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Bioidentical Hormone Therapy (BHRT) FAQ

Answers by Jannet Huang, MD, FRCPC, FACE, ABHM., Menopause Clinician and board certified in Endocrinology & Metabolism

Do you prescribe bioidentical hormones?
Does one have to go to a compounding pharmacy to get “bioidentical hormones?”
Do you prescribe “natural” bioidentical hormones?
What are the advantages and disadvantages of pharmaceutical hormone products vs custom compounded products?
I heard that compounded bioidentical hormones are safer than pharmaceutical products. Is that true?
How about breast cancer risk?
I read somewhere that estriol is a safer estrogen. Is that true?
Do you do salivary testing for hormones?
How do you decide whether to use a topical / transdermal form vs oral forms of hormone therapy?
Do I have to get a period to be “safe” or to benefit from hormone therapy?
Should women take androgen (male hormone) therapy? Will it help my sex drive?
Should I take pregnenolone?
What is the most important guideline for bioidentical hormone therapy?

Do you prescribe bioidentical hormones?

Yes. But let us clarify the definition of “bioidentical hormones”. “Bioidentical” is actually not a medical or scientific term, it is a marketing term coined by the custom compounding industry and their supporters. I have adopted the term “bioidentical” because women identify with it and understand it. You will not find a definition of “bioidentical” in medical dictionaries. In my opinion, “bioidentical” should mean identical to the human version of hormones (including estrogens, progesterone and androgens) that our bodies make endogenously.

Does one have to go to a compounding pharmacy to get “bioidentical hormones?”

No. Actually a number of FDA-approved pharmaceutical products are “bioidentical hormones” (according to above definition). Some examples of systemic hormones include estradiol patches (Vivelle Dot, Climara), estradiol gels (Estrogel, Elestrin, Divigel), estradiol mist (Evamist) and micronized progesterone (Prometrium). Vaginal products such as estrace cream, femring, estring and vagifem are all “bioidentical” as well. And this list keeps growing.

Do you prescribe “natural” bioidentical hormones?

There is NO SUCH THING as “natural bioidentical hormone”. The word “natural” is a medical term. It appears in Dorland’s and Stedman’s medical dictionaries and it means neither artificial nor pathologic. It also means unchanged from nature. The only way to obtain “natural bioidentical hormones” would be to grind up another woman’s ovaries! Of course that is not going to happen! All “bioidentical hormones” have to be synthesized from precursors found in plants (such as soy or yam). That means all bioidentical hormones are synthetic! Complex technology is required for the production of these hormone products. Compounding pharmacies do not actually make the hormones they dispense. Also, contrary to common advertising, the hormones used in custom compounded BHRT are in fact the same hormones used by the pharmaceutical industry. The statement that “pharmaceutical hormone products are synthetic and BHRT products are natural” is therefore completely false.

What are the advantages and disadvantages of pharmaceutical hormone products vs custom compounded products?

The advantage of pharmaceutical hormone products are: in order to gain FDA approval, studies have to done on the particular product showing efficacy and safety. The quality control is assured so there is negligible batch to batch variation. Another advantage is that many of these pharmaceutical hormone products are covered by insurance prescription plans. A disadvantage is that only certain fixed doses are available. On the other hand, custom compounding has the potential to achieve almost infinite variations of doses and combinations (although there are usual standard doses used in most custom compounding). Disadvantages of custom compounding include: there is no oversight of the compounding process so one is completely dependent on the skill and integrity of the individual compounding pharmacist to produce a hormone compound accurately. The risk of human error is much higher in custom compounding. A single decimal point error will result in 10 fold higher or 10 fold lower concentrations! I am not the only clinician with patients doing well on a compounded hormone and all of a sudden they develop side effects and are found to have received 10x the dose that was prescribed!

I heard that compounded bioidentical hormones are safer than pharmaceutical products. Is that true?

Absolutely NOT. There are no scientific studies showing any specific compounded bioidentical hormone to be safer than pharmaceutical products. There are virtually NO studies on compounded hormones at all. Since the actual hormones (estradiol, progesterone) used in compounded products are the same as in the pharmaceutical products, it does not make sense to claim a different safety profile. Actually, the fact that pharmaceutical products are more extensively studied make the FDA approved pharmaceutical products the safer choice!

How about breast cancer risk?

