Results: Standardized PM significantly decreased neuronal cell death in dose-dependent fashion in estrogen deprived cultures. In the presence of the neurotoxic agents, beta-amyloid, hydrogen peroxide, and glutamate, standardized PM and 17beta-estradiol were significantly neuroprotective. This protection was antagonized by ICI 164,384. neuroprotection studies demonstrated that 1 ml of PM and 10-8 M 17b-estradiol induced highly significant neuroprotection against betaamyloid,

hydrogen peroxide, glutamate-induced toxicity, 30 % and 37 %, 28 % and 34 % and 30 % and 35 %, respectively.

Inhibit action of PM and 17b-estradiol by estrogen antagonist (ICI164,384) after induce neurotoxic with glutamate and H2O2, cell dead decrease 50 % and 55 %, 3 % and 2 %, respectively and 34 %, 50 %, 21 %, and 33 %, respectively.

Conclusion: PM shows estrogenic activity similar in potency to 17beta-estradiol. Both agents prevent cell death induced by neurotoxic agents which appears to be mediated through the estrogen receptor signaling pathway. PM may have clinical utility for intervention in Alzheimer's and other neurodegenerative diseases of aging.


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PostPosted: Wed Jul 16, 2008 7:44 am 
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C2: Dear Dr. Burman,

The sole user of Pm in breast enhancement was ISIS, and this company left the business more than 5 years ago. None of the other suppliers are using anything more than a combination of phytoestrogens.

We identified the mechanism of action for breast enhancement, being the nearly identical structure of miroestrol with estriol

I attached some 20 citations from Medline, on the action of estriol, which is identical to the effect of Pm.

We are currently identifying the mechanism of action on the Estrogen Receptor in an MCF-7 cell line. There are at least 4 papers (in Medline or Google Scholar), showing that Pm inhibits breast cancer. We are looking at the mechanism in the α and β receptor. Our cell line researcher, Dr. Janis MacCallum published a paper in the British Journal of Cancer: MacCallum, J., Cummings, J., Dixon, J.M. and Miller, W.R. (2000). Concentration of tamoxifen and its major metabolites in hormone responsive and resistant breast tumours. Br.J.Cancer 82:1629-1635.

This citation doesnโ€™t appear in Medline; however, it was indeed published.
British Journal of Cancer (2000) 82, 1629-1635.
doi:10.1054/bjoc.2000.1120

Concentrations of tamoxifen and its major metabolites in hormone responsive and resistant breast tumours

J MacCallum1, J Cummings2, J M Dixon3 and W R Miller1

1Edinburgh Breast Unit Research Group 2ICRF Medical Oncology Unit 3Edinburgh Breast Unit, Western General Hospital, Edinburgh, EH4 2XU, UK

Received 5 January 1999; revised 11 November 1999; accepted 13 February 2000

Patients treated with tamoxifen (TAM) for primary breast cancer often manifest de novo or acquired resistance, possibly through changes in drug metabolism. Using solid-phase extraction methods and reversed-phase high-performance liquid chromatography separations, levels of TAM and metabolites 4-hydroxytamoxifen (4OH) and desmethyltamoxifen (DMT) have been measured in plasma and tumour tissue from breast cancer patients treated with TAM for at least 3 months. Patients were categorized into those with tumours responding to TAM and those showing de novo or acquired resistance. Levels of TAM, 4OH and DMT in both plasma and tissue samples were correlated with clinical response, length of treatment and patient weight. Interesting results included accumulation of 4OH in tumour tissues over time in all patients, with significance reached in the acquired resistance group. In addition, significantly lower levels of 4OH and DMT were found in plasma taken from responding patients after 3 months of treatment when compared to non-responding patients, and a small group of ER-poor patients showed significantly lower levels of all three species in plasma when compared to other patients. Whilst not explaining TAM resistance in all cases, these differences could account for the development of resistance to TAM treatment in certain subgroups of patients.
ยฉ 2000 Cancer Research Campaign

It was with some level of concern that Longevity Plus launched Pm to physicians, but Garry Gordon's knowing me for more than 3 decades, back in the days of MineraLab, I built up some level of credibility. This with having put together some 14 Kgs of our own research, articles / publications translated from Korean, Thai, Chinese and Japanese, all of which I've made available to him under confidentiality, he's pretty well convinced that our Pm, standardized by Bio-Botanica in NY, is all that has been written about for the 700 years it's been used by men and women in Thailand.

