Bioidentical hormone replacement therapy: Difference between revisions

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==Research==
==Research==
[[Peer review |Peer-reviewed assessments]] of the evidence for and against BHRT point to a lack of consensus, stemming from a dearth of [[randomized controlled trial | randomized controlled trials]]. A 2006 [[literature review]] concluded that BHRT is "well tolerated, provides symptom relief, and can address many of the health needs as well as the individual preferences of menopausal and perimenopausal women" [http://www.thorne.com/altmedrev/.fulltext/11/3/208.pdf]. A subsequent review (2009) assessed 200 studies and concluded that there was evidence to suggest bioidentical hormones were safer and more effective than synthetic hormones.<ref>{{cite journal |author=Holtorf K |title=The bioidentical hormone debate: are bioidentical hormones (estradiol, estriol, and progesterone) safer or more efficacious than commonly used synthetic versions in hormone replacement therapy? |journal=Postgrad Med |volume=121 |issue=1 |pages=73–85 |year=2009 |month=January |pmid=19179815 |doi=10.3810/pgm.2009.01.1949+|url=http://www.hormoneandlongevitycenter.com/nss-folder/pictures/Holtorf-Med-Clinics.pdf |unused_data=|http://www.postgradmed.com/index.php?free=pgm_01_2009?article=1949&ex=1949}}</ref>
There is little [[peer review]]ed evidence for or against BHRT and a lack of consensus regarding its appropriateness, effectiveness and [[adverse effect]]s. Some [[literature review]]s suggest benefits and advantages to the use of BHRT over conventional counterpartsis<ref>{{cite journal |author=Holtorf K |title=The bioidentical hormone debate: are bioidentical hormones (estradiol, estriol, and progesterone) safer or more efficacious than commonly used synthetic versions in hormone replacement therapy? |journal=Postgrad Med |volume=121 |issue=1 |pages=73–85 |year=2009 |month=January |pmid=19179815 |doi=10.3810/pgm.2009.01.1949+|url=http://www.hormoneandlongevitycenter.com/nss-folder/pictures/Holtorf-Med-Clinics.pdf |unused_data=|http://www.postgradmed.com/index.php?free=pgm_01_2009?article=1949&ex=1949}}</ref><ref>{{cite journal | url = http://www.thorne.com/altmedrev/.fulltext/11/3/208.pdf | pmid = 17217322 | title = A comprehensive review of the safety and efficacy of bioidentical hormones for the management of menopause and related health risks | last = Moskowitz | first = D | journal = Alternative Medicine Review | volume = 11 | issue = 3 | year = 2006 | pages = 208-23 }}</ref> while others state that there is still insufficient evidence to support the claims made about BHRT with a lack of [[randomized controlled trial]]s needed to form firm conclusions.<ref>{{cite journal |author=Boothby LA, Doering PL |title=Bioidentical hormone therapy: a panacea that lacks supportive evidence |journal=Curr. Opin. Obstet. Gynecol. |volume=20 |issue=4 |pages=400–7 |year=2008 |month=August |pmid=18660693 |doi=10.1097/GCO.0b013e3283081ae9 |url=}}</ref><ref>{{cite journal | last = Cirigliano | first = M | pmid = 17627398 | title = Bioidentical hormone therapy: a review of the evidence | journal = Journal of Womens Health | year = 2007 | volume = 16 | issue = 5 | pages = 600-31 }}</ref><ref>{{cite journal | last = Sites | first = CK | journal = Womens Health | year = 2008 | volume = 4 | issue = 2 | pages = 163-71 | title = Bioidentical hormones for menopausal therapy | pmid = 19072518 }}</ref><ref>{{cite journal | last = Fugh-Berman | first = A | coauthors = Bythrow J | title = Bioidentical hormones for menopausal hormone therapy: variation on a theme | pmid = 17549577 | journal = Journal of General Internal Medicine | year = 2007 | volume = 22 | issue = 7 | pages = 1030-4 }}</ref>

Another 2008 review concluded that there was little evidence to support the use of compounded hormone products based upon saliva testing, and that individualized compounded hormone products have no proven advantage over conventional hormone therapies. <ref>{{cite journal |author=Boothby LA, Doering PL |title=Bioidentical hormone therapy: a panacea that lacks supportive evidence |journal=Curr. Opin. Obstet. Gynecol. |volume=20 |issue=4 |pages=400–7 |year=2008 |month=August |pmid=18660693 |doi=10.1097/GCO.0b013e3283081ae9 |url=}}</ref>


