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Bioidentical hormone replacement therapy (BHRT, also known as bioidentical hormone therapy) refers to the treatment of symptoms and disorders of menopause using hormones that are molecularly identical to endogenous hormones. The term 'BHRT' is commonly used to describe a group of practices including the use of compounded hormone mixtures, saliva testing, and the attempt to restore certain levels of both hormones in the blood rather than simply aiming to provide symptom relief, which is the goal of standard hormone replacement therapy.

Bioidentical hormones used in BHRT include estriol, estrone, (not yet approved by the FDA for use) and estradiol and progesterone which are available both in FDA-approved manufactured products and as pharmacy-compounded products. In 2002, the Women's Health Initiative ended one arm of its study of conventional hormone replacement therapy due to previously unappreciated risks. This led to a decrease in prescriptions for conventional hormone replacement and a search for safer alternatives, spurred in part by popular promotion (such as a book on the topic written by Suzanne Somers and the discussion of BHRT on The Oprah Winfrey Show). Advocates have portrayed BHRT as superior to conventional hormone replacement therapy due to the individualized approach, match to endogenous hormones and the "naturalness" of the hormones. These claims for pharmacy-compounded BHRT's superiority are not supported by research and the risks and benefits of this form of hormone replacement therapy are unknown.

Some BHRT practitioners have published articles which argue that bioidentical hormones have a better safety profile than non-bioidenticals, and can be more effective. The International Menopause Society states that progesterone may be associated with no increased risk, or a lower risk of breast cancer than progestins. However, the American College of Obstetricians and Gynecologists, the Endocrine Society, the North American Menopause Society (NAMS), United States Food and Drug Administration and the Mayo Clinic have released position statements stating that there is no difference in benefits or risks of hormone replacement therapies using bioidentical molecules compared to those using non-bioidentical molecules, and that compounded hormone products may have additional risks related to compounding. BHRT and conventional HRT are expected to have the same risks and benefits, and while conventional HRT and FDA-approved BHRT products have been extensively studied and are heavily regulated, compounded BHRT products are regulated only by state pharmacy boards and lack an accepted evidence base. Since pharmacy-compounded products are not subject to FDA testing and quality control measures, their potency, purity and safety have been questioned.

Terminology

"Bioidentical" does not have a meaning that is universally recognized and there is confusion regarding its use. Some groups use it to describe molecules that are identical to those in the body, while others also include plant derivation in the definition. The term has been used in FDA packaging inserts since before 1998. The FDA states that there is no defined medical or conventional meaning to the term, and that many compounding pharmacies use it "as a marketing term to imply that drugs are natural, or have effects identical to those from hormones made by the body", implications for which there is no supporting evidence. Manufactured on an industrial scale, the hormones are available as commercial products available in standardized form which compounding pharmacies use to prepare individualized doses and delivery systems based on prescriptions from health care practitioners.

Patients requesting "bioidentical" hormones may not be clear on what they are asking for. What is sought may be individual or tailored hormone replacements, and the marketing and advertising of BHRT has resulted in a significant increase in its popularity. Compounded BHRT has been promoted as a treatment that could improve the symptoms of menopause without the risks of conventional hormone replacement therapy, though the evidence to support these claims is lacking.

Bioidentical estrogens and micronized progesterone are used to make a variety of FDA-approved products that are used to treat symptoms of menopause:

Erika Schwartz and Kent Holtorf criticized a 2008 review of literature on the subject for addressing only compounded bioidentical hormones, and not including a review of the already FDA-approved preparations that contain bioidenticals. Schwartz and Holtorf stated that this added to the existing confusion regarding bioidentical hormones and the fact that many FDA preparations already use them.

Uses

BHRT may be used like conventional hormone replacement therapy to reduce the symptoms of menopause. It is also promoted as providing benefits beyond mere symptom relief, though there is no evidence to support these claims and BHRT is not expected to offer benefits beyond increased bone density, the only demonstrated benefit of conventional hormone replacement therapy. In 2002, the Women's Health Initiative study (WHI) was terminated prematurely after preliminary data raised serious concerns over the increased risks of breast cancer, heart attacks and strokes in older women given conventional hormone replacement therapy. The early termination and subsequent publicity of these previously unappreciated risks led to a decline in prescriptions for HRT. BHRT has since been strongly promoted as a natural alternative with fewer risks than conventional HRT, though there is no evidence to support this claim. Estimates from sales of bulk hormones for compounding suggest that more than 1 million women may be using compounded BHRT in the US.

