The next in a series of articles published recently by Dr Michael Cutler on the “Easy Health Options” website. Michael Cutler, M.D. is a board-certified family physician with 18 years’ experience specializing in chronic degenerative diseases, fibromyalgia and chronic fatigue.

A graduate of Brigham Young University, Tulane Medical School and Natividad Medical Center Family Practice Residency in Salinas, Calif., he serves as a medical liaison to alternative and traditional practicing physicians. His practice focuses on an integrative solution to health problems.

These articles are reprinted with permission from “Easy Health Options”. In-text bolding by HCS.

Natural Ways to Deal with Menopause – Part 3

May 26, 2014

http://easyhealthoptions.com/natural-ways-deal-menopause-part-3/ 

Previously, I explained the important differences between synthetic and real estrogens and progesterone, including the research showing the benefits of the real, natural hormones (information that is still being ignored by mainstream doctors).

Women who take hormones should be taking natural progesterone with or without natural estrogen. You also need to know what happens when estrogen becomes dominant relative to progesterone levels.

Bio-Identical Progesterone

When you start to reach menopause, progesterone levels usually drop even before estrogen levels. Low progesterone levels cause the classic symptoms of premenstrual syndrome (PMS). These include irregular, heavy or painful periods; breast tenderness; mood swings; irritability; insomnia; migraine headaches; and bloating (puffy face and extremities). Therefore, progesterone supplementation becomes very useful for many women even before menopause.

In the body, progesterone is primarily manufactured in the adrenal glands and ovaries, though some is produced in the brain.

What does progesterone do for women? First of all, progesterone regulates your menstrual cycle and prepares your uterus for gestation: We know that pregnancy requires high levels of it for gestation to occur. Progesterone is calming and provides for restful sleep. Most notably, it prevents the symptoms of PMS.

Reasons For Natural Progesterone

In addition to treating PMS symptoms, progesterone supplementation during or near the menopause years acts much like estrogen in treating menopausal symptoms (hot flashes, breast tenderness, decreased sex drive, vaginal dryness, irregular periods and even urinary leakage or urgency). A one-year trial of bio-identical transdermal progesterone cream in postmenopausal women produced a significant reduction in hot flashes, according to a 1999 report in Obstetrics and Gynecology. ^[1] But it has important long-term health effects, too.

While the media successfully portrayed synthetic progestin and/or oral estrogen as harmful for long-term use (which they are), they failed to proclaim the health benefits of long term bio-identical progesterone and transdermal (e.g. topical cream) estrogen. These benefits include protection from uterine and breast cancers, lowering your heart disease risk (one of many ways to do this) and reducing osteoporosis (only one of many ways to do this, too).

Progesterone Lowers Breast And Uterine Cancer Risk

A long list of studies have taught us that natural progesterone helps reduce breast cancer:

• In 1981, the Journal of Epidemiology ^[2] reported that 1,083 women were treated for infertility and followed for 13 to 33 years for incidence of breast cancer. The premenopausal risk for breast cancer was 5.4 times higher in women with low progesterone levels compared to those with normal levels, and there were 10 times more deaths from cancer in the low progesterone group compared with those with normal progesterone levels.
• A 2002 study reported in Cancer Epidemiology, Biomarkers & Prevention ^[3] showed in a case-control study looking at third-trimester progesterone levels and breast cancer risk that increasing levels of progesterone were associated with decreased risk of breast cancer. This association was strongest before the age of 50. They also found that those in the highest quartile of progesterone levels had a 50 percent reduction in breast cancer compared with those in the lowest quartile of progesterone levels.
• In 2003, researchers found that transdermal or vaginal progesterone cream for four weeks reduced uterine lining thickening caused by an estrogen drug in postmenopausal women. ^[4]
• In 2004, a prospective study of progesterone levels and associated breast cancer risk in 5,963 women was reported in the International Journal of Cancer. ^[5]
• In 2008, researchers reported that they had followed 80,000 postmenopausal women for more than eight years. They showed that using natural progesterone along with estrogen significantly reduced breast cancer risk compared to the use of synthetic progestin. ^[6]

Progesterone Improves Heart Health

Progesterone also is beneficial to heart health. It has a vascular relaxation effect (to lower blood pressure and the strain on the heart). The Women’s Health Initiative studies showed that progesterone (unlike synthetic progestins) increases the cardio-protective effects of estrogen and reduces the risk of heart attack and stroke. Progesterone also improves lipid profiles and helps estrogen to improve lipid profiles (unlike synthetic progestins). There are several similar studies to show this beneficial heart health effect from natural progesterone.