==Regulatory status in the United States==
==Regulatory status in the United States==

Revision as of 19:54, 24 August 2009

Bioidentical hormone replacement therapy (BHRT) is the treatment of problems related to menopause using only hormones that have a molecular structure identical to those found in the human body. In contrast, standard hormone replacement therapy may incorporate hormones that are slightly different from those produced in the body, such as hormones that were originally created in a lab or that are derived from animal sources. Estradiol and progesterone, the two hormones most commonly replaced by replacement therapy, are available in both FDA-approved drugs in the United States and pharmacy-compounded products.[1]

The sales and compounding practices of BHRT have been criticized for offering no advantage over conventional hormone replacement therapy. In the United States they are not approved by the FDA and accordingly lack controls over their potency, purity or safety. In addition, the long-term effects of BHRT have not been studied and are not known. BHRT has also been referred to as a "marketing concept" with no scientific backing. BHRT proponents argue that studies show significant differences between bioidentical and non-bioidentical hormones, and that replacing hormones lost due to menopause not only improves quality of life but also long-term health.[2] The actress Suzanne Somers[3] has been a prominent advocate of BHRT in the media.

Terminology

Bioidentical hormones often use the term "natural" because the molecules are identical to those produced by the human body. However, the word natural means "found in nature", and also applies to estrogens like Premarin, which is synthesized from the urine of pregnant horses, as well as a variety synthesized from plants; these are natural as they come from natural sources and not a laboratory, but are not bioidentical. Many bioidentical hormones are "natural" in the sense that they duiplicate hormones found in the body, but are not natural in that they are chemically synthesized from sources not found in nature.[1]

Structure and administration

Bioidentical hormones mimic the chemical structure of hormones created by the human body exactly, while those used in standard hormone replacement therapy are synthesized in a laboratory or from animal sources and differ slightly in their molecular structure from human hormones. The 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 identical before their use, those taken orally can be modified by the liver before entering the blood, while those entering through the skin are unmodified. Creams and gels applied to the skin also enter the blood directly and unmodified, but it is not clear how much is actually absorbed. [1]

Uses

Main articles: Menopause and Hormone replacement therapy (menopause)

Reduced production of estradiol in menopausal women is associated with many symptoms, including hot flashes, vaginal dryness, poor memory, insomnia, and depression. Estrogen replacement has been shown to relieve these symptoms and to slow or partially reverse several medical disorders that are associated with the loss of estradiol, including osteoporosis, atherosclerosis,[4] vaginal atrophy, dementia,[5] and depression.[6] In 2002, the Women's Health Initiative study (WHI) revealed an increase in breast cancer, heart attacks and stroke in older women given conventional hormone replacement therapy (HRT) consisting of equine estrogens and a non-bioidentical progestin. This resulted in a significant decline in HRT prescriptions. Even before the WHI results, many women were looking for an alternative to conventional HRT that did not involve Premarin extracted from pregnant horses, or have unwanted side effects.[1] Proponents of BHRT depict it as a more natural alternative to conventional HRT.

BHRT practitioners generally prescribe estradiol transdermally, via a cream, gel or patch. Transdermal estradiol replacement has not been shown to increase the risk of blood clots, while oral estrogens are known to increase clotting risk. [7] Bioidentical hormones are often compounded to adjust the dose and delivery vehicle individually for each patient.[8]

While non-bioidentical hormones cannot be adequately measured in the blood, bioidentical hormones can be tracked precisely with conventional blood tests, which proponents argue is an advantage.[1] Critics 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.[1]

BHRT practitioners also generally prescribe progesterone for all post-menopausal women, whether they have an intact uterus or not. This contrasts with conventional therapy which prescribes a progestin only if the uterus is present, in order to prevent uterine cancer. European scientists have argued that progesterone does not increase the risk of breast cancer as do many progestins, and may possibly offer some protection against breast cancer. [9] [10] BHRT advocates also argue that progesterone may offer some protection against breast cancer.[2]

Research

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 to the use of BHRT over conventional counterpartsis[11][12] while others state that there is still insufficient evidence to support the claims made about BHRT with a lack of randomized controlled trials needed to form firm conclusions.[13][14][15][16]