Bioidentical hormones are often compounded to individualize the dose and delivery vehicle for each patient. While non-bioidentical hormones are not likely to be tracked in the blood because standard testing does not measure their byproducts, bioidentical hormones can be tracked with conventional blood tests, which proponents argue is an advantage. Skeptics of BHRT argue that it is uncertain if there is an ideal blood level of hormones, and that symptom control, not a specific blood level, is the primary goal of treatment.

Administration

Hormones can be administered in a variety of ways, including skin and vaginal creams, pills, topical gels, vaginal rings and tablets, and transdermal patches. Though all preparations are molecularly identical before their use, estrogens administered orally are modified by the liver before entering the blood, while those entering through the skin are not. Creams and gels applied to the skin also enter the blood directly and without modification, but it is not clear how much is actually absorbed. Pharmaceutical compounding is frequently used to modify the dose, form, and additives of the preparations, based on the instructions from a health care practitioner.

Criticisms

Bioidentical hormone replacement therapy has been criticized in many peer-reviewed sources for making unsubstantiated claims about being effective against a variety of health conditions, for lacking evidence of safety of the compounds, for marketing itself as more "natural" than conventional HRT and for the frequently-associated practices of compounding and saliva testing. Since bioidentical hormones are in fact used in many FDA-approved, standard hormone replacement therapy preparations, the relative advantages and differences between bioidentical and nonbioidentical hormones has been questioned. The primary differences between conventional and bioidentical hormone replacement therapy as popularly promoted mainly involves the testing of blood or saliva-bound estrogen levels and the use of individualized compounding rather than a standard dose, mixture and application of hormones. Saliva testing has not been shown to accurately measure blood-bound hormone levels, and neither approach has any research to support a relationship to symptom relief. The FDA recommends the lowest dose of hormone that effectively relieves symptoms and does not recommend custom-compounding, blood or saliva testing.

Advocates for BHRT have claimed that commonly compounded BHRT preparations are not commercially available, which is not true. Customized compounding does not actually provide customized results since it is aimed at producing a single hormone profile, which has not been demonstrated to be better than conventional hormone replacement therapy and does not consider rate at which individuals will differ in the activity, metabolism and excretion of the hormones.

Lack of evidence for claims

Bioidentical hormones have been advertised, marketed and promoted as being a risk-free panacea that is safer than standard HRT. There is little peer reviewed evidence for or against BHRT and a lack of consensus regarding its appropriateness, effectiveness and adverse effects. Some literature reviews suggest benefits and advantages in the use of BHRT over conventional counterparts but there is significant skepticism over the claims made about BHRT and many commentators state that there is insufficient evidence to support the claims made with a lack of randomized controlled trials needed to form firm conclusions. The United States Food and Drug Association warned that claims about compounded BHRT products are unsupported by medical evidence, unlike claims made by manufacturers of FDA-approved products. BHRT has been called a "marketing concept" with no scientific backing by the chief medical editor of Endocrine Today and the FDA stated that pharmacies use the term to imply the drugs are natural and have the same effects as hormones made in the body. It has also been claimed that compounded BHRT can prevent or treat diseases such as stroke, Alzheimer’s disease, breast cancer and heart disease. There is no credible evidence to support these claims. Bioidentical hormones and compounded BHRT are expected to have the same risks and benefits as conventional HRT, though the latter has the benefit of being heavily studied and regulated while BHRT has no scientific data to support claims of safety or efficacy. Despite this a variety of specific claims have been made for the effectiveness of bioidentical hormones and BHRT, with varying evidence to support or contradict them.

In 2006 actress Suzanne Somers released the book Ageless: The Naked Truth About Bioidentical Hormones, which endorsed the use of bioidentical hormones. Ageless mentioned one approach, the Wiley Protocol, specifically. The book was criticized by a group of doctors who, though generally supportive of the use of bioidentical hormones, state that more research is required and object to the Wiley Protocol in particular for its potential danger and its creator being unqualified. Bioidentical hormones have also been discussed on The Oprah Winfrey Show, with Somers as a guest.

