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What should GPs know about bioidentical hormone therapy?
Ii experts respond common questions on compounding bioidentical hormone therapy for menopause.
In the wake of recent warnings about bioidentical hormone therapy, RACGP Quality Care committee member Dr Magdalena Simonis and Dr Karen Magraith from the Australian Menopause Lodge (AMS) reply questions about a controversial therapy sometimes offered as an alternative to traditional menopausal hormone replacement therapy (MHT).
What is compounded bioidentical hormone therapy?
Dr Karen Magraith:
This term refers to hormone treatments that are compounded products which are marketed as hormones that are identical to those produced past the body. The production of these products is not subject area to the regulatory conditions of approved pharmaceutical products.
The hormones are often given as creams, troches or pessaries and are promoted every bit being 'natural'. Women are attracted to the idea of something that is natural and interpret it every bit being therefore safe. The preparations often contain a combination of oestrogens, progesterone, testosterone and other hormones.
It is unclear how many of these prescriptions are written or what the preparations actually comprise.
This needs to exist distinguished from the prescription of canonical pharmaceutical products such as oestradiol and progesterone. These Therapeutic Goods Administration-canonical [TGA] products are hormones that are known as 'body identical', i.due east. they are the aforementioned as hormones produced by the human ovary, and are available in Australia. Other approved pharmaceutical options are also available. Together these products are known as [menopausal hormone therapy] MHT.
Dr Magdalena Simonis:
The term 'bioidentical' has been defined by the Endocrine Society as 'compounds that accept exactly the same chemical and molecular structure as hormones that are produced in the homo body'. The term 'body-identical' is used hither interchangeably. Some prescribed MHT is 'bioidentical' and some is not.
The term 'bioidentical' can be misleading because it has been used to differentiate between MHT that is considered 'natural,' which patients may assume to mean 'safer' than traditionally prescribed hormone therapy (HT), which it is not.
A more comprehensive term is 'body identical', which ascribes the appropriate meaning being, 'identical to the hormones produced past the body'. There are approved trunk-identical hormones that tin be prescribed and unapproved body-identical hormones. Doctors should understand the departure between these and be able to advise their patients accordingly.
The gross misconception amongst the public is that MHT is 'synthetic' or unnatural and bioidentical hormones are 'natural.' In truth, both are synthesised in a laboratory – merely only MHT is strictly regulated for quality and safety.
Dr Magdalena Simonis has a longstanding interest in women'south health.
What are the concerns near the use of bioidentical hormone therapy?
Dr Simonis:
Concerns around 'bioidentical' hormone therapy include the post-obit issues:
- the safe of production, which encompasses the compounding process, the quality, purity and prophylactic of the products used
- the lack of regulation around product of the compounds
- misinformation amongst women that 'bioidentical' is synonymous with 'safety'
- the unnecessary cost
- the lack of reliability of salivary testing to titrate doses and formulations
- the unscientific basis effectually the mix of chemic compounds used for conditions other than menopausal symptoms
- the lack of large-scale studies and supporting peer-reviewed enquiry
- the estimation of compounded formulation doses that are bioequivalent to conventional HT is difficult.
Compounded bioidentical hormone therapy is non produced nether the usual strict pharmaceutical regulations. More frequently, they are prepared by pharmacists referred to as 'compounding pharmacists', in varying concentrations and proportions, which may vary from week to week, month to month based upon levels measured through expensive salivary fluid tests, as specified by the healthcare provider, who is usually a GP, or naturopath.
Compounding tin can allow for a variety of delivery mechanisms to be provided in a form that is better tolerated past the patient such as topical gels, creams, soluble tablets, powder, troches, [and] vaginal creams; still, the compounded hormones are non required to undergo rigorous pharmaceutical and TGA testing and there can be large variability in the concentrations of active and inactive ingredients, hence their efficacy is variable. There is testify to propose that levels of progesterone prescribed might not be sufficient to prevent endometrial hyperplasia, putting women at increased risk of endometrial carcinoma.
The 'bioidentical' hormone therapy is described every bit being more similar to naturally occurring hormones than synthetic preparations and can include a combination of a multifariousness of oestrogens such as oestriol, 'biest' (oestradiol and oestriol) and 'triest' (oestradiol, oestrone, oestriol), in combination with progesterone and other hormone compounds which may include DHEA, pregnenolone (a forerunner to cortisol), testosterone, thyroxine, melatonin and growth hormone. These other compounds may be required for conditions other than menopausal symptoms and tin cause undesirable side effects.
