Bioedical hormone replacement therapy ( BHRT ), also known as bioidentic hormone therapy or natural hormone therapy , is the use of hormones which is identical at the molecular level with endogenous hormone in hormone replacement therapy. It can also be combined with blood and saliva tests of hormone levels, and the use of pharmaceutical compounds to obtain hormones in an attempt to achieve targeted hormone levels in the body. A number of claims by some proponents of bioidentical hormone replacement therapy have not been established definitively through scientific testing. Special hormones used in BHT include estrone, estradiol, progesterone (which are available both in FDA-approved products and pharmaceutical-compound products), testosterone, dehydroepiandrosterone (DHEA) (both testosterone and DHEA have some strict limits placed on availability and approval at Canada and the United States), and estriol (available in Europe but not approved in Canada and the United States).
Custom-compounded BHT is a practice that is almost completely limited in the United States. BHT is a form of alternative medicine. It has been promoted as a panacea for many diseases and to relieve menopausal symptoms, beyond medical purposes to reduce the risk of osteoporosis. There is little evidence to support this incremental claim; These hormones are expected to share the same risks and benefits of approved drugs in proportion to existing evidence based on extensive research and regulation. An exception is progesterone, which may have a better safety profile than an artificial progestogen, although direct progestinal comparisons have not been performed. The risks associated with the uncontrolled process of combined bioidentical hormones are not clearly understood. In addition, the accuracy and efficacy of saliva testing has not been definitively proven, and the long-term effects of using blood tests to achieve targeted levels of the hormone have not been studied.
The International Menopause Society, American Congress of Obstetricians and Gynecologists, The American Society of Obstetricians and Gynecologists, The Endocrine Society, American American Menopause Society (NAMS), United States Food and Drug Administration, American Clinical Endocrinology Expert Association, American Medical Association, American The Cancer Society and Mayo Clinic have issued a statement that there is a lack of evidence that the benefits and risks of bioidentic hormones differ from well-studied nonbioidentical peers; until such evidence is produced, the risk should be treated as if they were similar; and that multiple hormone products may have additional risks associated with compounding. A major safety issue in bioidentic hormone replacement therapy is that there is no requirement to include package inserts, despite the potential serious side effects (including life-threatening adverse effects) associated with HRT. This can cause consumers to be deceived (and harmed), as they are misled to believe that any hormone-related problems and hazards are exclusively related to non-hormone hormones, and that BHT is therefore safe and has no side effects. In fact, the risk of bioidentic hormone has not been studied to hormone levels of non-hormones, so the risk is not well understood. The regulatory body requires pharmacies to enter important safety information with conventional hormone replacement therapy (CHRT) through packet inserts.
Video Bioidentical hormone replacement therapy
History
Bioidentic hormone was first used to relieve menopausal symptoms in the 1930s, after Canadian researchers James Collip developed a method to extract oral active estrogens from the urine of pregnant women and market them as active agents in a product called Emmenin. It was replaced on the market when its manufacturer, Ayerst (later Wyeth Pharmaceuticals), began producing conjugated horse estrogens that were more easily manufactured in 1941 under the brand name Premarin; in 1992, Premarin was the most widely prescribed drug in the United States.
In the 1970s, studies and reports showing the risks of synthetic conjugate estrogens began to emerge. Investigations determined that the addition of progestogen to estrogen treatment reduced the risk. In the early 1980s, British Medical Journal (now BMJ ) recommended oral bioidentic progesterone as an option when side effects of synthetic progestogen were declared mandated to stop treatment. In May 1998, the FDA approved Prometrium, an oral bioidentic progesterone produced by Solvay Pharmaceutical.
