BioIdentical Hormones

BioIdentical Hormones (BioH) are the rage right now among women and men.  The physicians at AIMS are highly skilled at properly analyzing a patient to see if they might be helpful, prescribing appropriate hormones and managing patients on BioH.

BioH are hormones which are made from natural products, such as yams, or soy, but in a laboratory are converted to the actual hormones our bodies naturally make.  BioH mainly include these hormones: estriol, estradiol (when both estrogens are used together it is called a “biest formula”), testosterone, DHEA.   Estrone used to be a hormone used in female formulas, but is most associated with causing cancers, so has been removed by the vast majority of BioH prescribersIf your physician is giving you a BioH formula which contains estrone, that is a “triest formula” you should seriously question them about it, and be worried they are not up to date on leading edge hormonal prescribing.  Pregnelelone can be used but AIMS physicians do not agree it is a valuable addition to a BioH formula.

Contraindications to using BioH:

1. For women:
   1. Until menopause, a woman cannot have BioIdentical estrogen added to her formula.
   2. Pregnant women cannot take it
   3. She cannot have estrogen added to a formula either if she has ever had a cancer that was estrogen positive, particularly breast, uterine, or ovarian cancer.
   4. She cannot have estrogens if she has a history of pulmonary embolism, deep vein thrombosis, heart attack or stroke.
   5. She has vaginal bleeding from an unknown cause.
   6. She has active liver disease.
   7. She should not have testosterone or DHEA added to a formula if she has polycystic ovarian syndrome.
   8. She should not have estrogen added to a formula if she smokes.
   9. A post-menopausal woman should watch the addition of testosterone to a formula as it can make her gain more weight around her abdomen, and increase her risk to become insulin resistant.
   10. A woman taking estrogens if she has a uterus should always be dosed the correct amount of protective progesterone.
2. For men:
   1. Testosterone makes a male infertile and can shrink the size of his testicles. If a male is interested in being fertile, testosterone should be avoided.
   2. Too much testosterone can also change a man’s moods.
   3. Men should only be dosed testosterone (with a little progesterone) and DHEA.

Four main patient populations should consider using BioH:

1. Menstruating women: In menstruating women, they can be prescribed progesterone, DHEA, and testosterone. They cannot be safely given BioIdentical estrogens (the only estrogens they can take would be in a birth control pill).  We would consider dosing a menstruating women with BioH if she had heavy, frequent periods, or had a low libido.
2. Peri-Menopausal women: in peri-menopausal women, they can be prescribed progesterone, DHEA, and testosterone. They cannot be safely given BioIdentical estrogens (the only estrogens they can take would be in a birth control pill).  We would consider dosing a menstruating women with BioH if she had heavy, frequent periods—which is the most common reason we dose progesterone to peri-menopausal women–or had a low libido.
3. Post-menopausal women: Post-menopausal women can be safely prescribed estroens, progesterone, testosterone, and DHEA. This is basically done when the women has symptoms of menopause, such as hot flashes and/or night sweats, or atrophic vagina, mood changes, insomnia, voice changes, headaches, slow down development of wrinkles, help keep gums healthy, or other symptoms.  It can also be used to help build bone growth in women with osteopenia or osteoporosis.
4. Adult men: Adult men can be prescribed testosterone, a small amount of progesterone and DHEA. This is considered when the man has one or more of the following: is low in testosterone and no serious pituitary problem is occurring; feels tired; weak; is gaining weight; has a hard time building muscle; lacks confidence and more masculine sense of strength and verve; has erectile dysfunction. (Note: only 10% of men with erectile dysfunction are improved with testosterone; that is usually due to anxiety, cardiovascular disease or neuropathy).

What is the advantage to using BioH?

There are a couple of key reasons why BioH is a much better way to go with hormone replacement than with most prescription formulas:

1. The Same Hormones As Your Body Makes: BioH are hormones which work well in your body as it is the exact hormone you body has been producing and knows how to metabolize and extract effectively. The vast majority of prescription hormones are synthetic, and foreign to the human body, and are difficult to metabolize and excrete.  Some, like Prevara progesterone has been associated with elevated lipid panels.  Some formulas are associated with increasing the risk for breast and other cancers.  While BioH are not risk-free, using a small amount of one’s natural hormones is believed to be safer and equally effective.

2. The Ability To Create the Exact Formula Your Body Needs: Standard prescription hormones come in a few doses, and that may or may not be what your body individually needs.  BioIdentical Hormones are compounded by pharmacists which allow physicians to create formulas in any way a patient needs.
   1. Changing the percent of hormones in the formula—a typical formula for a post-menopausal woman is a BiEst Formula with Progesterone. A typical Biest prescription means that both estriol and estradiol are in the formula, in an 80%/20% strength. However, a physican can change that percentage anyone she wishes, to make either of those hormones stronger or weaker in the formual.
   2. Changing the amount of hormones in the formula—a typical formula for a post-menopausal woman is a Biest 2.5 mg/gm formula. That means for every gram she applies to her skin a day, she is receiving 2.5 mg of an 80% estriol/20% estradiol formula.  However, a physician can change the amount of estrogen in the formula, generally going lower.  It is unusual to go above 2.5 mg a day, and  you would want to be concerned of your physicians BioH knowledge if your formula was above 2.5 mg.  However, a physician can reduce the amount to any dosage best for the patient.