Progesterone’s Effect On Bone Strength

Scientists have observed that natural progesterone stimulates osteoblast activity (new bone formation) and helps prevent osteoporosis. ^[7] Estrogen does, too. And when added together, progesterone and estrogen collaborate for maximal prevention of bone loss. ^[8]

The other contributors to bone loss are poor eating habits, vitamin and mineral deficiencies, and lack of exercise.

Bio-Identical Transdermal Estrogen

Natural estrogen (cream, not pills) replacement simply works better than synthetic estrogen pills do for reducing menopausal symptoms. A study using estriol therapy that was reported in the November 1987 Hormone and Metabolic Research ^[9] showed that it reduced menopausal symptoms in 92 percent of subjects and completely elimination hot flashes and sweating in 71 percent of the subjects. It completely eliminated depressed moods in 24 percent, and depressed moods were reduced in severity for another 33 percent. It also reduced headaches by two-thirds, and skin improved in some of the subjects. And there were no significant side effects reported.

Transdermal (topical) bio-identical estrogen does more than just control menopausal symptoms of estrogen deficiency. It provides these longer-term health benefits, too: prevention of memory loss, heart health, and improved sexual desire and functions. Added to progesterone, it also reduces breast cancer risk and strengthens bones, as mentioned above.

Estrogen For Better Memory

Animal and human studies show that transdermal estrogen replacement therapy, when started before menopause, decreases memory loss in older age. ^[10] In the Italian Longitudinal Study on Aging reported in 1998, researchers found that among the 2,816 women aged 65 to 84 years who were followed, the rate of Alzheimer’s disease was only one-fourth as much among estrogen users compared with the general female population of the same age and multiple other risk factors. ^[11]

A study reported in 1996 found that that among 156 women who reported taking estrogen after onset of menopause, those who later developed Alzheimer’s disease did so much later (delayed onset) and significantly less (60 percent fewer) compared with women who did not take estrogen. Also, those who had used estrogen longer than a year had even a greater risk reduction for Alzheimer’s disease. ^[12]

We know that transdermal estrogen lowers bad cholesterol (LDL) and raises good cholesterol (HDL). Coronary artery spasm, which precipitates a heart attack by squeezing down areas of the vessel where there is already atherosclerotic plaque, is decreased with the use of estrogen and also estrogen plus progesterone. ^[13] Estrogen lowers anti-thrombin III levels, thereby lowering recurrent venous thrombosis (vein clotting).

It is clearly known that transdermal estrogen supplementation reduces bone fracture rates in postmenopausal women. Subjects using only a low dose of only 0.1 mg per day stopped losing bone density and dramatically reduced their fracture rate as demonstrated in two clinical trials. ^[14][15]

Estrogen plus progesterone clearly decreases breast cancer risk. This was shown to be true in a double blind placebo-controlled trial ^[16] of women given estrogen plus progesterone prior to breast surgery reported in 1995. This was shown to be true in a randomized double-blind study ^[17] reported in 1998 and also in a primate animal study ^[18] reported in 2007.

Estrogen Dominance

Estrogen dominance occurs often because progesterone levels drop sooner and more dramatically than estrogen levels do, thus leaving estrogen levels too high relative to progesterone. The symptoms of estrogen dominance include anxiety, breast tenderness, headaches, allergies, fatigue, weight gain and more. This is largely due to progesterone deficiency, a poor diet, a consistently stressful lifestyle (high cortisol levels reduces progesterone), or exposure to hormone mimics (called xenoestrogens) from food, personal hygiene products, medications and plastics.

