Talk:Bioidentical hormone replacement therapy/Archive 2

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Definitions

• "BHT is the practice of individualizing hormone therapy based, in part, on salivary hormone concentrations, and perhaps more importantly on the assessment of individual patient symptoms [2]. The hormones that are subsequently prescribed and dispensed for individual patients are those hormones that are said to be ‘bioidentical’ to the hormones circulating in the body (i.e., identical in structure and function to endogenous hormones)[3]. These hormones, in various combinations typically include estrone, estradiol, estriol, progesterone, and testosterone. According to the proponents for BHT, ‘bioidentical’ hormones differ from ‘synthetic’ hormones in that synthetic hormones are manufactured into standardized dosage forms in various combinations and concentrations by large pharmaceutical companies, whereas ‘bioidentical’ hormones are individualized and often compounded extemporaneously for patients based upon an assessment of both salivary hormone levels and the patient’s symptoms [3]. Sometimes BHT proponents use the terms ‘bioidentical’ and ‘natural’ interchangeably, as they believe that traditionally manufactured hormones are unnatural and harmful, but ‘bioidentical’ hormones are natural and helpful."

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)

• "Commonly referred to as natural HRT, bioidentical HRT consists of individually compounded hormones that are chemically identical to those secreted by the female body...Advocates of bioidentical HRT frequently recommend salivary testing to quantify circulating hormones and guide the formulation of bioidentical HRT...All these publications champion bioidentical HRT as safer and more effective than traditional, commercially manufactured HRT preparations."

McBane, SE (2008). "Easing vasomotor symptoms: Besides HRT, what works?". Journal of the American Academy of Physicians Assistants. 21 (4): 26–31. PMID 18468366.

• "Bioidentical hormones (BHs) are molecularly identical to the endogenous hormones found in women that can be derived from a variety of sources, such as plants (soy or yams) after chemical modification, animals (pigs and horses) after purification, or through de novo synthetic production...Although rarely promoted as such, many commercially available CHTs, primarily estradiol and progesterone products, are in fact bioidentical, and almost all CHTs are made from the same plant sources as found in compounded and over-the-counter (OTC) BHTs." The table on page 606 also describes Esradiol, Estradiol, Estriol, Progesterone, Testosterone and Testosterone propionate as "compounded [and] customized for each patient, criteria vary; saliva, sera levels, or symptoms."

Cirigliano, M (2007). "Bioidentical hormone therapy: a review of the evidence" (pdf). Journal of Womens Health. 16 (5): 600–31. PMID 17627398.

• "the FDA has now concurred with The Endocrine Society that the term bioidentical is a marketing term and not one of scientific or medical merit...proponents of bioidentical hormones (including many physicians in private practice) began to use the WHI trial results as a marketing tool to promote bioidentical hormones as safer" The paper also discusses the Wiley Protocol specifically, which is a form of bioidentical hormone replacement therapy that uses compounded hormones and blood tests.

Rosenthal, MS (2008). "The Wiley Protocol: an analysis of ethical issues". Menopause. 15 (5): 1014–22. PMID 18551081.

• "The term bioidentical is a pseudoscientific neologism that refers to endogenous hormones, including estriol, estrone, estradiol, progesterone, testosterone, DHEA, thyroxine, and cortisol. Natural alludes to the fact that these are native human hormones. In fact, these hormones are synthesized or semisynthesized. Stigmasterol from soybeans (Glycine max) and diosgenin from an inedible Mexican yam (Dioscorea villosa) can be converted to progesterone in the laboratory,¹ but there is no evidence that plant sterols convert to progesterone endogenously. Many bioidentical hormone products that require a prescription are prepared by compounding pharmacies...Saliva testing for hormones has been promoted to individualize the dosing of bioidentical hormone treatment...these hormones are no more natural than (and in many cases are identical to) commercially available drugs...No reliable data support the claim that bioidentical hormones are safer than other hormones, and natural, bioidentical, and compounded preparations must be assumed to have the same risks as commercial hormone preparations."

Fugh-Berman, A (2007). "Bioidentical Hormones for Menopausal Hormone Therapy: Variation on a Theme". J Gen Intern Med. 22 (7): 1030–4. PMID 17549577. {{cite journal}}: Unknown parameter |coauthors= ignored (|author= suggested) (help)

• "Bioidentical hormone replacement therapy (BHRT) is defined by Boothby et al.¹ as ‘hormone treatment with individually compounded recipes of certain steroids in various dosage forms, including dehydroepiandrosterone, pregnenolone, testosterone, progesterone, estrone, estradiol, and estriol...the use of the term ‘natural’ refers to steroid hormones occurring naturally in women and does not refer to phytoestrogens or similar substances.’ Fugh-Berman and Bythrow² state that bioidentical hormones, a ‘pseudoscientific neologism...refer to endogenous hormones, including estriol, estrone, estradiol, progesterone, testosterone, DHEA, thyroxine, and cortisol [which are] synthesized or semisynthesized...Throughout the 1990s, the term used to describe compounded hormones from botanical sources was ‘natural hormone therapy’...BHRT is often prescribed to individuals based on the analysis of a person’s salivary hormone levels, however these tests are criticized for being unreliable because there is no correlation between symptoms and hormone levels"

Rosenthal, MS (2008). "Review: Ethical problems with bioidentical hormone therapy". International Journal of Impotence Research. 20 (1): 45–52. PMID 18075509.

• "NAMS recognizes that one area of confusion in clinical practice is so-called Bioidentical^ hormone preparations. This term has been used to refer to many well-tested, regulatory agency-approved, brand-name HT products containing hormones chemically identical to hormones produced by women (primarily in the ovaries), such as 17A-estradiol or progesterone. However, the term is most often used to describe custom-made HT formulations (called "bioidentical hormone therapy," or BHT) that are compounded for an individual according to a healthcare provider`s prescription...Use of BHT has escalated in recent years, often with the dose determined by salivary hormone testing, a procedure that has not been proven accurate or reliable."

The Board of Trustees of The North American Menopause Society (2008). "Position statement - Estrogen and progestogen use in postmenopausal women: July 2008 position statement of The North American Menopause Society" (PDF). Menopause: The Journal of The North American Menopause Society. 15 (4): 584–603. doi:10.1097/gme.0b013e31817b076a. PMID 18580541.

• "Many women assume that “natural” hormones would be better or safer — but the term “natural” is open to interpretation. Any product whose principal ingredient has an animal, plant, or mineral source is technically natural...The interest in a more natural approach to hormone therapy has focused attention on bioidentical hormones — hormones that are identical in molecular structure to the hormones women make in their bodies. They’re not found in this form in nature but are made, or synthesized, from a plant chemical extracted from yams and soy. Bioidentical estrogens are 17 beta-estradiol, estrone, and estriol. (Estradiol is the form of estrogen that decreases at menopause.) Bioidentical progesterone is simply progesterone...Much of the confusion about bioidentical hormones comes from the mistaken notion that they must be custom-mixed at a compounding pharmacy. But custom compounding is necessary only when a clinician wants to prescribe hormones in combinations, doses, or preparations (such as lozenges or suppositories) not routinely available...Some clinicians who prescribe compounded hormones order saliva tests to monitor hormone levels. Most experts say these tests are of little use because there’s no evidence that hormone levels in saliva correlate with response to treatment in postmenopausal women...There is no scientific evidence that the compounded preparations Biest and Triest, which are largely estriol, are safer or more effective than other bioidentical and FDA-approved formulations."

"What are bioidentical hormones?". Harvard Women's Health Watch. Harvard Medical School. 2006-08-01. Retrieved 2009-02-27.

• "Even the term “bioidentical hormones” has taken on a different meaning. The FDA has approved hormones that are bioidentical, or having the exact structure as those produced in the body. However, marketing of compounded hormone therapies as “bioidentical hormones” may lead to confusion over what the term refers to...Alan Garber, MD, PhD, chief medical editor of Endocrine Today, said that “bioidentical hormone replacement is a clever marketing concept devoid of scientific underpinnings, and preys upon the patient’s desire for better hormonal replacement therapies that are both safe and effective, properties totally unproven by the proponents of such agents”...Advocates of bioidentical hormones tout them as tailor-made mixtures that replicate the normal estrogen and progesterone profile of a women’s body lost to menopause, without the risks posed by synthetic HT. Proponents emphasize the natural aspect...Bioidentical hormone therapy typically contains various forms of estriol, estradiol, estrone, micronized progesterone and, sometimes, testosterone and dehydroepiandrosterone. These hormones are compounded for various routes of administration – oral, topical, transdermal or suppository...Saliva testing to determine the amount of hormones in a woman’s body has not been proven accurate or reliable....Salivary hormone testing creates a dubious basis for making any such hormonal determination, Cirigliano said. “What [bioidentical hormone advocates] are doing is selling an expensive test and repeat prescriptions that are very expensive,” Utian said. “They are actually selling a fallacy there.”"

Kalvaitis, K (2008). "Compounded hormone therapies: unproven, untested - and popular" (web reprint). Endocrine Today. 6 (5).

