May 2006 | Vol.2 | Issue  3

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The Hormone Health Connection Newsletter is a newsletter that provides featured articles on Menopause, PMS, and Natural Progesterone, new product reviews, tips for reducing the pain and dealing with related anxiety of pms and menopause symptoms, and information on how to promote a healthy, balanced lifestyle. The Hormone Health Connection Newsletter is brought to you by pms-menopause-progesterone.org


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Featured Article

Natural Progesterone - Cancer in a Cream?

We respond to a report published in the May 2006 edition of 'What Doctor's Don't Tell You' (WDDTY)
By: Catherine P. Rollins   
www.natural-progesterone-advisory-network.com

(WDDTY's statements are in green.)

The body of evidence gathered by this Network in collaboration with the women out there at the coal face using progesterone for over a decade is inconsistent with the findings of this report.

Let's tackle some of the more outrageous statements put forward in this report for the benefit of our readers (and the authors of this article) who are perhaps a little confused!

"The evidence is now clear - natural progesterone is just another form of HRT."

Clear to whom? A revelation to some members of the medical fraternity with their heads in the sand, perhaps!

Prior to the findings of the Women's Health Initiative July 2002, our doctors "pooh poohed" any suggestion that over-the-counter (OTC) progesterone creams were actually "working". If we were realising results then it had to be placebo (in other words, we'd have imagined the results we were seeing & feeling in our body!). Coincidental, don't you think, that these same creams should now be tagged 'dangerous' in articles like this one, a short time after conventional HRT has lost its lustre!

Women associated with this Network appreciate that "natural progesterone" is a (Schedule 4) drug that is a component of 'Bioidentical Hormone Replacement Therapy" (BHRT). Consequently, they are encouraged, where possible, to embark on their progesterone journey under the watchful eye of a skilled healthcare practitioner who embraces & understands BHRT treatment protocols.

"There are few long-term studies of the effect of rub-on progesterone. However, now that progestogens have been found to act on the body similarly to natural progesterone, the many studies of the Pill and HRT give some idea of the cancer risks."

Dr Grant's conclusions here are flawed! She wrongly asserts that natural progesterone is a "cancer risk" based on evidence pertaining to artificial progestogens (progesterone analogues) found in the Pill and Hormone Replacement Therapy (HRT) that are intentionally of a different molecular structure from natural progesterone so drug companies can patent.

The Women's Health Initiative revealed in July 2002 that women taking combined estrogen and progestogen hormone therapy were at increased risk of breast cancer and stroke. The hormone trial had two studies: the estrogen-plus-progestogen study of women with a uterus and the estrogen-alone study of women without a uterus.

In October 2002, the Women's International Study of Long Duration Oestrogen after Menopause (WISDOM), a British trial evaluating hormone therapy, was also stopped after finding elevated risks of breast cancer.

This was followed, twelve months later, by the results of the Million Women Study that indicated for the first time that the increased risk started between one and two years of HRT use (estrogen-plus-progestogen & estrogen-alone). The risks grew larger the longer the HRT treatment continued.

The results of the Million Women Study disagreed with the fact that the Women’s Health Initiative reported an increase in breast cancer not observed in the estrogen only arm of the clinical trial (an average follow-up has now reached about 7 years).

In early 2004, Swedish researchers stopped yet another study examining the impact of hormone replacement therapy (HRT) in women with a history of breast cancer because of an unacceptably high risk of recurrence of the disease.

These studies DID NOT include bioidentical progesterone.

The findings of the Bassett Healthcare study, published in March 2004, suggested that "a popular, over-the-counter progesterone cream (Pro-Gest) is absorbed into the blood to the same extent as FDA approved progesterone capsules, meaning that progesterone cream is as strong as the pills."

We've be saying as much for years! Bioidentical progesterone, when applied transdermally at a dose as low as 2% ~ 20mg per 1 gram application (such is the case with Pro-Gest), WILL replace the hormone progesterone in our body. And it will do this MINUS all the side effects and health risks of an artificial progestogen.

But then, typically, these same scientists begin losing whatever ground they might have gained in this debate but citing "multiple studies show that combined hormone replacement therapy—estrogen plus progestogen—or progestogen alone for five years or longer is associated with a 26-53 percent increase in breast cancer and other side effects."

"Progesterone, rather than estrogen, is the most carcinogenic hormone of the two."

IF this statement by Ms McTaggart IS based on scientific fact then hundreds of thousands of women undergoing IVF around the globe ought to seek legal advice most urgently, as human-identical progesterone is routinely used in fertility clinics as a supplement during assisted reproductive technology (ART) cycles and into early pregnancy.