The health effects of natural transdermal estrogen and progesterone (oral or transdermal) supplementation are very different than the synthetic hormone versions often promoted by mainstream doctors.

In my next article I’ll briefly discuss the best lab tests available to check your hormone levels. If indeed your levels are off, there are several treatment options I recommend even before hormone replacement. I’ll discuss these dietary, lifestyle, herbal and nutrient supplement options; and I’ll show some example cases to illustrate how estrogen and progesterone replacement fit in to make all the difference if your hormones are low or out of balance.

To feeling good in life,

Michael Cutler, M.D.

References

[1] Leonetti HB, Longo S, Anasti JN. Transdermal progesterone cream for vasomotor symptoms and postmenopausal bone loss. Obstet Gynecol. 1999 Aug;94(2):225-8.

[2] Cowan LD, et al. Breast cancer incidence in women with a history of progesterone deficiency. Am J Epidemiol 1981;114(2)209-217.

[3] Peck JD, Huka BS, Poole C, et al. Steroid hormone levels during pregnancy and incidence of maternal breast cancer. Cancer Epidemiol Biomarkers Prev 2002;11(4):361-368.

[4] Leonetti HB, Wilson KJ, Anasti JN. Topical progesterone cream has an antiproliferative effect on estrogen-stimulated endometrium. Fertil Steril. 2003 Jan;79(1):221-2.

[5] Micheli A, Muti P, Secreto G, et al. Endogenous sex hormones and subsequent breast cancer in premenopausal women. Int J Cancer 2004;112(2):312-318.

[6] Fournier A, Berrino F, Clave-Chapelon F. Unequal risks for breast cancer associated with different hormone replacement therapies: results from the E3N cohort study. Breast Cancer Res Treat 2008;107(1):103-111.

[7] Heersche JN, Bellows CG, Ishida Y. The decrease in bone mass associated with aging and menopause. J Prosthet Dent. 1998 Jan;79(1):14-6.

[8] Seifert-Klauss V, Prior JC. Progesterone and bone: actions promoting bone health in women.  J Osteoporos. 2010 Oct 31;2010:845180.

[9] Lauritzen C. Results of a 5 years prospective study of estriol succinate treatment in patients with climacteric complaints. Horm Metab Res. 1987 Nov;19(11):579-84.

[10] Craig MC, Murphy DG. Estrogen therapy and Alzheimer’s dementia. Ann N Y Acad Sci. 2010 Sep;1205:245-53

[11] Baldereshi M, Di Carlo A, et al. Estrogen-replacement therapy and Alzheimer’s disease in the Italian Longitudinal Study on Aging. Neurology 1998 Apr;50(4):996-1002.

[12] Tang MX. Jacobs D, et al. Effect of oestrogen during menopause on risk and age at onset of Alzheimer’s disease. Lancet 1996 Aug17;348(9025):429-32.

[13] Minshall RD, et al. Ovarian steroid protection against coronary artery hyperreactivity in rhesus monkeys. J Clin Endocrinol Metab 1998;83(2):649-659.

[14] Lufkin EG, Wahner HW, et al. Treatment of postmenopausal osteoporosis with transdermal estrogen. Ann Intern Med 1992;117(1):1-9.

[15] Cicinelli E, Galantino P, et al. Bone metabolism changes after transdermal estradiol dose reduction during estrogen replacement therapy: A 1-year prospective study. Maturitas 1994;19(3):133-139.

[16] Chang KJ, et al. Influences of percutaneous administration of estradiol and progesterone on human breast epithelial cell cycle in vivo. Fertil Steril 1995;63(4):785-791.

[17] Foidart JM, et al. Estradiol and progesterone regulate the proliferation of human breast epithelial cells. Fertil Steril 1998;69(5):963-969.

[18] Wood CE, et al. Effects of estradiol with micronized progesterone or medroxyprogesterone acetate on risk markers for breast cancer in postmenopausal monkeys. Breast Cancer Res Treat 2007;101(2):125-134

.

This is the second in a series of articles published recently by Dr Michael Cutler on the “Easy Health Options” website. Michael Cutler, M.D. is a board-certified family physician with 18 years’ experience specializing in chronic degenerative diseases, fibromyalgia and chronic fatigue.

