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Author Topic: Bioidenticals are NOT safer or more effective than HRT  (Read 8279 times)

Dana

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Re: Bioidenticals are NOT safer or more effective than HRT
« Reply #15 on: September 09, 2017, 02:47:36 AM »

From the outset it is very important to point out that THIS DISCUSSION IS NOT ABOUT THE NORMAL HRT YOU GET FROM YOUR GP. That type of HRT is perfectly fine. It is regulated and tested and is not the issue here or even part of the discussion.

What seems to be causing all the confusion is the “bioidentical” word. So I will just ask people to put aside that word for now and think in terms of “conventional HRT” (the kind you get from your GP – patches, tablets, gels) and compounded hormones (or what the marketers call BHRT). 


I posted a lot of information in my first post to which I got very dismissive and sarcastic responses. I would have been perfectly happy to have answered questions or explained things more simply if I'd been asked, but when I get that kind of response it's not very likely that I will put too much effort into my responses. I really do have better things to do.

Now that I've gotten that out of the way, I am perfectly happy to provide more information for those who don't want to click on a lot of links. However, just be aware that this isn't something that can be explained in 25 words or less. You will need to do some reading. If it's of no interest to you, that's fine. Just move on. No need to comment or be sarcastic. If you use “BHRT” or compounded hormones and are happy that's fine too.

Basically we've had one person create a post saying how great BHRT/compounded hormones are. They say they have done a lot of research to back up their positive comments, but I haven't actually seen any evidence of their research. So it basically then comes down to just one person's opinion.

On the other hand both Hurdity and I have posted links to medical information. Emma on behalf of Dr Currie has also posted information. Some may say that we are just posting our opinions too, and that's fair enough. I guess you have to decide for yourself which evidence you want to consider. I have posted what doctors and scientists say about it, and when I say “doctors and scientists” I'm talking about National Health Service (NHS), Federal Drug Administration (FDA), Australian Menopause Society (AMS), Endocrine Society etc. So I'm not just talking about “some” or “a few” doctors. We are talking about major medical authorities who have access to far more international research than any of us do. Now it's up to everyone if they want to read this information or not, but if you choose not to please don't then complain that no one will explain anything to you or post disparaging comments. This is supposed to be an adult conversation. Please don't encourage drama when there is no need for it.

It appears this BHRT issue is a fairly new phenomenon in the UK, so it is understandable there is a lot of confusion. However it is not new or something to get that excited about. It's been around a long time in other countries, so there has been plenty of opportunity for the compounding industry to show proof of their claims about BHRT, but they have chosen not to, or been unable to. For a long time I've been warning on MM against using the “bioidentical” word to describe the normal HRTs you get from your local GP. I've seen how that confusion has affected women in Australia and USA. Now it's happening in the UK as well. While it may have had some scientific meaning at one point, it was “hijacked” years ago by the compounded hormone industry to describe their version of HRT. Doctors don't actually use the word "bioidentical". Try asking your doctor for "bioidentical HRT" and they probably won't know what you're talking about, unless they are familiar with prescribing compounded hormones, which most doctors won't touch with a barge pole.

“Bioidentical” is actually nothing more than a marketing term, and it's that version of HRT that doctors are concerned about. The promoters of BHRT (compounded hormones) make a lot of promises and claims that really haven't been or can't be proven. The reason it has been allowed to flourish is mainly due to all the scare mongering women have endured since WHI. These “BHRT” promoters are really just cashing in on that fear by claiming that what they produce is more “natural” and “safer” than conventional HRT when it isn't, and Emma, on behalf of Dr Currie, has already confirmed that.

I will repost the links I put in my first post, and I will highlight some important information from each one. However like I said earlier, it is difficult to just reduce it down to a few lines so please click on the links and at least try to read what you can. Most of what is in these links is “important information”, so it is very hard to pick and choose what to post.

I will repeat again, at the end of the day it is an individual choice for each woman. I'm only posting the medical information, so don't shoot the messenger. I am by no means an expert in this matter, but I do know what I have personally experienced and what I have read and been told by those who know more than me. If you have any genuine questions please ask – nicely. :)




Australasian Menopause Society (Australia)
https://www.menopause.org.au/hp/information-sheets/212-bioidentical-hormones-for-menopausal-symptoms

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Key points

•   â€œBioidentical hormones” are defined as compounds that have exactly the same chemical and molecular structure as hormones that are produced in the human body.

