Hormones are proteins that have very important stimulatory effects on tissues, organs and glands within the body. In normal physiologic states, the production and release of the endogenous (made by the body) hormones is tightly controlled. However, when the normal hormonal physiology is disturbed these hormone levels may become too high or too low, potentially leading to a variety of deficiency or excess hormone states and conditions (i.e. hypogonadism, hypo/hyperthyroidism, adrenal insufficiency, menopause, diabetes, etc.) Hormones produced by the following tissues (i.e. thyroid, pituitary gland, adrenal glands, pancreas, ovaries, testes, etc.) control all of our most important bodily functions: digestion and metabolism, reproduction, tissue growth and repair, immune system, etc.
In the vast majority of cases, these hormonal states of excess or deficiency are only diagnosed when an individual begins to manifest symptoms. The most common deficiency state is menopause, and can be associated with such troublesome symptoms (i.e. hot flashes, mood disturbances, fatigue, low-libido, vaginal dryness, etc.) that many women seek relief with supplemental estrogen. As an oncologist, one concern regarding supplemental estrogen is that it can increase the risk of breast cancer development and possibly progression (particularly in women with estrogen receptor positive “sensitive” tumors).
Low-testosterone (hypogonadism) is one of the least diagnosed and undertreated deficiency syndromes. Read my blog post to learn more about “Low T”.
Health care practitioners should only prescribe supplemental hormones to patients after a thorough discussion of the potential risks and benefits. It is alarming that some patients are being told that there are no risks with the use of the highly-marketed and hyped hormone supplementation therapy called, “bioidentical hormone therapy” (BHT). The likes of famous personalities (i.e. Oprah Winfrey, Suzanne Somers, etc.) have even touted the benefits of BHT in the treatment of menopausal symptoms. Additionally, practitioners of “anti-aging” medicine promote the use of numerous “bioidentical” hormones to help slow the effects of aging (i.e. prevent bone loss, increased muscle mass, improve libido, reduce fatigue, etc.).
What is “bioidentical hormone therapy” (BHT)?
There are multiple names for this therapy: “bioidentical hormone therapy,” “bioidentical hormone replacement therapy,” and “natural hormone therapy.” Essentially, BHT is a process for assessing an individual’s hormone levels (via blood or salivary testing) and replacing any deficiencies with synthetic hormones. Practitioners who practice BHT frequently prescribe multiple hormones at a time to their patients using pharmacy-compounded products.
What conditions are commonly treated with BHT?
The most common is menopause and the associated symptoms (It is estimated that more than one-million women in the U.S. are taking BHT for menopausal symptoms). BHT is widely promoted as an “anti-aging” therapy. (We have all seen the advertisements of the 70 year old physician who has the muscular, tanned body of a 30 year old after starting on an “anti-aging” program…think hormonal supplementation.)
Low-testosterone (hypogonadism) is one of the least diagnosed and undertreated deficiency syndromes. Read my blog post to learn more about “Low T”.
What are the most common hormones that are prescribed and how are they administered?
The most common BHT drugs include: estriol, estrone, estradiol, progesterone, testosterone, dehydroepiandrosterone (DHEA) and growth hormone.
They can be administered by injection, orally, transdermally, or with intra-vaginal preparations.
How are levels of hormones assessed and followed?
BHT practitioners rely on blood and saliva tests (i.e. estrone, E2, E3, progesterone, pregnenolone, DHEA, testosterone, and cortisol) to help determine which hormones are “low” and therefore require supplementation. These tests are repeated to assess for response to supplementation.
It is quite appealing for patients to be offered an customized hormonal therapy prescription. However, each person is unique and has varying proportions of different endogenous hormones. What is normal for one person may not be normal for others. Blood levels of a hormone may not reflect the clinically relevant, cellular effects of steroid hormones. Thus, similar blood levels in 2 different patients may result in different biological effects. Salivary hormone assays are popular because of the ease of collection. Under ideal circumstances, salivary levels should reflect serum levels. However, salivary concentration can fluctuate greatly based on several factors: the salivary flow rate, toothbrushing, eating, time of day, etc. Additionally, there are no well-defined and standardized goal ranges for “normal” hormone levels. Based on the limitations inherent in blood and salivary testing, the current standard of care is to individualize hormone therapy based on symptom relief and side-effect profile, not laboratory results.
Is BHT a more “natural” alternative to conventional (non-bioidentical) hormone replacement therapy?
The term “natural” can be applied to all products where the principal ingredient originates from an animal, plant, or mineral source. Both bioidentical and non-bioidentical hormones can be produced from the same “natural” sources (Fact: Soybeans and yams are used in the development of both bioidentical and non-bioidentical hormones). The use of the term “natural” is a marketing gimmick that is misleading. “Natural” does not mean safe.