A graduate of Brigham Young University, Tulane Medical School and Natividad Medical Center Family Practice Residency in Salinas, Calif., he serves as a medical liaison to alternative and traditional practicing physicians. His practice focuses on an integrative solution to health problems.

These articles are reprinted with permission from “Easy Health Options”. (In-text bolding by HCS.)

Natural Ways to Deal with Menopause – Part 2

May 19, 2014

http://easyhealthoptions.com/natural-ways-deal-menopause-part-ii/ 

In my previous article I explained the important functions of estrogen in a woman’s body. I also mentioned some of the dietary contributors to hot flashes and other menopausal symptoms and listed the symptoms to look for when nearing the menopausal years. In this article I’ll explain the differences between synthetic and real estrogen and between synthetic progestins and real progesterone. I’ll share some of the scientific literature that makes this clear distinction, despite mainstream medicine’s continued ignorance concerning bioidentical hormones. 

Real Versus Synthetic Estrogen

What is synthetic estrogen? You may have heard of brand names such as Premarin®, Estrace® and Estraderm. These contain hormone molecules such as sodium equilin sulfate, 17 alpha and 17 beta-dihydroequilin, and 17alpha-estradiol. These synthetic estrogens are molecules that have been manipulated in a laboratory and don’t carry the same health benefits as hormones manufactured naturally in your body. But doctors and the public weren’t told this until as recently as 2002. The concept that synthetics are not as good as natural hormones seems pretty obvious — unless, of course, you are a pharmaceutical company and there is big money to be made from confusing the issue.

That’s what happened. Beginning in the 1970s, these companies told us that synthetic hormones were proven to be safe and, therefore, we prescribed them — almost universally to woman nearing menopause — in order to reduce their menopausal symptoms and long-term cardiovascular disease risk. We did this even though half of those women who used synthetic hormones quit taking it after one year because of adverse symptoms they could not tolerate.

Fortunately, a large study completed in 2002 called the Women’s Health Initiative (WHI) ^[1] revealed the truth: Synthetic oral estrogen plus progestin therapy is actually not as safe as we thought.

The Women’s Health Initiative again reported this effect of progestin (not progesterone) in 2009 with a report in the New England Journal of Medicine ^[2] and in 2010 with a study reported in the Journal of the American Medical Association ^[3] looking at more than 16,000 postmenopausal women from 40 U.S. clinical centers over nearly six years. These studies involved women taking synthetic, chemically modified prescription hormones for extended periods and showed that they had an increased incidence of breast cancer, ^[4] a higher risk of heart attack and stroke, ^[5] and increased chances of pulmonary embolism.

In reaction to these reports, headline news generated by the mainstream media warned that hormone therapy is dangerous, ignoring the fact that these studies pertained to synthetic hormones (not natural hormones). Television, radio and Internet reports made blanket assertions that the risks of hormone replacement therapy (HRT) exceeded the benefits. As a result, approximately 50 million women felt lied to by the medical system and were faced with going cold turkey off their hormones and living with symptoms and chronic effects of insufficient hormone levels.

Therefore, it is so very important to distinguish between synthetic and real (bioidentical) estrogen and progesterone. Natural estrogens are made in a woman’s body and are called estrone (E1), estradiol (E2) and estriol (E3).

Taking estrogen by mouth carries some health risks from unnatural metabolites created when it passes through your liver. But this doesn’t happen when it reaches your bloodstream by being applied to your skin. At the same time, progesterone is naturally manufactured and metabolized and can safely be taken by mouth or topically.

Even large clinical trials have now verified that natural (bioidentical) estrogens and progesterone are effective for curbing menopausal symptoms, plus they are safer and more effective in reducing diseases such as breast cancer, cardiovascular disease, osteoporosis and Alzheimer’s dementia, which I’ll discuss in my report next week.

Progesterone Versus Synthetic Progestins

Progesterone is a hormone the female body makes and needs for many health reasons. What are synthetic progestins? These are unnatural hormones known as medroxyprogesterone (Provera®), Norethindrone, Levonorgestrel and Norethindrone acetate. Biochemically, our bodies do not know how to manufacture synthetic progestins, nor do we naturally make any enzymes (that science has identified) to properly metabolize progestins.

