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Hormone Replacement Therapy

This is a confusing time for women in understanding the facts of bioidentical hormone replacement

This is a confusing time for women in relation to hormone replacement therapy. On the one hand they have the option of taking hormones to relieve the symptoms of menopause but, on the other hand, they are facedwith conflicting data on the safety of taking hormone replacement (HRT).  It is important to stand back, look at the real facts and use a little common sense. All of us know that the mass media often tends to sensationalize the news to grab your attention and make it more interesting. The decision to take HRT is too important to be made on the basis of a few sound bytes. Rather it requires careful discussion with your physician, who can inform you on the pros and cons of estrogen replacement in your particular circumstances.  Knowledge is power. Use it to arm yourself with the data you need to make an informed decision.  Because safety is a paramount issue, the fallback position should be to provide hormones that mimic Mother Nature.WHAT IS BIOIDENTICAL HORMONE REPLACEMENT THERAPY? Bioidentical hormone replacement therapy (HRT) is an approach, which provides the same hormones found in a human female. Bioidentical HRT can be found in pharmaceutical products ( Vivelle, Climara, Alora, Estragel, Estrasorb, Divigel, Evamist, Estrace, Prometrium ) and in custom formulas made by a compounding pharmacist.

Perimenopause is a condition that usually begins by age 40.

Bioidentical HRT can also be made by compounding pharmacists who mix up various oral and topical preparations in their stores using techniques they learned in pharmacy school. However, pharmaceutical companies must meet stricter standards for quality control and efficacy.  Therefore pharmaceutical bioidentical hormones should be the first therapy of choice over compounded ones. Compared to other progesterone preparations, topical compounded progesterone has the poorest absorption and should not be used. Progesterone reduces a woman’s risk of uterine cancer. Uterine cancer has been reported from inadequate dosing of topical progesterone in women receiving estrogen preparations.

Physicians need to measure estradiol blood levels to verify effectiveness of the products and to ensure adequacy of dosage. Transdermal hormone preparations is the medical term for products applied topically to the skin as patches, gels or creams.  For clarity, I will refer to them as topical preparations. Topical hormone products have fewer side effects than oral products because they do not cause the liver to produce harmful byproducts.  See risks of oral estrogen below.


It is important for women to know about perimenopause, the time-interval preceding menopause which can last months to years.  It begins as early as the late 30’s but typically starts in the 40’s.  Perimenopausal women still have periods but often experience typical symptoms of menopause. These women are often best treated with progesterone rather than estrogen since they often have adequate estrogen.


Some women have the good fortune to have few or minimal symptoms as they go through menopause. However, for many of us, the advent of menopause brings such symptoms as sweats and hot flashes.

These can range from a mild sensation of feeling warm to a very red face and drenching sweats which are embarrassing and obvious to others. Insomnia can also occur and are characterized by awakening abruptly at 2 or 3 AM and being unable to fall back into a deep sleep. The woman gets up at 6 or 7 AM exhausted from having slept only three or four hours. Sleep deprivation can contribute to a whole host of symptoms such as chronic fatigue, irritability, dizziness, headaches, palpitations and a weakened immune system which leads to frequent colds.


Estrogen deficiency has been associated with depression, poor memory and concentration, and fuzzy thinking which my patients often describe to me as “cobwebs on the brain”.  Most of us are busy with responsibilities in the workplace and/or home. These symptoms can be very disruptive to anyone who is trying to be productive.   Some of these acute symptoms can be controlled with various nutritional supplements and herbs that make a woman more comfortable. These can have a place in helping a woman go through that transition in her life.


First let’s consider the risks of NOT taking estrogen.  Taking nutrients and herbs do not address the equally devastating symptoms which can occur as a consequence of long- term estrogen deficiency. These symptoms include:

1. Loss of bladder tone, leading to frequent urination and urgency and even urinary incontinence;

2. Vaginal dryness and atrophy, which makes sexual activity uncomfortable, decreases libido and can be very disruptive to an otherwise healthy relationship;

3. Osteoporosis, which causes brittle bones leading to life- threatening hip fractures and spinal fractures which cause loss of height and the familiar “dowager’s hump”. Of those women who suffer hip fractures,  fifty percent die of complications within a year of the fracture.

4. Alzheimer’s disease is the most frightening disease of all. What good is it to be alive if you have no awareness of your existence?

5. Heart disease and heart attacks occurs more commonly in women not receiving HRT.

Lastly, estrogen is important for healthy collagen production. Skin is less likely to thin and wrinkle prematurely in women who take HRT. Cosmetic surgery alone can not compensate for the loss of estrogen. Women on appropriate estrogen replacement are also less likely to develop the thinning hair so common to older women.