First of all, literature findings suggest that estrogen does not create breast cancer, but estrogen may act as a “fertilizer” and make pre-existing breast cancer cells grow faster. Some studies even show women who were diagnosed of breast cancer while on estrogen therapy may actually have a better prognosis than women who were not taking hormones. Breast cancers diagnosed in women on estrogen therapy tend to be less aggressive. Even if we the studies indicating a 30-40% increase in breast cancer in women using combined hormone therapy (estrogen and progestin) to be valid, we need to keep in mind there are a number of other factors that may increase breast cancer to the same degree — eg. gaining 20lbs or more in adulthood, drinking more than 1.5 alcoholic drinks a day, never having been pregnant, etc. An accepted theory about the formation of cancer is the “multiple hit theory” — multiple “insults” (eg. genetic susceptibility, environmental toxins, stress, etc) have to happen before a cancer develops. Some scientists believe that the “first hit” in breast cancer actually happens when a person is developing in the womb! Moreover, we need to keep the magnitude of risk in perspective. Let’s look at a well documented carcinogen - no one will argue about cigarette smoking being a cause of lung cancer. Cigarette smoking increases risk of lung cancer by 40 times, and that is 100-fold different than the magnitude we are talking about regarding hormone therapy and breast cancer. Finally, we all have our own individual risk profile, so we must make our own decision with our personal physician’s guidance.

I read somewhere that estriol is a safer estrogen. Is that true?

Although some people hold the opinion that compounded bioidentical hormones using estriol are safer for the breast, it is an unfounded claim. Estriol is the form of estrogen that is really only present in any appreciable amounts during pregnancy. Estriol is a much weaker estrogen than estradiol, the predominant circulating estrogen in young women. It is true that if you put the same amount of estradiol and estriol in a petri-dish with breast cancer cells, the cells exposed to estradiol would proliferate faster. However, if one places equipotent amounts of estriol and estradiol in their respective petri-dishes, the degree of proliferation would be the same. Bottom line: there is no evidence to support the theory that estriol is safer for the breast.

Do you do salivary testing for hormones?

Not usually. I prefer obtaining blood levels of hormones at a reliable laboratory. Salivary hormone assays are very poorly standardized and results are thrown off easily because the salivary levels of hormones are in a very low range. For example, if you have a tiny bit of blood (so little that it is not visible to the eye) mixed in with the saliva sample, the results will be grossly distorted. Hormone measurements at best can only be used as crude guides. I would not adjust hormone therapy doses based on hormone levels. There is no “ideal target” blood or salivary level to strive for that will make all women feel fabulous. Moreover, blood or salivary levels do not correlate with symptoms. If you have a group of women all with the same estradiol level, some may be feeling great while some may be having hot flashes every 10 minutes! Each of us has different “host factors” (eg. efficiency of hormones getting to the target tissues, number of receptors and cofactors, rate of processing and excretion, etc.) that affect how we respond to hormone therapy. We should be treating each individual woman, not the numbers!

How do you decide whether to use a topical / transdermal form vs oral forms of hormone therapy?

For estrogen therapy — I prefer using estradiol which is the young woman’s predominant estrogen. Transdermal estrogen (patches and gels) are preferable because estradiol is absorbed directly into the bloodstream, bypassing the liver. When we take oral estrogen, it has to be processed through the liver before reaching the systemic circulation (this is known as the “hepatic first pass effect”). The liver breaks down 90% of the estrogen taken orally, so the dose of estrogen given orally need to be 10 times higher than the transdermal dose to reach comparable blood levels. Metabolism of this higher level of estrogen in the liver increases production of clotting proteins, thereby explaining the increase in blood clotting risk with oral estrogen use. Transdermal estrogen has been shown to NOT increase clotting risk, even in women with hereditary clotting disorder such as the Factor V Leiden mutation. Moreover, transdermal estradiol reaches the blood stream unaltered, so we know we are getting the form of estrogen we want. Oral estradiol, on the other hand, enters the blood stream as a combination of different metabolites due to the extensive metabolism by the liver. The advantages of the transdermal over oral estradiol can also be achieved by using vaginal route of delivery.

For Progesterone — I prefer using oral progesterone at bedtime to take advantage of the mild sedative effect to improve sleep quality. The purpose of progesterone is to protect the lining of the uterus (endometrium) from getting too thick (endometrial hyperplasia) or becoming cancerous. Progesterone is mandatory for women with intact uterus, but is not required in women who had hysterectomy. Forms of progesterone shown to protect the uterine lining include oral progesterone and vaginal progesterone. Non-bioidentical forms including oral progestins, transdermal progestin (as in combipatch or climara-pro patch) and progestin releasing intrauterine device (eg. Mirena) are also effective. Contrary to common belief, progesterone cream applied on the skin has not been shown to offer consistent absorption, and has not been shown to offer endometrial protection. In some women, progesterone is calming and sedating which can be desirable. Some women, however, may feel depressed or too lethargic while on progesterone. The schedule and formulation of progesterone (or progestin) should be tailored according to the individual woman’s needs.