Dr Magraith:
Australian Menopause Society members are concerned for a number of reasons.
These compounded products do non accept safety data and the appropriate dose of these products is unknown. In particular, information technology is not known if the doses of progesterone used are sufficient to provide endometrial protection. Inadequate progesterone dosing can pb to endometrial dysplasia and cancer. Information technology is as well unknown whether the products maintain bone density.
Prescribing often occurs by doctors who are non the patient's usual GP, making it more than difficult to perform a thorough cess. This is a item risk with telephone or online consultations. This exercise tin also lead to fragmentation of intendance.
Some women believe that by taking bioidentical hormones they are taking a natural or herbal product, and avoiding potential risks from conventional MHT products. Women oftentimes accept expensive and unproven blood or saliva testing to adjust doses.
Women often spend large sums of coin on compounded hormone treatments when they could be receiving appropriate MHT from their usual GP for a lower price.
There is misunderstanding in the community about the risks of conventional MHT and most what compounded bioidentical hormones are. This makes some women vulnerable to expensive, unproven, and potentially dangerous treatments.
Bioidentical hormones ofttimes do relieve women's symptoms because they contain real hormones. This is unlike to other 'culling' treatments that are sometimes idea of as being expensive placebos. However, having real hormones in the wrong balance as well raises the potential for harm.
What caused the increase in bioidentical hormone utilize?
Dr Simonis:
The dramatic increase in interest for bioidentical hormone treatment followed the findings of the Women'due south Wellness Initiative report (WHI) in 2002. The primal findings of this written report indicated that use of combined conjugated equine oestrogen therapy with medroxyprogesterone acetate therapy for more than eight years in postmenopausal women, was associated with an increased adventure of chest cancer, heart disease, stroke and thromboembolic events.
Within three months of the release of these findings there was a 63% reduction in prescribed HRT in the U.s.a. and the Australian reaction mirrored this. Women sought alternative treatments to manage the symptoms of menopause and lost trust in the FDA-approved forms of therapy.
Likewise, their treating GPs were every bit concerned about exposing their patients to farther risks of illness and found in that location was little available information at the time to support them in guiding their patients. The media sensationalised the findings ahead of the medical profession beingness properly informed so that a lot of endeavor on the function of GPs particularly, was required to reassure or brainwash their patients effectually the WHI (2002) findings.
Several years lapsed before the findings of the WHI (2002) study were put into perspective, giving GPs the comfort to prescribe HRT for their patients again.
It became increasingly difficult to assure them that the risks for five–8 years of HRT was not significantly increased, and that this was often all that was required to assist women through the perimenopause and menopause.
It was during this time that 'bioidentical' hormones were falsely marketed as being 'safer' than MHT traditionally prescribed, giving rise to an unregulated, multi-billion dollar industry.
There are concerns by the Australasian Menopause Social club that women who are prescribed bioidentical HT believe it to be safer, with fewer side effects, lower risks of cancer (breast and endometrium), ischaemic middle disease (IHD), thromboembolic events and stroke, such equally those associated with traditional forms of hormone replacement therapy.
A result of this, is that regular chest screening, chronic disease screens and bone density testing might exist neglected and they might exist prescribed these for much longer than the recommended maximum period of viii years.
Dr Magraith:
It is at present widely agreed by menopause experts that the risks of MHT reported in the WHI trial were misunderstood and overstated. For example, the risk of chest cancer attributable to the combined oestrogen plus progestogen treatment in the study amounts to less than ane extra case per thousand women per year compared with placebo.
In addition, at that place [are] now options which are likely to deport a lower risk than the formulations that were used in the WHI trial, including the availability of micronised progesterone which can exist used instead of synthetic progestogens.
Unfortunately the conventionalities that MHT is risky has persisted and many GPs and women still perceive MHT to be dangerous. In fact, the International Menopause Society states that the risks are very low and the benefits greater when initiated under the age of 60 to symptomatic women who have no contraindications.
Special mention should exist given to women with premature ovarian insufficiency, who demand thorough assessment and support. For these women MHT is advised until at least the age of 51 in the absence of contraindications.
Dr Karen Magraith is a board fellow member of the Australian Menopause Society.
Why are some GPs continuing to prescribe bioidentical hormones instead of MHT?
Dr Simonis:
The flawed media representation of the WHI findings in 2002 scared patients, and GPs had to reply quickly to their concerns.