It’s interesting that the American College of Gynecology still promotes the use of synthetic progestins while calling bioidentical progesterone a “so-called” hormone.

However, the scientific literature shows us that synthetic progestins promote breast cancer.

• The 1995 Nurse’s Health Study reported that in 58,000 postmenopausal women followed for 16 years, estrogen (oral) alone increased risk for breast cancer by 23 percent, but addition of synthetic progestin resulted in tripling the risk. ^[6]
• In 2000, Rose and colleagues compared breast cancer risk between 1,897 postmenopausal women on oral estrogen and synthetic progestin to 1,637 control women who had never used hormone replacement therapy. They found that the risk for breast cancer increased by 25 percent for every 5 years of progestin use compared with estrogen alone. ^[7]
• Lyytinen and colleagues in 2009 reported on the use of estrogen and a synthetic progestin and found increased breast cancer rates in 3 years. ^[8]
• There are many more such clinical studies with similar results that I could share with you.

Now consider how natural progesterone affects breast cancer. There are at least eight well-designed studies showing with clear clinical significance that the use of natural progesterone lowers the risk of breast cancer.

Another important difference between progestins and bioidentical progesterone is how they affect cardiovascular health. Synthetic progestins cause vasoconstriction while progesterone causes vascular relaxation. Also, lipid (cholesterol) profiles are worsened with progestins, but improved with progesterone. There are plenty of studies to show this in the peer-reviewed scientific literature too.

I want you to be clear about the difference between the synthetic and the natural forms of these two hormones so that I can continue my discussion in my next article about the delicate balance between these two and what symptoms to look for that indicate estrogen dominance or estrogen insufficiency relative to progesterone.

Michael Cutler, M.D.

References

[1] Rossouw JE, Anderson GL, Prentice RL, et al. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women’s Health Initiative randomized controlled trial. JAMA.2002 Jul 17;288(3):321-33.

[2] Chlebowski RT, et al. Breast Cancer after Use of Estrogen plus Progestin in Postmenopausal Women. N Engl J Med 2009; 360:573-587.

[3] Chlebowski, RT, et al. Estrogen Plus Progestin and Breast Cancer Incidence and Mortality in Postmenopausal Women. JAMA. 2010;304(15):1684-1692.

[4] Colditz GA, Hankinson SE, Hunter DJ, et al. The use of estrogens and progestins and the risk of breast cancer in postmenopausal women. N Engl J Med. 1995 Jun 15;332(24):1589-93.

[5] Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women JAMA. 2002;288(3):321-333.

[6] Colditz GA, Hankinson SE, Hunter DJ, et al. The use of estrogens and progestins and the risk of breast cancer in postmenopausal women. N Engl J Med 1995;332(24):1589-1593.

[7] Ross RK, Paganini-Hill A, et al. Effect of hormone replacement therapy on breast cancer risk: estrogen versus estrogen plus progestin. J Natl Cancer Inst 2000;92(4):328-332.

[8] Lyytinen H, Pukkala E. et al. Breast cancer risk in postmenopausal women using estradiol-progestogen therapy. Obstetrics and Gynecology 2009;113(1):65-73.

This series of articles was published recently by Dr Michael Cutler on the “Easy Health Options” website. Michael Cutler, M.D. is a board-certified family physician with 18 years’ experience specializing in chronic degenerative diseases, fibromyalgia and chronic fatigue.

A graduate of Brigham Young University, Tulane Medical School and Natividad Medical Center Family Practice Residency in Salinas, Calif., he serves as a medical liaison to alternative and traditional practicing physicians. His practice focuses on an integrative solution to health problems.

These articles are reprinted with permission from “Easy Health Options”. In-text bolding by HCS.

Natural Ways to Deal with Menopause – Part 1

May 12, 2014  

http://easyhealthoptions.com/natural-ways-cope-menopause-part-1/ 

Too many doctors and women don’t understand what happens in the body during menopause. But if you can grasp how this stage of life alters hormonal balance and changes other functions, you can cope more effectively with menopause and its symptoms.