Do I have to get a period to be “safe” or to benefit from hormone therapy?

The answer is NO. Women on HT do NOT need to have a period to show that they are on “healthy” doses of hormones. There are two basic schedules for HT — continuous combined (estrogen and progesterone daily), or cyclic (estrogen daily, progesterone 10-14 days a month to mimic the menstrual cycle). Both HT schedules are effective in protecting the endometrial lining (to prevent endometrial hyperplasia and cancer). Even women who are on cyclic regimen of HT eventually stop having periods (usually within a year). In order to keep an older woman menstruating, higher and higher doses of hormones would be needed, which I believe to be unsafe.

Should women take androgen (male hormone) therapy? Will it help my sex drive?

Women normally have androgens (DHEA, Testosterone) in our circulation. The finding that the ovaries still produce 50% of a woman’s testosterone after menopause explains why women whose ovaries were surgically removed tend to have much lower testosterone levels. DHEA, on the other hand, is the androgen primarily produced by the adrenal glands. At present, androgens are not thought to be a mandatory part of menopausal hormone therapy since their medical benefits have not been clearly established, except in specific groups of women. Studies have indicated women with Addison’s disease or those who underwent surgical menopause (by removal of both ovaries) may benefit from androgen therapy. Some women with autoimmune conditions such as lupus may benefit from DHEA supplementation. Small studies have indicated that in women and men over 65 years of age DHEA may provide benefits including improvement in mood, muscle strength and bone density.

Sex drive (libido) in women is a complicated issue. Women have a complex sexual response cycle and there is a wide range of “normal”. Sexual desire can be “spontaneous” or “responsive”. Many women may complain that they have no spontaneous desire, but when sufficiently stimulated are able to respond and enjoy sexual activity. These women have an intact responsive desire but a lack of spontaneous libido. It is important for women and their partners to realize that the brain is a woman’s most important sexual organ! In order for a woman to desire sex, she has to be relaxed, has enough energy, have a reasonably healthy body image, and be happy with her partner, and not be distracted. For many women, it may seem almost as difficult to meet all the criteria mentioned above as for the planets to be aligned! Women have to be relaxed to enjoy sex, while men have sex to help them relax. Furthermore, women have to feel love and intimacy in their relationship with their partner to desire sex, whereas most of the time men experience intimacy through sex. Women and men are just not on the same page when it comes to sexual desire. In many instances, I have recommended planned date nights, and women giving their partners a “homework list” to help create circumstances more conducive to sexual enjoyment. This homework list may include certain lighting, music to set the mood, and specific activities in foreplay (and of course, spending more time in foreplay usually helps!). The bottom line I am trying to make here is that hormones are important, but only play a small part in a woman’s sexual desire. So androgen therapy may or may not be helpful, but certainly can be tried after pros and cons are discussed. It is important to try to restore physiologic testosterone levels rather than “supra- physiologic” levels which may result in side effects such as acne, facial hair or scalp hair loss. These side effects would likely do more harm than good for a woman’s sexual desire. Finally, expectations should be realistic. Even in instances where testosterone therapy is helpful in enhancing sexual desire, it will not create aggressive prowess in an otherwise sexually passive woman.

In the US, DHEA supplements are available over the counter. There is no FDA approved testosterone product for women, so testosterone is usually custom-compounded. Laboratory assays for testosterone are challenging in women due to the much lower circulating levels in women as compared to men. I prefer to measure blood levels of DHEA-Sulfate and Testosterone (total, bioavailable and free levels) using reliable laboratories. Blood levels of androgens provide crude guides for diagnosis and management, but again, there is really no “ideal target range” in which every woman would feel good. The use of androgens must be individualized for each woman and appropriately monitored.

Should I take pregnenolone?

I do not recommend the use of pregnenolone. Pregnenolone is a precursor steroid which can be transformed in the body to other steroid products including progesterone, estradiol, testosterone, DHEA, cortisol and aldosterone. There is really no way to predict how the pregnenolone is going to be metabolized in an individual woman’s body and is therefore difficult to control exactly what one might be getting as the end result of pregnenolone supplementation.

What is the most important guideline for bioidentical hormone therapy?

In my opinion, the most important guideline is that one must individualize hormone therapy. Each individual woman must evaluate her own needs and risk factors with her personal physician in deciding about hormone therapy. Adjustment in hormone therapy should be based on her own individual response (with focus on her symptoms rather than hormone levels). There is no cookbook recipe for hormone therapy. One approach that may work for one woman may not work in another. Ultimately, the purpose of hormone therapy should be to enhance health and quality of life for an individual woman.

Answers by Jannet Huang, MD, FRCPC, FACE, ABHM., Menopause Clinician and board certified in Endocrinology & Metabolism