In recent days, Suzanne Somers has graced the pages of prominent magazines and newspapers touting the benefits of bio-identical hormone replacement therapy (HRT). She has also written about them extensively in her book The Sexy Years. What makes this 60 year old former star of Three’s Company and breast cancer survivor look so young and vibrant. Ms. Somers credits her hormone therapy that her endocrinologist specially compounds for her.
While I applaud Ms. Somers for bringing hormone replacement therapy back into mainstream society after it was deemed unsafe by the flawed 2002 Women’s Health Initiative Study, hormone replacement therapy is not for everyone. One must first weigh the risks and benefits of the treatment after an extensive work-up.
Is there a difference between synthetic HRT and bio-identical HRT? Yes, there is. Wyeth pharmaceutical company introduced a synthetic estrogen product in the 1960’s which was derived from the urine of pregnant mares. You may know this commonly prescribed HRT as Premarin. This synthetic estrogen product was marketed as the fountain of youth for which menopausal women had been waiting decades to find. All menopausal women could benefit from this medication because it would restore a women’s vitality and sex-drive after she stopped menstruating.
Unfortunately, a large number of women taking Premarin developed uterine cancer because, as we now know, unopposed estrogen stimulates the uterine lining unless it is opposed by progesterone. Wyeth soon after combined the popular Premarin with medroxyprogesterone (MPA), a synthetic progestin , and marketed their product as Prempro. A progestin is not a bio-identical hormone. This is not the same progesterone that the ovaries produce. It is a synthetic hormone that was created in a laboratory only to protect the uterine lining from overgrowing from the effects of estrogen replacement therapy.
For the past 40 years, physicians had been prescribing this synthetic therapy and others like it for the relief of menopausal symptoms until the results of the Wyeth funded study on hormone replacement therapy known as the Women’s Health Initiative (WHI) as published in the New England Journal of Medicine in 2002. This much publicized study found an increase in advanced breast cancer, stroke, and deep venous thrombosis (blood clot in the leg) if women took combined Prempro for at least five years.
Since 2002, the WHI study has been scrutinized and restudied. A huge flaw of this study was that the investigators studied women in their sixties instead of their late 40’s and 50’s, the average age of menopause in this country. Of course these women would have an increase in stroke, heart attacks and blood clots because their age and high blood pressure (38% of the study’s participants were hypertensive) put them at risk for these adverse effects even without taking hormone replacement therapy. Secondly, after five years, the investigators failed to find an increase in breast cancer occurrence in women who had only taken the estrogen alone but an increase in breast cancer in those who had taken the combined estrogen and progestin therapy. What was the breast cancer culprit in this study? It appears that it was either the synthetic progestin, medroxyprogesterone or MPA in combination with estrogen. MPA has been known to cause bloating, vaginal bleeding and an adverse change in a women’s lipid profile as it increases one’s bad cholesterol known as LDL cholesterol. Could this progestin also stimulate breast cancer? So far the studies have been inconclusive. What the medical community did learn from this study was that women need to be carefully selected for hormone replacement therapy and it should only be used for the minimum amount of time that it takes for a women’s symptoms to improved.
Bio-identical hormone replacement therapy (BHRT) was born in the 1980’s. As a health food craze took over this country, women were looking for hormone replacement therapies that mimicked their body’s own hormones. BHRT naturally replaces the hormones that the ovaries and adrenal glands produced before menopause. Perhaps the word “natural” should not be interchanged with “bio-identical” since “natural” connotates a product that is derived from nature and bio-identical hormone therapy is prepared in a laboratory. It is true that the components of BHRT come from whole food products such as soy and yams; however the estrogen and progesterone from these food sources are chemically altered so they function just as they did in the ovary.
My patients often ask why they cannot purchase bio-identical HRT in a local pharmacy using their insurance plans. The Food and Drug Administration cannot issue a patent on a naturally occurring substance such as bio-identical estradiol and progesterone because it is identical to the hormones produced in the human ovary. Therefore, a large pharmaceutical company cannot mass- produce this product. They are instead compounded by an ever increasing number of compounding pharmacies which are unregulated as to the content of the BHRT and of course, the pricing.
Before using BHRT, you will need to consult with your doctor, preferably a gynecologist or endocrinologist, and undergo either an extensive blood hormone work-up or saliva test. With this information in hand, your doctor will then prescribe a personalized formula designed to specifically meet your needs. Prior to receiving BHRT, every woman should undergo a physical exam, Pap smear, annual mammogram and bi-annual bone density study or DEXA scan.
Bio-identical compounded hormones are prepared for maximal absorption. They may come in capsules, creams, sublingual drops or troches (lozenges), patches, vaginal creams and suppositories. The products used for BHRT are plant based. They may contain any or all of the following hormones: estradiol, estriol, estrone, progesterone, dehydroepiandrosterone (DHEA) and testosterone.
It generally takes between two and four weeks for hormone levels to stabilize once therapy has been initiated. Hot flashes, moodiness, irritability, and sleep disturbances usually begin to subside in the first week of use.
The side-effects that you may experience during the first six weeks of BHRT use include the following: breast tenderness, vaginal spotting or bleeding, nausea, headaches and bloating. If bleeding is heavy and lasts more than three days, please call your doctor’s office to schedule a visit. You may be asked to undergo a transvaginal ultrasound of the uterus to assess the uterine lining and /or undergo an in-office biopsy of the uterine lining known as the endometrium.
What are the components of bio-identical hormone replacement therapy?
