Medscape

Dr Toni Hazell

Dr Toni Hazell Reviews NICE’s New Recommendations on Managing the Menopause with Medications and Therapy, Addressing Controversy Around the Use of Evidence

The introduction is also posted on Spotify as a podcast by “Gerry at The Health Equation”

You can search Spotify for “Gerry at The Health Equation”

Or use the link below

https://podcasters.spotify.com/pod/show/gerrygaj

Below is the specific link

Gerry Gajadharsingh writes:

NICE Menopause Guidelines Update

“The updated NICE guidelines on menopause recommend cognitive behavioral therapy (CBT) as a complementary or alternative treatment to HRT. Menopause-specific CBT is advised for vasomotor symptoms, depression, and sleep issues, particularly when HRT is contraindicated or unwanted.

For genitourinary syndrome of menopause (GSM), long-term vaginal estrogen remains a key treatment, with reviews at 3 months and annually. New additions include recommendations for women with breast cancer and non-estrogen drugs like prasterone (a vaginal DHEA pessary, contraindicated in breast cancer) and ospemifene (an oral selective estrogen-receptor modulator suitable for breast/endometrial cancer survivors post-treatment).

The section on HRT benefits and risks has been expanded, emphasizing absolute risk comparisons, such as breast cancer risk from combined HRT (8–10 more cases per 1000 women over 5 years) versus risks from obesity (10/1000) or alcohol intake (11/1000). NICE also highlights the small increase in breast cancer mortality and dementia risk with combined HRT, contrasting with BMS views on micronized progesterone’s potentially lower cancer risk.

Excess alcohol intake (≥45 g/day)—11 more cases per 1000 women

45g of pure alcohol  (10g per unit) = 4.5 units or 2 * 175ml glass of wine.

For early menopause (40-45 years) or premature ovarian insufficiency (POI) (<40 years), HRT is recommended until the average age of menopause unless contraindicated. Women with POI may also consider combined hormonal contraceptives as an alternative. Referrals to specialists are advised for complex cases or if psychological support is needed for distress.

The guidelines emphasize that lifestyle factors like diet, exercise, smoking, and alcohol have a more significant impact on cardiovascular health than HRT.

NICE does not consider many alternatives to managing menopause or perimenopause symptoms that many patients have found success with, such as Osteopathic Manual Treatment, acupuncture, other forms of psychological intervention, nutrition and nutritional supplements and techniques to improve balance within the autonomic nervous system such as adopting a more relaxed breathing pattern. However, it is good that they have included psychological support such as CBT, emphasising the impact on the mind/psychology and menopausal symptoms.

The London Osteopathic Society have asked me to present on “Menopause and Perimenopause, an integrated approach to Diagnosis and Treatment” on Wednesday 26th February, in person at UCO, Borough High Street. So, for Osteopaths, who want to expand their understanding and therapeutic approaches, please go to the LOS website.”

https://londonosteopathicsociety.org.uk

NICE updated its guideline on the menopause in November 2024, making changes in three main areas:

  • management of genitourinary syndrome of the menopause (GSM)
  • discussion of the health risks and benefits of hormone-replacement therapy (HRT)
  • use of cognitive behavioural therapy (CBT) as part of menopause management.

Use of CBT in Menopause Management 

NICE’s recommendation to offer CBT for menopause management caused concern when the draft version of the update was published, with press coverage raising fears that CBT would be advised instead of HRT. However, this is not the case, and the guideline’s recommendations about the use of CBT have turned out to be one of the least controversial inclusions.

Menopause-specific CBT is recommended on top of HRT, when HRT is not wanted, or when HRT is contraindicated. It is recommended as an option for treating vasomotor symptoms, depressive symptoms, and difficulties with sleep, and can be offered in various formats (face to face or remote, in individual or group sessions, or as a self-help option).

This is a sensible recommendation that widens the range of management options at healthcare professionals’ disposal, but implementation will, of course, depend on local services. Commissioners who are reading this may want to think about whether they provide menopause-specific CBT in their area and, if not, how to ensure that all their patients can access this, not just those who can afford it privately.