•   There is inadequate scientific evidence to show that:
      Compounded bioidentical hormones are effective.
These compounded hormones are safe and free of adverse side-effects.
These compounds are pure and free from contamination.

•   Conventional MHT/HRT often contains the same form of bioidentical hormones as compounded therapies.

•   If a doctor elects to prescribe an unregistered complementary or alternative therapy the woman must be fully informed that this therapy is unproven and that there may be risks.

•   The AMS does not endorse the prescribing of compounded bioidentical hormones.

What are Bioidentical Hormones?

•   (Compounded) Bioidentical hormones are hormones synthesised to resemble identically, the natural hormones produced by the ovary. These so-called 'natural' hormones are supplied by compounding pharmacists as creams rubbed on the skin or troches placed in the buccal cavity of the cheek both of which allow the compounded bioidentical hormone to be absorbed through the buccal mucous membrane or the skin.

•   While there is evidence that these routes of delivery are viable, there is very little evidence that HRT delivered in this format is able to achieve physiological levels capable of preventing endometrial stimulation, inhibiting osteoporosis, a reduction in cardiovascular damage or a positive influence on neurological function.

•   Progesterone is very rapidly degraded in the human gut, liver and circulation so it has been difficult using oral therapy to maintain a level of progesterone sufficient to inhibit hyperplasia or prevent cancer in the endometrium. Progesterone can be absorbed through the skin but the amount circulating after a measured amount of progesterone cream has been applied to the skin, is insufficient to have any effect on the endometrial cells. There is some evidence that progesterone can be absorbed through the vaginal epithelium and through the buccal mucous membrane, but at present there are no reliable studies available to confirm that the amount absorbed from this source has a protective effect on the endometrium.

•   Some of these compounded products contain abnormally high levels of hormones making them unsafe for women.

•   Compounding pharmacists often state that these compounded bioidentical hormones are a unique mix of oestrogens but fail to add that all natural bioidentical hormones are processed in the body in the same way as regular prescribed HRT.

•    There is inadequate scientific evidence to show that compounded bioidentical hormones are effective, safe and free of adverse side-effects, and contamination.

•   There are no studies comparing the effect of doses of compounded bioidentical hormones to conventional HRT.

•   The risk of cancer of the uterus may be increased with the use of compounded bioidentical hormones when estrogen is used with compounded progesterone cream, as the progesterone is poorly absorbed and therefore does not protect the uterus. (See AMS HRT pamphlets)

•   There is inadequate scientific evidence documenting interactions between the compounded hormones, or between these hormones and other drugs which may be taken at the same time.

•   Following reports of salivary hormone results patients may be told they have abnormal ovarian, thyroid or adrenal function and as a result may be started on a variety of unnecessary hormones. This may cause serious health problems.




Australasian Menopause Society (report on behalf of the Endocrine Society)
https://www.menopause.org.au/hp/news/334-endocrine-society-encourages-clinicians-to-avoid-prescribing-compounded-hormones

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new Scientific Statement issued by the Endocrine Society advises clinicians to avoid using compounded hormone medications to treat menopausal symptoms, female sexual dysfunction and other hormone conditions.

Compounded hormone medications can be unsafe when inappropriate practices are used. More than 60 people died from cases of fungal meningitis attributed to compounded medications in a 2010 case.

"In extreme cases, advertisers have marketed compounded products as being able to prevent the ravages of aging and implied they are risk free," said Nanette Santoro, MD, and the chair of the Society task force that developed the statement. "Few, if any, of these claims are supported by science."




NHS (National Health Service) (UK)
http://www.nhs.uk/Conditions/Hormone-replacement-therapy/Pages/Alternatives.aspx#bio-identical

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Bioidentical hormones are hormone preparations made from plant sources that are promoted as being similar or identical to human hormones. Practitioners claim these hormones are a "natural" and safer alternative to standard HRT preparations. However, bioidentical preparations aren't recommended because:

•   they aren't regulated and it's not clear how safe they are – there's no good evidence to suggest they're safer than standard HRT

•   it's not known how effective they are in reducing menopausal symptoms

•   the balance of hormones used in bioidentical preparations is usually based on the hormone levels in your saliva, but there's no evidence that these levels are related to your symptoms

Many standard HRT hormones are made from natural sources, but unlike bioidentical hormones they're closely regulated and have been well researched to ensure they're as effective and safe as possible.




