Talk:Bioidentical hormone replacement therapy/Archive 7

Shouldn't this be 2 articles?
″No editor has been able to demonstrate that there are missing, high-quality sources that support bioidentical hormones.″ Surely, this article should be about BHRT, not about bioidentical hormones in itself? The discussion tends to get the two things mixed up. I strongly suggest creating a new article called: Bioidentical hormones. This is not the same as BHRT, and these hormones are being used in other contexts as well, e.g. by the "Big Pharmas", as you call them. They must have their reasons.

While BHRT may be poorly defined the term "bioidentical" is not. The fact that some people use the term wrongly or use the term "natural" instead does not change the clear definition of the term bioidentical. Bioidentical means exactly what the article says: identical on a molecular level. A hormone either is or is not. And this definition is used by Solvay Pharmaceuticals (e.g. in their description of Prometrium)as well as other "Big Pharmas". Nothing dubious about it.

Only hormones used in the WHI-study has been properly tested. All other hormones, conjugated or bioidentical, has not. In this respect bioidentical hormones are as safe or unsafe as any other hormone not being used in the WHI. They are not more dubious than synthetic hormones. (And if they were - why would they get an FDA-approval and be used by Solvay and Wyeth-Ayers?)

This just to point out some of the major differences between BHRT and Bioidentical Hormones. The topic is confusing, yes, but it is getting even more confusing when the two are being mixed up. And as long as there is no article here on "Bioidentical Hormones" the two concepts will continue to be mixed up, no doubt.

To clarify my point: Take, for instance, your survey of FDA-approved bioidentical hormones. It's helpful and unique. But why should these products be found under "Bioidentical Hormone Replacement Therapy"? That's not what they're meant for. (Unless you redefine BHRT) JensPaulin (talk) 00:44, 26 January 2013 (UTC)
 * BHRT and "biodentical hormones" are both meaningless marketing terms. We already have many pages on bioidentical hormones, or as we call them, hormones.  Estrogen is a parent article but there is also, progesterone, estradiol, estriol, estrone, androgens for the male equivalent, testosterone, etc.  These are all "bioidentical" hormones in the sense that they are molecularly identical to the hormones produced by the human body.  Calling them "bioidentical" is meaningless noninformation.  For that matter, allegedly non-bioidentical hormones also already have their own pages, see premarin, progestin, etc.  "Natural" is equally meaningless, premarin is more "natural" (in the sense that no modification occurs) than human-identical hormones produced from yams in a lab.  Also, as indicated in the terminology section, there's no consistent use to the term in the scientific literature, only in the marketing literature of BHRT promoters.  All hormones that have FDA-approval have been tested, which isn't the same thing as having a complete understanding of their safety and efficacy in all humans (which will never occur, and which the WHI didn't give us - it merely indicated that there were unappreciated risks).  The objections to BHRT is again the marketing, the portrayal as safer and more effective than Big Pharma hormones, which is absurd since they either haven't been studied, or are currently produced by Big Pharma and repackaged by compounding pharmacies.  The confusion comes from nonscientific practitioners who use sloppy terminology and rehtoric to sell either unproven or unnecessarily expensive drugs.  The scientific literature is quite clear and pretty interesting in its nuances - and converges on the conclusion that BHRT is a scientifically meaningless marketing distinction.  So that's where the due weight goes.  WLU (t) (c) Wikipedia's rules: simple/complex 15:52, 7 February 2013 (UTC)


 * Your ”due weight” refers to BHRT, not to the term ”bioidentical hormones”, and so the two are getting mixed up once again – which was exactly my point.


 * I don’t see why you call the term bioidentical hormones ”non-information” or a ”meaningless marketing term”. You yourself use the term in your article as a perfectly meaningful distinction (”There are a variety of FDA-approved products made using bioidentical estrogens and micronized progesterone, used to treat the symptoms of menopause”) and give a survey on bioidentical hormones. Premarin is not among them, of course. Because it is not just ”allegedly” non-bioidentical, it is simply non-bioidentical. And so your survey is not a piece of meaningless non-information, though it is based on the term ”bioidentical hormones”.