• "The term “bioidentical HRT” refers to the use of hormones that are exact copies of endogenous human hormones, including estriol, estradiol, and progesterone, as opposed to synthetic versions with different chemical structures or nonhuman versions, such as CEE. Bioidentical hormones are also often referred to as “natural hormones,” which can be confusing because bioidentical hormones are synthesized, while some estrogens from a natural source, such as equine urine, are not considered bioidentical because many of their components are foreign to the human body."

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}}: Unknown parameter |month= ignored (help)

• "Bioidentical hormones are identical to hormones produced endogenously."

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.

• "'Bioidentical hormones' is a term created by the lay media to refer to chemicals derived from plants that are modified to be structurally identical to endogenous human hormones." (from abstract, need full text)

Sites, CK (2008). "Bioidentical hormones for menopausal therapy". Womens Health. 4 (2): 163–71. PMID 19072518.

• "The pharmacy operations improperly claim that their drugs, which contain hormones such as estrogen, progesterone, and estriol (which is not a component of an FDA-approved drug and has not been proven safe and effective for any use) are superior to FDA-approved menopausal hormone therapy drugs and prevent or treat serious diseases, including Alzheimer's disease, stroke, and various forms of cancer...The pharmacy operations receiving warning letters use the terms "bio-identical hormone replacement therapy" and "BHRT" to imply that their drugs are natural or identical to the hormones made by the body. FDA regards this use of "bio-identical" as a marketing term implying a benefit for the drug, for which there is no medical or scientific basis."

"FDA Takes Action Against Compounded Menopause Hormone Therapy Drugs". FDA. 2008-01-09. Retrieved 2009-02-17.

• "“Bioidentical hormones,” particularly estrogen and progesterone, have been promoted as safer and more effective alternatives to more traditional hormone therapies, often by people outside of the medical community. In fact, little or no scientific and medical evidence exists to support such claims about “bioidentical hormones.” Additionally, many “bioidentical hormone” formulations are not subject to FDA oversight and can be inconsistent in dose and purity. As a result of unfounded but highly publicized claims, patients have received incomplete or incorrect information regarding the relative safety and efficacy of hormone preparations that are referred to as “bioidentical.” “Bioidentical hormones” are defined as compounds that have exactly the same chemical and molecular structure as hormones that are produced in the human body. Though any hormone can be made to be “bioidentical,” the term is often used to describe formulations containing estrogens, progesterone, and androgens...proponents of “bioidentical hormones” assert that simple tests of saliva can provide the information necessary to customize hormone doses. They also allege that customized “bioidentical hormones” are safer and more effective than modified hormones synthesized under close FDA supervision. These claims are not supported by scientific data. Patients can obtain “bioidentical hormones” in two ways—as FDA-approved preparations that are formulated with strict oversight and dispensed by retail pharmacies; or from compounding pharmacies, where the hormones are changed from their original form into another form, purportedly for individual customization. Often these contain combinations of different forms of estrogen and/or progesterone with different potencies."

"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)

• "In response to recent media attention being given to so-called bioidentical hormones, The American College of Obstetricians and Gynecologists (ACOG) reiterates its position that there is no scientific evidence supporting the safety or efficacy of compounded bioidentical hormones." (obviously not a definition, but rather relevant; also treats bioidentical and compounded bioidentical hormones as synonymous)

"ACOG News Release: ACOG Reiterates Stance on So-Called "Bioidentical" Hormones". American College of Obstetricians and Gynecologists. 2009-02-03. Retrieved 2009-09-18. {{cite web}}: Cite has empty unknown parameter: |1= (help)

• "There's a lot of interest in bioidentical — or so-called "natural" — hormone therapy for menopause symptoms. However, there's no evidence that bioidentical hormones are safer or more effective than standard hormone replacement therapy...Bioidentical hormones are custom-mixed formulas containing various hormones that are chemically identical to those naturally made by your body. These prescription and over-the-counter products are marketed as being tailored to a woman's individual hormone needs, typically determined through saliva hormone testing."

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

• This reference doesn't define bioidenticals, but does come down quite strongly against them, calling them expensive, unproven and the prescribers dishonest.

Davis, SR (2008-08-14). "2003 November 29 - Bioidentical hormones (troches) advice for doctors". Australian Menopause Society. Retrieved 2009-08-25. {{cite web}}: Unknown parameter |coauthors= ignored (|author= suggested) (help)

• "In contrast to this, compounding chemists can “hand make” pharmaceuticals in novel delivery systems. Currently, these compounds are not directly regulated by the Therapeutic Goods Administration. Thus, little is known about the quality control, pharmacokinetics, safety and efficacy of these treatments. Compounded hormone replacement therapy is often termed “bioidentical” HRT. Typically, bioidentical HRT contains three oestrogens (oestrone, oestradiol and oestriol), progesterone, and androgens such as testosterone and DHEA, and is usually given either as cream rubbed onto the skin or as troches. Often, bioidentical HRT is monitored using blood or salivary levels of sex hormones."

Eden, JA (2007). "Three cases of endometrial cancer associated with "bioidentical" hormone replacement therapy" (pdf). Medical Journal of Australia. 187 (4): 244–5. PMID 17708728. Retrieved 2009-08-25. {{cite journal}}: Unknown parameter |coauthors= ignored (|author= suggested) (help)

• "In response to safety concerns promoted in the lay press, women have turned increasingly to phytoestrogens and other “natural” products as safer alternatives to pharmaceutical dosage forms of estrogens and/or progestogens. In addition, conventional hormonal substances prepared in unique, individualized dosage forms (eg, gels, sublingual tablets, suppositories) are promoted by some prescribers in conjunction with compounding pharmacies. These practitioners are touting “natural” (sometimes referred to as bioidentical) hormone therapy (NHT) as a safer and more effective alternative to conventional HT...The steroid hormones most commonly compounded include dehydroepiandrosterone (DHEA), pregnenolone, testosterone, progesterone, estrone (E1), estradiol (E2), and estriol (E3). To individualize the composition of the final product, women first submit a saliva or blood sample for determination of hormone levels. Based on the results, the prescriber will then select the individual agent or agents to be incorporated and the amounts of each. Proponents claim that NHT is better tolerated than manufactured products or synthetic preparations."

Boothby, LA (2004). "Bioidentical hormone therapy: a review". Menopause: The Journal of The North American Menopause Society. 11 (3): 356–67. doi:10.1097/01.GME.0000094356.92081.EF. PMID 15167316. {{cite journal}}: Unknown parameter |coauthors= ignored (|author= suggested) (help)

• "They are looking for something safe which will ameliorate their symptoms, but will not have any associated risks. Does this magic cure exist? Unfortunately, no. Nothing is all good and without any associated risk. However, women have a misperception that there exists some risk free panacea due to advertisements, marketing strategies etc., that may be feeding into the symptomatic woman’s fears and claiming that they have this magic potion, the “Bioidentical Hormone,” which they claim is safer than standard, prescribed hormone therapy. What exactly does the term Bioidentical Hormone mean? This is a somewhat nebulous term used to describe medications which are plant derived...and modified to be structurally identical to endogenous human hormones."

Chervenak, J (2009). "Bioidentical hormones for maturing women". Maturitas. doi:10.1016/j.maturitas.2009.08.002. PMID 19766414.

There's probably others too. There are several themes - molecularly identical, claims of "natural", unproven efficacy against a variety of conditions, salivary testing, compounding, and a substantial amount of criticism. WLU (t) (c) Wikipedia's rules:^simple/_complex 20:05, 2 October 2009 (UTC)

I've now expanded these quotes to include any mention of the safety concerns, use of the term "natural", the relationship to compounding and salivary testing. Now, nearly every single one of them contains mention of all of these ideas. I can not understand how it is not due weight to briefly mention what the "technical" definition of bioidentical is, then not focus on these issues since that is what the articles do. I think there is a point here. WLU (t) (c) Wikipedia's rules:^simple/_complex 18:22, 8 October 2009 (UTC)

I've got three more references from peer-reviewed journals that cite the same issues - unsupported, exaggerated claims, salivary testing, compounding, mis-use of "natural". I'll try to post them tomorrow. This takes time away from actually editing the article, but I hope it demonstrates where the weight should go in the article. WLU (t) (c) Wikipedia's rules:^simple/_complex 01:33, 9 October 2009 (UTC)

Table, derived from Boothby

A variety of specific claims have been made for the effectiveness of bioidentical hormones and BHRT, with varying evidence to support or contradict them:

Claim	Status	Evidence
Bioidentical hormones fit precisely in receptors while conventional HRT fit 'cockeyed'; this mismatch causes serious side effects	True, but misleading	Synthetic and endogenous progestins have different binding affinities for different receptors depending on the model and animal used; the differing pharmacodynamics have not been associated with specific side effects
The body is unable to metabolize synthetic hormones	False	The biological half-life for synthetic hormones is between five minutes and two days
Lack of progesterone causes 'estrogen dominance', resulting in irregular or painful, heavy menses	False	Oral progesterone is no more effective than placebo at alleviating symptoms of premenstrual syndrome
Progesterone can counter-act stress, increases metabolism and decreases abdominal fat	False	There is no evidence to support weight loss due to progesterone; progestin has only been associated with weight gain in patients with cancer-related anorexia
'Normal' levels of progesterone maintained with BHRT protects against breast cancer	False	The claim is based on a single study of infertile patients; there is some evidence to support a link between hormonal treatment for infertility and a reduced risk of breast cancer, but these benefits are not expected to translate to women seeking relief from the symptoms of menopause
Progesterone therapy can prevent cardiovascular disease, atherosclerosis and raise good cholesterol	False	The Women's Health Initiative found hormone therapy had no effect on cardiovascular disease but was associated with a greater risk of thromboembolism, strokes and pulmonary embolism; though BHRT proponents claim these events are due to the synthetic nature of the hormones used, "certain progestins are associated with increased cardiovascular risk, whereas pregnane derivatives and micronized progesterone neither increase nor decrease cardiovascular risk in the doses studied"

FDA information

According to the FDA

COMPOUNDED BIO-IDENTICAL HORMONE REPLACEMENT THERAPY PRODUCTS

FDA is aware that an increasing number of pharmacists compound hormone products for use by postmenopausal women. These pharmacies often promote their products as “bio-identical” to the hormones produced by a woman’s body, and the phrase “bio-identical hormone replacement therapy” (BHRT) has been used to describe these products. Compounded BHRT products typically contain various forms of estrogen and progesterone and, in some cases, testosterone and dehydroepiandrosterone. BHRT drugs are compounded for oral, topical, transdermal, suppository, and other routes of administration.

FDA’s regulatory approach toward compounded BHRT products is framed by its general approach to compounded drugs: FDA recognizes the legitimacy of traditional pharmacy compounding of BHRT products, i.e., when a pharmacist compounds a BHRT product in response to a licensed practitioner’s decision that a patient’s specific medical need cannot be met by an FDA-approved drug. FDA will generally continue to defer to state regulators regarding this practice. Claims Regarding Compounded BHRT Products

FDA is concerned, however, that a number of pharmacies make claims about compounded BHRT products that are false and that may mislead patients and practitioners as they decide whether these products are appropriate. Drugs that make false and misleading claims are misbranded under the FDC Act.

FDA believes that some promotional materials for compounded BHRT products contain inaccurate information and do not adequately advise patients and practitioners of the risks associated with compounded hormone products (risks that appear to be the same as the hazards related to FDA-approved hormone products). These promotional materials may also contain unsubstantiated claims about the safety and efficacy of compounded BHRT products.

Moreover, some compounding pharmacists claim that their BHRT products are a “natural” alternative to FDA-approved drugs, because the compounded hormones are identical to the hormones produced in the body. These pharmacists may further claim that their “natural” compounded BHRT products are a safe alternative to FDA-approved drugs because they lack the risks and side effects associated with those drugs. FDA is unaware of any credible scientific evidence supporting the assertions that these bio-identical compounded products are a safe or effective alternative to FDA-approved drugs containing hormones. Equally concerning are claims by compounding pharmacists that compounded BHRT products can be used to prevent serious illnesses, including breast and colon cancers, cardiovascular disease, and Alzheimer’s disease. These claims are not substantiated by scientific evidence for these compounded BHRT products, and they risk misleading consumers into using compounded BHRT products to prevent these illnesses in the absence of any evidence supporting there effectiveness.

FDA is also not aware of sound evidence showing the superiority of compounded BHRT products over FDA-approved drugs. Likewise, FDA has no information indicating that the side effects and risks of compounded BHRT products are dissimilar to those of FDA‑approved drugs. Thus, claims regarding the safety, efficacy, and superiority of compounded BHRT products have not been substantiated by FDA and may mislead patients and practitioners. -end quote- (restored 10/6/09, no copyright on FDA material)

The FDA's approach appears to me to be unbiased. The article as it currently stands does not appear to share this lack of bias.

Having no background exposure to this topic, I do not share the view that bioidentical automatically refers to compounded, and I was dismayed to find that it is used interchangeably in this article. As the Wikipedia should be an encyclopedic reference, I believe that these terms need to be de-linked here, as the FDA seems to have done inasmuch as it consistently refers to "compounded BHRT". Riverpa (talk) 14:59, 6 October 2009 (UTC)

Fortunately that's not what the article says. The article says it is frequently associated with compounding - among other things like dubious, unscientific claims, saliva testing, intense marketing and unacknowledged risks that are expected to be essentially identical to conventional hormone replacement therapy. Also fortunately, I've got sources to back up every statement in the article. I've removed the POV tag and added the sources to the lead. Since I have considerably more background in the topic (having read most of the sources used on the page), I'm content with the current presentation. Also note that this page is about bioidentical hormone replacement therapy - bioidentical itself is a bit of accurate, if misleading fluff used by advocates to make some money off of people scared by the WHI findings. The whole package of bioidentical hormone replacement therapy includes salivary testing, compounding and wild claims. Not that it can't be improved, but the sources I've read and included above seem to clearly place much of their weight on the idea that BHRT is less science, more greed. About the only positive piece on it in a peer-reviewed journal is that 2008 bit published by "Dr Erika" in Prim Care Clin Office Pract, which it is a bit early to claim it has revolutionized HRT. The FDA is certainly one authoritative source, but not the only source, on BHRT. WLU (t) (c) Wikipedia's rules:^simple/_complex 17:16, 6 October 2009 (UTC)

Your citations did not accurately reflect what you wrote in the text. I changed the quotes to more accurately reflect the content of the articles. I have no doubt that Compounding Bioidentical Hormone Therapy is a controversial topic. Perhaps the discussion of the compounding aspect and the popular marketing of it should be removed to a separate section and addressed separately. I accessed this article to get information and references about Bioidentical Hormone therapies which are manufactured and marketed through conventional channels. The introduction to this article barely acknowledges that this is a valid option in the pharmaceutical industry today, and does disservice to those of us who wish for this information. Riverpa (talk) 17:40, 6 October 2009 (UTC)

Please space your postings per WP:TALK. I have no problem with your content changes. As far as I know there is no such thing as Compounding Bioidentical Hormone Therapy, but BHRT and compounding are so closely intertwined (as evidenced by the many sources discussing this) that the two are considered essentially interchangeable. We are both editing the lead section, which should summarize the body - it shouldn't be moved elsewhere, it should be expanded upon based on reliable sources. There is lots of information and plenty of references to be accessed, and more on the talk page in the #Definitions section. Those definitions agree - there's not much science there, and a couple are explicit that bioidentical hormones have been an option for decades. The advocates for BHRT and bioidenticals in general are bringing nothing new to the table - no new research, no new information, no new studies, no new compounds, no new techniques for creating them. They are bringing a lot of hype, and the sources are again clear and given due weight - most doctors and researchers don't think the hype is justified. I'm sorry if this doesn't account with what you believe to be true about bioidentical hormones, but that is the majority opinion and that is what we are obliged to report. The FDA quote (which may be a copyright violation so I've removed it) pretty much restates this rather clearly. User:Hillinpa shared similar views about bioidentical not equalling compounding and being horribly besmirched by the association. I would suggest reviewing previous discussions on the matter from this talk page. However, several sources clearly equate bioidentical hormones with compounding, and the idea that there are no substantial benefits beyond conventional hormone replacement therapy and no evidence to support a unique magic to their functioning. WLU (t) (c) Wikipedia's rules:^simple/_complex 18:00, 6 October 2009 (UTC)

I have tried to clarify the differences between compounded and manufactured bioidenticals in several places. I understand that some sources equate compounding and bio-identical, that is why I copied the FDA source which clearly differentiates between the two as it always qualifies BHRT with compounded if that is what it wants to say. I don't believe that we need to propagate an error if we can be more accurate. I extracted the FDA quote here as you have extracted the Boothby table above. I don't really see much difference and wonder why your extract is ok but not mine. As far as the POV tag, I understood that there should be consensus before it is removed. You did not attempt to reach any consensus, you just removed the tag, both times, even though I reduced the scope of the second tag. I still have some issues with the statement beginning "Other features associated with compounded bioidentical hormones". It may have cites, but I cannot find anything in the citations that directly reflect this statement. I would appreciate some clarification.Riverpa (talk) 18:37, 7 October 2009 (UTC)

Nope, you've misrepresented the sources. NAMS is explicit about it being "most often" used to refer to compounded bioidenticals, as are numerous other sources (McBane, Rosenthal, Boothby, Kalvaitis, ACOG, Mayo and Eden are explicit, others are probably implicit). You seem to think that you can provide the truth about bioidentical hormones and correct what you see as misconceptions about them. In fact, we only discuss what can be verified in reliable sources. Until science catches up with the presumed benefits of bioidentical hormones, we stick with what the sources say. Again, I've been over this - please review the talk page and base your arguments on sources, not your own research. WLU (t) (c) Wikipedia's rules:^simple/_complex 20:59, 7 October 2009 (UTC)

I can't figure out what your answer "Nope" is in response to. So, I guess the easiest thing to do is start clean, and ask for an answer to my question regarding my issues with the statement in the first paragraph beginning "Other features associated with". You added the cites, but I cannot find anything in the citations that directly reflect this statement. —Preceding unsigned comment added by Riverpa (talk • contribs) 03:08, 8 October 2009 (UTC)

Undent. Try the Definitions section on this talk page. The FDA is one source. I've identified seven above that clearly associate the two (as demonstrated in the quotes from each article in the definition section ). As for the "other features", the references speak for themselves, and I'm not sure what difficulty you are having. Try reading the second paragraph of the Mayo clinic article, the Boothby definition above, and Eden article. All three are quite clear, and I am frankly confused how they could not be seen as verifying the text they are appended to.