Doctors John R. Lee and Jonathan Wright are pioneers in the field of BHT. Lee wrote several popular books on BHT and promoted a special combined BHT, with the goal of achieving what he called the "natural hormone balance". He bases this goal on saliva clinical trials to establish where "deficiencies" exist, although agencies such as the FDA and the Congress of Obstetricians and Gynecologists of America claim that blood and saliva tests are unreliable and biologically insignificant. Lee also believes that progesterone acts as a panacea and general health tonic for many health conditions; it bases its claims on anecdotal data rather than peer-reviewed studies, and no clinical trials have shown that this is true. Wright also wrote a popular book about BHT; he promotes the triple-estrogen formula he calls "Triest", which combines the three most common estrogens (more than 25 species) found in human women: estriol, estradiol, and estrone. Previous biootic formulas only use estradiol. This triple formula is based on an unpublished study whose conclusions do not take into account how estrogen is processed and excreted in the body - especially how the liver processes oral estrogens, converting most estrogens into estrone. No follow-up was undertaken by Wright to replicate this observation. Wright may be the first proponent of BHT to use the term "bioidentical" - a word he created to describe unsustainable molecules derived from plants he believed to be synonymous with human hormones. However, no structural evidence of crystallography has been used to support the idea that these molecules are actually identical to endogenous human hormones. When the Women's Health Initiative report on unappreciated taxonomic estrogen risks is released, many BHT recipes use Wright's (and its terminology) statement to express the superiority of bioidentic molecules even though there is no scientifically supported evidence. Following the publication of a popular book written by actress Suzanne Somers in 2006, the term "bioidentis" became more popular in popular consciousness as the "poorly understood adjectives" of hormone replacement therapy.
Maps Bioidentical hormone replacement therapy
Terminology
There is no single definition for the term "bioidentic hormone replacement therapy" (BHT); usually used to refer to 17? -estradiol, but other uses include plant-based or combined estrogen-based products that combine estradiol with estriol and sometimes with estrone. The "bioidentic hormone" is defined as a molecule that is identical to the hormone produced by the human body (though not all bioidentical hormones suspected to be sold by specialty compounding pharmacies are usually molecularly identical to endogenous humans). The FDA considers "BHT" as it is currently used by BHT supporters to be a marketing term, not a scientific term, and does not recognize its use. The meaning of "plant-derived" has also been attached to the term "bioidentical", and it could also mean that the hormone is "natural"; throughout the 1990s, mixed hormone compounds were added as "natural hormone therapy". However, the term "natural" can be applied to all products where the main ingredient is derived from animals, plants, or mineral sources, and bioidentic and nonbioidentical hormones can be produced from the same plant source.
"BHT" is often used to refer to a series of diagnostic, prescribing, preparing, and marketing practices including compounding (mixed hormone preparation by pharmacists, prescribing), saliva tests, and emphasis on action against the effects of aging rather than relieving menopausal symptoms. This combined BHT package has been promoted by Suzanne Sommers, Oprah Winfrey and other supporters as being safer and more effective than CHRT, although there is no evidence to support this claim. Compounded BHT has been marketed on the internet by pharmacies that make unfounded claims for safety and effectiveness for a variety of conditions.
There are various products that are FDA approved, made using bioidentic estrogen and micron progesterone, which is used to treat menopausal symptoms:
The term "synthetic" is also incorrectly used by lay experts in two different ways - to refer to the process used to produce all estrogen, including bioidentic estrogen, and for compounds that interact with estrogen receptors similar to those of estrogen molecules, but that is not found in nature. Examples of the latter two include diethylstilbestrol and ethinylestradiol.
Usage
BHT is used to reduce menopausal symptoms. It is also promoted by some practitioners for anti-aging purposes and provides benefits beyond the help of menopausal symptoms - improving quality of life, although there is little evidence to support this claim.
Components and merge
Typically, the preparation of bioidentic hormone compounds includes estriol, estrone, estradiol, testosterone, progesterone and sometimes dehydroepiandrosterone (DHEA), either individually or in some combinations. They are promoted as natural, safer and (in some cases) more efficacious than CHT; However, there is no scientific study to support BH's claim of superiority over CHRT. Estimates of bulk hormone sales for mergers show that more than one million women may be using a combined BHT in the US. Bioidentic hormones are expected to have the same risks as conventional hormones made with the same hormone category.
Estrogen
In premenopausal women, the majority of estrogens produced by the body are estradiol (produced primarily in the ovaries), whereas in postmenopausal women estrone (produced in fat cells) is the largest number of estrogens present; However, the body is able to convert one type of estrogen into another one to a certain degree. Because the study is limited to the potential, delivery methods and conversion of various estrogens, a valid scientific understanding of compound estrogen products has not been achieved. Synthetic Estradiol, taken orally, is divided when absorbed in the gastrointestinal tract and provides bioidentic estradiol to the bloodstream.