 * ”Bio-identical hormones” is a clearly defined term, logically derived from the fact that you might need a term to describe hormones that are identical on a molecular level to the hormones produced by the human body – contrary to hormones that are not identical to the hormones produced by the human body, whether conjugated or not. You, as the author of the article, may find this distinction irrelevant, but that would be an opinion, not a fact.


 * It may be that social circumstances have made the term ”bioidentical” dubious, but that is not science. The distinction still exists and some people may find it relevant. That’s why we need an article on Bioidentical Hormones – without the therapy.


 * If this distinction doesn’t interest you and you don’t find it relevant – that’s a different story. Someone else may right the article. This is non-profit work and I guess no one wants to write an article on something that are of no interest to them.


 * Still - the bioidentical products in your survey are wrongly placed under BHRT. They have nothing to do with it and should not be associated with it. This should be corrected. JensPaulin (talk) 00:30, 15 February 2013 (UTC)
 * Actual "bioidentical" products are dealt with separately. There is a page for estriol, estradiol, estron and the like.  "Bioidentical hormones" and "bioidentical hormone replacement therapy" are both scientifically meaningless marketing terms - see references 10, 13, 14, 15, 16, 17 and 18.  Science deals with each molecule individually, lumping them together merely because of "bioidenticality" doesn't make scientific sense.  But it's a great appeal to the naturalistic fallacy.
 * Premarin is bioidentical by the way, it's just bioidentical to the hormones found in horses. It's also metabolized by digestion into a hormone that is bioidentical to one found in humans.
 * Without reliable sources to substantiate your opinion, there is no reason to change the page. Logic is not sufficient.  Please provide any citations you think could be used to make adjustments.  WLU (t) (c) Wikipedia's rules: simple/complex 17:15, 21 February 2013 (UTC)

1. I don’t need to give any references to any research since I’m not disputing the content of your article. See 4 and 5.

2. You should consider your own references in this discussion. You argue that the term ”bioidentical hormones” is ”scientifically meaningless” and give 7 references. None of them supports your claim.

On the contrary - The Endocrine Society (13) gives a clear definition: “Bioidentical hormones” are defined as compounds that have exactly the same chemical and molecular structure as hormones that are produced in the human body. And then they describe a lot of misunderstandings – which, once again, does not change the clear definition.

As for your ref. 10 and 17 from the FDA: The fact that bioidentical hormones are not necessarily safe and not necessarily approved by the FDA is an example of what an article on bioidentical hormones might include. It’s not an argument for not having an article on bioidentical hormones on Wikipedia.

Your references 14, 15, 16 and 18 is about BHRT, not about the term ”bioidentical hormones”.

None of these articles state that the term ”bioidentical hormones” is scientifically meaningless. Please note: You cannot combine material from multiple sources to reach or imply a conclusion not explicitly stated by any of the sources. WP:SYNTHESIS

3. As for your argument that ”lumping them together makes no scientific sense”: Harvard Medical School has no problem lumping them together (your own reference 12):

”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.”

- which in itself could form a descent basis for an article entitled ”bioidentical hormones”. Note that the definition is the same as the one provided by the Endocrine Society. There’s a consensus.

You yourself seem to have no problem ”lumping them together merely because of bioidenticality”. That’s what your own survey does.

4. Your survey is not in it’s proper place. It belongs to an article called ”bioidentical hormones”. It cannot be placed under the articles you mention because they describe a single hormone, while your survey includes multiple hormones. And since the products mentioned in your survey is not intended for ”Bioidentical Hormone Replacement Therapy” the survey does not belong to an article called ”Bioidentical Hormone Replacement Therapy”. If you don’t see the point of this, a DRN may be appropiate.