HRT can often result in blissful relief of many of these symptoms but women are frightened by a mass media who primarily emphasizes the dangers of estrogen.


When choosing any medicine for maintenance use, it’s wise to pick the product with the fewest side effects. It’s important to know that all estrogen has risks but oral estrogen has more risks than topical estrogen. When estrogen is taken orally, it goes to the liver causing production of harmful clotting factors, binding proteins and proinflammatory hormones, Oral estrogen leads to weight gain, sexual dysfunction, headaches including migraines, gallstones and elevations in blood pressure, triglycerides and cholesterol. The proinflammatory and clotting factors increase the risk of thrombophlebitis, heart disease and strokes.  The British Medical Journal, May 15th, 2008 issue showed that oral estrogen may double or triple the risk of clots. A meta-analysis is a review of multiple studies looking for a common finding in all the studies.  The French meta-analysis of eight observational studies and nine randomized control trials found that hormone replacement therapy given as a patch showed no significant risk of clots unlike the pills.

Why would I want to subject a woman to all those increased risks when I could avoid them by simply prescribing transdermal hormones?  That’s why I have been a proponent of transdermal preparations since 1986 when they were first introduced.


The Women’s Health Initiative (WHI) study in 2002 showed that oral horse estrogens and progestins (Prempro) increased the risk of breast and ovarian cancer and heart disease and strokes. Many experts feel the study design was flawed because they used older women (average age 62) some of whom had been on no HRT for 20 years so they were more likely to already have disease.  Furthermore, many of these risks may be from the use of oral estrogen.

When oral estrogen is combined with a daily dose of a synthetic progestin, like Prempro, in addition to the side effects of oral estrogen, the synthetic progestin confers more risks:  breast cancer, urinary incontinence, hearing loss, blood clots to the lungs (pulmonary emboli,) cognitive decline and dementia. Another possible explanation for the risks in WHI may arise from using synthetic hormones instead of the natural hormones.  Premarin comes from horse estrogen and the synthetic progestin, medroxyprogesterone (Provera) is substituted for progesterone. WHI utilized a specific product, Prempro, that combines Premarin and Provera in one pill that’s taken daily. So the adverse effects could be caused from the use of oral estrogens,  synthetic hormones or from the unique combination of two synthetic hormones.  Is it any wonder that a woman’s body might not react well to continuous exposure to pregnant horse urine?

Nonetheless when WHI came out in 2002, millions of women were abruptly taken off ALL hormones and made to suffer needlessly. The implication being that if Prempro was bad then all hormones must be bad!  Rarely in medicine are issues that simple.  In my own practice, once I carefully explained that WHI used oral synthetic horse estrogen and synthetic progestin, most of my patients were comfortable with continuing their transdermal therapy.  WHI was an important study showing Prempro was associated with adverse effects. However, these findings should be attributed to those specific formulations and not extrapolated to include all hormones.


It’s important to emphasize that ALL published studies on bioidentical HRT utilized pharmaceutical and NOT compounded bioidentical HRT. An important 2008 observational study, published in the European Heart Journal showed that in 698,098 Danish women followed for five years, women on combined oral estrogen plus oral synthetic progestin had a 35% increased risk of heart attacks while women on topical pharmaceutical gel or patch estradiol, with or without progesterone, had a 38% decreased risk of heart attacks.  Women on oral estrogen alone had no increase or decrease risk showing NO benefit compared to women taking no HRT.

There is a French study in 3175 women using transdermal estradiol and oral progesterone for 8.9 years which found no increased incidence of breast cancer.  More such studies need to be done including studies of preparations made by compounded pharmacists. However, for the time being, it seems prudent to choose the natural hormones, estradiol and progesterone, over Prempro and Premarin.


In summary, the human body is a wonderfully complex organism with many internal systems in place to ensure survival of the species.  The endocrine system is a powerful and important part of that system that has evolved over the millennia to regulate various organ systems.  To the extent that we can mimic Mother Nature and provide a woman with natural hormones like estradiol, progesterone and testosterone, we are less likely to encounter worrisome side effects.  No prescription drug, including bioidentical HRT, is without side effects. That is why it requires a prescription, so that your physician can safely develop a hormone program, that takes into account your medical concerns. Each woman needs to weigh the risks and benefits of HRT with her physician and decide what is best for her own body.  It is also important to recognize that estrogen, progesterone and testosterone exist in harmony with the other hormones of the endocrine system. Being mindful of this interplay between hormones requires the skill of an endocrinologist who is the definitive hormone specialist.  It is ideal when HRT is prescribed by an endocrinologist experienced in physiologic hormone replacement therapy.  If you do not have access to an endocrinologist, then seek out a physician with extensive experience in “pharmaceutical” bioidentical hormone replacement therapy.



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