Natural Hormones Are Safe

Recently, the Women's Health Initiative (WHI) released a study that has gained national attention regarding the risks of breast cancer, heart disease and stroke associated with using HRT (Hormone Replacement Therapy), with synthetic hormones (Premarin and Provera or PremPro.)

Harvard Associate Professor, Hope Ricciotti, M.D., wrote, "This report does not present any new research." We at Giovane agree this is old news, but it is great news and we hope the public is taking the study seriously!

Doctors who have studied and recommended the use of natural hormone replacement have warned for years about the synthetic administration of hormones, and instead, have advocated the use of natural hormone replacement.

Unfortunately, pharmaceutical companies cannot patent hormones (like the synthetics used in this study), which replicate what the body makes naturally. As a result, the funding for educating physicians is not as readily available.

Natural hormone replacement is finally receiving the attention it deserves, offering a safe alternative to synthetic hormones. In addition, this study also reinforces the benefits of precursor hormones that are naturally absorbed by the body, assimilating only what are needed for proper hormonal balance. This includes Melatonin, Pregnenolone, DHEA, and Androstenedione.

Giovane's natural hormone supplements are and always have been the safe and natural alternative!

Please share this good news about natural hormones with your friends, families and clients! In addition, for those of you who would like more information, we have included the following resources below, for further study.


Natural Hormone Physicians and their Patients
By, Neal Rouzier, MD

Recently there has been tremendous confusion concerning the article published in the Journal of the American Medical Association, July 3, 2002, over the use of Prempro. It is important to understand that this study only involved the use of Prempro and no other hormones. Prempro consists of the synthetic estrogen (Premarin) from horse urine and the synthetic progestin (Provera). Unfortunately, many physicians are now calling for a discontinuation of all hormone replacement based on reported increases of heart disease, breast cancer and thrombosis. This is not appropriate, since reviewers have incorrectly targeted other, safe hormones, which were not included in this study. The conclusion of the latest study does not apply to natural hormones and the JAALA article specifically addresses this issue. Unfortunately, the media takes information out of context, precipitating mass misinterpretation of the findings. The intent of my response, therefore, is to clarify this issue and the article.

Conventional HRT History: About the Risks

First I would like to get you historically up to date. Two years ago an article appeared in JAMA 2000 Jan 26;283(4):485?91, that determined the risk of breast cancer increased 8 times with Provera. The more recent JAMA article comes to the same conclusion. It has been known for some time that Provera increases breast cancer risk, but it has never received media attention or medical criticism until now. In the wake of the HRT disparagement, it is important to remember that Provera does not equal biological progesterone. Progesterone is pro-gestational; it is the hormone that maintains pregnancy. Loss of progesterone results in miscarriage. It is absolutely necessary and healthy in pregnancy and normal menstruation. On the other hand, Provera is a teratogen that causes birth defects and is absolutely contraindicated in pregnancy. They are two completely different molecules with completely different effects!

Four studies, I can think of off hand, identify biologically identical progesterone with health enhancing benefits.

Two recent studies indicated that natural progesterone protects against breast cancer by decreasing epithelial cell proliferation in the breasts (Fertility Sterility 1998; 69:963?69).

Another study showed that progesterone was more protective than Tamoxifen, which is a treatment for breast cancer Japan Journal of Cancer Research 1985; 76: 669?04).

And another documented study illustrated a 400% decreased ductal stimulation by progesterone (Fertility Sterility 1995; 63: 785?91).

It is clear that natural, human identical progesterone decreases the risk of breast cancer while synthetic progestin (Provera) increases breast cancer risk. Again, progesterone does not equal Provera.

In the PEPI trial of 40,000 women, it was shown that estrogen and progestin increased the risk of heart disease, whereas estrogen and natural progesterone did not. Provera increased cholesterol and clotting; progesterone caused the exact opposite and actually protected the heart. This July 3, 2002 study from JAMA shows the same results. It amazes me that it still comes as a surprise to the medical community that progestins increase the risk of heart disease and breast cancer when it is so well documented in our literature: Provera antagonizes the inhibitory effects of Premarin on coronary artery arteriosclerosis. (Arterioscler Thromb Vasc Biol 1997 Jan; 17(l):217?21) By now it should be apparent that not only does progesterone ;e Provera, it is it's exact opposite.

An article in the journal American Family Physician showed that Provera and progestins cause significant side effects of swelling, fluid retention, breast tenderness, bleeding, depression and mood disorders. Progesterone is devoid of these side effects.

What About Premarin by Itself?

The recent JAMA article stated that Premarin by itself did not increase the risk of breast cancer. The National Breast Institute and the National Institute of Health have emphatically stated that there is no conclusive evidence that Premarin alone causes an increased risk of cancer. Overall 75% of the studies in the medical literature show no increased risk of breast cancer?? the risk comes into play in the addition of a synthetic progestin (Provera). Although, there are a few ?studies that show a slight increased risk of breast cancer with Premarin, the overall risk from these few studies is still very low. In summary, most studies show no increased risk of cancer and a few studies show a very low risk, if any, with the use of Premarin by itself.

It is my opinion that we should not use Premarin because it produces cancer-causing metabolites. Premarin contains equilin, which has been reported in cancer research journals to cause cancer. (Chem Res Toxicol 1999 Feb; 12(12(:204?13)

We should also look at the absolute risk, discussed in the JAMA paper, versus relative risk. There is an increased absolute risk of breast cancer of 8 per 10,000 women (a risk, but a very small risk), The risk of heart disease increased 7 per 10,000 women. Again, statistically significant, however a very small risk overall.

