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Feature Article
Bioidentical Hormones
To E or not to E™?
(Updated May 2008) - 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 faced This is a confusing time for women in understanding the facts of bioidentical hormone replacementwith 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 bites. 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, which mimic Mother Nature. 

What is bioidentical hormone therapy?

Bioidentical hormone therapy (BIHT) is an approach, which mimics the normal physiology of the human female by providing the identical molecules in the same cyclical pattern.  BIHT can be found in pharmaceutical products ( Vivelle, Climara, Alora, Estragel, Estrasorb, Divigel, Evamist, Estrace, Prometrium ) and in custom formulas made by a compounding pharmacist.  It is noteworthy to add that there can be considerable variability in compounded products Perimenopause is a condition that usually begins by age 40.(estrogen and progesterone gel and cream formulations) and it is important to utilize an experienced compounding pharmacist who adheres to strict quality control measures.

The physician needs to verify the efficacy of the products, pharmaceutical or compounded, to ensure adequacy of the dosage.  Transdermal hormone preparations have fewer side effects than oral products.  Oral hormones can cause side effects such as headaches, gallstones and elevations in blood pressure, triglycerides and cholesterol.  They can also increase clotting factors which increase the likelihood of thrombophlebitis and strokes.

Perimenopause - the stage which precedes menopause
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 best treated with progesterone rather than estrogen since they often have adequate estrogen.


Menopause - the physical symptoms
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. 

Menopause - the emotional and mental symptoms
Estrogen deficiency has been associated with depression, poor memory Lack of estrogen is associated with fuzzy thinking like "cobwebs on the brain"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.  

Many of these acute symptoms can be controlled with various nutritional supplements and herbs which make a woman more comfortable. These all have a place in helping a woman go through that transition in her life.

To E or not to E™?  That IS the Questrogen™

"The Long term consequences of estrogen deficiency"

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, which for most of us is the most frightening disease of all because what good is it to be alive if you have no awareness of your existence. 
 
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.  
 
Hormone replacement 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.  

What about the WHI Study?
The Women's Health Initiative is an important study which reported some very disturbing findings of an increased risk of heart disease, breast cancer and strokes among women taking HRT. 

( Click here to view the abstract linking Prempro use in menopause to increased breast cancer risk  JAMA 289: 3243-3253, 2003  )

However, it is critical to note that the study involved the use of a specific product called Prempro, which is a combination of Premarin and Provera, taken daily. Premarin is conjugated equine estrogens and Provera is medroxyprogesterone. The adverse effects may be a result of the Premarin, the Provera, or from the unique combination of bothProvera is a synthetic form of progesterone.   Premarin is a synthetic estrogen made from the urine of pregnant mares!   Is it any wonder that a woman’s body might not react well to continuous exposure to pregnant horse urine?   
 
A safer choice is to take estradiol and progesterone which are both bioidentical to the estrogen and progesterone of a human female.  Yet in the mass frenzy of the media all hormones have been lumped into one category.  The implication being that if Prempro was bad then all hormones must be bad!  Rarely in medicine are issues that simple.  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, i.e., BIHT, that closely approximates the natural physiologic human state, we are less likely to encounter worrisome side effects.

Are there studies using BIHT? 
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 BIHT over Prempro and Premarin

Click here for the abstract showing no increase in breast cancer from use of bioidentical hormones ( delivered via transdermal estradiol and oral progesterone) de Lignieres, Climacteric 5 (4): December 01, 2002, pp 332-340.

Hormonium™


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, i.e., BIHT, that closely approximates the natural physiologic human state, we are less likely to encounter worrisome side effects.  No prescription drug, including hormones, is without side effects. That is why it requires a prescription, so that your physician can safely develop a hormone program, which takes into account your medical concerns.   It is also important to recognize that estrogen,  progesterone and testosterone exist in harmony with the other hormones os the endocrine system - a state I call Hormonium™.  Being mindful of this interplay between hormones requires the skill of an endocrinologist who is the definitive hormone specialist.  It is ideal when BIHT 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 BIHT. 

UPDATE - MAY 22, 2008

I read with interest the recent meta-analysis study published in the British Medical Journal, May 15th, 2008 issue showing that oral hormone replacement pills 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 analysis of eight observational studies and nine randomized control trials found that hormone replacement therapy given as a patch showed no significant risk unlike the pills. 

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) who would be more likely to already have disease.  Now this meta-analysis shows that the risks in that study were also related to the fact that they used only oral estrogens and progestins.

Nonetheless when that study came out in 2002, millions of women were abruptly taken off all hormones, even transdermal preparations were made to suffer needlessly.   In my own practice, very few of my patients were taken off their transdermal hormone preparations when WHI came out.  Once I explained to them that this study involved oral synthetic horse estrogen and synthetic progestin, they were comfortable with continuing their transdermal therapy. 

The amazing fact is that this association of increased risks of clots with oral hormones is not a new finding.  It was first reported in the literature in the 1970’s! 
Transdermal estradiol was introduced in 1986 because it was a safer form of therapy.  When estradiol is taken orally, it goes to the liver and causes unhealthy production of clotting factors which can cause strokes, heart disease and phlebitis.  Furthermore, oral estrogen causes increased risk of  hypertension,  elevated cholesterol, gallstones, migraine headaches and weight gain.  Why would I want to subject a woman to all those increased risks when I could avoid them by simply prescribing transdermal hormones?  That is why I have been a proponent of transdermal preparations since 1986 when they were first introduced. 

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