Once upon a time most of us moved here, to LA, from other states or countries. And we love it!  As veteran Los Angelinos we live, work and of course, look at others in this, our youth and media oriented city. The inevitable follows: we would like to look like a celebrity worthy of an appearance on Oprah or at least appear younger than our chronologic age. So when we see ads politely inquiring whether we are developing a bulge above our jeans, flushing, flashing (from heat, not exhibitionism), sleeping poorly, loosing our libido or worse… wrinkling; we go on the alert. Who can resist that spiel? : Step right up and spit here; we’ll see what you’re missing and order you a very special, made- just- for- you therapy. Rub this cream on, swallow these capsules, put these drops under your tongue and don’t worry, these “bioidentical” hormones are chockfull of health, not like the ones made by those big, bad pharmaceutical companies.

Many of my tenured (note I refrain form using the adjective “old”) and new patients want to know if they should start these “bioidentical” hormones or switch to them.  To quote Shakespeare, who was hormonally clueless but recognized some distressing female symptoms:  Here’s the rub.

“Bioidentical” is a marketing term. It’s as ingenious as the word natural when it comes to selling a product; both appeal to consumers’ aversion to artificial ingredients. But remember, hemlock is natural.

When the term “bioidentical” is used by compounding pharmacies and celebrities who are often selling their products or touting their own books, it refers to formulations of various types of estrogens, progesterone, adrenal hormones, and androgens (male hormones) compounded within creams, gels, lotions, capsules, drops, capsules, and even suppositories.  The compounded estrogens are often a combination of weak forms of estrogen (estrone or estriol) as well as the stronger  estradiol. In order to get significant relief of menopausal symptoms, large doses of the estriol or estrone   have to be used and there is no evidence that this is safer than the lower dose of estradiol which, by the way, was produced by our ovaries and accepted by nearly every cell in our bodies during our reproductive years. Estradiol is the estrogen contained in many of the FDA approved hormone therapy medications, and/or the metabolite (the end result after processing in the body) of these medications.  Nearly all plant derived estrogen therapy, both individually compounded formulations and pharmaceutical products come from the same soy and yam precursors. They all undergo chemical conversion to become hormones. ( The concept of plant gathering followed by stomping created a great “I Love Lucy” sketch and will work for grape juice and ultimately wine, but will not result in a biologically active hormone product, no matter how skillful the stomping and crushing.) Compounding pharmacies may claim that the combination of their estrogens is either safer or more natural than any of the products that are commercially prepared by pharmaceutical companies. No clinical studies published in reputable peer review journals have shown this to be true. As for the claim that estriol may reduce the risk of breast cancer; this is pure speculation based on old studies that were usually carried out on animals. The FDA has unequivocally stated that it is not aware of any credible scientific evidence to support claims made regarding the safety and effectiveness of compounded “bioidentical” hormone replacement drugs. They have taken action against seven pharmacy operations that claim their compounded “bioidentical drugs” which contain hormones such as estrogen, progesterone and estriol are superior to FDA-approved menopausal hormone therapy medications. The American College of Obstetricians and Gynecologists (my professional entity) has the same concerns stating that “most compounded products have not undergone rigorous clinical tasting for safety or efficacy and issues regarding purity, potency and quality”.

Doctors who prescribe these “bioidentical” hormones often use salivary (spit) testing to tailor the amount of hormones they prescribe. But salivary hormone levels vary tremendously throughout the day and differ from woman to woman. Moreover we don’t have studies that demonstrate a correlation between the levels of spit hormones and a woman’s clinical state or her response to hormone preparations. The major mavens on menopause (we have a society for everything), The North American Menopause Society, does not recommend saliva testing to determine hormone levels, nor do they recommend custom compounded products over “well tested, government approved products for the majority of women”. All these institutions are concerned that patients do not see the black box warnings that are prominently displayed with FDA approved medications…the ones that state that hormones should not be used if you have had certain conditions that include estrogen related cancers and blood clots and the concerns about risks for long term use.

Finally who pays? Sometimes insurance companies do, but often the patient is stuck with a bill that is higher than the one she would pay (or co-pay) for commercially prepared hormones. Moreover if the practitioner who prescribes “bioidentical” hormones also sells them from her or his office, there is a potential conflict of interest.

Some hormones including testosterone and DHEA (used for low libido or specific deficiency disorders) may not be available in pharmaceutical products and will have to be compounded. As a matter of full disclosure, I do prescribe compounded hormones when the latter are needed or when a patient becomes allergic to standard therapy. But I advise all my patients that there are no free hormones, no matter how they are made. There is an indication and contraindication to every medication and it’s imperative that your physician use appropriate, up-to-date studies in order to inform you of both.

Unfortunately, no hormone will provide you with that lost fountain of youth. But when prescribed for significant symptoms in appropriate doses, hormone therapy will help you feel better. Exercise, proper nutrition, weight control, hair color, make-up, and the right lighting are the only proven (and risk free) ways to help you feel and look your best.