But then would governing medical authorities in any country sanction prenatal exposure to a supposedly carcinogenic hormone at the very point where life begins if they genuinely believed, or were sitting on evidence to suggest human-identical progesterone is linked to cancer?

Maybe Ms McTaggart can answer this one for us?

"Results show that natural progesterone and synthetic progestogens both have a similar action in the body."

Similar does not = the same!

Progestogens are associated with birth defects, yet progesterone is essential for a viable and healthy pregnancy.

Synthetic progestogens don't show up in blood and saliva tests, meaning they don't raise progesterone levels in the body.

Progesterone does not cause the side effects listed for medroxyprogesterone acetate (Provera).

Progesterone 101

Bioidentical progesterone is NOT the same as an artificial progestogen.

To lump both bioidentical progesterone and artificial progestogens in the same basket is, in my humble opinion, "stupid science".

An artificial progestogen has a different molecular structure to that of bioidentical progesterone. That's how drug companies get their progestogens patented in the first place ... by manipulating the progesterone molecule way beyond its 'natural' state.

Major pharmaceutical companies 'tamper' with the molecular structure of USP progesterone to produce progesterone's synthetic cousin - progestogen - that the body no longer sees as bioidentical. Typically, our doctors insist on prescribing artificial progestogens despite new emerging evidence that these unnatural-to-the-body, synthetic analogues of progesterone ineptly replace our natural hormones, and have been found to increase the risk of heart disease, cancer and blood clots.

Bioidentical progesterone has a significant safety margin because the body see as 'natural' that which has the same molecular configuration.

Bioidentical progesterone is not produced anywhere in the plant kingdom. It is manufactured in a laboratory with the aid of an enzyme. The substance diosgenin, found in the Mexican Wild Yam or Soy plants, has to undergo a series of chemical changes whereby it is synthesised or converted from its raw state into United States Pharmacopeia (USP) or British Pharmacopoeia (BP) grade progesterone.

The difference between a progesterone and a progestogen is NOT their source - whether they come from soy or yam or are developed in a test tube. The distinction lies in their basic molecular arrangement. If the chemical structure of the product identically matches that of a woman's naturally occurring hormone, it is considered to be natural. Simply, a natural hormone is intended to mimic the human female hormone. The natural form of progesterone appears to have several benefits. The bioidentical version helps to balance estrogen as well as other sex hormones; it utilizes more efficiently and leaves the body quickly, as do our own hormones.

Here's what the "natural" progesterone hormone looks like:

progesterone molecule

Here's what the altered molecular structure of a progestogen looks like:

progestogen molecule

Look closely at the two molecule below. Not much difference? Wrong. Estradiol tells your body it is female and testosterone tells your body it is male. The lesson here is obvious enough ... if such small differences in molecular structures have such big real effects then beware of man made alterations.

 

estrogen-testosterone molecule

 

"Progesterone encourages breast cancer to spread rapidly and metastasize."

The Johns Hopkins University conducted a 20 year study, published in 1983 in the American Journal of Epidemiology, showing that women who had good progesterone levels had less than a fifth of the amount of breast cancer, and less than a tenth of all the cancers that occurred in women who were low in progesterone. These outcomes suggest that having a normal level of progesterone protected women from nine-tenths of all cancers that might otherwise have occurred.

Dr. David Zava, Ph.D., hormone expert and co-Author, What Your Doctor May Not Tell You About Breast Cancer writes, “Most oncologists and general practitioners that work with natural progesterone find that primary breast cancer, and breast cancer recurrences are less frequent in women using topical progesterone, but it does happen. My experience, in reviewing pathology reports from women who have developed breast cancer while using topical progesterone, is that they usually have tumors that do not contain progesterone receptors, or the receptors are very low.

Dr. Jane Murray, a respected M.D. in the States and former President of the American Academy of Family Physicians and author of a Women's Health in Primary Care paper Natural Progesterone: What Role in Women's Health Care? argues there have been no studies to date that document harm to women from real progesterone.

"According to this article, I should be dead by now!" writes Alyssa. "This is an astonishing piece of reporting and publishing and as someone who had invasive breast cancer in 2001, had no drugs or radiotherapy, and has been using natural progesterone to balance my hormones ever since, I have been rendered almost speechless!"

"Progesterone is more carcinogenic for the breast than estrogen."

Estrogen dominance is a term coined by the late Dr John Lee in his first book on natural progesterone. It describes a condition where a woman can have deficient, normal, or excessive estrogen but has little or no progesterone to balance its effects in the body. Even a woman with low estrogen levels can have estrogen-dominance symptoms if she doesn’t have any progesterone. Xenoestrogens and obesity are contributing factors.