The estriol hormone, produced during pregnancy, is often aggravated into bioidentic preparation in the United States. While some people think of it as a weaker estrogen, with a more limited effectiveness period than estradiol, it has been shown to be a stronger estrogen in certain ways. Although initial research in the 1970s suggested possible use, continued research failed to confirm this potential. Estriol is not found in FDA-approved drugs, and its safety and effectiveness as a hormone supplement is unknown.
Estriol is part of the United States Pharmacopeia before FDA approval is required for its use. Approval was excluded by the FDA until 2008 when the agency banned its use, stating that estriol producers should make new applications and estriol would be treated as new drugs. Its use is not approved by Health Canada; estriol is not available as a pharmaceutical preparation in Canada or the United States but is a conventional treatment commonly prescribed in other countries and available as a vaginal cream or suppository in the UK and EU. Estradiol is available as a branded product in both oral and transdermal form.
Progesterone
Progesterone is used either orally or transdermally. Oral progesterone is micronized (soil) to increase availability, and is approved by the FDA to treat endometrial hyperplasia when used against estrogen. It has also been approved to relieve symptoms of menopause, either alone or in combination with estrogen. It's more reliable in treating menopausal sleep disorders than synthetic progestin. Transdermal progesterone is often used as a compound BHT component but has not been clinically proven to prevent endometrial hyperplasia, such as oral progesterone. Climacteric scientific journal editor Climacteric states that the biggest difference in function between bioidentic and synthetic hormones can be found in progesterone behavior compared with progestin. Laboratory studies show that bioidentic progesterone binds primarily to the progesterone receptor, while synthetic progestin activates other receptors with various effects. The editors suggest that progesterone may have a neutral-to-positive effect on the cardiovascular system, and induce apoptosis in breast epithelial cells. They also called for further research to examine and confirm the effects of progesterone on health, and to continue to use circulatory products that are regulated individually (not unregulated) provided by pharmacies. These compounds have not been directly compared to each other in the appropriate scientific tests, although in 2010 trials have begun. Progesterone is approved for use by FDA and Canadian Health as a brand oral preparation. Epidemiological studies in France suggest that micron progesterone may offer a reduced risk of breast cancer compared to other progestin, although large-scale clinical trials have not been performed. The 2012 practice adviser published by the Canadian Family Doctor's journal concluded "... there is no convincing evidence that bioidentic hormones are safer or more effective than synthetic HRT."
Other hormones
Testosterone supplements can increase libido in postmenopausal women, but also can decrease levels of high-density lipoprotein (good cholesterol). Commercial sources for testosterone for women in the US are limited, and include Estratest's commercially prepared estrogen-testosterone mixture; Compounding pharmacies are the main source of testosterone only preparation for women. The testosterone patch has been approved for use in the UK and the EU, but in Canada and the United States, long-term security data is still waiting.
DHEA is an androgen precursor that does not have FDA and Canadian Health approval for use in women, and is not available in Canada as a pharmaceutical preparation; it is sold as an over-the-counter drug or put into complicated preparations in the United States. In the body, it can be converted into testosterone and then into estrogen; there are no consistent scientific findings or safety information that supports its use. High DHEA levels have been associated with breast cancer.
Compounding
Compounding pharmacies use commercially available bulk drugs to create different new formulations (in form or dosage) from those produced on a large scale by pharmaceutical companies. Custom-compounded BHT is almost completely limited in the United States, where pharmaceutical compounding is regulated at the state level while the FDA has regulatory authority over multiple products. Some internet-based compounding pharmacies undermine the dangers and claim the combined benefits of BHT beyond what can be proven with evidence-based drugs, and many of their claims exceed those made by other more mainstream BHT practitioners.
Adverse effects
Benefits - as well as side effects - are expected to be the same for bioidentic and synthetic hormones. The dose used in BHT can be as high as ten times that of oral doses administered by comparable HRT regimens; the hormone used is known to adversely affect the biological markers of cardiovascular disease and can lead to a much higher risk of heart attack or stroke because of this. There are potentially serious adverse effects and vital safety information to be provided with an FDA-approved HRT in the form of package inserts; however, packet inserts are usually not provided (or required) with combined bioidentic preparations. This has led consumers to the false assumption that bioidenticals are safer than FDA-approved hormones or have no adverse effects - one of the hormonally expressed concerns. BHT is also associated with endometrial cancer.