North American Menopause Society (USA)
http://www.menopause.org/publications/clinical-practice-materials/bioidentical-hormone-therapy/compounded-bioidentical-hormones-what%27s-the-harm-

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What is a bioidentical?

It's not a lot of things. It is certainly not a scientific term. There is no uniform definition of it in any medical dictionary.

How does BHT harm patients?

BHT has not been tested in good clinical trials. There are very little safety data. Natural doesn't equal safer. There is no clinical or patient package insert documenting safety or efficacy, no black box warning, no uniform manufacturing standards, and there is no formal review of the accuracy of any of the advertised claims. One problem with this is it doesn't even matter, probably, to the people who are really committed to taking these products. And the other problem is that if this is true, why are there so many prescriptions being written for this stuff?




Federal Drug Administration (USA)
https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm049311.htm

Quote
"BHRT" is a marketing term not recognized by FDA. Sellers of compounded "bio-identical" hormones often claim that their products are identical to hormones made by the body and that these "all-natural" pills, creams, lotions, and gels are without the risks of drugs approved by FDA for menopausal hormone therapy (MHT). FDA-approved MHT drugs provide effective relief of the symptoms of menopause such as hot flashes and vaginal dryness. They also can prevent thinning of bones. FDA has not approved compounded "BHRT" drugs and cannot assure their safety or effectiveness.




Menopause Matters (Dr Currie)
http://www.menopausematters.co.uk/pdf/article Bio identicals 2017.pdf

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Compounding bio identical pharmacies have been practicing in USA for a number of years and have recently appeared in the UK. Investigations in the USA are being reported. In 2001 the Food and Drug Administration (FDA) collected and analysed 29 compounded drugs. Two of the compounded hormone drugs failed analytical tests because of contamination risks. In 2012 “More” magazine commissioned laboratory tests of bio identical hormones produced by 12 compounding pharmacies. It was found that these hormones were of unreliable potency and would not meet the standards for the FDA requirements for commercially manufactured drugs and in fact because of the variable hormone levels, concern was expressed that endometrial cancer risk would be increased

Recently published national and international guidelines support this advice with NICE guideline on Diagnosis and Management of Menopause stating “…bio identical formulations that are compounded for an individual woman according to a healthcare provider's prescription are not subject to government regulations or tested for safety or quality and purity of constituents, therefore their efficicy and safety are unknown”. The recently updated International Menopause Society recommendations on women's midlife health and menopause hormone therapy state that “Prescribing of compounded BHT is not recommended due to the lack of quality control and regulatory oversight associated with these products, together with the lack of evidence of safety and efficacy”.




I'm so sorry that this post is so long and wordy, but it simply can't be written as a short memo. However it really just boils down to something very simple....

If you are using or want to use HRT talk with your GP and make sure you are prescribed regulated conventional HRT, the type that comes in patches, pills, and gel (eg Estradot, Femoston, Utrogestan, Provera - anything that is shown on MM under the "HRT Preparations" in the menu above). According to medical research you should avoid anything that is described as BHRT, Bioidentical Compounded hormones or anything that has to be manufactured specially by a compounding pharmacist. If you choose to use BHRT ("bioidentical" compounded HRT) please make sure you are fully aware of what you are being prescribed.
« Last Edit: September 09, 2017, 04:36:46 AM by Dana »
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Jintyhilton

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Re: Bioidenticals are NOT safer or more effective than HRT
« Reply #16 on: September 10, 2017, 09:56:23 AM »