According to Dr Cavalieri, Professor at the Eppley Institute for Research in Cancer and Allied Diseases and his team at the University of Nebraska Medical Centre in Omaha Nebraska, all the evidence implicated estrogens (including the natural hormones estradiol and estrone), as a major cause of breast cancer [National Cancer Institute Monograph #27, Oxford University Press]. Estrogens, says Dr Cavalieri, are initiators and promoters of cancer. All the important human cancers that we get in Western civilisation have the same origin - which is estrogen.

In two studies funded by the National Institute of Environmental Health Sciences, researchers at Fox Chase Cancer Center in Philadelphia have demonstrated that two plasticizer compounds, BPA and BBP, are environmental estrogens capable of affecting gene expression in the mammary glands of young female laboratory rats exposed to the compounds through their mothers' milk.

Raquel Moral, Ph.D., a postdoctoral associate in the Fox Chase laboratory of Jose Russo, M.D., presented the results on April 19, 2005 at the 96th Annual Meeting of the American Association for Cancer Research. "Development of breast cancer entails multiple events, in which estrogen appears to play an important role," explained Russo. "Our laboratory has pioneered an in vitro system of cell transformation using estrogens and their metabolites as carcinogenic agents in human breast cells. Estrogenic agents involved in breast development and possibly in breast cancer may include foreign estrogens, or xenoestrogens, that are used in manufacturing a number of products."

Breast cancer is a growing risk for both men and women, and it’s a cancer for which the obesity link has been clearly established. Fat produces excess estrogen; excess estrogen produces breast cancer. And in the reverse, weight loss reduces cancer risk. The data are clear.

Researchers write in the Archives of Internal Medicine, "we found that estrogen therapy was associated with an increased risk of breast cancer with longer-term use."

We know that the only known cause of uterine cancer is unopposed estrogen. Without progesterone to balance the hormone cycle, estrogen overstimulates the tissue lining the uterus and causes uncontrolled growth, a condition known as hyperplasia. If untreated, hyperplasia may develop into cancer.

Who's agenda does this sort of reporting serve?

In Australia, the number of HRT scripts plummeted by more than 1.2 million (from nearly 4.2 million in 2001-2002) the year after the WHI's seemingly calamitous findings. The Bulletin, October 2005 reported that Wyeth Australia, one of the largest HRT manufacturers, had lost 50% of its market and it says its numbers are "still in steady decline".

"If I were a pharmaceutical company think tank", says Dr Zava some years ago, "I would set up a front to first get other competitors off the market (i.e., OTC progesterone) by scare tactics. I would do this by saying that a) topical progesterone is far more potent than we ever thought (duh, we have been saying this for years); b) recent studies show that progesterone in combination with estrogens leads to increased health problems (false statement but most doctors don't know the difference between medroxyprogesterone acetate and progesterone); c) because of a and b indicating the potency and potential danger of progesterone, OTC progesterone should be banned and only used by prescription.

Something for us to think about, particularly when we review articles like this one.

"For nearly 200 years the main treatment for breast cancer was removal of her ovaries to take away her main source of progesterone production."

Why not reveal the 'whole' story here. Removal of a woman's ovaries would not only cut off her source of progesterone, it would interrupt her production of estradiol and estriol, and reduces her testosterone production by half.

Breast cancer treatment these days centre around anti-estrogen drugs that can be given to women with estrogen-receptive tumours to reduce estrogen-receptor activation (selective estrogen receptor modulators or SERMs).

Progesterone confers a degree of protection against estrogen-driven cancers.

Women using BHRT for over a decade have found that progesterone, at optimal levels, is the body's natural anti-estrogen.

Where's the research on bioidentical progesterone?

The 1995 PEPI trials clearly demonstrated that natural progesterone actually works better than synthetic progestogen in terms of protecting the heart, and that natural progesterone can protect against uterine cancer as well as synthetic progestogen. Yet drug companies continue to convince us otherwise!

A study from researchers at the College of Nursing and Health Sciences at The University of Texas at Tyler, led by Kenna Stephenson, M.D., clearly showed that 30 women using 20 mg of progesterone daily, in a cream, had relief of their menopausal symptoms and didn't have the side effects associated with the progestogens such as Provera. The study was published in the November issue of Blood: The Journal of The American Society of Hematology.

"We are gratified that such a highly recognized, authoritative journal has published our abstract," said Dr. Kenna Stephenson, visiting associate professor and scholar in residence, "and we are confident that women can consider bio-identical hormones, such as natural progesterone cream, to be a viable option for relief of menopausal symptoms…. With natural progesterone cream, we found no markers for inflammation or clotting-indicators for most of the serious diseases related to use of traditional hormone replacement therapy, like Provera and Prempro."