As far as the cardiovascular risks are concerned, this applies to a very small segment of the population. First, we know that menopause causes a significant increased incidence of heart disease. There is a plethora of information and literature over 30 years documenting a 50% decreased risk of heart disease by taking estrogen. But the problem with these recent studies and conclusions is that they evaluated only women with pre?established coronary disease and possibly genetic predisposition to further heart disease. One cannot extrapolate these abnormal results in patients with pre?established disease to include those without disease when years of study have shown benefits to those patients without heart disease. In addition these studies utilized a progestin that we already know causes heart disease!

Where Do We Go From Here? Natural, Biologically Identical Hormones, of Course!

The original intent of using the bio-identical, natural hormones is to avoid the side effects and complications of the synthetics. What needs to be clarified is that the concern is only with the synthetic progestin, whereas the media and newspaper generalize that all hormones are damaging. The solution to the problem is the same that we have been recommending for years?natural, bio identical estrogen, progesterone, and testosterone. The landmark papers that document the importance of this therapy over the problematic synthetic hormones are: Infertility And Reproductive Medicine Clinics Of North America Vol 6, number 4, Oct 1995, and Obstetrics And Gynecology Clinics Offorth America Vol 21, number 2, June 1994.

None of these studies provide any new information to me nor do they affect the way I prescribe hormones. The recent WHI studies are finally the eye opener for both patient and doctor to avoid the synthetic hormones and replace what normally occurs in the human body. Menopause results in a tremendous increased risk of heart disease, osteoporosis, urogenital atrophy and cerebral deterioration--all which can be prevented by simply maintaining biologically identical hormone levels. And in spite of the health benefits, we should not ignore the symptomatic improvement and quality of life issues that are the primary reason to use the hormones in the first place. Just use the right hormones at the right doses and monitor the levels. I hope that this clarifies all the issues.

Natural Hormones Verses Cancer Causing Synthetics:
Additional Resources

Conventional HRT not only fails to measure hormones and use physiologic doses, it uses synthetic, not-found-in-nature "hormones" that are foreign to the human body and cause a long list of unwanted side effects.

John Lee, MD
http://www.johnleemd.com/

Synthetic hormones are simply no replacement for natural hormones. After many years of getting poor or no results with conventional HRT in my practice, natural hormones proved more effective and safer than any other treatment I've seen or used.

Erika T. Scwartz, MD
Author, The Hormone Solution

What people need to understand is that when their natural hormones are at optimal levels in their youthful prime is when they are the healthiest. It's only when hormones decline and synthetic hormones are introduced to the body that we see these problems. In my practice of prescribing natural hormones to women for five years, I have never seen the problems and side effects as we have seen with the synthetic hormones. Why not replace the body with biologically identical hormones. Anything else, as we have seen with the recent discontinuation of the WHI Trials, is dangerous to a woman's health.

Neal Rouzier, MD
Author, Natural Hormone Replacement for Men and Women: How to Achieve Healthy Aging.

In conclusion, we agree that this study [International Position Paper on Women's Health and menopause] has established that women taking continuous combined HRT with oral Premarin and Provera should discontinue therapy because the albeit small risks outweigh the benefits of the therapy. We do not, however, believe that this study has at all reduced the importance of replacing a woman's loss of estrogen during the perimenopause and beyond. Simply put, there is a better way. The available clinical, animal, and laboratory data all point to the benefits-without the risks mentioned above-of Dermal estradiol replacement with micronized progesterone, if a woman has not had a hysterectomy, to protect her heart, bones, brain, mood, skin, and eyes.

Joseph M. Raffaele, MD
Anti-aging Medicine Associates Manhattan
http://www.antiagingny.com/

Natural Hormone Replacement For Women Over 45 shows how natural hormone replacement offers a safe and effective alternative for the treatment of menopause. Conventional hormone replacement treatment as prescribed by most medical doctors in the United States, relies on unnatural versions of the hormones progesterone and estrogen that are dangerous and completely foreign to a woman's body. Risky and unpleasant, conventional hormone replacement treatment has long been women's only choice because of the influence of the drug companies. Natural Hormone Replacement For Women Over 45 provides compelling evidence that natural hormone replacement provides all the benefits of conventional treatment, but with drastically reduced risks of unwanted side effects and cancer.

Jonathan V. Wright, MD and John Morgenthaler
Natural Hormone Replacement -- For Women Over 45 ... The safe and natural menopause treatment alternative.
Copyright © 1997 Smart Publications - ISBN: 1-9627418-0-9

The report [International Position Paper on Women's Health and menopause] does not present any new research. Instead, its findings are based on a review of previously published research, most of which focused on elderly women with established disease...

The North American Menopause Society (NAMS), a well-respected authority on menopause, does not recommend making any changes in its current HRT recommendations as a result of this study

Hope Ricciotti, MD
Assistant Professor
Obstetrics, Gynecology & Reproductive Biology
Harvard Medical School

It is important to consider that not all estrogens and progestins are used with the same dosage, route of administration...and, mostly, different estrogens do not show the same bioavaliability and tissue effects. The available data do not allow to discriminate for all these variables and therefore it is inappropriate to consider jointly all forms of hormonal therapy.

Climacteric 2001; 4: 181-193
Hormone Replacement Therapy and Cancer

BIO-IDENTICAL Natural Hormones (BINHs) are hormones that are molecularly (bio chemically) identical to your true major ovarian steroid hormones-- progesterone, estradiol, estrone, estriol and testosterone. They are derived from a Natural source soybean or yam and are BIO-IDENTICAL to your ovarian Hormones-- thus, the name BIO-IDENTICAL Natural Hormones (BNHs).

Angela Svoboda,
Pharm.D., BCPS