GPs were inundated with concerned patients seeking alternative treatments and at that time, the only over-the-counter, non-hormonal medication that had received some acceptance past the medical profession was the utilize of Black Cohosh, for hot flushes. Women sought support for the sleep deprivation and mood disturbance, resulting in many requiring oral antidepressant therapy to assist them cope with their symptoms.
During this aforementioned fourth dimension, the opportunity for some other market arose which included unregulated treatments branded equally 'safe' and 'natural'. In that location was a trend for women to see naturopaths and homeopaths for their menopausal symptoms and through this avenue, received a lot of misinformation which was fed back to their GPs.
It was a double bind situation where GPs were reluctant to prescribe MHT due to the chance of being sued for cancer years down the track, and patients feared traditional HT or had lost trust in the GP also. We were all made to wait like we were backtracking on the promise of relative safety we had given our patients.
In the United states of america, the FDA has issued statements warning against the practise of prescribing non-FDA approved drugs. By contrast, Australia's TGA does not classify bioidentical compounding hormones as pharmaceuticals, which would require strict regulation.
Their position is that medicines that are extemporaneously compounded past a pharmacist for private patient utilise are non required to be on the Australian Register of Therapeutic Goods (ARTG) and therefore, need non be assessed for safety and efficacy by them.
Without a clear statement from the TGA that classifies the bioidentical compounded hormones as potentially equivalent in activity to other pharmaceutical drugs – thus requiring rigorous controls in testing for purity and safety – this will remain open for misuse.
The TGA considers the procedure of compounding bioidentical formulations to be a Pharmaceutical Board of Australia (PBA) affair. The Pharmacy Guild of Australia (PGA) forth with the PBA state that a pharmacist should 'chemical compound a medicine only when an advisable commercial product is unavailable or unsuitable'.
The standards for compounding vary and there is no mandatory training, supervision nor quality assurance. This is very concerning as the quality of production, concentration of components and the mixing agents tin can vary enormously from chemist's shop to pharmacy and even from day to day with the aforementioned compounding pharmacist.
Dr Magraith:
I can't say why GPs are prescribing compounded bioidenticals but I would remind them that the AMS does not endorse the prescribing. The FDA and international menopause bodies too recommend against prescribing. Suitable approved preparations are available for GPs to prescribe.
AMS would like to encounter an increase in education regarding menopause for medical students, GP registrars and GPs.
What advice should GPs requite if a woman asks about the best way forrad?
Dr Simonis:
A woman who comes to her GP asking for handling of her menopausal symptoms should exist offered MHT, after evaluation of her symptoms and the touch they are having on her life emotionally, professionally, socially and physically. A thorough history should be taken to assess her adventure profile for chest cancer, stroke, IHD, osteoporosis and the appropriate screens ordered.
Following this, where conservative treatment and lifestyle modifications have failed, or when she simply simply wants something to assistance her every bit before long as possible, MHT can be offered.
If there are urogenital symptoms of the menopause alone, this can be treated topically. Where there are systemic symptoms such equally hot flushes, sleep impecuniousness, mood changes, the broad range of options tin be discussed with her regarding her choice of transdermal patches or gels, versus oral tablets and transvaginal therapy.
The GP can direct the woman to the Australian Menopause Guild to find a doctor with the appropriate skills in managing her and maintaining acceptable surveillance of her symptoms and ongoing screening.
Dr Magraith:
Women presenting with symptoms around perimenopause or menopause should be assessed thoroughly. This should include an assessment of her symptoms, general health and chance factors. AMS provides guidance on appropriate cess.
Focusing on the woman's chief concerns helps GPs to understand what she is seeking and to respond appropriately. Nigh symptomatic women tin be offered conventional MHT.
For women who are seeking bioidentical hormone therapy, this tin exist provided by prescribing 'trunk identical' oestradiol and micronised progesterone. Using this combination has potential advantages over another forms of MHT in terms of hazard contour.
The treatment of menopausal women, including the prescription of MHT, should be within the realm of all GPs and tin be seen as part of mainstream general practice. GPs are accustomed to discussing potential benefits and risks of new treatments with patients, and MHT should be no exception to this.
Where should GPs go for more information?
The AMS has a fact canvass, the Endocrine Society has a position statement and the American College of Obstetricians and Gynecologists also has a position statement on the topic.
Dr Magraith has recently published an article on making choices at menopause in the Australian Periodical of Full general Practice.
bioidentical hormones hormone therapy menopause patient safety therapeutic goods assistants
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Source: https://www1.racgp.org.au/newsgp/clinical/what-should-gps-know-about-compounded-bioidentical
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