Erika Schwartz and Kent Holtorf believe there is evidence supporting the assertion that the bioidentical hormones estradiol and progesterone have a safety profile that is superior to that of synthetic progestins, as well as a variety of studies comparing bioidentical with conventional hormones and the various administration methods used to deliver them to the body. Results cited include lower proliferative effects on certain breast cancers, improved relief of postmenopausal symptoms, bone density and lipoprotein levels in the blood. Schwartz and Holtorf also claim bioidentical hormones can be used to promote wellness and prevent diseases.

The International Menopause Society has stated "There are no medical or scientific reasons to recommend unregistered ‘bioidentical hormones’."

Safety

Though bioidentical hormones are often claimed to be safer than conventional hormones, there is no evidence to support these claims and they are expected to carry the same risks and benefits of their non-bioidentical counterparts. Conventional hormones as used in menopausal HRT have been studied for years and their risk, benefit, and effectiveness profiles are demonstrated through years of research.

The Endocrine Society issued a position statement that bioidentical hormones carry essentially the same risks and benefits as non-bioidentical molecules. The American College of Obstetricians and Gynecologists in February 2009 re-iterated its position from November, 2005 that there was no proven benefits to safety or efficacy of compounded bioidentical hormones, nor is there any benefit to salivary testing of hormone levels or customized dosing of hormones. The Mayo Clinic states that there is no evidence that pharmacy-compounded BRHT is safer or more effective than conventional hormone replacement, and that some bioidentical hormones are already available in certain FDA-approved products. The U.S. Food and Drug Administration has warned several pharmacies about making unsubstantiated claims about the safety and effectiveness of compounded hormone products. The North American Menopause Association has stated that compounded bioidentical hormones have not been approved by the FDA, so there is no guarantee of purity, potency, efficacy or safety, and they may contain unknown contaminants, and the Australian Menopause Society has similarly stated that there is no evidence that bioidentical hormones administered using lozenges are any safer than conventional hormones.

BHRT has been linked to three cases of endometrial cancer in Australia, with the authors suggesting the ratio of estrogen to progesterone used was inadequate, leading to endometrial hyperplasia and possibly endometrial carcinoma. As with the estradiol produced in the body and the estrogens used in conventional HRT, bioidentical estradiol that is unopposed by progesterone can cause proliferation of cells in the breast, increasing the risk of breast cancer. Erika Schwartz, founder of The Natural Hormone Pharmacy, and Kent Holtorf, founder of the Holtorf Medical Group, state that bioidentical hormones are more safe than non-bioidentical hormones when administered correctly, and combination therapy using bioidentical estrogens and progesterone has a better safety profile than regimens including a synthetic progestin.

Estriol

The hormone estriol is frequently compounded into bioidentical preparations. It is claimed that estriol, along with the also-bioidentical estrone, is a weaker and safer estrogen. These claims are not supported by unbiased research. The claims are based on research that is several decades old, using animal models rather than humans. These claims often misrepresent the implications and overstate the benefits of the studies, as well as overlooking the risks. The custom-compounded preparations promoted by BHRT advocates are not FDA-approved. The FDA has acknowledged that they are unaware of any adverse events connected to the use of estriol but ordered pharmacies to discontinue its use. Estriol's safety and effectiveness is unknown; the agency's Assistant Director of the Office of Compliance has stated that use of the hormone would require a permit for research and application for a new drug.

"Natural" claims

Bioidentical hormones are frequently marketed as being "natural", or more natural than conventional HRT. Women who purchase compounded BHRT are more likely to associate the term "natural" with the idea that the hormones are derived from plant sources. The source and extraction processes used to create bioidentical and nonbioidentical hormones from plants are exactly the same - most are produced through conversion of diosgenin (extracted from soy or yam plants) into progesterone which is used as a hormone chemical precursor. Natural is also used to refer to the hormones being molecularly identical to those found endogenously. The Harvard Women's Health Watch, published by Harvard Medical School, states that the "natural' part of the marketing of BHRT may be a euphemism for "unregulated" rather than safe.

However, the term "natural" can technically be used to indicate any product with an animal, plant, or mineral source, and as such applies to hormones that are not bioidentical, including Premarin (a non-bioidentical hormone extracted from the urine of pregnant horses), as well as to the molecules extracted from soybean and yam sources.

