Bioidentical Hormone Therapy

For those familiar with the Women’s Health Initiative (WHI) that was sponsored by the National Institutes of Health the link between oral contraceptives and breast cancer is no surprise. Women who participated in the WHI and who used a combination of Premarin and Provera had an increased risk of breast cancer, heart disease, blood clots, and stroke.

Premarin contains estrogens from horses and Provera is the brand name for medroxyprogesterone acetate. They are not messenger chemicals that are normally found in the human body.

This article makes the mistake of referring to oral contraceptives as hormones. These chemicals do not meet the dictionary definition of hormone because they are not produced by the hormone glands of the human body. Because they are not normally found in the human body they have a different effect on the body’s hormone receptors: that effect is one of hormone disruption.

The estrogen component of the “estrogen+progestin-based birth control” consists of non-bioidentical chemicals like ethinyl estradiol that is not found in the human body. Likewise, the progestin component consists of chemicals like norethindrone that is not produced by the human body. Similar chemicals are also found in injectable contraceptives such as Depo Provera and implanted contraceptives such as Norplant and IUDs.

The side effect profiles of Premarin and non-bioidentical “estrogens” and Provera and so-called progestins is similar. It is unfortunate that many physicians prescribe them inappropriately not only for contraception but also for complaints of acne or diagnoses of polycystic ovarian syndrome, and amenorrhea. It is my opinion that these chemicals have no place in the human body because they poison hormone receptors and disrupt hormone physiology throughout the body.

If a woman seeks contraception I recommend natural family planning or barrier contraceptives such as condoms, diaphragms, and cervical caps.

Pete Chagnon – OneNewsNow – 5/26/2009 7:00:00 AM

A cancer awareness group says as schools pass out birth control to young girls, they are failing to notify them about an increased health risk.

According to Karen Malec, president of The Coalition on Abortion/Breast Cancer, young girls who are prescribed estrogen+progestin-based birth control by their school nurses are at an
increased risk for breast, cervix, and liver cancer. World Health Organization conducted a study in 2005 and found that type of birth control carcinogenic.

“In other words, they cause cancer in human beings,” she notes. “And they assign these drugs the highest level of carcinogenicity — the highest level is group one.”

Malec believes the worst time in a young woman’s life to be exposed to this level of carcinogen is before the birth of her first child. The Coalition is urging concerned parents and individuals to contact their school officials.

“But it’s really the doctors and the nurses who are responsible for giving the information to the high school officials. They’re not doing that, and so we’re just asking people to please contact the high school’s officials and let them know about this fact that the World Health Organization has acknowledged these drugs as cancer-causing.”

This afternoon I watched the Oprah Winfrey Show with featured guest Suzanne Somers speaking on the topic of bioidentical hormone therapy.

Suzanne Somers has been an important advocate for bioidentical hormone replacement and anti-aging medicine in general. She is now 62 and looks great!

I enjoyed watching the show and seeing many women explain how bioidentical hormone replacement therapy has given them their lives back.

There was one obstetrician gynecologist from Northwestern University who had an opposing viewpoint.

I’m sure that after watching the show many women had questions and reasons to rethink any treatment that they may have been receiving for perimenopausal or postmenopausal hormonal imbalances.

In my medical practice I first started with statically dosed bioidentical hormone replacement therapy and now I use rhythmically dosed bioidentical hormone replacement therapy. I have found the latter to be vastly superior.

FDA approval does not mean that a medication or drug is safe. In my opinion, it simply means that it benefits Big Pharma or that it does not conflict with its interests. Estradiol, progesterone, and testosterone are examples of hormones that are FDA approved. They are made by compounding pharmacies and they are also marketed by Big Pharma. Estriol is not FDA approved, but that does not mean that it is not safe. We know that Wyeth Pharmaceuticals, the maker of Premarin and PremPro, was the driving force behind the FDA’s crackdown on pharmacies that use estriol in compounded formulations. Yet, we also know that Wyeth sells two types of estriol drugs in Europe. How much more hypocritical can you get? See

Premarin and PremPro are FDA approved but contain estrogens derived from horse urine and the latter also contains medroxyprogesterone, a non-bioidentical chemical that has been shown to increase the risk of breast cancer, heart disease, and stroke.

As I sought to learn all about BHRT I read many books and attended seminars by Dr. Thierry Hertoghe, Dr. Jonathan Wright, Dr. Eldred Taylor, and T.S. Wiley. Ironically, the one that I found to be most helpful was not taught by a health professional: T.S. Wiley.

So like Suzanne Somers I endorse the Wiley Protocol ( and have seen outstanding results in my patients. Women feel like they are able to get their lives back, just like the women on Oprah today.