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Ask any woman…as she traverses her “”f” years…the forties and fifties and then gets to the “S” decades (or watches her Mother or Grandmother get there) she worries about memory loss, Alzheimer disease or other forms of dementia. Surely there is something we can take to prevent or at least forestall these dreaded disorders of maturity! And wouldn’t it be great if that something were obtainable without a prescription…and, to use that magic marketable word, natural. Well according to the advertisers (and the salesperson at the vitamin and herb counter) there is; and many of us (including me a few years back) dutifully took it saying, “You never know, maybe it will help”. We now know a bit more. A study of over 3,000 volunteers aged 75 and older with normal or mild cognitive impairment volunteered for a study carried out in five medical centers in the United States between 2000 and 2008. They received either a 120 mg extract of G. Biloba or placebo twice daily. Neither they nor the investigators knew which they were taking. They were assessed every 6 months over the next 6.1 years for development of dementia. The end result: Ginko Biloba did not prevent Alzheimer disease or other forms of dementia.

We would all like a simple herb or medication to keep our minds in thinking, enjoying, remember and adapting order. This important study indicates that Ginko Bilboa is probably not that mind preserver.

For a while the first question posed by my patients during their visits (after I enquired as to their well-being) was how could this happen? What do I (and other doctors) think? How could this happen here in Los Angeles?

After I marveled at the ability of the obstetricians, perinatologists and neonatologists to successfully deliver an 8-fetus pregnancy and keep those babies alive, I too was horrified. Like many of you I questioned how a woman who was already a mother of 6, living with her parents and who receives state disability wanted and indeed obtained IVF. And my next more medical oriented question regarding the standard of care was simply; what was her doctor who performed this assisted reproductive procedure thinking and doing?

When it comes to the provision of reproductive care, physicians are not supposed to make decisions about sexual preference, married or economic status. But we are trained to think in consecutive steps especially when it comes to reproduction. If a woman under the age of 40 is able to conceive with minimal therapies such as timed intercourse, insemination or judicious use of fertility medications…. the first step should not be IVF.  And when reproductive technologies are called for, the number of implanted embryos should be geared to a single live birth, not multiple or super-multiple ones.

The past and present presidents of our major reproductive societies (to be technical, the American Society for Reproductive Medicine and The Society for Assisted Reproductive Technology) agree. They published an editorial in the Journal of Obstetrics and Gynecology stating that the recommended number of fresh embryos (not frozen) transferred in a patient younger than 35 with a good chance of success is one or at most two. They point out that once these guidelines were followed the percentage of IVF pregnancies with triplets or higher has been reduced from 6.9% in 1996 to 1.7% in 2007. Moreover there are regulations in place to help regulate, accredit and audit reproductive procedures by fertility clinics and reproductive endocrinologist. One of these is the Fertility Clinic Success Rate and Certification Act of 1992, which requires annual reporting of pregnancy and live birth rates to the Centers for Disease Control and Prevention. (I guess the report of the octuplet pregnancy quickly reached them through less official means.)

The reproductive organizations are upset…. and they have called for what they term “a comprehensive evaluation of the medical practice in question”. But in the end all they can do is establish guidelines and revoke a physician’s membership. The Medical Board of California has the right to do more and many of my colleagues and I certainly hope they do.

A quick reminder (or as I like to put it, a 101 course on menstrual cycles):

Two ovarian hormones are responsible for your menstrual cycles; estrogen and progesterone. Each has some amazing effects on your tissues and may instigate  good days and bad days. Estrogen  begins to be synthesized from cholesterol  within the ovary on day one of your cycle (when your period starts). It’s production in the primitive eggs your born with (called follicles) is “commanded”  by the pituitary release of FSH (follicular stimulating hormone), which in turn is produced in response to the low levels of estrogen that occur just before the onset of your period. Levels of estrogen begin to exponentially rise about a week before ovulation and peak just a day before. This estrogen peak then sensitizes the pituitary and it responds with a surge of LH (luteinizing hormone). LH then causes the follicle to release an egg (ovulation). The “shell” of the follicle now becomes a corpus luteum which now concentrates on producing increasing amounts of progesterone.  Circulating progesterone can rise 10 fold during the week following ovulation. Estrogen production also rises about 6 or 7 days after ovulation. Both these hormones cause the glands in the lining of the uterus to become thick and lush so, if an embryo were to be deposited, it could implant, be nourished and grow. If there is no pregnancy to keep the corpus luteum going it succumbs and there is a decline (so sad) of both estrogen and progesterone. These fallen levels can no longer support the lining of the uterus….it sloughs and hence bleeding occurs. The now low level of estrogen stimulates the pituitary to begin to produce FSH and the entire process begins once more. (Just think of it as waves of rising and falling hormones each month.) Androgens (male hormones) are also produced in the ovaries.