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 BHRT according to the doctor's prescription.[8] The U.S. Food and Drug Administration has warned several pharmacies about making unsubstantiated claims about the safety and effectiveness of compounded hormone products.[17]

Criticism

The Endocrine Society issued a position statement that bioidentical hormones carry essentially the same risks and benefits as non-bioidentical molecules.[18] 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.[19] 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.[19] Compounding pharmacies were warned by the FDA to stop using the "non-scientific" term "bio-identical" in 2008, a warning supported by The Endocrine Society and the American Association of Clinical Endocrinologists.[20] The FDA warns that claims about compounded BHRT products are unsupported by medical evidence, unlike claims made by manufacturers of FDA-approved products.[17] BHRT has been called a "marketing concept" with no scientific backing by the chief medical editor of Endocrine Today.[21][1] 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.[1]

The FDA has taken measures against compounding pharmacies that produce bioidentical hormone products. It sent letters warning seven pharmacies that the claims they were making about the safety and effectiveness of their compounded BHRT products they were selling were unsupported by medical evidence, and were considered false and misleading by the agency.[17] The FDA has also expressed concern that unfounded claims made about BHRT mislead women and health care professionals, but is willing to allow compounding of the products when a licensed practitioner decides that an approved drug does not meet the patient's needs.[22]

Wiley Protocol

Main article: 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.[23] Others have sharply criticized the Wiley Protocol.[24][25][26][27]