What Many Women Don’t Know About Menopause

Most women probably know that menopause is defined as the time in your life when your ovaries no longer release eggs, naturally ending your reproduction at 40 to 50 years of age. Not only are your eggs gone, but your body responds to rapidly fluctuating and dropping hormone levels. The symptoms of perimenopause vary greatly from person to person. During the few years before menopause (when your periods end), your ovaries produce decreasing amounts of estrogen, triggering a host of possible symptoms. These symptoms usually lessen during the postmenopausal years.

Yet did you know that even after menopause, estrogen continues to be manufactured by your adrenal glands and your body fat? But these two sources normally produce much lower amounts of estrogen than your ovaries used to make, and they cannot keep up with your body’s demands for estrogen when menopause comes.

I think it would be interesting for you to know all the important functions of estrogen in a woman’s body. Natural estrogen:

• Increases sexual interest.
• Improves mood by increasing brain serotonin; less depression, anxiety and irritability.
• Enhances energy and improves sleep.
• Keeps skin thick and soft, maintains skin collagen, decreases wrinkles and helps you retain your teeth.
• Regulates body temperature. (Hot flashes begin when estrogen is low.)
• Helps maintain muscle and prevent muscle damage, and helps fine motor skills.
• Helps keep memory strong and protects you from Alzheimer’s disease (via acetyltransferase stimulation); improves reasoning, concentration and creativity.
• Decreases the overall risk of heart attack by 40 percent to 50 percent when it: decreases blood pressure by keeping arteries elastic and naturally dilating them, decreases oxidized LDL (bad cholesterol); increases HDL (good cholesterol); inhibits platelet stickiness; decreases arterial plaque accumulation; decreases lipoprotein; reduces homocysteine
• Improves insulin sensitivity (decreasing diabetes risk).
• Maintains bone density.
• Decreases risk of cataract and macular degeneration.
• Decreases risk of colon cancer.

As you read this list, you can see why decreasing estrogen levels of menopause can so adversely affect a woman. You can also see that the degree of symptoms caused by estrogen deficiency in perimenopause can vary and is affected by your underlying health.

According to the Center for the Advancement of Health, menopause symptoms of hot flashes and night sweats affect Japanese women significantly less than their North American counterparts. Only about 10 percent of women in China and 22 percent of women from Japan report hot flashes, compared to an estimated 75 percent of women in the U.S. over age 50.

The explanation could relate to dietary health: U.S. women eat much more meat, approximately four times the fat, and less than half the fiber as do Asian women whose diet is high in rice. From the higher-fat diet we expect higher estrogen levels, and with the rapid drop in estrogen levels from menopause the effect is much more dramatic in U.S. women than Asian women. Also, soy (tofu, miso, tempeh) is a staple food in Japan, and it contains genistein and daidzein, which are estrogenic.

Some women feel that dairy products in the U.S. contribute to the hot flashes of menopause. It has been observed that diets high in cold-pressed oils, green leafy vegetables, nuts, and other mineral- and fiber-rich foods decrease the symptoms of menopause.

Menopausal Symptoms

Without sufficient estrogen, any woman will eventually feel symptoms. You may not even realize they are related to estrogen deficiency. Here are some symptoms and signs of menopause.

• Weight gain
• Hot flashes
• Night sweats
• Vaginal dryness
• Mood swings, depressed mood, anxiety
• Breasts that shrink, sag or lose plumpness
• Breast soreness
• Loss of shapeliness at the waist
• Wrinkles around eyes
• Irritability, panic attacks
• Insomnia
• Loss of sexual desire
• Facial hair growth, hair loss (head)
• Strange dreams
• Urinary leakage, urinary tract infections, frequent urination
• Vaginal itching
• Lower back pain
• Bloating, gas, indigestion
• Aching joints (ankles, knees, wrists, shoulders, heels)
• Snoring
• Heart palpitations
• Varicose veins
• Dizzy spells
• Memory lapses
• Migraine headaches
• Painful intercourse
• Lower back pain
• Vertical lines above mouth
• Dry or irritated eyes

That is quite a list. I have good news about the safety and effectiveness of using natural hormone replacement which I’ll discuss in future articles.