The results of a large cohort study in 2005 suggest that, when combined with synthetic progestogens, even short-term use of estrogens may increase breast cancer risk. Micronized progesterone may be preferred to synthetic progestogens in short-term HRT.

In one of the few “head to head” comparisons of bioidentical vs. synthetic hormones, the effects of substituting a synthetic oral progestogen, with a bioidentical progesterone cream were studied in 26 healthy menopausal women with an average age of 57. The aim was to determine patients’ acceptance of transdermal progesterone cream and its effects upon the endometrium (uterine lining) compared to standard hormone therapy.

Dr. Helene Leonetti's study shows promise for using a bioidentical progesterone cream instead of a synthetic progestogen (medroxyprogesterone acetate or MPA) to protect the uterus in women using hormone replacement therapy. The demonstration of effectiveness here might warrant a study with a larger cohort of women over a longer period of time to confirm the effectiveness of progesterone cream. At the end of the study, 77% of the 26 women stated they preferred the bioidentical progesterone cream over the MPA.

Women in Balance recently had the opportunity to talk with several presenting officials, including Dr. Jacques Rossouw, one of the original designers of the WHI study, and the Project Officer of the WHI National Heart, Lung and Blood Institute, a division within NIH. They asked Dr. Rossouw for his comments regarding the future of hormone research, and what in particular, he thought might be explored, designed, or funded.

“We are interested in the role that progesterone plays in women’s health and its protective attributes,” he said. “There are currently two studies that might yield information about the role of bioidentical hormones: the KEEPS (Kronos Early Estrogen Prevention Study) and the ELITE (Early versus Late Intervention Trial with Estradiol), both using a bioidentical estrogen and progesterone.” Dr. Rossouw revealed that NIH agencies are already providing funding to the ELITE study.

"Taking extra sex hormones at any point in your life is likely to give you cancer."

Is there any evidence out there to suggest this is actually true of BHRT? Clearly, women find ourselves between a rock and a hard place. All the more reason to examine the quality of the information we take on board.

"I think that those of us who are serious about the use of natural progesterone are not suggesting that women be on progesterone for the rest of their lives," responds Loretta Lanphier, ND, CN, HHP and founder of Oasis Advanced Wellness. "We are using something that is bio-identical which means the exact same molecular structure as what the body produces to alleviate symptoms and bring the hormones into balance. Once symptoms have been relieved, women can begin to cut-down. In many cases this will trick the body into producing the correct amount of progesterone in order to maintain balance. Let’s be reminded that for many natural supplementation products, huge studies or clinical trials have not been done. Studies and clinical trials are not indicative of promising results or even safety. The pharmaceutical industry is the “poster child” for clinical trials and studies and still provide the public with drugs that are not safe or even effective."

No wonder women are confused and frightened

The standard line now parroted by every doctor and expert committee on HRT is that women should access the risks themselves and make up their own minds!

Dr. Randolph, trained pharmacist and Board Certified practicing gynecologist, and co-author of From Hormone Hell to Hormone Well dispenses some advice for his peers: “If doctors want to do the right thing and keep their patients’ loyalty, they need to get their heads out of the pharmaceutical companies’ pockets. They need to return to their role as patient advocates. They need to take the initiative to read all the medical evidence; e.g. the studies that incriminate synthetic HRT as well as the ones that support bio-identical HRT. More women will be better off once more doctors find their brains, review the literature and, then, decide for themselves what type of HRT they feel is best for their patients”.

Was Dr John Lee's "message" not only wrong, but dangerous, as Ms McTaggart claims? We, the "guinea pigs" in this HRT debate, don't believe so. Dr Lee bravely championed the use of bioidentical progesterone despite the medical fraternity's inability to embrace his theories. Millions of women around the world continue to be eternally grateful to him for having discovered the benefits of its use because of his indefatigable stance.

Please take a minute to click on the links below to learn what leaders in the BHRT field have to say on this subject ...



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A natural, pharmaceutical grade, progesterone cream designed to promote the relief of severe symptoms associated with PMS, peri-menopase, and menopause. Oasis Serene is the only excipient-free nautral progesterone on the market.  Used for hot flashes, night sweats, insomina, low libido, vaginal dryness, weight gain, fatigue mind fog, headaches and moodiness.  May help prevent uterine fibroids, breast cancer, fibrocystic breasts and depression.
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This newsletter is brought to you by pms-menopause-progesterone.org and Oasis Advanced Wellness.

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