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Sandbox Some random guy who thinks IM BEETTER

Anti-aging

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As lately as 1998, a Wyeth-ghostwritten research article called for the use of estrogen therapy for anti-aging purposes:

[1]



Uses

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As one of several treatment options, BHRT may be prescribed to reduce the symptoms of menopause, as recommended by mainstream medicine. FDA approval of various products comprised of bioidentical hormones in standard dosages brought these options to the US market in the 1990s.[1]

BHRT is also promoted, especially by people lacking medical credentials, as providing benefits beyond menopausal symptom relief, including for anti-aging and disease prevention, though there is no evidence to support these claims. Internet pharmacies have promoted the use of individual or compounded bioidentical hormones for purposes as diverse as the prevention of Alzheimer's disease and the restoration of sexual libido, with little to no scientific foundation. Compounded BHRT is not expected to offer benefits beyond increased bone density, the only demonstrated benefit of CHRT.[2]


Doesn't belong

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In 2002, the Women's Health Initiative study (WHI), which was designed to confirm widely-believed benefits beyond menopausal relief, was terminated prematurely after preliminary data indicated increased risks of breast cancer, heart attacks and strokes in older women given CHRT.[3] The early termination of the WHI study and subsequent publicity of these previously unappreciated risks led to a decline in prescriptions for CHRT.[4] BHRT has since been strongly promoted as a natural alternative with fewer risks than CHRT, though there is no evidence to support this claim.

Modes of Treatment

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Transdermal hormones are often available in the US without a prescription. Absorption rates of transdermal hormone preparations are variable, making dosage recommendations unreliable. [5]

Criticisms

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The primary differences between CHRT and compounded BHRT as popularly promoted involve testing of blood or saliva-bound estrogen levels, use of individualized compounding rather than standard doses, dosing to attain certain levels in the body rather than to relieve symptoms, and the use of hormones for purposes other than relief of menopausal symptoms. Proponents of compounded BHRT have been criticized by many mainstream medical sources for making unsubstantiated claims about its effectiveness for a variety of purposes, and for promoting it as more safe and "natural" than CHRT.

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 CHRT and does not consider the rate at which individuals will differ in the activity, metabolism and excretion of the hormones.[1]

Salivary testing and compounding

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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.[6][2][7][8] 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.[1][9] 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.[1] Other concerns include lack of evidence that samples are stable during storage and transportation, poor reproducibility of results, and considerable variability between assays.[1][9] There are also no studies that link symptoms with blood or saliva levels of hormones.[8][1] The FDA recommends instead adjusting hormone therapy based on the symptoms of the patient,[10][11][12] and there is no reason to adjust the dosing or monitor patients receiving BHRT.[13] Skeptics of BHRT have also pointed out that there is also no certainty regarding what level of hormones should be found in the body.[14]

Although promoted as a way of customizing treatment, hormone therapy does not require customization.[11] 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[8][1] or the administration of unnecessary hormones to asymptomatic women resulting in greater risks to the patient.[10][8] 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.[9] 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.[10]

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.[9]

Saliva testing has not been shown to accurately measure blood-bound hormone levels. The FDA recommends the lowest dose of hormones that effectively relieve symptoms and does not recommend custom-compounding, blood or saliva testing.[15][12]

Lack of evidence for claims

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Bioidentical hormones have been advertised, marketed and promoted as a risk-free panacea that is safer than standard HRT.[10] Literature reviews by private practitioners who sell bioidentical preparations suggest benefits and advantages in the use of BHRT over conventional counterparts,[16][15][17] but there is significant skepticism over claims made about BHRT and there is no peer-reviewed evidence that compounded bioidentical hormones are safer or more effective than FDA-approved formulations or that they carry less risk.[18][2][8][1][19] The United States Food and Drug Administration (FDA) warned that claims about compounded BHRT products are unsupported by medical evidence, unlike claims about manufactured, FDA-approved products.[20] The chief medical editor of Endocrine Today called compounded BHRT a "marketing concept" with no scientific backing,[14][21] and the FDA warned that pharmacies use these terms to imply that the drugs are natural and have the same effects as endogenous hormones. Some[who?] also claim 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.[citation needed] Bioidentical hormones and compounded BHRT are expected to have the same risks and benefits as CHRT, though the latter benefits from years of study and regulation, while compounded BHRT has no scientific data to support claims of superior safety or efficacy.[2][14][8][22][11][1][12] The following specific claims have been made for the effectiveness of bioidentical hormones and compounded BHRT, with varying evidence to support or contradict them:[2]