PROGESTERONE
Progesterone is an important hormone for normal reproductive and menstrual function in reproductive years. It influences the integrity of bone, blood vessels, heart , brain, and skin among others. Progesterone is the building block for other hormones such as DHEA, cortisol, estrogen and testosterone. It also plays a role in mental well-being, sugar balance, libido thyroid and adrenal function. It has been shown to increase bone density and decrease the risk of bone fracture and can, by itself, be used to decrease hot flashes. Furthermore, progesterone is a natural diuretic that decreases bloating.
In the premenopausal woman, progesterone can be used to reduce the size of fibroids , thereby avoiding surgery and can also help to reduce the size of endometrial implants and reduce pain in patients diagnosed with endometriosis. Progesterone has also been used extensively to prevent the irritability, breast tenderness, bloating and perceived weight gain in the weeks preceding a woman’s menses.
ESTRIOL, ESTRADIOL, ESTRONE
Estriol, estradiol and estrone are produced by both the ovaries and in fat cells. Thus, an obese woman may enter menopause much later in life and have very heavy menstrual cycles.
Estriol is the estrogen that is produced in the least quantity by the ovary. It is a weak form of estrogen which has its best effect on the vaginal mucosa. Preliminary research has shown that estriol may protect women against estrogen related cancers such as breast and uterine cancers.
In contrast, estradiol is the most abundant estrogen produced by the ovaries. It has the highest potency of all three types of estrogens. Its potency is 12 times that of estrone and 80 times that of estriol. Estradiol positively influences cardiovascular health, neurological function, bone density, vaginal health, and libido.
Estrone, on the other hand, becomes the primary estrogen produced in the menopause as the ovary loses function. Estrone is synthesized not only in the adrenal glands but also through the conversion of another precursor hormone, androstendione in adipose or fat tissue. Given that obesity has been proven to increase a woman’s risk of developing breast and uterine cancer, estrone has been implicated as a causative agent and therefore should not be compounded into bio-identical hormone therapy. Be aware that one of the most commonly compounded estrogens, known as Triest, typically contains 80% estrone.
TESTOSTERONE
Testosterone helps women maintain lean body mass, skin elasticity, bone density and most importantly, libido or sex drive. This hormone is derived from progesterone and helps to increase the efficacy of the estrogens in decreasing hot flashes. Used as a cream twice to three times per week, it can significantly boost libido after a few weeks of use. Unwanted side-effects such as facial hair growth, hair loss, or acne should be reported to your doctor immediately.
DEHYDROEPIANDROSTERONE
DHEA is a precursor to other hormones that is produced by both the ovary and the adrenal gland. DHEA gradually declines as a woman ages. It is important in the prevention of fatigue ie. adrenal burn-out and also serves as an anti-inflammatory agent in conditions such as fibromyalgia, arthritis, lupus and scleroderma. DHEA is best absorbed if taken by mouth.
Bio-identical HRT shares the same inherent risks as synthetic HRT, namely, stroke, heart attack, blood clots, breast cancer and uterine cancer. If given in a cream or patch form, BHRT will be absorbed directly into body tissues instead of entering the blood stream and broken down by the liver. The above mentioned risks are then substantially reduced by avoiding this “first pass” effect in the liver. Similarly, both cream and patch form do not interfere with the production of cholesterol in the liver and in theory, should not have a negative impact on the circulatory system.
Should a woman take BHRT if she has been diagnosed with breast cancer or is a breast cancer survivor? What if she has a family history of breast cancer but has never had it herself. Most oncologists strictly forbid the use of any kind of hormone replacement therapy after breast cancer has been diagnosed.
I have a handful of breast cancer survivors in my practice who are on BHRT creams. All of these woman are at least two years past their last chemotherapy or radiation therapy and have been deemed cured by mammograms and /or PET scan. Hormone replacement therapy has been labeled a causative agent of breast cancer. However, a synthetic form of estrogen replacement therapy, namely Premarin, did not increase a woman’s risk of breast cancer in the Women’s Health Initiative Study. If a woman has a small estrogen or progesterone receptor positive tumor growing undetected in her breast, it will most definitely be stimulated by exogenous hormone therapy. The good news is that women who develop breast cancer while taking HRT are usually diagnosed with a much earlier stage of breast cancer and have a better recovery and prognosis than women with breast cancer who are not taking HRT. In short, hormone replacement therapy, whether it be bio-identical or synthetic does not cause breast cancer. Instead , it may stimulate the growth of a pre-existing cancer. I do believe that women suffering from hot flashes, vaginal dryness, sleeplessness and decreased libido should not be denied hormone therapy because of a previous history of breast, ovarian, uterine or even colon cancer.
Taking hormone replacement therapy is a personal choice that every woman must decide with the help of her physician. Over 500 of my patients are enjoying the benefits of bio-identical hormone replacement therapy with minimal side-effects and only one known case of contained stage I breast cancer.
Please be sure that your physician has been trained in bio-identical hormone therapy and that he or she is checking your hormone levels with either blood testing or saliva testing six to eight weeks after initiating HRT and at least every year thereafter. It is possible to overdose patients on any kind of hormone therapy and great care needs to be taken to keep a woman’s hormones in correct balance without stimulating breast or uterine cancer. A common fallacy made popular in The Sexy Years is that women should have HRT stimulated periods in the menopause to simulate a natural menstrual cycle. This is absolutely incorrect ! Any post-menopausal women who has bleeding on HRT needs to be ruled out for uterine overgrowth, hyperplasia, or uterine cancer. If estrogen and progesterone levels are adequately balanced, a women should never have a menstrual cycle on HRT.
The transition from pre-menopause to menopause does not have to be a rough one if hormone replacement therapy is used at the right time and in the correct dose. Life in the flash lane has gotten a lot better with bio-identical hormone replacement therapy.
Dr. Tara A. Solomon, FACOG
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