I removed the FDA statement as a WP:COPYVIO because it was essentially the whole page from the FDA. My understanding is that brief exerpts are acceptable for reproduction, but whole pages are not (and completely unnecessary since the link takes you there immediately). My adaptation of Boothby above isn't a series of lengthy quotes, it's paraphrasing the information from the source. WLU (t) (c) Wikipedia's rules:^simple/_complex 14:54, 8 October 2009 (UTC)

The excerpt I copied is approximately 20% of the page it was excerpted from. Here is the FDA policy on copyright: Linking To or Copying Information On the FDA Website: Unless otherwise noted, the contents of the FDA Web site (www.fda.gov)--both text and graphics--are not copyrighted. They are in the public domain and may be republished, reprinted and otherwise used freely by anyone without the need to obtain permission from FDA. Credit to the U.S. Food and Drug Administration as the source is appreciated but not required. -end quote-

Your adaptation from Boothby does not differentiate between the use of compounded BHRT and conventionally manufactured BHRT, which is the basis for this discussion.

Your Definitions section clearly shows a split on the terminology issue, several sources clearly state Compounded BHRT when they want to refer to the treatment, and further qualify that terminology as being used "often", not always. Since they are all excerpts of larger articles it is hard to say what context for the term BHRT has been established elsewhere in other articles. Riverpa (talk) 17:07, 8 October 2009 (UTC)

I've amended the definitions to include the points in the articles where there is mention of the lack of support for its claims, safety concerns, compounding, saliva testing and misuse of the term "natural". It seems to me that WP:NPOV requires that the page focus therefore in these issues, not on the much less discussed idea that bioidenticals happen to be molecularly identical. The story of bioidenticals is the story of its flaws, not of its totally unsupported, claimed triumphs. WLU (t) (c) Wikipedia's rules:^simple/_complex 18:24, 8 October 2009 (UTC)

Seeking Consensus on Definitions

Please do not cut my quote here, your quotes have been allowed to stand above. This is quoted from [1]

The FDA says:

What does the term “bio-identical” mean?

The term “bio-identical” has no defined meaning in any medical or conventional dictionary, and FDA does not recognize the term. Even different medical groups define the term differently. The Endocrine Society, for example, defines “bio-identical” hormones as “compounds that have the exact same chemical and molecular structure as hormones that are produced in the human body,” while the American College of Obstetricians and Gynecologists (ACOG) defines “bio-identical” hormones as “plant-derived hormones that are biochemically similar or identical to those produced by the ovary or body.”

Many compounding pharmacies use “Bio-identical” as a marketing term to imply that drugs are natural, or have effects identical to those from hormones made by the body. FDA is not aware of credible scientific evidence to support these claims. Compounded products that have identical chemical structures to synthetic hormones can be expected to have the same benefits—and risks— associated with FDA-approved hormone therapy.

While you wish to conform to the NAMS definition of bio-identical, even the FDA acknowledges that there is no one definition. I think that qualifying the term BHRT with 'compounded', as the FDA does, eliminates any confusion, as do several of the other editors, as they have indicated in the preceding sections. While the meaning you espouse is perfectly valid, and we are not trying to negate it, the "non-marketing" meaning is also valid, and should be considered when writing this article. It may be used by a minority, but it is used by expert professional organizations such as the Endocrine Society and ACOG, and should therefore be considered significant. Riverpa (talk) 03:29, 8 October 2009 (UTC)

I can click on a hyperlink and read, so the whole quote is unnecessary. Your shorter quote is probably acceptable, but still unnecessary.

The first sentence of the lead of the article clearly states the definition of bioidentical hormones as molecularly identical. The second sentence equally clearly states that bioidentical hormones are mostly associated with compounding. The third equally clearly states other associations - salivary testing and the meaningless term "natural". All are sourced. The majority of the sources I have read portray bioidentical hormones as a sham used to sell expensive compounding processes while making claims about benefits that are wildly out of character with the actual benefits (that are expected to be about the same as conventional hormone replacement therapy). Accordingly, I have given due weight to this coherent set of ideas expressed within the appropriate expert body, the mainstream medical community. People agree that bioidentical hormones, as a technical definition of "identical to molecules produced by the human body", do exist. But the scientists just don't think the claims made are supported by evidence. There's far more to "bioidentical hormones" to just chemical mimicry, and that's what the page should represent. "Bioidentical hormones" as molecules exist and are used, but "bioidentical hormones" as a set of unsupported claims, unnecessary compounding, unclear testing and an unethical marketing concept is what people are pissed off about and what most of the publications are about.

Bioidentical is both a technical definition of molecules identical to those produced by the human body, and a set of unsupported claims made about their effects. The latter is what most people have written about and object to. It's due weight to discuss these ideas in the most depth while more-or-less ignoring the actual effects of bioidentical hormones - which have been used for years and are not expected on the basis of current research to have effects and side effects substantially different from conventional hormone replacement therapy. The NAMS statement doesn't spend large amounts of time discussing molecularly identical hormones; it briefly mentions then, and goes on to talk about compounding, saliva testing, lack of scientific support, safety concerns and expense. For us to wax eloquent on "bioidentical hormones" as a set of molecules is inappropriate original research. Most sources talk about the problems and illegitimacy of the concept that is marketed to women. They don't talk about how great individual molecules are, or the effectiveness of these molecules that have been used for years. That's because individual molecules have individual effects for individual women, and different tissues thereof - each molecule is treated separately and not as if it were a magic group because they happen to be structurally the same as those in the body. The reason they use estrogen-blocking drugs on women with breast cancer (or at risk of it) is because these molecules can be, in certain cases, cancer-promoting even though they are produced endogenously.

But all of this is just meaningless talk - WP:NPOV clearly states we represent the views as we find them in the literature, and WP:OR equally clearly states we don't write about what we think is important.

Incidentally, who is "we"? Are you a representative of an authoritative body? WLU (t) (c) Wikipedia's rules:^simple/_complex 15:11, 8 October 2009 (UTC)

please see WP:IDHT - Riverpa (talk) 19:51, 8 October 2009 (UTC)

The sources explicitly support my points. You have your own opinion and have yet to provide any evidence to support your assertions. You do not appear to understand WP:RS, WP:V, WP:OR and WP:NPOV, or you are deliberately ignoring them. I get your opinion, I got Hillipna's opinion, I got QB's opinion, but none are supported by sources so I don't see any reason to take them seriously. Since I'm the only one of the three that seemed to have actually read the sources, and has used them to substantiate my points, repeatedly, using many, many sources, all from peer-reviewed journals, all converging on single points, I don't know what I'm supposed to listen to. WLU (t) (c) Wikipedia's rules:^simple/_complex 01:01, 9 October 2009 (UTC)

undent

Allmost every one of the citations that you provide attempts to clearly differentiate between the fad treatment use of the term "BHRT" and the use of the term bioidentical to differentiate these estrogens from CE estrogens.

The Cirigliano, M (2007). "Bioidentical hormone therapy: a review of the evidence" text directly supports my contention that the term "Biodentical" is used in two different ways.

Moskowitz, D (2006). "A comprehensive review of the safety and efficacy of bioidentical hormones for the management of menopause and related health risks". Alternative Medicine Review 11 (3): 208-23. PMID 17217322. http://www.thorne.com/altmedrev/.fulltext/11/3/208.pdf.

which abstract you excerpted very briefly, also includes this text which clearly refers to the use of bioidentical hormones for replacement therapy while not referring to the fad treatment plan:

"Research indicates these synthetic hormones vary clinically in safety and efficacy. As such, women and their physicians have, in increasing numbers, been opting for the use of bioidentical hormones; i.e., those that match the structure and function of hormones produced in the body. With greater utilization and research surrounding bioidentical hormones, the differences can now begin to be fully assessed and appreciated. This article reviews the disparities between synthetic and bioidentical estrogens and progestins/progesterone with respect to safety and efficacy; special attention is devoted to clinical outcomes in the breast, endometrium, bone, cardiovascular system, and brain. The studies reviewed suggest bioidentical progesterone does not have a negative effect on blood lipids or vasculature as do many synthetic progestins, and may carry less risk with respect to breast cancer incidence. Studies of both bioidentical estrogens and progesterone suggest a reduced risk of blood clots compared to non-bioidentical preparations. Bioidentical hormone preparations have demonstrated effectiveness in addressing menopausal symptoms. The author advocates for continued research on bioidentical hormones and concludes there is currently sufficient evidence to support their preferred use over that of their synthetic cousins."