Claim Evidence
Bioidentical hormones fit precisely in human hormone receptors while conventional hormones fit "cockeyed"; this mismatch causes serious side effects[2] Synthetic progestins and endogenous progesterones have different binding affinities for different receptors depending on the model and animal used; these differing pharmacodynamics have not been associated with specific side effects[2]
The body is unable to metabolize synthetic hormones[2] The biological half-life for synthetic hormones is between five minutes and two days[2]
Lack of progesterone causes "estrogen dominance", resulting in irregular or painful, heavy menses[2] Oral progesterone is no more effective than placebo at alleviating symptoms of premenstrual syndrome[2]
Progesterone can counter-act stress, increase metabolism and decrease abdominal fat[2] There is no evidence to support weight loss due to progesterone[2]
"Normal" levels of progesterone protect against breast cancer[2] The claim is based on a single study of infertile patients during child-bearing years; there is some evidence to support a link between hormonal treatment for infertility and a reduced risk of breast cancer, but these benefits may not translate to women seeking relief from the symptoms of menopause[2]
Progesterone therapy can prevent cardiovascular disease and atherosclerosis, and raise good cholesterol[2] The use of micronized progesterone neither increases nor decreases cardiovascular risks[2]
The side effects reported in the Women's Health Initiative study were due to the synthetic nature of the hormones used[2] "Cardiovascular benefit has not been proven with micronized progesterone in observational or experimental research...a multicenter, case–control study was conducted in postmenopausal women aged 45–70 years to examine potential differences in cardiovascular risk between the subtypes of synthetic progestins and micronized progesterone...Micronized progesterone and pregnane derivatives were not associated with an increased venous thromboembolism risk, whereas norpregnane derivatives...were associated with increased risk of thromboembolism...Thus, certain progestins are associated with increased cardiovascular risk, whereas pregnane derivatives and micronized progesterone neither increase nor decrease cardiovascular risk in the doses studied"[2]
Proponents claim that bioidentical hormones, in addition to the demonstrated benefit of improving bone mineral density, protect the eyes and skin from drying out, regulate the menstrual cycle, improve mental function, improve blood cholesterol and reduce hot flashes and night sweats associated with menopause[2] There is no published evidence derived from controlled research that supports the claims of superior beneficial effects for bioidentical hormones as compared to conventional hormome therapy. Risk data have been published for conventional hormone therapy, and CHRT is not recommended to manage any chronic diseases, or for the prevention of cardiovascular disease[2]
Estriol can decrease the risk of breast cancer[2] Estriol has been shown to cause breast cancer cell growth[2]
Pharmacists use their expertise regarding bioidentical hormones to meet the needs of their clients and improve health outcomes[2] Compounding is a legitimate practice, but there is no evidence that clearly illustrates the benefits and risks of BHRT[2]

In 2006 actress Suzanne Somers released the book Ageless: The Naked Truth About Bioidentical Hormones, which endorsed the use of bioidentical hormones. 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 protocols mentioned in the book on the basis of their potential danger, as well as the lack of qualification of the promotors.[23] Somers' book may have raised the profile of BHRT for the growing number of menopausal women, but also may cause confusion in making unsubstantiated claims for BHRT, and in referring to bioidentical hormones as non-drug products with fewer risks.[1] Bioidentical hormones have also been discussed on The Oprah Winfrey Show, with Somers as a guest.[24]

Bioidentical hormone proponents Erika Schwartz and Kent Holtorf criticized a 2008 review of literature on bioidentical hormones for addressing only compounded bioidentical hormones, and not reviewing FDA-approved bioidentical products, which they believe added to the existing confusion.[16][15] Michael Cirigliano and Judi Chervenak have stated in reviews of literature on BHRT that large-scale, peer-reviewed studies should be used to establish the safety, efficacy and beliefs about the use of bioidentical hormones.[1][10]

M. Sarah Rosenthal, Director of the University of Kentucky Program for Bioethics and Patients’ Rights, has stated that she believes BHRT is an experimental therapy that is often prescribed by practitioners who sell the products, and are thus in an unethical position of conflict of interest. Rosenthal has also described problematic issues with BHRT including patients receiving information from popular books while lacking the scientific literacy to separate rhetoric from evidence about hormone replacement, illegitimate claims of a "big pharam" conspiracy to suppress bioidentical prescribing, the extra and unnecessary cost of the products that are often not covered by insurance plans, and the inaccurate depiction of bioidentical prescribing as "cutting edge science" rather than unproven alternative medicine.[18]

"Natural" claims

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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.[1] 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 and state that 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.[14]

Cost

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Compounded BHRT is more expensive than conventional, FDA-approved HRT and is often not covered by health insurance plans.[25][18]