Estrogen
The less common (but serious) side effects of all postmenopausal estrogens include an increased risk or severity of breast, ovarian or uterine cancer, stroke, heart attack, blood clotting, dementia, gallbladder disease, high blood pressure, liver problems, blood sugar high. , fluid retention, enlargement of benign tumors (fibroids) of the uterus, darkening of the grooved skin, especially on the face (melasma), and vaginal yeast infections.
Estradiol
Estradiol (a type of estrogen) - in the case of natural menopausal women - is only recommended for use for the shortest period and at the lowest effective dose due to its side effect profile. There is potential for various adverse effects on the breast, skin, eyes, cardiovascular, gastrointestinal, genitourinary or central nervous system. However, this risk is very low.
Progesterone
Progesterone can cause the appearance (or worsening) of abdominal pain, constipation, yeast infection, breast cancer, cystitis, acne, conjunctivitis, thrombotic disorders resulting in pulmonary embolism, stroke or heart attack and - due to increased fluid retention - epilepsy, migraine, asthma and disorders heart or kidney function. Psychiatric reactions may include emotional instability, depression, aggression, decreased libido and drowsiness. Side effects can also occur in the urinary, central or peripheral nervous system or bone and muscle. A review of clinical trials that studied the use of bioidentic progesterone found that was not effective in managing menopausal vasomotor symptoms, but had mild side effects and self-limiting.
Administration
Hormones can be administered in a variety of ways, including percutaneous skin and vaginal creams, oral pills, topical gels, vaginal rings and tablets, and transdermal fillings. Although all the preparations of certain types of estrogens (eg estradiol) may be identical molecularly before their introduction into the human body, the estrogens administered orally are modified by the liver before entering the bloodstream and in this process, largely converted into estrone. However, estrogen passes through the gastrointestinal tract and the liver and enter through the skin is not converted into a new form before entering the bloodstream. Creams and gels applied to the skin also go into the blood directly and without modification but the absorption of gels, creams, and patches can vary from application to app, depending on the temperature and skin condition. Pharmaceutical compounding is often used to modify doses, forms, and additives from preparation, based on instructions from health care practitioners.
Criticism
The main difference between popular CHRT and BHT combined promotions involves the use of BHT from routine blood tests or salivary blood levels, individual compounding rather than standard dosage, the dose to reach a certain level in the body rather than for symptoms. relief, and hormone use for purposes other than relieving menopausal symptoms. BHT combined advocates have been criticized by many major medical sources for making unfounded claims about their effectiveness for various purposes, and to promote it as safer and "natural" than CHRT.
Advocates for BHT have claimed that complicated BHT preparations are generally not commercially available; this is wrong, as there are many FDA-approved hormone preparations containing bioidentic molecules available either as proprietary or generic brands. The exception is estriol, used in bioidentic preparation of Triest and Biest compounds - in 2008, the FDA prohibited estriol until the New Drug Application was completed; This preparation is not approved by the FDA or Canadian Health. Some proponents of compounding have also falsely claimed that the particular compound gives tailored results; this is incorrect as it is intended to produce a single hormone profile with absolute blood or saliva levels - which has not been shown to be better than CHRT - and does not consider the degree to which the individual will be different in activity, metabolism and hormone excretion. There has been no direct clinical trial comparing the effectiveness or efficacy of bioidentic versus nonbioidentical compounds.
A 2010 article published in Drugs and Therapeutic Letters concluded â € Å"There is no acceptable evidence that the 'bioidentic' hormone is safe or effective. Patients should be prevented from taking it. "
Saliva testing and compounding
BHT is often associated with saliva testing to establish basic hormone levels and compounding of substances by pharmacists (according to doctors' advice) to produce individualized (and blood) hormone preparations for patients. No research has shown any benefit to any of these practices. Although BHT claims promoters that saliva testing can be used to "adjust" hormone levels for individuals, and tests are used to determine which hormones should be deficient and require supplementation, there is no scientific basis to support the use of saliva. testing. Estrogens are secreted in pulses in and over days, producing different levels of saliva. Certain compound formulations also seek to use a single profile for all women, without evidence that a particular profile is beneficial in all cases and there is no recognition that women differ in their sensitivity to hormones and metabolic rates. Test-based adjustments also do not take into account many effects, and hormone synthesis occurs within tissues rather than in the blood; Therefore, blood hormone or salivary levels may not necessarily reflect actual biological activity. Other concerns include a lack of evidence that samples are stable during storage and transportation, poor replication of results and considerable variation among tests. Nor is there any study linking symptoms with blood hormone or saliva levels. The FDA recommends, instead, adjusting hormone therapy to patient symptoms, and there is no reason to adjust the dose or monitor patients receiving BHT. BHT skeptics also show that there is no certainty about hormone levels in the body. The American American Menopause Society has endorsed warnings about the potential hazards that BHT may cause, since they do not need FDA-approved compounds in a way that has no evidence of safety or harm; This warning is supported by the Society of Obstetricians and Gynecologists of Canada.