Also look at your extract of Holtorf K (January 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?". Postgrad Med 121 (1): 73–85. doi:10.3810/pgm.2009.01.1949. PMID 19179815. http://www.holtorfmed.com/wp-content/pdfs/BHRT-PGM-2009.pdf. While Holtorf muddies the water by discussing the term 'natural', he has a clear definition of bioidentical HRT as in opposition to the use of synthetic homones, rather than using it as the fad definition.

The excerpt you provided from the FDA Statement cut this sentence which indicates that the concern the FDA has is primarily directed at compounded drugs:

"Compounded drugs are not reviewed by the FDA for safety and effectiveness, and FDA encourages patients to use FDA-approved drugs whenever possible. The warning letters state that the pharmacy operations violate federal law by making false and misleading claims about their hormone therapy drugs."

The excerpt that you provided from the Endocrine Society Postion Statement has this statement cut out if it by you:

"As women seek safer treatments, they often request “bioidentical hormones” from their physicians."

"The Endocrine Society- Position Statement: Bioidentical Hormones" (pdf). The Endocrine Society. 2006-10-01. http://www.endo-society.org/advocacy/policy/upload/BH_Position_Statement_final_10_25_06_w_Header.pdf. Retrieved 2009-02-29.

There is considerable controversy over the use of compounded BHRT. There does not appear to be a great deal of controversy over the actual use of FDA-approved bioidentical hormones as hormone replacement therapy. The FDA may not approve of the term bioidentical as applied to compounded bioidentical pharmaceuticals, but the term appears to already have a consensus meaning as bio-equivalent.

As well, the WP article on [Hormone replacement therapy (menopause)] refers to Bioidentical Hormone Replacement Therapy with no reference at all to the controversial compounding.

As far as due weight goes, if you google "BHRT" you will probably get a ton of references to the fad therapy. But if you google "sex" looking for information, you will probably get a lot of XXX sites. Does that mean we should give due weight to the XXX sex sites on WP? Why, because the commercial interests have over-weighted their influence in popular culture by intensive marketing?

I am trying very hard to WP:AGF. But it is not easy when you write things like "That being said, I think BHRT is a load of crap,... Fortunately, we're still allowed to edit pages we think are a load of crap. " [2]. Then you continue to edit the page to make it reflect your opinion of the fad, rather than attempting to reflect WP:NPOV.

I see you are still making personal attacks. Please stop or point out exactly where the original research is in my contributions. As for reliable sources and verifiability, your sources are my sources, so I fail to see the conflict. Riverpa (talk) 02:49, 10 October 2009 (UTC)

WP:TLDR WLU (t) (c) Wikipedia's rules:^simple/_complex 13:16, 10 October 2009 (UTC)

WP:POT You asked for sources. I provided them. WP:GAME Riverpa (talk) 13:44, 10 October 2009 (UTC)

You are correct, I dismissed your work far too quickly and apologize for that. I still see your analysis as flawed and promoting a version which does not give due weight to the general opinion, but I will get to specifics later on when I have time. WLU (t) (c) Wikipedia's rules:^simple/_complex 13:55, 10 October 2009 (UTC)

I'll try to respond point by point, but the length of your post could make this confusing. I'll do my best.

Citations do differentiate clearly between CHT and BHRT, but also make it clear that BHRT is not simply molecularly identical molecules, it's a series of claims and practices that have nothing to do with the molecular structure. It's claims about safety, about benefits to the cardiovascular system, about a lack of side effects, none of which are proven through any research. It's not simply a matter of stating what bioidentical hormones actually are; it's a matter of explaining how the term is used. Do most of the articles say just "bioidentical hormones are molecularly identical to those produced in the body" then stop? Or do they go on to say more? I'm trying to get at the "more" part, which is generally not good. The WP:NPOV nutshell states "Articles must be written from a neutral point of view, representing all significant views fairly, proportionately, and without bias." It's the proportionately part that results in the emphasis on criticisms - most articles are mostly critical. Emphasizing and rewriting the page based primarily on a small number of articles places undue weight on those articles. Since most of the articles are critical, and most of the position statements made by official bodies are also critical, the page should be mostly critical as well. A small number of articles taking a different position doesn't mean rewriting the article, that's undue weight. Determining appropriate weight is difficult, which is why I excerpted the large number of definitions above to show that due weight requires emphasis on the compounding, saliva testing and "natural" claims, as well as the criticisms of these claims.

We can't decide what is a "fad" or "appropriate" definition. We can only write what we can cite and we have to write and cite in proportion to what the sources say. I can't speak to the contents of other wikipedia pages, if I ever get the time I may try to correct them.

Please see WP:GHITS and again NPOV - we represent significant views as published in reliable sources. Those commercial sites are not reliable sources, the appropriate sources are medical ones. No websites, no popular books, no talk show postings, just medical literature. I do my best to avoid polluting the page with opinion, primarily by using large amounts of references. As for personal attacks, where have I made them? I have gotten frustrated before because of editors who kept pushing truth that runs in the face of sources. It's not sufficient to cherry-pick sources, they must be represented, as best possible, en masse. That is NPOV, and it's something I've tried to work towards during my three years and 40,000 edits on wikipedia. WLU (t) (c) Wikipedia's rules:^simple/_complex 20:53, 12 October 2009 (UTC)

I would actually prefer that you do respond point by point, since you seem to not take notice of details very well. For example, the first detail that you have missed, and the underlying fallacy in your argument is that "Citations do differentiate clearly between CHT and BHRT". They do not differentiate between CHT and BHRT, they differentiate between CHT and Compounded BHRT, almost 100%, because they treat some BHRT as a sub-set of CHT. That is clearly indicated in almost every article by using the phrase "compounded BHRT" to indicate the type of BHRT which is not a subset of CHRT, which is controversial, and all the tempest is about. When you look at the small amount of primary research that is being done in the field, it is being done about FDA-approved BHRT - the type that you don't want to acknowledge exists.

Yes, we all understand that you are the expert editor and must let everyone know. And because, of course, you are not pushing truth, and everyone else here must have a hidden agenda, because you have decided that you are the absolute arbiter of NPOV where this article is concerned.

As far as NPOV goes, you should re-visit the table you inserted and re-consider, that if a claim has not been proven, it does not make it false. It makes it "unproven". Is that not NPOV? Is that not how FDA and other expert sources refer to unfounded claims about this therapy? They answer "Unproven", you translate that to "False". There is a difference.

That type of transformation occurs with great frequency in your writing on this page, which is why I would like compounded BHRT treated separately from the FDA-approved BHRT, which you do not acknowledge as a notable subject, though millions of women use it.Riverpa (talk) 23:45, 12 October 2009 (UTC)

A page about real and fake BHRT will turn out pretty much the same. The "real" BHRT page will be extremely short, and say that bioidentical hormones exist and have for a long time and are FDA-approved. It would then be a list of bioidentical hormones, and a link to the "fake" page. The "fake" page would look pretty much like this one - it would list all the unsubstantiated claims about bioidentical hormones, call them refuted or unproven, criticize bioidentical hormones for being associated with dangerous, expensive and unnecessary compounding, salivary testing and "natural" public relations crap, list the many agencies that criticize bioidentical hormones, and talk about celebrity testimonials. Focusing on details and individual publications means losing sight of the overall thrust and coherence of the sources on a set of points of general agreements. WLU (t) (c) Wikipedia's rules:^simple/_complex 02:11, 13 October 2009 (UTC)

Per Riverpa's comment I've removed the "status" column from the table and allowed the claim and evidence colulumns to stand on their own. The table still needs further expansion based on Boothby & Doering. WLU (t) (c) Wikipedia's rules:^simple/_complex 18:14, 13 October 2009 (UTC)

Seeking input on terminology

The term Bioidentical Hormone in this sense is used in two discrete ways, one: as a scientific term to indicate the identical nature of two hormones, and 2: as part of the term Bioidentical Hormone Replacement Therapy, popularized by Suzanne Somers and others (primarily compounding pharmacists and some naturopathic physicians) as an unproven therapeutic approach for menopause symptom relief. I would like this distinction emphasized, particularly in the opening paragraphs, and the emphasis maintained throughout, by consistently qualifying the therapeutic approach as "compounded BHRT", as the FDA and many other citations currently do. The word "compounded", and the quotes around the term "bioidentical", tend to get lost between the cited articles and the WP article. Riverpa (talk) 16:02, 8 October 2009 (UTC)

This ignores the numerous citations that not only directly treat the two as identical, but also qualify the the relationship - bioidentical hormones are molecularly identical, and are often associated with compounding. See the verbatim quotes from the above #Definitions section. This is already emphasized, quite clearly in the lead. WLU (t) (c) Wikipedia's rules:^simple/_complex 16:29, 8 October 2009 (UTC)