References

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  1. ^ a b c d e f g h i j k l Cirigliano, M (2007). "Bioidentical hormone therapy: a review of the evidence" (PDF). Journal of Womens Health. 16 (5): 600–31. doi:10.1089/jwh.2006.0311. PMID 17627398.
  2. ^ a b c d e f g h i j k l m n o p q r s t u v w x y Boothby LA, Doering PL (August 2008). "Bioidentical hormone therapy: a panacea that lacks supportive evidence". Curr. Opin. Obstet. Gynecol. 20 (4): 400–7. doi:10.1097/GCO.0b013e3283081ae9. PMID 18660693.{{cite journal}}: CS1 maint: date and year (link)
  3. ^ Writing Group for the Women's Health Initiative Investigators (2002). "Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women: Principal Results From the Women's Health Initiative Randomized Controlled Trial". JAMA. 288 (3): 321–333. doi:10.1001/jama.288.3.321. PMID 12117397.
  4. ^ Chlebowski, Rowan T.; Kuller, Lewis H.; Prentice, Ross L.; Stefanick, Marcia L.; Manson, Joann E.; Gass, Margery; Aragaki, Aaron K.; Ockene, Judith K.; Lane, Dorothy S.; Sarto, Gloria E.; Rajkovic, Aleksandar; Schenken, Robert; Hendrix, Susan L.; Ravdin, Peter M.; Rohan, Thomas E.; Yasmeen, Shagufta; Anderson, Garnet; WHI Investigators (2009). "Breast cancer after use of estrogen plus progestin in postmenopausal women". The New England Journal of Medicine. 360 (6): 573–587. doi:10.1056/NEJMoa0807684. PMC 3963492. PMID 19196674. {{cite journal}}: Unknown parameter |jounral= ignored (help)CS1 maint: date and year (link)
  5. ^ Cite error: The named reference Fugh-Berman was invoked but never defined (see the help page).
  6. ^ Cite error: The named reference Mayo was invoked but never defined (see the help page).
  7. ^ Cite error: The named reference McBane2008 was invoked but never defined (see the help page).
  8. ^ a b c d e f Fugh-Berman, Adriane; Bythrow, Jenna (2007). "Bioidentical hormones for menopausal hormone therapy: variation on a theme". Journal of General Internal Medicine. 22 (7): 1030–4. doi:10.1007/s11606-007-0141-4. PMC 2219716. PMID 17549577.{{cite journal}}: CS1 maint: date and year (link)
  9. ^ a b c d Cite error: The named reference Boothby2004 was invoked but never defined (see the help page).
  10. ^ a b c d e Chervenak J (October 2009). "Bioidentical hormones for maturing women". Maturitas. 64 (2): 86–9. doi:10.1016/j.maturitas.2009.08.002. PMID 19766414.{{cite journal}}: CS1 maint: date and year (link)
  11. ^ a b c "ACOG News Release: ACOG Reiterates Stance on So-Called "Bioidentical" Hormones". American College of Obstetricians and Gynecologists. 2009-02-03. Retrieved 2009-09-18.
  12. ^ a b c Cite error: The named reference FDAFAQ was invoked but never defined (see the help page).
  13. ^ Pastner, B (2008). "Pharmacy Compounding of Bioidentical Hormone Replacement Therapy (BHRT): A Proposed New Approach to Justify FDA Regulation of These Prescription Drugs". Food & Drug L.J. 63 (2): 459–91. PMID 18561473.
  14. ^ a b c d Cite error: The named reference Harvard was invoked but never defined (see the help page).
  15. ^ a b c Cite error: The named reference Holtorf2009 was invoked but never defined (see the help page).
  16. ^ a b Cite error: The named reference Schwartz was invoked but never defined (see the help page).
  17. ^ Cite error: The named reference Moskowitz2006 was invoked but never defined (see the help page).
  18. ^ a b c Cite error: The named reference Rosenthalethical was invoked but never defined (see the help page).
  19. ^ Sites, CK (2008). "Bioidentical hormones for menopausal therapy". Womens Health. 4 (2): 163–71. doi:10.2217/17455057.4.2.163. PMID 19072518.
  20. ^ Cite error: The named reference FDA was invoked but never defined (see the help page).
  21. ^ Cite error: The named reference Kalvaitis was invoked but never defined (see the help page).
  22. ^ Cite error: The named reference Endocrinesociety was invoked but never defined (see the help page).
  23. ^ Ellin, A (2006-10-15). "A Battle Over 'Juice of Youth'". The New York Times. Retrieved 2009-10-27.
  24. ^ Cite error: The named reference Oprah was invoked but never defined (see the help page).
  25. ^ Cite error: The named reference NAMS was invoked but never defined (see the help page).
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