Footnotes

  1. ^ a b c d e f g h "What are bioidentical hormones?". Harvard Women's Health Watch. Harvard Medical School. 2006-08-01. Retrieved 2009-02-27.
  2. ^ a b Schwartz, E (2008). "Hormones in Wellness and Disease Prevention: Common Practices, Current State of the Evidence, and Questions for the Future" (pdf). Prim Care Clin Office Pract. 35: 669–705. doi:10.1016/j.pop.2008.07.015. PMID 18928825. {{cite journal}}: Unknown parameter |coauthors= ignored (|author= suggested) (help)
  3. ^ Somers, Suzanne (2004). The sexy years: discover the hormone connection: the secret to fabulous sex, great health, and vitality for women and men. New York: Crown Publishers. ISBN 0-609-60721-9.
  4. ^ Christian, RC (2002). "Estrogen status correlates with the calcium content of coronary atherosclerotic plaques in women". J Clin Endocrinol Metab. 87 (3): 1062–7. doi:10.1210/jc.87.3.1062. {{cite journal}}: Unknown parameter |coauthors= ignored (|author= suggested) (help)
  5. ^ Zandi, PP (2002). "Hormone replacement therapy and incidence of Alzheimer disease in older women: the Cache County Study". JAMA. 288 (17): 2123–9. doi:10.1001/jama.288.17.2123. {{cite journal}}: Unknown parameter |coauthors= ignored (|author= suggested) (help)
  6. ^ Rudolph, I (2004). "Influence of a continuous combined HRT (2 mg estradiol valerate and 2 mg dienogest) on postmenopausal depression". 7 (3): 301–11. {{cite journal}}: Cite has empty unknown parameter: |unused_data= (help); Cite journal requires |journal= (help); Text "coauthors Palombo-Kinne E, Kirsch B, Mellinger U, Breitbarth H, Gräser T" ignored (help)
  7. ^ Canonico, M (2008). "Hormone replacement therapy and risk of venous thromboembolism in postmenopausal women: systematic review and meta-analysis". BMJ. 31 (336): 1227–31. doi:10.1136/bmj.39555.441944.BE. {{cite journal}}: Unknown parameter |coauthors= ignored (|author= suggested) (help)
  8. ^ a b Romero, M (2002). "Bioidentical hormone replacement therapy. Customizing care for perimenopausal and menopausal women". Advance for Nurse Practitioners. 10 (11): 51–2. PMID 12478948.
  9. ^ Campagnoli, C (2005). "Progestins and progesterone in hormone replacement therapy and the risk of breast cancer". J Steroid Biochem Mol Biol. 96 (2): 95–108. {{cite journal}}: Unknown parameter |coauthors= ignored (|author= suggested) (help)
  10. ^ Modena, MG (2005). "The TREAT". 16 (52(1)): 1–10. {{cite journal}}: Cite journal requires |journal= (help); Unknown parameter |coauthors= ignored (|author= suggested) (help); Unknown parameter |jounal= ignored (help)
  11. ^ Holtorf K (2009). "The bioidentical hormone debate: are bioidentical hormones (estradiol, estriol, and progesterone) safer or more efficacious than commonly used synthetic versions in hormone replacement therapy?" (PDF). Postgrad Med. 121 (1): 73–85. doi:10.3810/pgm.2009.01.1949+. PMID 19179815. {{cite journal}}: Cite has empty unknown parameter: |unused_data= (help); Unknown parameter |http://www.postgradmed.com/index.php?free= ignored (help); Unknown parameter |month= ignored (help)
  12. ^ Moskowitz, D (2006). "A comprehensive review of the safety and efficacy of bioidentical hormones for the management of menopause and related health risks" (PDF). Alternative Medicine Review. 11 (3): 208–23. PMID 17217322.
  13. ^ Boothby LA, Doering PL (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}}: Unknown parameter |month= ignored (help)
  14. ^ Cirigliano, M (2007). "Bioidentical hormone therapy: a review of the evidence". Journal of Womens Health. 16 (5): 600–31. PMID 17627398.
  15. ^ Sites, CK (2008). "Bioidentical hormones for menopausal therapy". Womens Health. 4 (2): 163–71. PMID 19072518.
  16. ^ Fugh-Berman, A (2007). "Bioidentical hormones for menopausal hormone therapy: variation on a theme". Journal of General Internal Medicine. 22 (7): 1030–4. PMID 17549577. {{cite journal}}: Unknown parameter |coauthors= ignored (|author= suggested) (help)
  17. ^ a b c "FDA Takes Action Against Compounded Menopause Hormone Therapy Drugs". U.S. Food and Drug Administration. 2008-01-09. Retrieved 2009-02-17.
  18. ^ "The Endocrine Society- Position Statement: Bioidentical Hormones" (pdf). The Endocrine Society. 2006-10-01. Retrieved 2009-02-29. {{cite web}}: Check date values in: |accessdate= (help)
  19. ^ a b Mayo Clinic (2007-08-21). "Bioidentical hormones: Are they safer?". Retrieved 2007-08-27.
  20. ^ Frieden, Joyce. "FDA Cracks Down on Bioidentical Hormones" (web reprint). Retrieved 2008-03-05.
  21. ^ Kalvaitis, Katie (2008-03-25). "Compounded hormone therapies: unproven, untested - and popular" (web reprint). 6 (5). Endocrine Today. Retrieved 2009-02-17. {{cite journal}}: Cite journal requires |journal= (help)
  22. ^ "Statement of Steven K. Galson, M.D., M.P.H., Director, Center for Drug Evaluation and Research, U.S. Food and Drug Administration before Senate Special committee on Aging, "Bio-Identical Hormones: Sound Science or Bad Medicine"". FDA. April 19, 2007. Retrieved 2007-12-01. {{cite web}}: Check date values in: |date= (help)
  23. ^ Hermann, AC (2005). "Over-the-counter progesterone cream produces significant drug exposure compared to a food and drug administration-approved oral progesterone product". J Clin Pharmacol. 45: 614-619 \ url = http://jcp.sagepub.com/cgi/content/abstract/45/6/614. {{cite journal}}: Missing pipe in: |page= (help); Unknown parameter |coauthors= ignored (|author= suggested) (help)
  24. ^ Ellin, Abby (October 15, 2006). "A Battle Over 'Juice of Youth'". New York Times. Retrieved 2007-12-01. {{cite news}}: Check date values in: |date= (help)
  25. ^ Sherr, Lynn and Glenn Ruppel (February 16, 2007). "Suzanne Somers: Super Saleswoman: Has Somers Found the Fountain of Youth?". ABC News, 20/20. Retrieved 2007-12-01. {{cite web}}: Check date values in: |date= (help)
  26. ^ "A Real Somers Storm: At war over Suzanne Somers's book on 'bioidenticals'". Newsweek. November 13, 2006. Retrieved 2007-12-01. {{cite news}}: Check date values in: |date= (help)
  27. ^ Patricia Yarberry Allen (2007-01-12). "Ask Dr. Pat: Bioidentical Hormones". Retrieved 2007-05-04.

External links

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