Cirigliano clearly differentiates between compounded BHRT and FDA-approved BHRT (by not using the term 'compounded' when referring to it) throughout his article, as did the FDA (when it used the them bioidentical, as it no longer does), and most other papers. If you do not notice this distinction, you can end up very confused, as WLU appears to be. The only article that clearly does not differentiate between the two at some point is the Mayo column, which is a very short, consumer oriented question-and-answer column which addresses only custom-compounded hormone replacement. Riverpa (talk) 15:10, 16 October 2009 (UTC)

Cirigliano is one citation of more than 30 in the page, and most treat the terms as indistinguishable for consumers - bioidentical hormones are compounded. I'm not confused, I know the difference between them, and I know that most articles treat them synonymously. Cirigliano doesn't differentiate between FDA-approved BHRT because FDA-approved BHRT is just conventional HRT that uses bioidentical molecules. The lead and first section clearly differentiates between compounded, conventional and bioidentical HRT. Cirigliano is used four times - production and terminology 1, lack of evidence twice 2 and 3 and "natural" claims 4. The first clearly distinguishes between the compounded and BHRT. The second justifies the idea that BRT lacks evidence. Cirigliano is clear on this and distinguishes between compounded BHRT and just BHRT - using the latter to refer to the claims made by advocates, the former to discuss the actual science behind compounded BHRT (primarily that there isn't any). Since advocates don't use "compounded BHRT", Cirigliano also uses BHRT when quoting or discussing claims made by advocates. Essentially, when Cirigliano is referring to existing science on molecularly identical hormones he refers to BHRT; when he quotes or discusses advocates he uses BHRT (because advocates do not distinguish) and when he discusses the scientific claims about BHRT he is forced to use "compounded BHRT" because that is what advocates are refering to (but don't specify) and there's no research on the topic. Cirigliano uses the terms appropriately, advocates don't, and this page is forced to walk the line between them. I think it does so successfully. WLU (t) (c) Wikipedia's rules:^simple/_complex 16:26, 16 October 2009 (UTC)

undent. References used in the article and statements on their use of the term Bioidentical - compounded or no - italics added

Cirigliano - "This review of the literature related to compounded BHT and the practices of its advocates is to determine if sufficient scientific evidence supports claims of greater efficacy and safety and any additional risks and uncertainties not generally associated with CHTs."

From the abstract: "It is generally accepted that estrogen-based hormone therapies share similar efficacies as well as risks. Many FDA-approved and regulated pharmaceutically manufactured and branded conventional hormone therapies (CHTs) employ BHs." WLU

Adriane Fugh-Berman, MD and Jenna Bythrow, MS candidate "This article will focus on compounded bioidentical hormone preparations aimed at menopausal and perimenopausal women"

From the first lines of the first two paragraphs: "Bioidentical or natural hormones are being promoted to consumers as benign health tonics. The term bioidentical is a pseudoscientific neologism...Many bioidentical hormone products that require a prescription are prepared by compounding pharmacies" WLU

Lisa A. Boothby and Paul L. Doering "It is the purpose of this review to systematically examine the scientific rigor of the arguments posed by the proponents of bioidentical hormone therapy, and to differentiate the practice of bioidentical hormone therapy from the legitimate practice of pharmacy compounding."

From the abstract: "Bioidentical or natural hormones are expected to have similar efficacy and safety profiles as the commercially available hormonal therapies that have been studied in clinical trials, regardless of whether the active principle hormones are compounded by individual pharmacies or manufactured by large companies" WLU

Holtorf - "Bioidentical hormones are not a marketing term. The term has been used for more than a decade in the inserts to all FDA-approved commercial hormone preparations that contain hormones molecularly identical to human hormones. In a recent review of bioidentical hormones in menopause, Boothby and colleagues reviewed only the compounded formulations of bioidentical. The investigators made no mention of the commercially available bioidentical hormones. This omission inadvertently perpetuated the confusion, credibility, and even existence of bioidentical hormones in FDA-approved commercially available preparations."

Holtof and Erika Schwartz are the sole voices to claim anything special for bioidenticals. Schwartz sells bioidenticals and books singing their praises, and as the many other sources point out, there is no reason to expect their safety and efficacy profiles to be any different from any other forms of HRT. WLU (t) (c) Wikipedia's rules:^simple/_complex

NAMS - "NAMS recognizes that one area of confusion in clinical practice is so-called "bioidentical" hormone preparations. This term has been used to refer to many well-tested, regulatory agency approved, brand-name HT products containing hormones chemically identical to hormones produced by women (primarily in the ovaries), such as 17A-estradiol or progesterone."

Adding the follow-up sentence: "However, the term is most often used to describe custom-made HT formulations (called "bioidentical hormone therapy," or BHT) that are compounded for an individual according to a healthcare provider`s prescription." WLU

Kalvaitis "The controversy centers around the idea that compounded hormone therapies have not been tested and are, therefore, questionable for use."

Adding first sentence in article - "As a growing population of women reaches menopause, physicians may be fielding more questions about compounded hormone therapies — or, more commonly, “bioidentical hormones.”" WLU

Harvard Women's Health Watch - "Much of the confusion about bioidentical hormones comes from the mistaken notion that they must be custom-mixed at a compounding pharmacy....Unless your clinician has considerable experience with bioidentical hormones and a particular compounding pharmacy, you’re better off with a prescription for commercially available hormones, many of which are bioidentical."

And, the only citation that I found that uses the term Bioidentical to always refer to the compounded product and associated treatments:

Mayo - "Bioidentical hormones are custom-mixed formulas containing various hormones that are chemically identical to those naturally made by your body."

As you can see, Cirigliano makes it clear that his paper is about compounded BHRT, therefore he doesn't unnecessarily differentiate between compounded and non-compounded throughout the paper. He distinguishes between the two when he needs to differentiate between the use of conventional FDA-approved BHRT products, and BHRT the controversial treatment modality.

Riverpa (talk) 17:38, 29 October 2009 (UTC)

I should also mention that Cirigliano only uses "BHRT' once in his article, only when referring to another citation - he invariably uses the acronym BHT.Riverpa (talk) 18:07, 29 October 2009 (UTC)

And as I've said before, "bioidentical hormone therapy" without compounding, unjustified claims, saliva and blood testing is just "hormone replacement therapy". Science treats individual compounds and their effects as varying based on research specific each compound. It doesn't say "because this molecule is identical to that found in the body, it's magical". I'm not sure what changes are suggested based on this. Did you want to portray bioidentical hormones as safer, as more effective, as more dangerous and less effective? My point has been for a long time that most people don't research "bioidentical hormones". They research hormones. Some of these are molecularly identical to those found in the body, some are not. Each has its own profile of risks and benefits, delivery mechanisms, effects, pharmacodynamics, etc. But they're not treated as a single class, except by bioidentical hormone replacement therapy advocates. And the majority opinion of bioidentical hormones per the relevant experts is exactly that - there's no reason to treat them differently because they are identical to endogenous molecules. Cirigliano also states that "It remains unclear whether women who opt for BHT understand that it is not an alternative therapy to HT if it contains estrogen and, as a result, must be assumed to carry the same potential harms and benefits as any of this class." He goes on to discuss the unacknowledged risks and unsubstantiated claims about bioidentical hormones. Cirigliano is also clearly discussing the problems and issues of bioidentical hormone replacement therapy as popularly understood. He also points out that there are clinically tested bioidentical hormones (tests which don't support these fanciful claims) and classifies them with conventional HRT. Also states "The BHs most commonly used by compounding pharmacists in the United States are produced by extracting diosgenin from plants, usually highyield soy and Mexican yams (Dioscorea)", certainly implying that what the article is essentially talking about is compounded BHT.

Cirigliano clearly supports the idea that bioidentical hormones have a lot of wild, exagerrated claims made for them, and these claims are not supported with evidence. I would also draw any reader's attention to Cirigliano's section entitled "Individualizing therapy and saliva tests". Far from refuting my points, Cirigliano's article seems to unequivocally support the current state of the page - bioidentical hormones exist, but scientists don't treat them any different from regular hormones merely because they are identical to enogenous hormones. Further, BHRT advocates claims are unsubstantiated, but advocate for saliva testing and compounding. This page is about bioidentical hormone replacement therapy, not bioidentical hormones, which should be dealt with on separate pages for each individual molecule. WLU (t) (c) Wikipedia's rules:^simple/_complex 22:29, 31 October 2009 (UTC)

These are the components used in FDA-approved bioidentical hormones, as well, as C is saying. When he says "BH' he is referring to all, FDA-approved, and hormones provided to compounding pharmacies. They are FDA-approved, they must be in order to be dispensed to the compounding pharmacies. C classifies them with conventional HRT because they are conventional HRT, they are FDA-approved BHRT. He is not conflating the saliva testing and compounding with them, you are.

And as I noted before, C makes it clear that his paper is about compounded bioidentical hormone replacement therapy, not bioidentical hormone replacement therapy, you just conveniently left off the compounded when you cut and pasted, as you have before. I quoted his intro above, as an entire sentence, in context, not cut and taken out of context as you so often do.