This forum really helped me when I was struggling last year, I wasn't even a member but I used to be able to read posts and it made me think 'thank goodness' I'm not alone, I'm not going mad, I'm going to get through this.  After a struggle with my GP who only knows how to dole out antidepressants and horse pee preparations, I 'educated' myself on the options available, because I really didn't know what the hell was happening to me or how to fix it!  All I can say is that after trying a few synthetic options that gave me horrendous side effects  (hair loss, depression, weight gain, insomnia to name a few) and refusing antidepressants from my GP I researched and researched, had a full set of blood tests taken and found almost immediate symptom relief from a compound route that I tried (menopause woman- unfortunately an online money making outfit, flogging vitamins and hormones with no professional follow up) I'm now a patient of John Studd's on an oestrogen, testogel & prog prescription.  My body and my brain are telling me this is right for me. He prescribed what my blood tests show I no longer have. I feel amazing (apart from a bit chubby ;-)     I believe we have to find our own way on this journey and this lovely forum is a great way of 'educating' ourselves to make the decisions that are right for us. I have read so much valuable information from this site and It has made me feel supported knowing I wasn't alone ...  let's keep caring and sharing  :-*
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Wrensong

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Re: Bioidenticals are NOT safer or more effective than HRT
« Reply #17 on: September 10, 2017, 11:11:05 AM »

Hi Jintyhilton, glad to know you feel so well on Prof Studd's regime, as a number of other posters also seem to.  I can really understand the desire to share info about treatments that have been life-changing & believe access to a range of experiences, knowledge & opinions is what makes the forum so valuable.  Although I am on conventional HRT & have yet to find my best fit, as a long-standing thyroid patient I have had to pursue unconventional treatment for that condition in order to be as well as possible, so I share your view that sometimes it is necessary to think outside the box in order to have a decent QOL.  That said, adopting something other than a mainstream approach is not for the faint-hearted & I believe we owe it to ourselves to do as much research as poss before embarking on any sort of medical treatment that doesn't currently carry the same degree of endorsement as those approved as mainstream. 

The regime of thyroid medication I take is controversial & I have had a very long struggle to get it, but blood tests show that in common with 15% of hypothyroid patients, I don't convert Thyroxine efficiently into its usable form.  Other women on the forum are in the same boat & it can be a miserable situation.  Many GPs are unaware of the conversion defect scenario, some Endocrinologists do not like to prescribe the missing hormone, NHS labs have guidelines discouraging them from performing the diagnostic (or follow-up) testing that shows the defect & prevents overdosing on replacement, pharmacies often have problems obtaining the 2nd hormone these patients require, the hormone itself comes in tiny tablets that crumble to dust but nevertheless usually have to be split into 4 to avoid overdosing AND - because it is now so expensive, the NHS has withdrawn funding for the hormone in some cases.  The situation can be a continual, stressful trial for patients & many of us feel obliged to go private to get the treatment we need to function from day to day.  All this info about conversion defects in hypothyroidism would be irrelevant here but for the point that it is sometimes necessary to follow an unconventional route and I believe there is a parallel here with HRT, especially regarding the use of testosterone & short duration cycles of progesterone. 

However, if we do choose to follow an unconventional route, I believe we have a responsibility to point out to others who may want to follow in our footsteps, that the regimes we have felt obliged to adopt may not be as safe as those currently believed to be from the "gold standard" range.  I use that term loosely, given how poorly some HRT preparations work for some women!

Also always in mind is the revolution in the history of treatment of gastric ulceration by antibiotics to kill H Pylori, which was vigorously ridiculed, but is now accepted as part of the gold standard.

I'm glad to have learned about Prof Studd's regime from this forum & also grateful for the knowledge also learned here, that it is not approved as a mainstream treatment.  If I come to the stage where I feel I have no remaining option but to approach Prof Studd, I will do so with my eyes open! 

I hope I haven't now upset two sets of members by having a foot in both camps when it comes to conventional v. non-standard treatments!  I am grateful to everyone who posts on the forum to share experience of what has worked or failed for them & to those who remind us of what the current guidelines are.  Sorry everyone - have gone on & on again, but taking responsibility for our own health is an issue I feel very strongly about.