Management of GSM 

GSM (also known as urogenital atrophy or atrophic vaginitis) is common and often presents some years after the onset of the menopause. It may be the underlying cause of symptoms that are initially thought to represent thrush (candidiasis) or recurrent urinary tract infections. Symptomatic candidiasis is unusual in this age group, so GSM should be considered with any request to treat that condition in these women, or if a woman in this population has been buying antifungal thrush creams over the counter.

Parts of NICE’s guidance on the management of GSM will be familiar to anyone who treats menopausal symptoms. It is not new to recommend that vaginal oestrogen should be used long term (with a review after 3 months and then annually), to advise patients that systemic absorption is minimal, or to propose that vaginal oestrogen can be used alone or in combination with systemic HRT and nonhormonal lubricants. There are various preparations of vaginal oestrogen available, and the choice between pessary, gel, cream, or tablet should be made using a shared decision-making process, as there is little to recommend one formulation over another for most women.

However, new to this update are recommendations on the management of GSM in women who have had breast cancer, and on the use of two non-oestrogen drugs: ospemifene and prasterone.

Prasterone and Ospemifene 

Prasterone is a pessary that contains dehydroepiandrosterone (DHEA)—a hormone produced by the adrenal glands and ovaries, the natural level of which falls after the menopause. The DHEA in prasterone is converted to oestrogens and androgens in the vagina; it is contraindicated if there is a history of breast cancer.

Ospemifene is the only oral treatment available for GSM. It is a selective oestrogen-receptor modulator that acts as an oestrogen agonist in the vaginal mucosa but, crucially, as an oestrogen antagonist in breast tissue and the endometrium. Ospemifene can therefore be used in women who have had breast or endometrial cancer, as long as treatment is complete;these are groups for whom HRT provision can be difficult, so this is a welcome addition to the range of treatment options.

Unsurprisingly, prasterone and ospemifene both cost more than vaginal oestrogen, and NICE therefore does not recommend them as standard first-line options. Prasterone is recommended as a second-line option for GSM after vaginal oestrogen, nonhormonal moisturisers, and/or lubricants, and ospemifene as a first-line option specifically for those with dexterity issues.1 Local implementation of this change will be supported by making sure that local medicines management teams have added these medicines to the formulary, so that no warning about cost appears when they are prescribed.

History of Breast Cancer 

The new recommendations on the management of GSM in those who have had breast cancer offer a useful framework for decision-making in this group. As always, clinicians should work within their competence—depending on their experience and qualifications, some GPs will feel more comfortable than others managing the menopause in women who have had breast cancer. Advice should always be sought when unsure, and it is generally sensible to involve the woman’s cancer specialist in discussions in this area.

Benefits and Risks of HRT 

The section on the benefits and risks of HRT is the longest in the updated guideline and was revised in this version based on an evidence review. In conjunction with the update, NICE published a helpful discussion aid explaining the impact of HRT on an individual’s risk of developing certain medical conditions, with the intention of assisting clinicians when explaining the risks to their patients.

The document presents the information in both numerical and graphical forms, and some patients will find the negative numbers useful (for example, ‘4 women out of 1000 women with a uterus who never take HRT develop endometrial cancer, [but] 996 do not’). Figures are generally slightly different for combined versus oestrogen-only HRT. An immediate practice action could be to make a template that texts or emails a link to this discussion aid to patients after an initial menopause consultation, as it offers a helpful explanation of the risks.

Presenting Information Effectively 

When discussing risks, it is important to consider absolute risks, not just relative ones. The National Lottery offers an example of this: by buying two lottery tickets instead of one, I double my ‘risk’ of winning the lottery; however, I only increase my absolute risk by one in several million. Similarly, the absolute risk of breast cancer, a common fear, is increased by only a small amount in women who take HRT. For those who experience menopause aged ≥45 years and take combined HRT for 5 years, there will be 20 extra cases of breast cancer, per 1000 women, over a 20-year period that is, one case per 1000 women per year. This framing sounds much less worrying than the relative increase of 34% (an increase from 59 to 79 cases per 1000 women).