5. The term ”Bioidentical hormones” is scientifically definable (see your own reference 12 and 13) and it’s being used in a meaningful way, also by yourself, whether the bioidenticality refers to horses or humans. As will appear from p. 4 this is about how a dictionary should be structured. None of us will find any medical research on that. The result of your argument would be that a non-biased, well-referenced article on bioidentical hormones should be deleted. That would probably be a violation of the Wikipedia guidelines. And, as described in p. 4, your own survey makes such an article necessary. JensPaulin (talk) 11:50, 7 March 2013 (UTC)
 * "BHRT" is a marketing term not recognized by FDA."
 * "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.'"
 * While it is trivially true that "bioidentical" could have a specific meaning, in actuality it is used as a marketing term that combines several features - naturalness, safety, saliva testing, compounding and overall unproven claims. There's no reason to have an article separate from this one regarding bioidentical hormones, since the term is either trivially true but meaningless (scientifically and medically bioidentical hormones are not separated from nonbioidentical hormones as a class, all are treated as unique molecules with different risks and benefits), or as a conflated marketing term.  Nobody treats bioidentical hormones as a class except quacks.  Your overall claim seems to be that this page is not well-balanced or non-biased.  I disagree.  The majority of references, and the best references, are critical of claims made about BHRT and bioidentical hormones, and rightfully point out that BHRT is mostly about selling unregulated, poorly standardized compounded hormones or scientifically meaningless tests.  That is what the page should reflect.  "Bioidentical" is used by marketers to sell hormones, or by scientists to criticize these claims.  Scientifically it is not used as a useful way of describing a group of hormones.  WLU (t) (c) Wikipedia's rules: simple/complex 18:59, 8 April 2013 (UTC)

"No" evidence of superiority?
The data from the 80,000+ woman E3N cohort study undercut the "no evidence of superiority" claim.

Their findings, expressed in the title, were

Unequal risks for breast cancer associated with different hormone replacement therapies: results from the E3N cohort study

Agnès Fournier, Franco Berrino, and Françoise Clavel-Chapelon

Breast Cancer Res Treat. 2008 January; 107(1): 103–111. Published online 2007 February 27.

HALMS: HALMS201813

On estrogen alone (type not specified) breast cancer risk was raised (RR 1.29) compared to no-estrogen group.

This significant elevation was neutralized (RR restored to 1.0) in the estrogen-progesterone combination group, only.

In the estrogen–dydrogesterone group cancer risk was raised (RR 1.16), but still lower than with estrogen alone.

And the risk was significantly higher in the groups combining estrogen with other progestagens. (RR 1.69) (95% confidence interval 1.50–1.91).


 * ... Compared with HRT never-use, use of estrogen alone was associated with a significant 1.29-fold increased risk (95% confidence interval 1.02–1.65). The association of estrogen–progestagen combinations with breast cancer risk varied significantly according to the type of progestagen: the relative risk was 1.00 (0.83–1.22) for estrogen–progesterone, 1.16 (0.94–1.43) for estrogen–dydrogesterone, and 1.69 (1.50–1.91) for estrogen combined with other progestagens. This latter category involves progestins with different physiologic activities (androgenic, nonandrogenic, antiandrogenic), but their associations with breast cancer risk did not differ significantly from one another. This study found no evidence of an association with risk according to the route of estrogen administration (oral or transdermal/percutaneous). These findings suggest that the choice of the progestagen component in combined HRT is of importance regarding breast cancer risk; it could be preferable to use progesterone or dydrogesterone. ...

The investigators "... used data from the French E3N cohort study, with 80,391 postmenopausal women followed for a mean duration of 8.1 years ... ".

If the evidence provided by this large observational study showing the relatively lower risk of women receiving bioidentical progesterone is less than conclusive, it is evidence. And thus it undercuts the assertion that there is "no" evidence of a superior risk profile for bioidentical progesterone.

A review undercutting the "no" evidence claim denying superior risk ratio for bio-identical progesterone. Breast cancer RR 0.9; synthetic progestin RR 1.4.
A review undercutting the "no" evidence claim denying superior risk ratio for bio-identical progesterone. Breast cancer RR 0.9; synthetic progestin RR 1.4.

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1974841/

Carlo Campagnoli, Françoise Clavel-Chapelon, Rudolf Kaaks, Clementina Peris, and Franco Berrino

Progestins and progesterone in hormone replacement therapy and the risk of breast cancer

The breast cancer RR was only 0.9, (CI 0.7–1.2), for French women receiving transdermal estradiol with micronized bioidentical progesterone, but RR was significantly higher 1.4, (CI 1.2–1.7), for women receiving transdermal estradiol with synthetic progestins

J Steroid Biochem Mol Biol. 2005 July; 96(2): 95–108.