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Jintyhilton

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Re: Bioidenticals are NOT safer or more effective than HRT
« Reply #18 on: September 10, 2017, 11:29:45 AM »

Hi wrensong, I agree with everything g you say :-).  I'm doing what I believe is right for me. Also ensuring I am checked regularly - BP, womb breasts etc. With Local GP. I live in Scotland and so the Prof studd route wasn't the most convenient or cost effective. But after a really terrible time (I feel emotional even writing that) I am an able bodied woman again with bags of energy and optimism and all I know is I felt broken before... that's why I guess I am a believer :-). I have carol vordermans article and awareness in the spring to thank for even knowing who prof studd was and what he does... she too was told to take AD's and get on with it ....  my body did not like the horse pee hormones and is happier with the alternative preps - long may that continue ! X
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dangermouse

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Re: Bioidenticals are NOT safer or more effective than HRT
« Reply #19 on: September 10, 2017, 11:39:53 AM »

I hope I haven't now upset two sets of members by having a foot in both camps when it comes to conventional v. non-standard treatments!  I am grateful to everyone who posts on the forum to share experience of what has worked or failed for them & to those who remind us of what the current guidelines are.  Sorry everyone - have gone on & on again, but taking responsibility for our own health is an issue I feel very strongly about.

Well, being in both camps to me is the healthiest so I'm definitely with you there! Extremes are always (in CBT terms) exaggerated and imbalanced.

An open but cautious mind has always served me well, like balanced risk.
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Wrensong

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Re: Bioidenticals are NOT safer or more effective than HRT
« Reply #20 on: September 10, 2017, 12:11:51 PM »

Babyjane - thanks for the additional comments about T3 treatment - I am lucky to get the Liothyronine prescribed on the NHS as blood tests have repeatedly confirmed the clinical picture without it, but I still had to go private to get it prescribed in the first place as my NHS Endo's hands were tied, as much as she'd have liked to prescribe it for me.  As my original private prescriber sadly passed away, I had to find another & although my GP surgery co-operates with the private consultant, there are often problems with routine testing which causes a lot of stress for all concerned and I have had on several occasions to have bloods done privately.  My consultant has even written to the NHS lab asking them to perform all 3 necessary tests, stating that this is essential to my treatment, but this has often been ignored.  I do still see him privately, as his support is invaluable to me & without it I'm not sure my GP surgery would feel able to continue to prescribe the T3.  I'm glad to know your treatment seems to go more smoothly!

Jintyhilton your use of the word "broken" is poignant for me as this is exactly what I said more than a decade ago to my then GP when I was first very unwell with horrible symptoms in peri.  Without HRT I continued to feel that way, but HRT has improved my QOL, though there's still some way to go!  I was also offered ADs, but did not want to take these when symptoms were due to declining levels of gynae hormones.  It's a great shame the two now largely discredited large scale studies caused the use of HRT to decline for so long, as many women must have suffered horribly in the subsequent years & many GPs are out of practice & not up to speed with knowledge or prescribing as a result.  I hope you continue to feel so well - it's always good to hear of women who get their lives back.

Thank you Dangermouse & Sparkle - it can be daunting posting when none of us wants to upset anyone, but feelings naturally run high on issues that matter so much to us & everyone's experience is different.
« Last Edit: September 10, 2017, 08:25:10 PM by Wrensong »
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Maryjane

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Re: Bioidenticals are NOT safer or more effective than HRT
« Reply #21 on: September 11, 2017, 05:46:48 AM »

Jintyhilton😊In case I have mis-read ( don't think so but you never no 🤔 ) Proff studds HRT route is not compounded or anything that can't be got via the NHS ? as I am on the same as many ladies are via there GP on the NHS , as he doesn't do compounded HRT? ( although I don't take T due to other reasons ) . Unless you can't get this combo in Scotland ? Don't no how the NHS works your way.

His normal protocol is oestrogel pump , utrogestin orally or vaginally , and testogel ?

You probably needed to go private from pure frustration of a lot of GPs not being aware of this combination ? I do however understand that it is very hit and miss re if a GP swill prescribe the T bit.

But glad you have you're life back by whatever means, as that's the most important.

I read CV article and assumed it would have been Proff S , but thought it rather misleading as it read as only available privately as it was bio-identical hormones.
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Emma

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Re: Bioidenticals are NOT safer or more effective than HRT
« Reply #22 on: September 11, 2017, 10:35:35 AM »

I've taken the unusual step of paring down this thread. I really apologise to anyone who has had a post removed - not all of them were contentious but there were a few heated posts and going off-topic. It does meander towards the end but that's forum life.

As a final word for anyone who missed the edit to my first post here's the ASA report

The Advertising Standards Authority report on Bioidenticals is here:
https://www.menopausematters.co.uk/newsitem.php?recordID=186/The-ASA-report-on-Bioidenticals

This thread is now locked.
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