Although promoted as a way of adjusting treatment, hormone therapy requires no adjustment; The use of tests to determine the amount of hormone administered may result in higher doses of the recommended minimum level to relieve symptoms, or the unnecessary administration of hormones in asymptomatic women can lead to greater risk in patients. In addition, analysis of the ingredients used to promote BHT suggests that instead of basing the dose of hormones on saliva results, the practitioner actually adjusts the dose based on symptoms. Health practitioners adjust their patient care on an ongoing basis by choosing individual drug, dosage and route of administration, using approved drugs that have a security record indicated and are not subject to specially prepared faulty and inconsistent combinations. Different bioidentic preparations produce mixtures of different strengths, and practitioners using aggravated formulations may not be aware of the total dose of hormones the patient receives. In a 2001 test of compound bioidentic hormone products, the FDA found that 10 of 29 products failed their quality tests; nine out of ten potential tests failed (comparable rates for drug manufacturers of less than 2% and 0.13%, respectively) A 2006 test found potential levels ranging from 67.5% to 268.4% of the potential specified on the label; several samples of different hormone mixtures with some of them, and others below, the specified potential. Potential testing failure can be problematic and dangerous for progesterone products, where specific progesterone levels are needed to protect the endometrium against precancerous hyperplasia.
Boothby, Doering and Kipersztok summarize this problem as a poor attempt to apply the pharmacokinetic principle to achieve individual doses for drugs that do not need it.
Saliva tests have not been proven to accurately measure blood-bound hormone levels. The FDA recommends the lowest dose of hormones that effectively relieve symptoms and does not recommend testing of compounds, blood, or specific saliva.
Lack of evidence for claims
The bioidentic hormone has been advertised, marketed and promoted as a risk-free elixir safer than standard HRT. A review of literature by private practitioners selling bioidentic preparations shows benefits and benefits in the use of BHT compared with their conventional counterparts, but there is significant skepticism over claims made about BHT; there is no peer-reviewed evidence that compound bioidentic hormones are safer or more effective than FDA-approved formulations or that they carry less risk. The hormones are thought to carry the same risks as their conventional counterparts, while the risks including estriol - a hormone that is usually produced in large quantities only in pregnant women - have not been studied. The United States Food and Drug Administration (FDA) warned that claims about aggravated BHT products are not supported by medical evidence - unlike claims about products manufactured, FDA approved. The bioidentic hormone has been described as a form of marketing; head of the medical editors of Endocrine Today called the BHT combination a "marketing concept" without scientific support, and the FDA warns that pharmacies use these terms to imply that drugs are natural and have the same effects as endogenous hormone. Other claims include the compounded ability of BHT to prevent or treat conditions such as heart disease, stroke, Alzheimer's disease, endometrium and breast cancer; fewer side effects; and special blending to uniquely handle individuals. There is no credible evidence to support this claim. Bioedical hormone and combined BHT are expected to have the same risks and benefits as CHRT; the latter benefits from years of study and regulation, while aggravated BHT has no scientific data to support superior safety claims or efficacy. The following specific claims have been made for the efficacy of bioidentic and combined BHT hormones, with varying evidence to support or contradict them:
In 2006, actress Suzanne Somers released the book Ageless: The Naked Truth About Bioidentical Hormones that supports the use of bioidentic hormones. This book was criticized by a group of doctors who (although generally support BHT) stated that further research is needed, and objected to the protocols mentioned in the book - due to their potential danger and lack of promoter qualifications. Somers' book may have raised awareness of the presence of BHT for more menopausal women, but it can also cause confusion by making unproven BHT claims and referring to the bioidentic hormone as a non-drug product with less risk. The bioidentic hormone has also been discussed on The Oprah Winfrey Show, with Somers as a guest.
