How safe is your HRT dose?
The pros (and cons) of hormone replacement therapy (HRT) are rarely out of the news, and today, after years of declining levels, 15% of women aged 45-64 are using HRT. While celebrity advocates like Davina McCall and Mariella Frostrup make menopause and its treatments more visible, and studies regularly appear in the news linking HRT to sharper cognition, decreased risk of heart attack, and better bone strength, there is also reason for caution, says Good Housekeeping’s Dr Sarah Jarvis. There are still many unknowns, particularly around the off-label prescribing of higher doses of HRT in some private clinics – a practice at the centre of a recent Panorama documentary.
The accusations made by the BBC’s Panorama investigation are against Dr Louise Newson, a GP who vigorously promotes HRT prescriptions and runs Newson Health, the largest private menopause clinic in the UK. She is also at the helm of a popular podcast; a free ‘Balance’ app that has been downloaded more than a million times; and has accrued a celebrity following. But the Panorama documentary argued that Dr Newson advocates for high dosages of oestrogen that are unsupported by evidence.
Newson Health refutes the claims made in the documentary, saying: ‘As the UK’s leading menopause clinic, Newson Health utilises a wealth of clinical experience and data, as well as the best available scientific evidence, to treat every patient on an individualised basis and provide the best possible menopause care.
‘This is particularly important in an area of health that is chronically underfunded, undervalued and underresearched.’
But Good Housekeeping’s Dr Sarah Jarvis points out: ‘If it is not a licensed dose, you do not have the evidence for safety. It’s as simple as that. Today, there are hundreds of preparations which have different licensed doses – but for all forms, the British Menopause Society (and general best practice) recommends that you should be sticking to the maximum licensed dosage except in very exceptional circumstances.’
The best practice outlined by the MHRA is still that HRT should be prescribed in the lowest dose and the shortest time possible for symptom control. ‘The original papers which gave rise to this guidance were the 2003 Women's Health Initiative and the Million Women Study. It has been argued that these studies involved very different, non ‘body-identical’ forms of HRT compared to those used today.
'Nonetheless, the latest draft NICE guideline on menopause states that based on best available evidence, combined HRT increases the risk of breast cancer compared to not taking HRT, that the increase rises with duration of use and that the increase declines after stopping but persists at least 10 years after stopping use. I would be very concerned if any woman were offered a higher dose without being advised of these risks,’ says Dr Jarvis.
HRT advocates point out that many studies used to inform the current guidelines were done with old-fashioned HRT; and that there is no robust evidence that higher doses of oestrogen are associated with a greater risk to a patient. However, the simple fact is that we don’t have studies of higher doses, so we simply don’t know, says Dr Jarvis.
‘It’s true that more modern ‘body-identical’ forms of HRT, which have the same structure as the hormones your body produces naturally, are probably lower risk. But we cannot be certain, and that’s why the MHRA still errs on the side of caution.’
Ideally, says Dr Jarvis, women struggling with difficult menopausal symptoms would see a doctor who fulfils the British Menopause Society criteria for being a menopause specialist – either a GP with a specialist interest in HRT or an NHS consultant gynaecologist. They would hold a recognised menopause qualification and follow national and international guidelines, which do not recommend routinely prescribing unlicensed doses of drugs. They would be able to give the most up-to-date advice.
‘But,’ she adds, ‘It's very difficult, because waiting times for NHS clinics are so long. So in the first instance, go and speak to your GP.’
What dose of HRT should I ask for?
‘If somebody comes in to my surgery and asks to go HRT, I ask what their symptoms are, and we discuss the risks and benefits of HRT, Unless you’ve had a hysterectomy, you’ll always need to use a combination of oestrogen and progesterone or progestogens (a synthetic form of progesterone) to protect your womb; and you do not increase the dose of oestrogen without increasing the amount of progesterone.
'Excess levels of so-called ‘unopposed’ oestrogen could raise your risk of endometrial hyperplasia, which is a precursor to endometrial cancer – so they could increase your risk of endometrial cancer.
‘As for higher doses’, she adds, ‘a wide consensus of expert bodies is completely clear. Last year, after concerns about unlicensed high dose prescribing came to light, the Royal College of Obstectrics and Gynaecology, Royal College of GPs, British Menopause Society and others issued a joint safety alert. It is rare to see a situation where licensed doses are routinely being breached – because, as the warning states, “these limits are informed by the results of clinical trials, to ensure patient safety".'
What if you’re considering stopping HRT?
‘If you have been taking HRT for some time and you want to come off it, there are two ways of doing it. You can go cold turkey, or come off slowly. There is no consensus about which is best. While tapering your HRT off slowly may limit the degree to which your symptoms recur short-term, there’s no significant difference in the long term where symptoms are concerns.
'If you started HRT because of symptoms around the menopause, the chances are you will get symptoms again. I would make it very, very clear that those symptoms could come back for a few months. But the chances are that in most but not all women, they would settle over the course of a few months.’
‘I am very much in favour of HRT for the right patients. However, some proponents of HRT will say every woman should be taking HRT, when about one in five women get no menopausal symptoms, and three in four don’t find their symptoms severely affect their quality of life. A heart-healthy diet and regular exercise will also protect your heart and bones.’
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