As the years and the research progresses, you too should be satisfied. Unfortunately, we are unable to allow Garry to release all our data. We have a Patent Pending and once that has been issued, we'll be more open with some of our research. We also hold papers from researchers still completing their research. As with Dr. Sayan, we're unable to present his complete data.

I hope this gives you a bit more confidence and understanding.

Dr. Sandy


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PostPosted: Wed Jul 16, 2008 7:45 am 
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C3: Dear Dr Sandy,
thanks a ton for this impressive looking data base.
as you see, we in the International Menopause Society penumbra are sceptical, concerned about phytostrogens for longterm HRT because, like premarin, DES, Estinyl and progestins, they are ipso facto xenohormones ie not human. Only prime human hormones are used for replacement in all branches of endocrinology- and (relative) sex hormone deficiency is universal in those who survive other life hazards..

Historically, all symptom-relieving oral doses of HT seem to associate long term with either breast proliferation, or endometrial proliferation (unless combined with progestins - over which there are major questions) - let alone other adverse effects of hepatic first pass, and now the rare association of black cohosh and kava with liver fatalities.

since no phytoestrogens have been shown to have the global systemic benefits of appropriate HT (eg even lowdose dose PremPro) long term, and since appropriate balanced non-oral and even micrionized lowdose oral bioidentical human HRT does nothing but good over decades, we are concerned that it is unethical to expose women for even a few years to phytosubstitutes let alone synthetics just for symptoms;
when after eons of evolution and 60 years of intensive use- in thousands of women who have used such titrated BID human hormones for up to 40 years- there is no evidence of adverse effect, only global benefit. Otherwise most people are crippled and die early of preventible premature vascular, malignant, dementing or fracturing disease. .

The evidence so far for all phytoestrogens - from primrose oil and soya to black cohosh and DePM- is that they should not be used except under medical surveillance. So they have no advantage yet over long-proven BID HRT - appropriate combination of testosterone, estradiol and progesterone, thyroid, insulin, cortisone etc.
.
Unlike drug corporates whose motive is mega$ profits from designer drugs, our concern is longterm global health at low cost - and so far no designer drug has proved its equivalence to let alone superiority over natural medicines (minerals, vitamins, biologicals, herbs) for prevention of the major chronic degenerative diseases.

We look forward to the first phytohormone that fulfils this criterion. So far metformin (a simple ester from galega) is the only medicine which is almost as good a panacea as fish oil, and appropriate HRT (testosterone for men, and combined testo-estradiol for women), and appropriate combination of minerals+vits+biologicals+herbs - ie (unlike all modern chronic patent designer prescription drugs), true medicines that reduce virtually all major chronic degenerative diseases and deaths (and hospitalizations and surgery) by almost half.
Remember that because of the overwhelming power of the drug corporate $$ on politicians and Legislators and the AMA, Reguators do not even allow us to broadcast such truths - I have been threatened with prosecution if I do so.

We look to pioneers like you to produce this evidence for DePM for us, hopefully while Dr Gary and I are still around to rejoice with you in the biggest breakthrough for chronic degenerative diseases since thyroid around WW1; metformin (1922), sex hormones in WW2, and cortisone (1949).

am I correct that deoxymiroestrol will be no exception to the rule- that it is simply an ester of the natural hormone estriol, ie it is even closer to human physiology than metformin as an insulin-sensitizing cohormone is to plant and human physiology?

kind regards,
Neil
http://www.healthspanlife.com


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