The combination birth control pill basically supplies amounts of synthetic estrogen and progestin which shuts off the pituitary signals to the ovary and hence cyclical hormone production (and ovulation) cease. After menopause, when the follicles in the ovary are “used up” the levels of both estrogen and progesterone will drastically fall.  In an abortive effort to get the ovary to produce these hormones, FSH levels rise and continue to remain high for the rest of our postmenopausal lives.

How do the rise and fall of these hormones effect our skin:

  • The skin is the largest organ we “own”….There are hormone receptors in the skin and the blood vessels that supply it. Most of what we know regarding to the effects of estrogen on the skin come form studies of what happens to the skin in the absence of estrogen (during menopause).

Here is the estrogen good stuff: It increases skin thickness, decreases collagen breakdown, increases collagen production, increases water binding capacity, increases the ability of blood vessels to dilate, increases elasticity and improves wound healing. This hormone helps prevent sebum (lipid) production, which feeds bacteria and increases the development of pimples. Estrogen also effects fat accumulation under the skin (subcutaneous). Here’s an interesting stat: The thickness of subcutaneous fat has been measured during the menstrual cycle, using ultrasound and MRI. The maximum thickness of subcutaneous fat over the thighs and abdomen has been found to increase during the menstrual cycle (as much as 7.3% in the abdominal region and 4.1% in the thighs). This certainly appears to validate your frequently voiced concerns that you are “get fatter” during your period. Whether this is due to an increase in water retention or changes in the fat cells is not clear.
There is also estrogen bad stuff that can occur in the skin. It increases pigmentation (this is especially evident when combined with sun exposure and use of the estrogen containing birth control pills in sensitive women who then develop pigmentation on the cheeks (chloasma). It also has been associated with decreases cellular-immune response.
Here is what has been noted during the luteal (progesterone) phase of the cycle: There is more sebum production and an increase in skin microbial count….these 2 factors can make you more prone to acne a week before and during your period. The skin is also more sensitive to UVB rays between days 20 and 28 which mean an increase in sun sensitivity.
Effects on the Immune system:   This is complicated….estrogens suppress immune response in the cells as well as what we call natural killer activity. (There is a war going on between our bodies and the antigens to which we are exposed. )  Estrogen also increases certain immune proteins in the blood. Because of this increase in antibodies, estrogen may be the significant factor in our high ratio compared to men (20:1) of developing the autoimmune disorder systemic lupus erythematosis (SLE).  And if you remember that T cells help us fight infection….well progesterone seems to suppress their formation. (Note T cell numbers remain depressed throughout pregnancy when there is a huge amount of progesterone produced by the placenta….a possible reason for infection severity in pregnant women.)

Effects on Vaginal Discharge: Obviously in the beginning of the cycle there is menstrual blood flow. The average amount is 50 to 100 mL and lasts for 4 to 6 days. As estrogen levels rise the cervix produces more and more mucous and the discharge becomes clear and slippery …sort of like uncooked egg white. (Women as well as their doctors have been checking for this type of mucous to predict fertile days for decades….I even wrote a paper about it in medical school.) As progesterone levels rise after ovulation the mucous becomes stickier. There is a greater glycogen (a form of sugar) content and some women complain of an increase in yeast infections. On the other hand growth of bacteria that don’t like oxygen (bacterial vaginosis) is more likely to become worse during the first 2 week of the cycle.
Effects on overall health:  Disorders and distress seem to increase during the luteal phase of our cycles. The list is long: asthma, acne, epilepsy, migraines, myasthenia gravis (severe muscle weakness), certain tachycardias (fast heart beat), sleeping disorders, Reynaud syndrome (where hands and feet become blue from diminished circulation), schizophrenia, glaucoma, insulin resistance and viral diseases. Skin disorders that worsen include acne, rosacea, skin lupus, psoriasis, eczema, vulvar itching, lichen planus and uticaria.

When it comes to estrogen surges and cancer there seems to be an influence on melanoma, certain blood vessel cancers of the skin and of greatest impotence to so many of us, breast cancer. This is a subject for multiple entries and I still wouldn’t be able to give all the final conclusions….But estrogen does stimulate cell divisions in the breast. Many therapies for breast cancer are geared to stopping this estrogen stimulation….these include removal of the ovaries before menopause, inhibition of estrogen production with compounds termed LH agonists  and aromatase inhibitors as well as estrogen receptor blockers such as tamoxifen. But pregnancy with its high production of estrogen, especially in younger women is protective! And I have to add this….estrogen and progestin (now termed hormone therapy or HT) may not increase breast cancer for the first few years of use, moreover estrogen therapy given alone (in postmenopausal women who have had a hysterectomy) seems to have little impact on breast cancer risk.

This started out as a simple menstrual cycle primer….sorry that it (and the complexity if our hormonal responses) became more than that. I guess this is the reason that some of us intensely study the effects of female hormones during and after our reproductive years.

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