Michael Cirigliano and Judi Chervenak have stated in the literature review of BHT that large-scale research, peer-reviewed should be used to establish safety, efficacy and beliefs about the use of bioidentic hormones. Two 2008 studies conducted in France found that estradiol plus synchronized progesterone did not increase the incidence of breast cancer, while estradiol comparisons plus various types of progestin found a reduced risk of invasive breast cancer with micron progesterone. Christine Derzko stated that the evidence supports the use of bioidentic estrogen plus progesterone, but because the experiment was an observational cohort study rather than a randomized controlled trial comparing different types of hormones from head to head, more data was needed before concluding the bioidentic hormone. more secure and preferable. Derzko concluded that there is weak (but promising) early evidence that bioidentic hormones may exhibit the same (or perhaps lower) risk than conventional HRT; However, no data support the use of compounding. Derzko recommends the following evidence-based medication and cites concerns over BHT by many medical organizations - the requirement for supervision of mixing, black box warning for all bioidentis products, and the establishment of a compulsory-event registry.
M. Sarah Rosenthal, Director of the University Program for Bioethics and Patient Rights, has stated that she believes BHT is an experimental therapy that is often prescribed by practitioners who sell products, and thus is in a position of unethical conflict. flower. Rosenthal also explains problematic issues with BHT including patients receiving information from popular books while lacking scientific literacy to separate rhetoric from evidence about hormone replacement, the unlawful claims of a "big pharmaceutical" conspiracy to suppress bioidentic prescription, surcharges and costs no need. products that are often not covered by insurance plans, and inaccurate portrayal of bioidentical recipes as "the latest science" rather than an unproven alternative medicine.
The monthly bulletin Harvard Women's Health Watch, published by Harvard Medical School, states that "natural" does not automatically mean "safe," and "natural" can be used to denote any product with animals, plants, or mineral sources - including non-bioidentical hormones (such as Premarin), as well as molecules extracted from soybeans and yam sources used in many bioidentic and nonbioidentical commercial preparations.
Cost
Compounded BHT may be more expensive than conventional, FDA-approved HRT, and often not covered by health insurance.
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Security
Bioidentic hormones are expected to carry the same risks and benefits as their non-bioidentic counterparts, but no studies have directly compared the bioidentic hormones that have worsened with their non-bioidentic counterparts. Hormones - such as those used in CHRT - have been studied for years and their profiles of risks, benefits, and effectiveness are known and demonstrated through adequate research.
In 2002, the Women's Health Initiative (WHI) study, designed to demonstrate additional benefits for conventional hormone therapy (study participants given Prempro or placebo), was terminated prematurely after preliminary data showed a small increase in risk of breast cancer, heart attack and stroke older women use Prempro. The early discontinuation of the WHI study (which uses conjugated horse estrogens) and subsequent publications of these previously unappreciated risks led to a decrease in prescriptions for CHRT. Results from WHI used by BHT prescriptions to promote bioidentic hormones are safer than FDA-regulated preparations despite lack of evidence; according to the FDA, the results found by this study apply to all estrogens. Since then BHT has been promoted strongly as a natural alternative with less risk than CHRT, although there is no evidence to support this claim. BHT practitioners recommend compound products because of their claim that they more closely mimic the composition and ratio of hormones circulating in the female body than commercially produced products.
The Endocrine Society issued a statement of the attitude that bioidentic hormones have the same risks and benefits as non-bioidentic molecules. In February 2009 the American Congress of Obstetricians and Gynecologists reiterated its position (November 2005) that there is no proven benefit in terms of safety or efficacy of aggravated bioidentic hormones, nor is there any benefit in testing hormone levels or adjusted hormone doses. The Mayo Clinic states that there is no evidence that BHT pharmaceutical mixtures are safer or more effective than conventional hormone replacement, and that some bioidentic hormones are already available in FDA-approved products. The American Cancer Society also states that "natural" and "bioidentical" hormones show the same risks as synthetic hormone replacement therapy such as heart disease, blood clots, stroke and increased risk of breast cancer with long-term use.
The US Food and Drug Administration has warned several pharmacies about making unfounded claims about the safety and effectiveness of multiple hormone products. The American American Menopause Society has stated that a compound bioidentic hormone has not been approved by the FDA; there is no guarantee of purity, potency, efficacy or safety, and they may contain unknown contaminants. The Australian Menopause Society has also stated that there is no evidence that the bioidentic hormones given using a lozenge are safer than those approved by them. The International Menopause Society has stated "There is no medical or scientific reason to recommend unregistered bioidentical hormones • Measurement of hormone levels in saliva is not clinically useful." These 'customized' hormonal preparations have not been tested in the study and its purity and risk is known. "
In November 2006, the American Medical Association adopted a policy calling for the FDA to better monitor and regulate bioidentic hormones, releasing an editorial stating that joint bioidentic molecules are expected to have the same risks as conventional hormones until proven otherwise.