FDA-approved hormone replacement therapies can be very costly, whereas compounding pharmacies typically sell BHT compounds for a lot less money. This cost-advantage enables many more people to take advantage of hormonal replacement.
Is BHT effective and safe?
To date, the data supporting both the safety and efficacy of BHT is inconclusive. Bioidentical hormones are expected to carry the same risks and benefits as their non-bioidentical counterparts, but there have been no studies that directly compare bioidentical hormones with their non-bioidentical counterparts. Based on high-quality trials that have studied hormone replacement therapy use over many years, we know the risks and benefits of conventional (non-bioidentical) hormone replacement therapy. The American Cancer Society, The Endocrine Society and others have stated that these risks are expected to be the same for patients treated with BHT.
- Estrogen risks: The large Women’s Health Initiative (WHI) study randomized 16,608 postmenopausal women to combined hormones versus placebo and discovered that women given the conjugated equine estrogens plus medroxyprogesterone acetate (Prempro) had an increased risk of breast cancer, coronary heart disease, stroke, and venous thromboembolism.
- DHEA and testosterone supplementation are commonly prescribed by BHT practitioners to treat and prevent numerous conditions (i.e. mood disturbances, sexual dysfunction, enhance well-being, cognition and memory, loss of bone density, fatigue, decreased muscle strength, etc.) Low-testosterone (hypogonadism) is one of the least diagnosed and undertreated deficiency syndromes. Read my blog post to learn more about “Low T”.
- Adrenal hormone replacement: “Adrenal fatigue” is a diagnosis commonly treated by BHT practitioners. It is claimed to be responsible for a variety of symptoms (i.e. nonspecific body aches, fatigue, nervousness, sleep disturbances and digestive problems), and is treated with adrenal supplements. BHT practitioners believe that the adrenal glands burn out from chronic stress. “Adrenal fatigue” is not an accepted medical diagnosis. Unlike in patients with “adrenal insufficiency” (a well-recognized condition that can be diagnosed by blood and urine tests), assays for adrenal function and stimulation tests are often normal in patients who have been diagnosed with “adrenal fatigue” by BHT practitioners. Patients with “adrenal fatigue” are typically prescribed dried extracts of raw animal glandular and nonglandular tissues or glucocorticoid (steroids) medications. These compounds may contain infectious material, such as prions, which can cause mad cow disease. If they contain glucocorticoids, they can suppress the body’s hypothalamic-pituitary axis, ultimately leading to adrenal insufficiency.
- BHT product quality: The pharmacy custom-compounded hormones (typically used in BHT) are not regulated by the FDA, so there is no guarantee of purity, potency, efficacy or safety, and they may contain unknown contaminants.
Unfortunately, many practitioners continue to market BHT as if the science is supportive of both efficacy and safety.
Concerned that patients are being deceived into believing that these therapies are natural, safe and effective, numerous medical organizations have released statements warning patients of the potential risks (some of which are life-threatening) associated with BHT. As of 2011, the following organizations have released such statements: The International Menopause Society, American Congress of Obstetricians and Gynecologists, Society of Obstetricians and Gynaecologists of Canada, The Endocrine Society, the North American Menopause Society (NAMS), United States Food and Drug Administration, American Association of Clinical Endocrinologists, American Medical Association, American Cancer Society and the Mayo Clinic.
The Bottom Line:
I support the use of BHT as long as my patients are well-informed:
- To date, there are no robust, quality and long-term data supporting the safety and efficacy of these therapies.
- Comparative studies between BHT and conventional HT replacement have not been conducted.
- Conventional hormone replacement therapy is prescribed not solely on laboratory assessed hormone levels, but instead based primarily on the individuals’ symptoms and only after thoroughly reviewing the potential risks and benefits with the patient. BHT is prescribed based on results of hormone levels from assays (saliva and blood), levels that may not make any sense clinically or physiologically.
- BHT is not any more “natural” or safe than non-bioidentical hormone therapy. BHT may increase the risk of developing certain cancers and cancer progression. Cancer can increase the risk of blood clots in some patients. BHT may further increase the risk of risk of cardiovascular conditions (i.e. stroke, blood clots, etc.).
- Low-testosterone (hypogonadism) is one of the least diagnosed and undertreated deficiency syndromes. Read my blog post to learn more about “Low T”.
I highly recommend that patients discuss their use or interest in BHT with their cancer care team to make sure they have been carefully counseled on the potential risks.