And what is it about Holtorf, NAMS, and the Harvard Women's Health Watch quotes that make them not applicable to this discussion?Riverpa (talk) 15:51, 2 November 2009 (UTC)

Adjusted per WP:TALK. Cirigliano is saying, like most of the articles, that there's no reason to believe that bioidentical hormones are any safer or more effective than regular hormones merely because they are bioidentical. Cirigliano is trying to make the point that hormones that happen to be bioidentical are expected to be no better or worse than those that aren't merely because they are bioidentical. The thing that separates conventional HRT from BHRT is the claims made for them, the saliva testing and compounding. Cirigliano isn't claiming a revolution in HRT using bioidenticals. He's going through the claims made about BHRT and debunking them. He's not saying that all hormones that are bioidentical are magic. And specific claims about specific hormones should be discussed on those specific pages. No doctor uses bioidentical hormones for CHRT simply because they are bioidentical; they are used based on their individual risk and benefit profiles. It's not a good use of a source to cite specific claims while overlooking the overal conclusions, particularly when the overall conclusions converge with other sources.

I read half the study before realizing that it's supporting my assertion, I figured re-reading the same studies to arrive at the same conclusion wouldn't be a good use of my time. WLU (t) (c) Wikipedia's rules:^simple/_complex 21:32, 2 November 2009 (UTC)

Reviewing the other citations above, and adding a bit more context, it's still quite obvious to me that bar the Holtorf and Schwartz paper, the sources converge - bioidentical hormones generally refers to bioidentical hormone replacement therapy, which often uses testing and compounding, and often makes unsupported claims. Bioidenticals are expected to have the same risk and effectiveness profiles as other types of HRT. The reason there is so much confusion is that "bioidentical hormones" are not treated as a "class" or "group" - each molecule has its own specific risk/benefit profile and there's no reason to specify that X hormone is bioidentical and therefore special. Much of the confusion is due to the conflation of compounding, naturalness, testing and safety, none of which is warranted. Claims made and warnings about "bioidentical hormones" and "compounded bioidentical hormones" are equally valid to each, because most articles explicitly state they go together. This page deals with, and should continue to deal with, bioidenticals as a class of hormones as generally advertised - a group of molecules that happen to be identical to those in the human body but are not special because of this. Until there is evidence that most doctors and researchers consider bioidenticals to be any different, each molecule should be dealt with on each page separately - progesterone on the progesterone page, estriol on its page, etc. When dealing with them as a class, as "bioidentical hormoneS rather than "a bioidentical hormone", the page should give due weight to the scholarly majority and state that they are expected to be as risky, and as beneficial as all other types of conventional hormone replacement therapy. Certainly noting that progesterone as packaged and sold is identical to that produced in the body is worth noting, but worth noting in the progesteron page.

Holtorf and Schwartz are outliers in their promotion of bioidenticals, which at least she has a long history of doing. Neither are particularly well-published (three and one citation apiece). It has also not yet been cited by any other article that I have seen. Accordingly, basing large amounts of text on this article would seem to be undue weight. WLU (t) (c) Wikipedia's rules:^simple/_complex 18:23, 3 November 2009 (UTC)

"Bioidentical Hormones: Ethics and Misinformed Consent"

Focusing specifically on ethical considerations: [3] Debv (talk) 01:08, 9 October 2009 (UTC)

Unless that was published in a peer-reviewed journal somewhere, I wouldn't use it. There's lots of sources from the scientific literature, so there's not much reason to use web pages that aren't from notable agencies or mission statements from authoritative bodies. WLU (t) (c) Wikipedia's rules:^simple/_complex 01:14, 9 October 2009 (UTC)

I'm not familiar with the publication myself but it appears to be peer-reviewed. See for instance About Us and Author Guidelines. And this indicates it is a printed and circulated publication. Debv (talk) 01:29, 9 October 2009 (UTC)

Just to add, this article obviously doesn't serve to supplement or supplant existing sources for the medicine and science of BHRT. It focuses on BHRT in terms of medical ethics.

It does raise an interesting scientific point in passing: "Wright used 'bioidentical' to communicate his still unsubstantiated claim that plant-derived hormones are 'identical' in molecular structure to human hormones. The necessary structural crystallographic data demonstrating this do not exist, which is why the term bioidentical remains misleading." It seems there are reliable sources asserting that bioidentical hormones are actually chemically identical, but on what basis? Are there primary sources validating this? I wouldn't argue for a change in the article on this reference alone, but it does raise an interesting question. I think it would be worthwhile to look for any primary sources that actually prove that they are identical. Debv (talk) 04:07, 9 October 2009 (UTC)

Pubmed won't let me link to it, but a search indicates it's not indexed, which is a vague minimum standard for being a WP:MEDRS. There's already lots of sources, including one by Rosenthal that focusses on the ethics of BHRT. There's a lot of other, more basic issues to be addressed as well and I'd rather focus on them.

As for primary sources asserting they are molecularly identical, there are plenty to justify this but again the molecularly identical assertion is only one rather minor part of the whole story of BHRT; without a solid source stating they are in fact not identical, I don't think it's worth exploring. WLU (t) (c) Wikipedia's rules:^simple/_complex 14:31, 9 October 2009 (UTC)

If you don't personsonally want to use the source, I'm certainly not saying that you must. I'm simply offering it for consideration, should anyone choose to expand on the medical ethics aspect of BHRT. If you're arguing that it's not an acceptable source, I don't find anything compelling in your argument. WP:MEDRS does not require that sources be indexed in PubMed nor in any way suggest that PubMed indexing should be used as substitute for judgment in evaluating sources. In fact it makes clear that PubMed's scope is limited and suggests other search engines. Debv (talk) 17:18, 9 October 2009 (UTC)

The question of whether bioidentical hormones are in fact chemically identical to endogenous hormones is not a minor point. It's central to the argument offered by proponents of BHRT -- that the difference between the hormones tested in the WHI study and the hormones they're selling is that the former are chemically different, hence the deleterious results published by the WHI, and that the latter are safe, truly identical, "bioidentical", to endogenous hormones.

Yes, there are reliable sources, in WP terms, that accept the identicality of bioidentical hormones. Rosenthal here questions this premise and says it remains unproven. The question this raises -- are there any primary sources that actually validate this claim? -- hardly seems to me unworthy of consideration. Whether this question will turn up anything that warrants a change in the article's language, I don't know and I'm not at this point arguing for it. Debv (talk) 06:46, 10 October 2009 (UTC)

Regarding Safety vs Regulation

WLU, please read a little more closely here. The FDA is not making a statement about safety in this quote. They are warning the compounding pharmacies not to make safety claims. This is very different from the FDA making a statement about safety, because they have no opinion about safety in this area because they have no research about it - Here is their statement: "The FDA does not have evidence that “bioidentical hormones” are safer or more effective than other hormone products. FDA believes that the benefits and risks are likely to be the same." If you want a quote on safety from the FDA, that would be the better one to use in that section.

Please read things a bit more closely for context. Just because the word "safety" appears in the quote does not mean it is a statement regarding relative safety of the product.Riverpa (talk) 03:03, 12 October 2009 (UTC)

PS - I didn't see the added text you had made about estriol until after I reverted. (since you did not mention making additional changes, I did not look for any.) While it looks like a perfectly respectable sourced statement, it doesn't really seem to belong to the Wiley Protocol section since that section has no mention of estriol, and there seems to be no linkage between the two. (Estriol and Wiley) Plus, why did you delete my quote regarding the FDA's statement on estriol? Please discuss things like that first. You had no justification to delete it and it should have been left in place since it was properly cited and from a reliable, verifiable source. Riverpa (talk) 03:25, 12 October 2009 (UTC)

The FDA statement belongs in the safety section - the issue is the lack of evidence about claims of safety made by manufacturers and proponents. They have an opinion - claims about safety are unwarranted because there's no evidence to support it. This is the same idea as the other statements made about safety by many other sources. I've replaced the estriol quote with my earlier statement, in the appropriate section; I also did mention it in my edit summary - "integrated statement with citation template". See HELP:DIFF for how the diff-by-diff comparison shows changes. WLU (t) (c) Wikipedia's rules:^simple/_complex 14:51, 12 October 2009 (UTC)

Please do not use my Talk page

Hid tangent and reply

If you wish to address me use this Talk Page.

You message to me :Nuvola apps important.svg You currently appear to be engaged in an edit war according to the reverts you have made on bioidentical hormone replacement therapy. Note that the three-revert rule prohibits making more than three reversions on a single page within a 24 hour period. Additionally, users who perform several reversions in content disputes may be blocked for edit warring even if they do not technically violate the three-revert rule. When in dispute with another editor you should first try to discuss controversial changes to work towards wording and content that gains a consensus among editors. Should that prove unsuccessful, you are encouraged to seek dispute resolution, and in some cases it may be appropriate to request page protection. Please stop the disruption, otherwise you may be blocked from editing.

WLU (t) (c) Wikipedia's rules:simple/complex 12:27, 16 October 2009 (UTC) -end quote-

should go here, as well as any other communication you wish to have with me.