Deborah Moskowitz published an article stating that the bioidentic hormone is superior to non-bioidentic hormones in safety and effectiveness, although this review is criticized for "trying to show that BHT has a good safety profile, but the data presented serve only to show similarity risk to conventional HRT. "
Quackwatch recommends not to use bioidentic hormones due to the lack of quality control over compounding, which poses the same risks as conventional hormones, the use of unnecessary saliva tests, and to include approved non-FDA estriol. Stephen Barrett, the site owner, summed up his review with the statement "The bottom line for consumers is very simple: Avoid anyone who prescribes hormones" bioidentis "or recommends a saliva test as a basis for evaluating hormone status."
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Regulatory status in the United States
Compounded BHT is used almost exclusively in the United States, and many FDA-approved formulations are wholly or partially made of available bioidentic hormones. Topical hormone preparations such as progesterone, estrogen, and DHEA creams can be purchased at stores or over the internet and are not regulated by the FDA, as they are generally considered cosmetic.
When prescribed by licensed practitioners, bioidentic hormone compounding is controlled by the state pharmaceutical council rather than the FDA, and pharmacists are allowed to adjust the dosage and delivery method according to the prescription. However, the FDA does have the authority over multiple products. In 2001 the FDA conducted a survey of mixed preparations, including eight hormone compounds. All three estradiol products pass each test; However, two out of five progesterone products fail at least one potential test, content or uniformity.
In October 2005, Wyeth Pharmaceuticals, the manufacturer that approved the preparation of the FDA's bioidentic and nonbioidentic HRT, filed a Citizens Petition with the FDA to request law enforcement actions against dispensing pharmacies that distributed BHT, and to investigate advertising labels and guidelines. Soon after, the FDA took a number of law enforcement actions against several (mainly internet-based) pharmacies that produced combined BHT and in 2008, banned the use of estriol in the US. The FDA declared that they had not taken this regulatory action against a compound bioidentic hormone in response to Wyeth's request, since it was not the purpose of the citizen petition. They said they had an ongoing investigation when they received the petition. The FDA orders pharmacies to stop using estriol. The Assistant Director of the Office of the Compliance Office states that the use of estriol will require permission for research and application of new drugs. The FDA also stated that they have not approved any drugs containing estriol and that no information has been submitted to the FDA regarding its safety and effectiveness. The FDA's attention to the marketing and use of bioidentic hormones is supported by the American Association of Clinical Endocrinologists. In response to FDA action, the International Academy of Pharmacists started a letter-writing campaign to the FDA to reverse this action, citing Wyeth's efforts as a "self-serving, and sometimes rowdy, campaign to limit patient access to alternatives to his own products."
In November 2006, the American Medical Association adopted an urgent Food and Drug Administration policy to conduct a survey of combined BHT products for purity and dosage; to maintain the registry and require reporting of compulsory disadvantageous effects by producers and dispensing pharmacies associated with bioidentic hormones; to mandate inclusion of uniform patient information, including warnings and precautions concerning bioidentic products; and to prohibit the use of the term "bioidentical hormone" unless the agency has agreed to the preparation.
On July 18, 2008, the US Court of Appeals issued a ruling stating that a new drug approval process should not be applied to mixed drugs that meet established guidelines, and also that the relevant regulatory provisions with estriol use still apply, preventing the FDA taking action against pharmacies using estriol in the combined product.
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Wiley Protocol
The Wiley Protocol is a combined BHT version, supported by T. S. Wiley, whose goal is to produce serum estradiol and progesterone levels that are identical to young women with normal menstrual cycles. The Wiley protocol has been criticized for various reasons.
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See also
- European Menopausal Society and Andropause
- Women's health
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References
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External links
- Senate Hearing on Bioidentic Hormones: Sound Science or Poor Drugs? by the United States Senate Special Committee on Aging
- Interview on bioidentic hormone with Arlene Weintraub on the Canadian Broadcasting Corporation radio program The Current , November 8, 2010
Source of the article : Wikipedia
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