Salivary testing and compounding

BHRT is frequently associated with testing of saliva to establish a baseline hormone level, and compounding of the substances by pharmacists, on the advice of doctors, to produce preparations and blood-levels of hormones that are individualized to the patients. There is no research that demonstrates there is any benefit to either of these practices. Though promoters of BHRT claim that saliva testing can be used to "customize" the level of hormones for individuals, and tests are used to determine which hormones are supposed to be deficient and require supplementation, there is no scientific basis to support the use of saliva testing as estrogens are secreted in pulses within and across days resulting in varying saliva levels. Certain compounding formulations also attempt to use a single profile for all women, with no evidence that a specific profile is beneficial in all cases and no recognition that women differ in their sensitivity to hormones and rate of metabolization. Customizing based on testing also does not account for much of the effects and synthesization of hormones occurs within tissues rather than in the blood, and therefore blood or saliva levels of hormones may not necessarily reflect actual biological activity. Other concerns include lack of evidence that samples are stable during storage and transportation, poor reproducibility of results, and considerable variability between assays. There are also no studies that link symptoms with blood or saliva levels of hormones, and no evidence clearly linking progesterone to any changes in the endometrium. The FDA recommends instead adjusting hormone therapy based on the symptoms of the patient, and there is no reason to adjust the dosing or monitor patients receiving BHRT. Skeptics of BHRT have also pointed out that there is also no certainty regarding what level of hormones should be found in the body. Although promoted as a way of customizing treatment, hormone therapy does not require customization. and the use of testing to determine the amount of hormones administered could result in the dose used being higher than the minimum recommended level to alleviate symptoms or the administration of unnecessary hormones to asymptomatic women resulting in greater risks to the patient. In addition, analysis of the material used to promote BHRT suggests that rather than basing hormone doses on saliva results, practitioners are actually adjusting the dose based on symptoms. Health practitioners customize the care of their patients on an ongoing basis by choosing the medication, dose and administration route individually, using approved medications that have a demonstrated safety record and are not subject to the errors and inconsistencies of custom-prepared combinations. In addition, the different bioidentical preparations result in mixtures with different strengths and practitioners using compounded formulations may be unaware of the total dose of hormones their patients receive.

Boothby, Doering and Kipersztok summarize the issue as being a poor effort to apply principles of pharmacokinetics to achieve individualized dosing for drugs that do not require it.

Wiley Protocol

The Wiley Protocol is a controversial type of compounded BHRT endorsed by T. S. Wiley. It attempts to produce serum levels of estradiol and progesterone that are identical to those of a young woman at the various times throughout the menstrual cycle. In contrast, most bioidentical hormone practitioners instead seek to produce consistent estradiol and progesterone levels that are less than the average levels of a normal menstrual cycle. It has been shown that using serum levels to judge the effects of transdermal progesterone can be misleading. The Wiley Protocol has been criticized by others for a variety of reasons.

Regulatory status in the United States

Pharmacy-compounded BHRT is not regulated by the FDA, but is regulated by the boards of pharmacies for each state. Pharmacists can adjust the doses and delivery methods of compounded BHRT according to the doctor's prescription.

In 2008 seven compounding pharmacies that used the term 'bio-identical hormone replacement therapy' were warned by the FDA to stop making unfounded claims about their safety and effectiveness, which were considered false and misleading by the agency a warning supported by The Endocrine Society and the American Association of Clinical Endocrinologists. The FDA considers the word bioidentical to be "a marketing term implying a benefit for the drug, for which there is no medical or scientific basis." The FDA also objected to statements that BHRT was better than approved drugs at treating the symptoms of menopause, and the unsubstantiated claims that it could be used to prevent and treat serious medical conditions and diseases including strokes, Alzheimer's and certain cancers. The inclusion of estriol in bioidentical preparations was also problematic as it has not been tested for safety and effectiveness, and is not approved by the FDA for any use. The FDA has also expressed concern that unfounded claims made about BHRT mislead women and health care professionals, but allows compounding of products when a licensed practitioner decides that an approved drug does not meet the patient's needs.

Footnotes

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2. ^ Mayo Clinic (2007-08-21). "Bioidentical hormones: Are they safer?". Retrieved 2007-08-27.
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External links

• Senate Hearings on Bioidentical Hormones: Sound Science or Bad Medicine? by the United States Senate Special Committee on Aging

• Misplaced Pages neutral point of view disputes from November 2009
• Endocrinology
• Menopause