J Steroid Biochem Mol Biol. Author manuscript; available in PMC 2007 September 25.

HALMS: HALMS151947


 * It is important to realize that recent findings relating to the use of natural progesterone, in sharp contrast with those referring to the use of progestins, are reassuring. These findings come from two cohort studies carried out in France, where oral micronized progesterone has been used by large numbers of menopausal women since over two decades. The first study was on a cohort of 3175 women followed for a mean of 8.9 years in a menopause clinic. Of these, 55% were classified as HRT users, the majority of whom received exclusively or mostly a combination of a transdermal estradiol plus either progesterone (60%) or progesterone-derived progestins other than MPA. No increase in the BC risk was found in women receiving these treatments [45]. The second, much larger study, based on the E3N-EPIC cohort, included 54,548 postmenopausal teachers who had not taken any HRT before enrolment and who were followed an average of 5.8 ± 2.4 [26]. At our knowledge this is the single prospective study in which women were followed up with periodic questionnaires since the beginning of exposure, thus avoiding the misclassification of treatment duration that may occur in the cohort studies with cross-sectional definition of exposure to HRT at the time of enrolment. Such a study design also avoids the bias of selectively enrolling only the women who have not developed BC after starting HRT, which systematically affects the studies based on the follow-up of women who have already started HRT before enrolment. In this study [26], oral micronized progesterone, contrarily to synthetic progestins, did not increase BC risk in women treated with transdermal estradiol. The RRs with respect to untreated women were, respectively: 1.2, 95% CI 0.8–1.8, for transdermal estradiol alone; 0.9, CI 0.7–1.2, for transdermal estradiol with micronized progesterone; 1.4, CI 1.2–1.7, for transdermal estradiol with synthetic progestins (Fig. 1).

Ocdnctx (talk) 02:44, 10 April 2013 (UTC)
 * Neither article uses the term "bioidentical". Please feel free to integrate them into the progesterone page, though they are a little old.  Again, this page is essentially about the widespread incorrect claims that "natural" hormones, as a class, are inherently better than synthetic ones.  Individual results about individual hormones should be located to those pages.  WLU (t) (c) Wikipedia's rules: simple/complex 13:36, 10 April 2013 (UTC)

Article is not objective
I don't know how any article on this subject can be considered objective without reviewing the pioneering works of Dr. John Lee. Dr. Lee in his clinical practice, as described in his books, one of which is "What your doctor may not tell you about menopause" makes a strong case for the use of bioidentical hormones, particularly progesterone. The clinical practice of Dr. Lee is supported by research, however the extent of research then and today is still less than optimal. Use of bioidentical hormones is not necessarily related to saliva testing and compounding pharmacies.

Dr. Lee in his practice preferred transdermal to oral administration. Bioidentical hormones, particularly progesterone, are available without prescription as trans-dermal creams. Transdermal estrone is generally not available and not recommended for use. Estrogen is available in transdermal creams in the form of estriol  and estradiol and combinations between them. These creams based on personal observation are effective and appear to be safe when used correctly, minimal amounts and when progesterone accompanies use of estriol/estradiol.

This is a very large and important subject. In my opinion a scientific (medical) orthodoxy backed by significant business interests is attempting to quash what may be one of the largest medical breakthroughs of the last 50 years. If significant research studies were to be performed based on the limited studies I have seen, I suspect that the use of biodentical hormones, particularly progesterone will be shown to be very safe, use of bioidentical estrogens with progesterone will be shown to have minimal risks compared with prescription hormone replacement of synthetic steroids which are not bioidentical. AFarber (talk) 08:12, 27 May 2013 (UTC)AFarber
 * If you have any reliable sources to substantiate any objective improvements or science indicating that bioidenticals are superior to non, feel free to include them. Your personal opinion, your personal experience and in particular your conspiracy theories, are not sufficient to change the page.  I doubt Dr. Lee's books would be considered reliable sources, but feel free to list any peer-reviewed secondary sources on this page for discussion.
 * Note that pages are not "objective", they are neutral. An objective page would discuss the health effects of BHRT without bais; this is impossible.  Wikipedia relies on neutral summaries, as found in proportion to their appearance in reliable sources.  WLU (t) (c) Wikipedia's rules: simple/complex 15:40, 12 August 2013 (UTC)

JAMA study: Conjugated Equine Estrogen (CEE) group OR 1.78 higher for clots compared with bioidentical esterified estrogen group.
Esterified Estrogens and Conjugated Equine Estrogens and the Risk of Venous Thrombosis


 * Conclusion


 * Our finding that conjugated equine estrogen but not esterified estrogen was associated with venous thrombotic risk needs to be replicated and may have implications for the choice of hormones in perimenopausal and postmenopausal women.