This is a tangent and a failure to appreciate the use of talk pages on wikipedia. Article talk pages should be used only to discuss the article. User talk pages are for discussions of specific issues with editors. The 3RR warning, which is standard, should not be used on this page. If you want to edit wikipedia, you'll have to accept people posting on your talk page, even if you don't like them. WLU (t) (c) Wikipedia's rules:^simple/_complex 15:06, 16 October 2009 (UTC)

I fail to see the conflict in my reversion. You seem to think that reverting is an acceptable way to edit the page, as you have reverted several of my properly cited and written edits, and have deleted content that I have inserted in order to improve the article. You have reverted the same material several times, though it meets WP standards for citation and relevance. When you could not revert again because you would trigger the 3R rule, you re-wrote the affected sections.

I'll be interspersing comments. I don't like doing it, but it'll let me get at specifics. I revert when I see an edit which demonstrably worsens the page. I rewrite sections when there's something of merit in the contribution, not to avoid the 3RR (note that a revert can mean rewording as well as simply changing back). I'm also not the only one reverting, so any comment you make about reverting applies to yourself as well. I've also given reasons for my changes each time. WLU (t) (c) Wikipedia's rules:^simple/_complex 15:06, 16 October 2009 (UTC)

I have deleted statements because your cited sources do not support them. [4]

Placing multiple citation sources on a single statement is almost certainly synthesis, especially since you had a single cite on the statement until I found that the cite did not support the statement. [5]

Wikipedia is not made up of a series of quotations - rewording means I won't be using the exact same wording as the sources. My replacement kept the idea (intense promotion) and added extra citations (Kalvaitis - "Advocates of bioidentical hormones tout them...Proponents emphasize" McBane - "All these publications champion bioidentical HRT as safer and more effective than traditional, commercially manufactured HRT preparations" Rosenthal - "proponents of bioidentical hormones...promote bioidentical hormones as safer" Endocrine Society "Bioidentical hormones,” particularly estrogen and progesterone, have been promoted as safer and more effective...As a result of unfounded but highly publicized claims" Boothby -"[compounded hormones] are promoted by some prescribers...these practitioners are touting “natural” (sometimes referred to as bioidentical) hormone therapy (NHT) as a safer and more effective".) I've even removed the word "intense", as it's unnecessary given the previous sentence. It's only a synthesis if it takes two separate ideas and links them to advance a third, but all sources collectively justify the same idea - bioidentical hormones are heavily promoted as safe and effective. Some sources specify "compounded", some say just "bioidentical" but note that this generally means compounded, but the two are in most cases synonymous and many references note this specifically. You seem to think the two concepts are wildly different; to a certain extent you are correct but what the sources say is that in most cases they are treated the same way. If bioidenticals get a separate research and testing life away from compounding and saliva testing, the page will adjust to reflect this - but we'll need sources to justify this point. Right now that's not the case. WLU (t) (c) Wikipedia's rules:^simple/_complex

I, and others, have tried to engage you to collaborate on this page, yet you continue to "own" the article and block any attempt to introduce any material that you do not find meets the standard of your POV. You make citations, but do not read for the actual content, choosing instead to only absorb the parts of the articles that match your views. You drop words that change the intent of articles,[6] you change words to more support what you want to support. [7]

It's not my POV that's the issue. It's NPOV - representing views as found in the articles. Regards the first diff, did you note that since that time the word "compounded" has remained in the page despite 35 revisions by myself alone? Doesn't that support the idea that if your edit has merit, I don't interfere? Even regards that edit, based on all the other sources it's arguable that "compounded" is unnecessary, but I left it in. So I see no merit to your point either in your first or your second - in the 20 edits since your intial one, the idea has remained the same; the first section states that BHRT differs from HRT because of its association with compounding, and the only change I made regards estriol was to reword it (but keep the intent) to avoid a direct quotation. The idea is the same. WLU (t) (c) Wikipedia's rules:^simple/_complex 15:34, 16 October 2009 (UTC)

You will not discuss anything that is counter to your POV, or tolerate any entries in the article that may conflict with it. You response is always "No" to anyone's attempt to arrive at any decision that does not mirror your own POV in this matter.

I discuss very, very much, probably half the text on this talk page is written by me. I see no merit in most of your, and other editor's points, mostly because you are not backed up explicitly by the sources. You think bioidenticals are totally unrelated to compounding. Most of the sources state that bioidentical hormones do exist, but are most often associated with compounding. Your idea may be true but it is verifiable that the two are seen synonymously. Consider that you keep missing my point. Wikipedia is about verifiability, not truth. WLU (t) (c) Wikipedia's rules:^simple/_complex 15:34, 16 October 2009 (UTC)

WLU is not being honest here. WLU repeatedly edited out references to research and review articles that demonstrate that bioidentical estradiol and progesterone, delivered in the correct way, do not have the risks associated with FDA-approved non-bios. He/She brands the studies and the opinions of top researchers in the field that contradict the drug-companies' "Bios are no better than non-bios" position as "original research". WLU accepts only "mainstream" opinion as being valid, no matter how contrary to the evidence. I have demonstrated above in the archives of this discussion that "mainstream" opinion in the US is formed by three private organizations, ACOG, Endocrine Society, and NAMS, which are funded by and therefore unduly influenced by the drug companies that make the dangerous non-bios. The vast majority of doctors simply accept the statements of these organizations as best medical opinion, and do not take the time to research the evidence themselves. So the lies are repeated and heard from multiple media sources. That's just good information control! WLU's article is biased, and will remain so until pro-bioidentical evidence is included and given due weight, and the obvious errors and disinformation removed.Hillinpa (talk) 14:25, 8 November 2009 (UTC)

Do not address me on my talk page. Keep you comments, accusations, and threats on this page. Riverpa (talk) 14:02, 16 October 2009 (UTC)

I've never threatened. As required, I pointed out to you that you were in danger of violating the three revert rule and could be blocked. This is a courtesy and a necessity. I will use your talk page for comments about your edits that don't apply to the main page, and I will keep removing tangential comments here - talk pages are "To let multiple users collaborate on improving an article". You can't keep me off your talk page, and it's inappropriate to do so if my own comments are appropriate. They are. You may not like them, you may think I'm wrong, but as long as I'm editing within the bounds of the policies and guidelines, that is the reality of wikipedia and you will have to obey them if you want to keep editing. WLU (t) (c) Wikipedia's rules:^simple/_complex 15:34, 16 October 2009 (UTC)

Do Not Delete my entries - I am restoring an entry of mine that you deleted. My understanding is that you never get to delete someone else's content unless it is pure vandalism.

- Please do not address me on my talk page.

- - You wrote" WLU (t) (c) Wikipedia's rules:^simple/_complex 12:27, 16 October 2009 (UTC)

-

When I have a comment that is directed squarely at you, I will use your talk page. Part of wikipedia is communication, and when the issue is with an editor's actions and not the page itself, then it is appropirate to use their talk page and not the article talk page. You are free to remove my comments if you wish, but doing so without reading them will inevitably lead to problems because you will not see the reasons for my changes - which I always provide and always do my best to base on the policies and guidelines. There's a reason my signature links to the P&G pages - I take them very seriously and if I'm wrong, I admit it and change my behaviour accordingly.

-

I am not threatening you. An edit war is an unfortunate but common occurence on wikipedia. You are an inexperienced editor, and are therefore unlikely to be familiar with the specific policies and guidelines governing editorial disputes. Ergo, I am informing you. A three revert warning is a standard template ({{uw-3rr}}) that is meant to be neutral and informative. It is also a necessary step to ensure that you are informed of the policies and intolerance of 3RR issues, and if you continue to revert, you will be blocked. Not by me, I am not an admin and can't block anyone. I would report it at the three revert noticeboard where an uninvolved admin would review the incident and issue a ruling - possibly a block, possibly a warning. In neither of our cases would the block be permanent, in your case it would probably be for a day at the most. You wouldn't be blocked if I hadn't delivered a warning on your talk page; it's both a necessary step and a check against abuse.

-

A final note - I find it very easy to justify my changes. This is one of the main indications that I have that my changes are aligned with the intent of WP:NPOV. I try to base my changes on direct quotes from reliable sources with minimal interpretation. If I'm wrong, please demonstrate it by citing the relevant source and appropriate sections. Most are either PDFs or web pages, either of which allow searching of exact phrases. If I'm wrong, prove me wrong. In cases where your edits have added value to the page (i.e. the estriol comment in this edit) I have kept them. And if I didn't have ready access to direct quotes from six sources that contradicted your points, I wouldn't object to them so much. That I can find so many sources that contradict so many points without having to perform any extra searches is the reason why I am reverting so readily. WLU (t) (c) Wikipedia's rules:^simple/_complex 14:55, 16 October 2009 (UTC)

- - end quote-

- - You may think you are addressing personal behavior: I am addressing content. You may not perceive your statements as threats: I do.

- - You find it easy to justify your changes because you appear to only absorb what you want to absorb from the research that is presented to you.

- - Keep it in the sunshine, please, on this page.

- - Riverpa (talk) 15:04, 16 October 2009 (UTC)