It is important to know that there are a few BioIdentical prescription hormone formulations:

1. Oral micronized progesterone (Prometrium)—this is a perfectly good form of progesterone and AIMS physicians do prescribe it regularly.
2. Estrace, Gyndiol—these are bioidentical estradiol.
3. Androgel and Testim are bioidentical testosterone formulas

Investigating Hormonal Status For Replacement:

1. Serum—in the serum, we can easily measure a patients estrogens, free and total testosterone, and DHEA. We can run this through your insurance.  There are some important key points to discuss about this, however.
   1. For post-menopausal women it is a fallacy that measuring one’s hormones is helpful. For one thing, post-menopause means a woman is no longer producing any estrogens or progesterone from her ovaries, so of course her serum numbers will be low, as fat tissue and adrenals can only produce a miniscule amount compared to one’s ovaries.  So, this is not clinically helpful.  Also, this is very important to read, there are no standardized lab values for post-menopausal women on hormone therapy, synthetic or Bioidentical. Thus, checking lab values after being prescribed BioH is not helpful as there is not reference range lab values that a women should fit within.  In general, a woman should receive the least amount of hormones as possible.  But, that is why AIMS physicians do not regularly draw for female hormones in post-menopausal women.   We do not mislead patients in our treatment of them.
   2. For menstruating women, measuring their estrogens may or may not be helpful. If a woman is having a monthly cycle, they are obviously producing enough estrogens and it does not need to be tested. AIMS Physicians will draw exactly what makes sense and what has logic and medical value to draw.
2. Saliva—There are saliva lab companies who believe saliva is the best way to measure reproductive hormones, but science and the American Academy of Clinical Endocrinologists do not agree. AIMS physicians do not use saliva testing to measure reproductive hormones, only cortisol and DHEA. 
3. Urinary Testing—a 24 hour collection of urine is the Gold Standard for measuring of the amount of hormones a person made during that day. In premenopausal women we would want to check the urine around day 20 of her period. It does not make sense to do this test for post-menopausal women.

Which labs might be measured:

1. For men:
   1. Free and Total testosterone
   2. DHEA
   3. Estradiol—since testosterone can be turned into estrogen we need to measure this hormone in men regularly to ensure we are preventing this problematic pathway from occurring.
   4. CBC—changes in the blood can occur to men on testosterone
   5. Lipid panels—changes in the lipids can occur to men on testosterone
2. For Women:
   1. Free and total testosterone
   2. FSH—this is a hormone which physicians use to diagnose menopause is occurring
   3. Estradiol and estriol
   4. DHEA
   5. Progesterone
   6. Liver enzymes—it is rare, but sometimes estrogens can irritate the liver
   7. Pap—a woman on a BioH should have a pap performed each year
   8. Mammogram—a woman on a BioH should have a mammogram performed each year.
   9. Glucose, Lipids, A1C, Insulin—a post-menopausal woman on testosterone should be checked yearly they are not becoming more insulin resistant.

BioH can be prescribed in several different ways:

1. Cream/gel—a cream/gel is an effective way to go and prevents “first pass” through the liver which is what happens when you take the hormone orally, and the liver can change it into various metabolites. For men using a testosterone cream it should be applied to forearms or calves, not over fatty areas of the body; on the other hand, for women applying estrogen creams, it should be applied on the abdomen, buttocks, hips, areas which generally contain a little more fat.  When testosterone is put over fatty tissue it could transform more easily into estrogens.  There are prescription gels and compounded ones.
   1. Women: A typical cream is a combination of estriol, estradiol, and progesterone.
   2. Men: A typical cream of testosterone should have 5-10 mg of progesterone added to help prevent the testosterone from becoming estrogen.
2. Pills—hormones can be taken orally, but orally estrogens cause more harm to the liver, and change one’s lipid panels to the worse. Testosterone is not well absorbed orally so is not used that way. AIMS physicians do not prescribe oral estrogens or testosterone.
3. Troches (Lozenges)—A troche is a thickened gel type lozenge which a person sucks on to absorb the hormones. Raspberry is a very good flavor for them to help balance the oiliness of the hormones.  We can put less hormones in a lozenge than in a cream or pill.
4. Injections—I do not like the pellets injected into one’s buttocks, which is promoted by a big name hormone replacement center. Patients complain to AIMS physicians that the hormones do not last that long, do not come out in equal daily doses, and testosterone implanted in the buttocks can easily transform it to estrogens.  In general, just testosterone is injected, but because it is so strong in that form, it should be balanced with an aromatase inhibitor, usually Anastrazole 1 mg two days a week.  Testosterone injections are either testosterone cyprionate or testosterone enanthonate, they are not classically considered BioH, hormones but they are close to that designation.
5. Vaginal Suppository/cream: A vaginal estriol suppository is one of the most common BioH formulas AIMS physicians make. A drier, atrophic vaginal is a common symptoms of menopause and dosing a 0.5-2.0 mg estriol product can be extremely helpful in regenerating normal vaginal tissues and lubrication.

Possible Side Effects To BioH:

1. For Women
   1. Breast tenderness
   2. Water retention
   3. More hot flashes
   4. Vaginal bleeding
   5. Nausea
   6. Weight gain
   7. Gallstones
   8. Spotting or darkening of the skin on the face
   9. Mood changes
2. For Men
   1. Too aggressive
   2. Infertility
   3. Smaller testicles

Patient who are prescribed BioH are followed up within a month by their AIMS physician.  We may do more labs, and we will certainly discuss with the patient how they are feeling, if they feel better, if they could feel even better, if they are having any negative side effects.  AIMS physicians monitor patients very closely to ensure the BioH is the correct dose, and is having the positive effects wished for without any problematic side-effects.

If you are looking for BioH, seek out a physician from AIMS.  We are knowledgeable, up to date, aware, caring, and compassionate.  We know the ins and outs, and nuances and complexities of BioH, and prescribe them with skill and efficiency, safely and professionally.