[emphasis added]

JAMA. 2004;292:1581-1587. Vol. 292 No. 13, October 6, 2004

FULL FREE TEXT:

http://jama.jamanetwork.com/article.aspx?articleid=199532


 * Nope.
 * It's an old primary source that doesn't use the word "bioidentical". WLU (t) (c) Wikipedia's rules: simple/complex 23:15, 12 February 2014 (UTC)

" However, no structural crystallographic evidence has been used to support the idea that these molecules are actually identical to endogenous human hormones."

This statement is highly inaccurate and should be removed as it is misleading. I have a MS in chemistry and spent some years in a crystallography lab. Crystallography is used for protein structure, and most bio-identical hormones are steroid molecules. There is no need to determine their crystallographic structure. Crystallography structure is useful in designing drugs to fit protein receptors. I think that this sentence should be removed. — Preceding unsigned comment added by MSX2MD (talk • contribs) 22:04, 12 April 2014 (UTC)

Please tell me it's April fools day !
This is either April fools day or the article is being edited by Pfizer. — Preceding unsigned comment added by XUYT64KX84EV (talk • contribs) 04:51, 8 April 2015 (UTC)

Semi-protected edit request on 16 May 2015
This article states repeatedly that bioidentical HRT is almost exclusively used in the US. However this information is out of date. BHRT is now available in other countries, and I have personally been given bHRT in Singapore. The sole source cited for this assertion is from 2007. I think that the availability of bHRT has changed in the last 8 years so this assertion should now be deleted.

98.26.73.172 (talk) 02:38, 16 May 2015 (UTC)
 * Red information icon with gradient background.svg Not done for now: If you can fine a WP:RS that shows it's being used in Singapore and elsewhere, I'd be happy to make this change Cannolis (talk) 04:19, 16 May 2015 (UTC)

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N=1
The author fails to realise that science and medicine have moved beyond RCTS and the average peer review.Meta and systemic analysis has shown just how worthless studies can be on many topics. There are just too many variables to control and be aware of when talking about health, diet and hormones and the incredibly complex biochemistry of the body. In all honesty the author of this article sounds like a highschool student with virtually no experience with the real world. To fully understand how important hormones are to the body, and if you really care, start interviewing patients. I've been on BioTE for four weeks and I'm a new person. And I know dozens of people personally and 100s professionally who have a renewed life energy because of hormone replacement. Until you go through hormone issues yourself it's something that is difficult to comprehend. And it's just as dramatic for males as it is with females. I'm a 47 year old male NP working everyday and finishing graduate school and have just spent the last 3 months in an OBGYN clinic. I've taken care of millions of patients in my life. Modern accepted practice taught in medical schools is as much as 30 years behind what's being done in the real world and what is working for people as it relates to wellness and continuing health. The literature and need for experience has just become too vast for the average person to comprehend as the author of this wiki obviously has no idea what he is talking about. Wiki is an incredible resource. This is the first time I have read a page that is completely incompetent on the subject it coverers. It fails to even mention males or the endless list of serious symptoms such as exhaustion, depression, weight gain, lack of muscle mass, lack of joy, nightmares, night sweats, ect that bioidenticals reverse. It's so dramatic that it is described by myself, patients, family, friends, doctors and 1000s of other clinicians patients as turning the lights back on again. If you have the money and the need - you are on bioidenticals. I recommend completely scraping this article as it really does make wiki look bad. — Preceding unsigned comment added by 68.203.210.129 (talk) 23:16, 4 May 2017 (UTC)
 * You are welcome to suggest edits with suitable sources to back them up. LeadSongDog come howl!  21:21, 5 May 2017 (UTC)