To feeling good in life,

Michael Cutler, M.D.

References:

http://www.sciencedaily.com/releases/1998/07/980727080103.htm

Ho SC, Chan SG, Yip YB, Cheng A, Yi Q, Chan C. Menopausal symptoms and symptom clustering in Chinese women. Maturitas. 1999;33(3):219-27.

Melby MK. Vasomotor symptom prevalence and language of menopause in Japan. Menopause. 2005;12(3):250-257

The following Statement on Bio-identical Hormones from the International Hormone Society (IHS), is an online petition to the US Food & Drug Administration. IHS is a group of physicians with two major goals: One is to make the public aware of the importance and availability of doctors specializing in the medical science of hormone deficiencies or excesses and in the medicine of aging. The second goal is to work within the medical community to bring the “medicine of aging” to a more prominent level of utilization in the various medical specialties.

Posted with permission from Dr Thierry Hertoghe , President of the International Hormone Society.

http://intlhormonesociety.org/index.php?option=com_content&task=view&id=31&Itemid=53&tomHack_idp=9

December 05, 2006

After a literature review and discussions with physicians from all over the world who are well versed in treating patients with endocrine abnormalities, we, the members of the International Hormone Society, think the time is right to release a statement on the use and delivery of bio-identical hormones.

A “bio-identical hormone” has exactly the same chemical structure as a hormone produced by the human body. The term “bio-identical” is generally used for preparations containing sex hormones such as estradiol, estrone, estriol, progesterone and testosterone. The alternatives are non-bio-identical hormone preparations such as those widely commercialized in most birth-control pills and in post-menopausal hormone treatments. The prevailing concept is that bio-identical hormones may be safer to use than non-bio-identical hormones because they fit the body, in particular when a safer route of administration is used such as transdermal delivery.

The members of the International Hormone Society were concerned about product safety long before the publication of studies such as Women’s Health Initiative [WHI] in 2002 and the British One Million Women study in 2003 that found an increase in the incidence of breast cancer in postmenopausal women using non-bio-identical hormones as compared to placebo or nonusers. In the WHI study, the use of non-bio-identical female hormones was also associated with an increased risk of cardiovascular and cerebrovascular diseases.

In accordance with the recommendations of a growing number of medical societies, the International Hormone Society, in a consensus on “Estrogen and Progesterone Treatment of Pre- and Postmenopausal Women” issued on December 11, 2005, did not and still does not recommend the use of non-bio-identical estrogens and progestogens for the treatment of ovarian deficiencies. However, the use of synthetically modified female hormones used for birth control may be considered for a limited time if no other contraceptive alternative exists. The consensus is based on an extensive review of the literature on the use of bio-identical and non-bio-identical estrogens and progestogens. Greater potential toxicity and risks were found in the non-bio-identical compounds.

On the other hand, the International Hormone Society did and still does recommend in the consensus the use of bio-identical estrogens, in particular estradiol and estriol, and also bio-identical progesterone, for the correction of ovarian deficiencies. In contrast with the recent Endocrine Society’s position (October 2006) and the American Medical Association’s resolution (November 2006) that state that little or no scientific and medical evidence exists to support the claims that bio-identical hormones may be safer, a review of the literature contradicts this statement. There currently is sufficient evidence confirming the greater safety of bio-identical sex hormones compared to the non-bio-identical ones, in particular when the transdermal, nasal or intramuscular routes are used instead of the oral route.

Critics object to bio-identical hormones sold by compounding pharmacies due to the lack of oversight by the Food and Drug Administration (FDA), and assume that there is no guarantee of dosage, purity, efficacy and safety. We share with the American Medical Association, the Endocrine Society, the American College of Obstetricians and Gynecologists, and the American Academy of Family Practitioners the concern that patients should be offered the best products at all times, and that all products must be as consistent as possible in dosage, and as pure, efficient and safe as possible.