These are the things I like about the Wiley Protocol:

1) The hormones are identical to the ones that the human body makes.
2) Because the hormones are bioidentical they are able to form a perfect fit with the body’s hormone receptors, which results in physiological responses when dosed properly.
3) Dosing of the hormones is rhythmic and follows the pattern that we see in healthy young women with estradiol peaking on Day 12 and progesterone peaking on Day 21.
4) Among other things, the peak of estradiol on Day 12 causes activation of the progesterone and testosterone receptors, allowing these hormones to work better.
5) We are able to verify that women use the optimal amount of estradiol and progesterone by checking the levels on Day 12 and Day 21 of the cycle.
6) For postmenopausal women we synchronize the dosing schedule with the cycle of the moon.
7) Symptom relief is excellent. It simply works and patients are very happy with it.
8 ) Absence of side effects when dosed properly.
9) All the Wiley Registered Pharmacies use the same methods and raw materials to compound the Wiley Protocol hormones. This is very important! Standardization means that you can be sure that the Wiley Protocol hormones are exactly the same whether you get them from Knowles Apothecary in Kensington, Maryland, or any other Wiley Registered Pharmacy in North America.

The same cannot be said about other compounded hormones. There is no standard method for compounding Bi-Est and Tri-Est (estradiol/estriol +/- estrone combinations developed by Dr. Jonathan Wright) and other hormone creams. Different pharmacies use different compounding methods, raw materials, and bases to make these hormones so absorption and bioavailability may vary from pharmacy to pharmacy and even within the same batch if the hormones are not mixed properly.

10) The route of delivery is transdermal which is convenient and optimal compared to hormone injections, capsules, troches, and pellets. Transdermal application of hormones allows for rhythmic dosing, and absorption into the fat base creates a depot that fosters steady state serum levels of hormone. Oral estradiol produces undesirable changes in C-reactive protein and metabolites from the first-pass effect through the liver.

Here are some resources for further study:

“Sex, Lies, and Menopause” and “Lights Out” by T.S. Wiley
The Wiley

After having been referred to me by a colleague, a woman who was interested in bioidentical hormone therapy contacted me. She told me that she had suffered a stroke while taking FemHRT. She thought that FemHRT was a form of bioidentical hormone therapy and she asked me if the hormone therapy that I offer to my patients could put her at risk of developing another stroke.

This is a concern that many women have. In the mainstream media estrogen is depicted as a hormone that causes cancer and other health problems. It is this misinformation that causes many women to shy away from seeking treatment for hormone deficiencies or imbalances.

FemHRT DOES NOT contain bioidentical hormones. It consists of norethindrone acetate and ethinyl estradiol.

What is the difference between bioidentical hormones and nonbioidentical hormones?

Bioidentical hormones are messenger chemicals that are identical to hormones that the human body makes in its hormone glands. There is no difference. They are identical in every way. They are made from ingredients of wild yams or soy beans. So they are synthetic hormones but bioidentical. Examples of bioidentical hormones are estradiol, estriol, estrone, testosterone, progesterone, pregnenolone, dehydroepiandrosterone (DHEA), growth hormone, triiodothyronine (T3), thyroxine (T4), hydrocortisone, and aldosterone. The body’s hormone glands make all of these and more and compounding pharmacies are able to make them available for therapeutic applications.

“Nonbioidentical hormones” are not produced by the human body and as such they are considered foreign to the body. Examples are norethindrone, ethinyl estradiol, hormones from other species (e.g., Premarin which contains estrogens derived from horse urine), all oral contraceptives, and most injectable hormones. It would be better to refer to these chemicals as hormone disruptors because they are not hormones. I prefer to reserve the term hormones to those messenger chemicals that are produced by the hormone glands of a human body and their synthetic counterparts (bioidentical hormones).

In 2004, the National Institutes of Health discontinued the Premarin-Provera arm of its Women’s Health Initiative study 1 year early, citing an increase in the risk of breast cancer, heart disease, blood clots, and stroke in women taking the study medications. This study did not use bioidentical estradiol, estriol, estrone, or progesterone. Instead, in the Premarin-Provera arm of the study women were given Premarin, a drug which contains non-bioidentical hormones that are derived from horse urine and Provera (medroxyprogesterone).

There is no evidence that the use of bioidentical hormones increases the risk of developing cancer when the dosage schedule follows the pattern that we see in healthy, young individuals.

In a recent newsgroup message somebody posted a list of estrogen side effects (see below) in response to a research study which concluded that estradiol appears to be a useful treatment for women with schizophrenia.

Here is my response to that post.

This list of “side effects” of “estrogen” is misleading.

First of all, the term “estrogen” is very imprecise.

