Is bioidentical hormone replacement therapy (BHRT) a safer alternative to conventional hormone replacement therapy (HRT)? Dr Hannah Sweillam investigates.
Menopause isn’t fun. Hot flushes, mood swings, bathed in a pool of sweat and unable to sleep at night – it’s no wonder women seek relief. And these days it seems more and more women are seeking ‘natural’ alternatives in the form of bioidentical hormones.
It’s hard to get exact figures on how many women are using bioidentical hormones as they can be bought online or over-the-counter on private prescription in compounding pharmacies, but according to the North American Menopause Society it’s anywhere between 28-68% of women.
But do they really know what they’re taking? One survey of 3000 women in America asked: “Do you believe that bioidentical hormone therapies compounded at a specialty pharmacy are FDA-approved?”
A staggering 90% of respondents either didn’t know or thought they were government approved treatments – but nothing could be further from the truth. In the UK they aren’t regulated by the Medicines and Healthcare Products Regulatory Agency (MHRA) or by the FDA in the US, and the Menopause Societies of both countries do not support their use.
So what are bioidentical hormones?
Bioidentical hormones are sourced from plants like soy and yams and are said to be chemically identical to those produced by the body. They are promoted as a ‘natural’ alternative to HRT, which has had a bad wrap in recent years. (see below)
Both forms of HRT work by replacing the hormones that decline as a woman ages. The most common ones are the main sex hormones, oestrogen and progesterone, although testosterone is also prescribed if required.
These days, in conventional HRT – the type prescribed by your GP on the NHS – the oestrogen used is called ‘body identical’ as it replaces what the body needs, and it too is sourced from yams and soy. (They no longer come from a pregnant mare’s milk, although some women may still be on these older prescriptions.)
These prescriptions are regulated and each tablet, cream or gel will contain what is says it does on the packet.
Custom-mixed bioidentical hormones
When people talk about bioidentical hormones, they are usually talking about a bespoke or customised hormone replacement treatment which is formulated based on the results of a blood or saliva test results.
They are prescribed by a doctor or nurse and ‘compounded’ by a local chemist or lab, and are intended to provide a tailor-made dose to match the woman’s needs.
This service is not available on the NHS and there are a number of reasons why.
Saliva tests have been found to be unreliable and the idea that salivary hormone levels are related to menopausal symptoms has no scientific foundation.
And the blood tests, that can cost upwards of £400 a pop, don’t fare much better according to menopause experts.
As Gynaecologist and co-founder of the The Menopause Clinic London on Harley Street, Vikram Talaulikar explains, our bodies emit these hormones regularly – around every 90 minutes or so, so the result you get at any one moment in time is a snap shot of that period only and doesn’t always correlate with the symptoms being experienced.
The current NICE guidelines do not recommend blood or saliva tests for diagnosing menopause or for monitoring symptoms unless there is a specific reason for it, such as premature menopause or ruling out another underlying medical condition. Instead, doctors are advised to treat the symptoms, start patients on a low dose and adjust the dose according to how well their symptoms respond.
What’s the problem with HRT?
HRT is effective at alleviating menopausal symptoms like hot flushes, fatigue, trouble sleeping and vaginal dryness. It’s also helps reduce the risk of bone thinning and may even reduce the risk of dementia. It is currently recommended as the first treatment a menopausal woman should be offered, depending on their health and medical history. This recommendation is based on recent studies and changes in the medications used that have lowered their risk of side effects such as cancer or strokes.
But, questions still remain in many women’s minds. This is because, in the past large studies showed that ‘combined HRT’ (that is the older types that combined oestrogen and progesterone in one tablet) may increases the risk of breast cancer, stroke and blood clots in the legs and lungs.
This type of combined HRT increased the incidence of:
- breast cancer from approximately 15 to 20 women per 1,000 women,
- stroke from 11 to 15 women per 1,000 women, and
- clots in the legs and lungs from 8 to 18 per 1,000 women over a five year period.*
Not surprisingly, some women looked for an alternative to HRT; one that’s perceived to be safer – and the rise of the bioidentical hormone began.
*(It is important to note that these risk are only for that older form of HRT and NOT for the new ‘body identical’ versions, the gels or the creams. See HRT: The Risks Explained.)
Are bioidentical hormones safer and better?
The claim that bioidentical hormones are safer because they have the same chemical structure as those produced by our own body is attractive, but as yet, there’s no reliable evidence to support this theory. That’s because there have been no long term studies done on them as there has been with HRT that prove their safety.
And, as Professor Isaac Manyonda, co-founder of The Menopause Clinic London says, without that data we can’t say what the long term effects will be and as such, bioidentical hormones are still considered controversial by many practitioners.
Another concern regarding bioidentical hormones relates to the custom-made formulations. These formulations are unregulated and haven’t been tested for safety or effectiveness. They can include a wide variety of ingredients and the regulatory authorities can’t check that these ingredients are used together in an effective way or that they will be absorbed properly.
As such claims that custom-mixed bioidentical therapy is safer in terms of long-term health risks or are more effective are not supported by clear evidence.
In March 2017, the British Menopause Society issued the following statement expressing concern about the safety of unregulated bioidentical hormone treatments:
“It should be noted that such products are not regulated, licensed nor monitored by the MHRA, which is the regulatory body in the UK with responsibility to ensure that medicines meet applicable standards of safety, quality and efficacy. The term ‘bioidentical hormones’ is misleading; when Hormone Replacement Therapy (HRT) is indicated, women should be advised to only take those hormone therapies that are regulated and approved by the MHRA, which include hormones which are natural and identical to those produced in the body.”
The take home message from the British Menopause Society is that it endorses ‘body identical’ hormones that are licensed and regulated, but does not endorse unlicensed bioidentical hormones or tailor-made mixtures.
In short, bioidentical hormone therapy means more unknowns than HRT, and claims stating that bioidentical hormones are safer than HRT have not been validated.
Bear in mind that there are licensed biomedical hormones to choose from and that custom-made mixtures are untested. And there’s also a question mark over whether or not your actually getting what you pay for.
According to Harvard Health the FDA randomly tested 37 products from 12 compounding pharmacies in 2001 and found that nine (24%) were less potent than they claimed to be. By contrast, random samples from FDA approved products found only 2% failed the potency test.
In the end the type of HRT you choose – if any- will be an individual decision, but it’s always wise to consult your doctor, especially if you have a family history of breast cancer or cardiovascular disease. Even if you’ve been given the all clear, you may decide to steer clear of HRT in any form altogether, but if you do decide to try it may be a case of trial and error to get the symptom relief you’re looking for, but you don’t need expensive tests. Let you symptoms be the guide.