The physicians of the International Hormone Society think they can provide a valuable, decisive opinion in this debate for two reasons. First, many of them have broad experience in the use of bio-identical hormones compounded by compounding pharmacies, experience which does not seem to be shared by the writers of the various positions and resolutions of the aforementioned societies. Second, the opinion of the International Hormone Society members is independent of any pressure from advertisers, sponsoring pharmaceutical firms, or compounding pharmacies.

The physicians of the International Hormone Society wish to stress the following points:

1. Control of compounding pharmacies: The production of bio-identical hormone preparations by compounding pharmacies is under control of the pharmacy state board in each state. This control has sufficiently warranted high quality products, in dosage, purity, efficacy and safety, to satisfy physicians. Better control may be acceptable as long as it does not restrict physicians from exercising their therapeutic freedom to prescribe compounded preparations for the full benefit of patients.
2. Major advantage of compounded preparations: Compounded preparations of bio-identical hormones offer a major, indispensable advantage over standardized preparations, namely that the dosage and formulation of the product can be tailored to each patient. Concentration and composition, including solvents or fillers, can be individualized to what the patient needs or is able to tolerate. We think personalized treatments such as those offered by compounding pharmacies offer the best prospect for optimal health care.
3. Production and distribution of bio-identical hormones is not limited to compounding pharmacies: The FDA approval of “bio-identical” hormones already exists in the form of patches and mass-produced estrogen gel and cream. Compounding pharmacies are merely making a cream or gel that better suits the individual patient.
4. Conjugated estrogens, an example of widely sold non-bio-identical hormones: The form of estrogen, conjugated estrogen, which initiated this entire debate, is actually an estrogen waste product found in the urine of pregnant mares. Many of the estrogens in horse urine cannot be considered “bio-identical” to the human body because they are structured differently than human estrogens. Although some of the estrogens are equivalent to human estrogen, they have been altered biochemically by conjugation. Conjugation takes place in the liver of horses and humans in order to excrete unwanted estrogen. Therefore, conjugated estrogen medications are not bio-identical because they are waste product forms of estrogen marked for removal by a horse liver.
5. Use of the term “bio-identical” hormones. The AMA’s request to the Food and Drug Administration to prohibit use of the commonly employed term “bio-identical hormones”, unless the preparation has been approved by the FDA, contradicts the first amendment rights of the Constitution of the United States, denying the freedom of speech ensured by the amendment, and unacceptably interferes with the rights of medical doctors currently prescribing compounded preparations of bio-identical hormones. Section 503A of the FDA Modernization Act of 1997 attempted to restrict the first amendment rights of compounding pharmacies, stipulating “that they refrain from advertising or promoting particular compounded drugs”. However, the Supreme Court, in a 2002 decision, found that restriction unconstitutional. In the words of the FDA itself: “The Supreme Court affirmed the 9th Circuit Court of Appeals decision that found section 503A of the Act invalid in its entirety because it contained unconstitutional restrictions on commercial speech”. This Supreme Court decision should firmly establish for all parties that first amendment speech applies to compounding pharmacies as to all Americans, and that first amendment speech does not require approval from anyone, including the FDA.
6. Testing: Most physicians who work with bio-identical hormones from compounding pharmacies use traditional blood tests, not saliva tests, as incorrectly stated by the American Medical Association (resolution of November 2006) and the Endocrine Society (position statement of October 2006).
7. Safety: As previously stated, there is currently sufficient evidence confirming the greater safety of bio-identical sex hormones as compared to non-bio-identical ones, particularly when administered transdermally, nasally or intramuscularly instead of orally.
8. Research: We recommend future research in this area, and, in particular, we support independent research on the potential risks and benefits of bio-identical and non-bio-identical hormones.

In conclusion, we urgently advise the American Medical Association to revise its position and the Food and Drug Administration to take all points of the International Hormone Society’s statement into consideration and to preserve physician’s rights to prescribe the best possible products for their patients, including compounded preparations of bio-identical hormones.

To see the references for this statement go to:

http://www.intlhormonesociety.org/ref_cons/Ref_cons_IHS_statement_on_bio-identical_hormones_.pdf