When NICE released its 2015 Menopause guidelines1, the direction of travel seemed pretty clear – a generation of women had missed out on HRT, largely as a result of the WHI trial2, and it was setting out to redress the balance, offering HRT as a first line treatment for symptoms of the menopause. So why has the draft 20233 update been so controversial? Mainstream media has widely reported the suggestion that women be offered CBT – in fact this recommendation is not new, it was in the 2015 guidelines. But what is new, is the recommendation that women be told the menopause is a ‘normal life transition’ with symptoms ranging from ‘minor to more troublesome’. This is in stark contrast to the British Menopause Society (BMS) who describe it as a ‘major life event affecting all women in a variety of ways’ and that 1/3 of women will experience severe symptoms. It certainly seems odd that NICE would want to introduce opinion to seemingly minimise symptoms, when we have good evidence of the profound impact it can have – the BMA found that 2/3 of female doctors had either changed, or wanted to change their working hours because of the menopause4. Given this is a generation who worked 120-hour weeks as junior doctors, I would suggest this is a bit more than ‘troublesome’.
Whilst the draft does still suggest HRT for symptoms such as hot flushes, it has swapped the order, putting ‘non hormonal’ a line above hormonal. NICE states that we should explain the risks and benefits to women. Absolutely. No one will disagree with this. The problem is that the guidelines themselves are not a useful source of information to do this. The tables are fiendishly complicated and make it very hard to present in a meaningful way in a 10 minute consultation. What would be helpful at the outset would be a plain English statement such as the BMS does, explaining that HRT is the most effective solution for the relief of menopausal symptoms, helps prevents osteoporosis and is likely to provide protection against heart disease5. So where does the hesitation over HRT come from? The answer probably lies, as it does for many women and health care professionals in the 20 year hangover from the infamous WHI study. And this fear is completely understandable, although as we will see, misplaced, because whilst the original eye catching headlines from the WHI have been repeatedly debunked, this debunking, and the rowing back that the WHI investigators themselves have done, has never quite caught the attention that the original release did.
Our old nemesis, the WHI3, was a health outcomes RCT, that recruited women aged 50-79 and randomised them either to receive placebo or HRT. The AVERAGE age was 63 at the time of recruitment and 70% of the women had overweight or obesity, and they were prescribed oral oestrogen and synthetic progesterone. So already, not our typical 45-55 year old UK women, on transdermal oestrogen plus micronized progesterone, which is the majority of UK prescribing. The study was halted early due to claims of increased risk of breast cancer in the combined HRT group and that led to a massive drop in prescribing of HRT in the UK from around 30% to 10% at best6. Had that breast cancer claim been true then the least we could have hoped for was similar drop in breast cancer rates over the next couple of decades. You will all know that hasn’t happened. In fact according to Cancer Research UK, since the 90’s, the rates in women have risen by 25%.7 So, the complete opposite of what you might expect then. What was going on with the WHI findings then? The claim of the increased risk of breast cancer in combination HRT actually didn’t reach statistical significance, but the investigators ‘set the bar lower’ for breast cancer8. As the British Menopause Society note in their advice to women, subsequent review showed the risk was only present in those who had taken HRT before the study, and crucially there was a significant reduction in breast cancer diagnosis and mortality in women taking oestrogen only HRT. So, we don’t need to be afraid of oestrogen, but just like that night on your best mates 18th when you drank too much tequila, the memory of its ill-effects is hard to abolish.
Even if we were to gloss over the fact that NICE use some very dated data, not reflective of modern prescribing habits, the tables claim that for 10 years of HRT use, you will see an extra 5-13 cases of breast cancer per 1000 women over a 5 year period, depending on age. So between 1 and 2.6 extra cases per 1000 women per year. The 10 year survival for breast cancer is 87.2% but the one year mortality of a hip fracture is anywhere from 20-50%. There is indeed a table showing there should be 25 fewer fragility fractures per 1000 women, but it is incredibly hard to pick out and share the risks and the benefits from these tables. As the BMS points out we have good data from a large Danish RCT demonstrating a significant reduction in the incidence of heart disease (actually 50%!) in women who started HRT within 10 years of the menopause, with no increase in the incidence of cancer9, but this gets lost in the data storm of the guidelines.
Menopause has become an oddly divisive topic, and it doesn’t need to be. Symptoms can be life changing and we have a cheap and effective treatment. A generation of women were denied HRT from 2002, and the 2015 NICE guidelines really helped to redress that balance, as has the BMS guidance. I hope that feedback on the draft will ease out the unnecessary opinion that has crept into this update, and lay out a much simpler way to convey the very many benefits, as well as risks to women.
1. NICE NG23 Menopause: diagnosis and management November 2015
2. Rossouw JE, Anderson GL, Prentice RL, LaCroix AZ, Kooperberg C, Stefanick ML, Jackson RD, Beresford SA, Howard BV, Johnson KC, Kotchen JM, Ockene J; Writing Group for the Women's Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results From the Women's Health Initiative randomized controlled trial. JAMA. 2002 Jul 17;288(3):321-33. doi: 10.1001/jama.288.3.321. PMID: 12117397.
3. NICE GID-NG10241 Menopause: diagnosis and management November 2023
4. BMA : Challenging the culture of menopause for working doctors 2020
5. BMS & WHC’s 2020 recommendations on hormone replacement therapy in menopausal women
6. Vinogradova Y, Dening T, Hippisley-Cox J, Taylor L, Moore M, Coupland C et al. Use of menopausal hormone therapy and risk of dementia: nested case-control studies using QResearch and CPRD databases BMJ 2021; 374 :n2182 doi:10.1136/bmj.n2182
8. Bluming & Travis, Oestrogen Matters (Piatkus 2018) p. 29
9. Schierbeck L L, Rejnmark L, Tofteng C L, Stilgren L, Eiken P, Mosekilde L et al. Effect of hormone replacement therapy on cardiovascular events in recently postmenopausal women: randomised trial BMJ 2012; 345 :e6409 doi:10.1136/bmj.e6409