The three main endogenously produced estrogens which are also available as bioidentical formulations for hormone replacement therapy are estradiol, estriol, and estrone.

In the mainstream media and even in some of the scientific literature the term estrogens is used very loosely. It is often not clear to the layperson or health professional if it is used to reference endogenously produced estrogens, bioidentical replacement hormones, or nonbioidentical patent drugs like Premarin or ethinyl estradiol which are foreign to the body.

Many of the “side effects” listed below are unique to these nonbioidentical patent drugs which have very little in common with endogenously produced estradiol, estrone, and estriol.

When patients experience symptoms of hormonal imbalance it is important to consider the following elements:

1) The hormone levels could be too high – This is rare in the case of estradiol, except when patients are using supraphysiological doses of replacement hormones.
2) The hormone levels could be too low – This is most common in perimenopausal and postmenopausal women but is unfortunately more commonly seen in younger women of childbearing age as well.
3) The number of hormone receptors may have declined. Receptors are essential to hormonal functioning because it is only when a hormone connects with a receptor that a signal is transmitted to the cell.
4) Loss of rhythmicity – All hormones have unique rhythms that when disrupted can explain many symptoms that women experience when their hormones are out of balance.

Except for those “side effects” that are unique to nonbioidentical patent drugs, all other symptoms can be expected to improve if the bioidentical hormone replacement therapy is used to reestablish the optimal hormone levels AND the rhythm that we see in healthy young women.

“[Talking] to your doctor about the risks of taking estrogen” is usually an exercise in futility because most doctors (even endocrinologists and gynecologists) don’t know how to evaluate and treat hormone imbalances. This lack of knowledge and experience leaves women either hormonally depleted or with inadequate hormone replacement therapy using statically dosed bioidentical hormones or inherently dangerous patent drugs.

Here is a good resource for those who want to learn more about rhythmically dosed bioidentical hormone replacement:

Fred Bloem, M.D.

Sent: Tuesday, August 19, 2008 8:00 PM
Subject: Re: [IntPsy] Estrogen as a treatment for schizophrenia in women

Estrogen may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

breast pain or tenderness
upset stomach
weight gain or loss
leg cramps
burning or tingling in the arms or legs
tight muscles
hair loss
unwanted hair growth
spotty darkening of the skin on the face
difficulty wearing contact lenses
swelling, redness, burning, itching, or irritation of the vagina
vaginal discharge
change in sexual desire
cold symptoms
Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

bulging eyes
sore throat, fever, chills, cough, and other signs of infection
pain, swelling, or tenderness in the stomach
loss of appetite
yellowing of the skin or eyes
joint pain
movements that are difficult to control
rash or blisters
swelling of the eyes, face, tongue, throat, hands, arms, feet, ankles, or lower legs
difficulty breathing or swallowing
Estrogen may increase your risk of developing cancer of the ovaries or gallbladder disease that may need to be treated with surgery. Talk to your doctor about the risks of taking estrogen.

On Tue, Aug 19, 2008 at 2:22 PM, Dan Stradford wrote:
Estrogen in severe mental illness: a potential new treatment approach.
Kulkarni J, de Castella A, Fitzgerald PB, Gurvich CT, Bailey M, Bartholomeusz C, Burger H.
Alfred Psychiatry Research Centre, The Alfred and Monash University, School of Psychology, Psychiatry, and Psychological Medicine, The Alfred Hospital, Melbourne, Victoria 3004, Australia.

CONTEXT: Accumulating evidence suggests that estrogens may have therapeutic effects in severe mental illnesses, including schizophrenia, via neuromodulatory and neuroprotective activity. OBJECTIVE: To compare the efficacy of adjunctive transdermal estradiol with that of adjunctive placebo in the treatment of acute psychotic symptoms. DESIGN: Randomized, double-blind study. SETTING: Patients were recruited from inpatient acute hospital wards and outpatient clinics of 2 metropolitan Melbourne general hospitals. PARTICIPANTS: One hundred two women of childbearing age with schizophrenia. All participants were in an acute or chronic phase of their illness; 73 participants were outpatients and the rest were inpatients. Intervention Patients were randomized to receive 100 microg of transdermal estradiol (n = 56) or transdermal placebo (n = 46) for 28 days. MAIN OUTCOME MEASURES: Psychopathological symptoms were assessed weekly with the Positive and Negative Syndrome Scale. RESULTS: The addition of 100 microg of transdermal estradiol significantly reduced positive (P < .05) and general psychopathological (P < .05) symptoms during the 28-day trial period compared with women receiving antipsychotic medication alone. CONCLUSION: Estradiol appears to be a useful treatment for women with schizophrenia and may provide a new adjunctive therapeutic option for severe mental illness. TRIAL REGISTRATION: Identifier: NCT00206570.