The risk presented by HRT should also be considered in the context of other risk factors. Obesity is a significant risk factor for breast cancer, for example, with an 11% increase in risk for every 5 kg gained in adulthood. Menopause symptoms may affect a woman’s ability to eat healthily and do exercise; therefore, if HRT enables her to live more healthily such that she loses weight, the overall effect on her breast cancer risk could theoretically be positive.

This comparison has been made in absolute terms as well: according to the British Menopause Society (BMS), the increased risk of breast cancer over 5 years from combined HRT, obesity, and excess alcohol intake is as follows:

  • combined HRT use of up to 5 years—8–10 more cases per 1000 women
  • obesity—10 more cases per 1000 women
  • excess alcohol intake (≥45 g/day)—11 more cases per 1000 women.

45g of pure alcohol = 4.5 units or 2 * 175ml glass of wine.

Concerns About Data 

This updated section on risks and benefits has been somewhat controversial, with the BMS issuing a statement raising concerns about some of the data used and contesting some of the guidance given. This statement is available on the website of Women’s Health Concern (the patient-facing arm of the BMS), so patients may ask their GP about it. The main areas of difference are related to cardiovascular disease and breast cancer mortality, with further concerns raised about breast cancer risk, micronised progesterone, ovarian cancer, and early menopause.

Cardiovascular Disease 

Although clinicians should not be prescribing HRT purely for cardiovascular risk (in the absence of menopausal symptoms), it has been established that HRT started in the first decade after the menopause is likely to be beneficial for the heart. NICE states that using HRT does not increase an individual’s risk of coronary heart disease or mortality from cardiovascular disease, and the difference cited in the discussion aid is not considered statistically significant (one extra case of coronary heart disease per 1000 women over 5 years of combined HRT use).However, it is surprising to see that no benefit is noted in the guideline.

The BMS statement, to which NICE has not responded (as of 17 December 2024), notes that NICE did not look at studies in which combined and oestrogen-only HRT were both considered, and that the Women’s Health Initiative study and a large Cochrane review were therefore erroneously excluded. The BMS adds that the Cochrane review showed a reduction in coronary heart disease in those starting HRT less than 10 years after the menopause and that, for those starting later than that, there was no clear evidence of harm. Pragmatically, the difficulty of collating large amounts of data into one guideline could be explained to patients who raise this issue, as well as the fact that their decisions on diet, exercise, smoking, and alcohol are much more significant to their risk of cardiovascular disease than the decision to start, or not to start, HRT.

Breast Cancer Mortality 

NICE suggests that there is ‘a very small increase in risk of death from breast cancer’ associated with combined HRT, disagreeing with the BMS’ conclusion that there is no increase. In its response to this update, the BMS suggests that NICE has cited the literature incorrectly. Looking at this issue in practical terms, however, a discussion about breast cancer mortality seems likely to be small-print, brought up by only the most well-read women who will have probably already seen the BMS statement and made up their own minds.

Micronised Progesterone 

Keeping to the issue of breast cancer, the BMS also points out that the studies on which this update was based include a minority of women taking micronised progesterone. This is commonly prescribed in the UK and is thought to be associated with a lower risk of breast cancer than other progestogens. This issue is not new, and I have been having this discussion with patients for some time—a useful explanation may be as follows: ‘The studies NICE bases its figures on used older forms of progestogen, which we don’t prescribe so much now. I’m giving you a progestogen that is thought to have a lower risk, so these figures probably represent a worst-case scenario for you. Your actual risk may be lower, but I can’t put a figure on how much lower.’

Dementia Risk 

NICE’s discussion aid also covers dementia risk, citing a small increase for users of combined HRT (nine cases per 1000 women over 4 years); however, this statistic is in relation to a cohort starting HRT at the age of 65 years or over. This is relatively unusual in the UK, where HRT is usually initiated much earlier, so will have only limited relevance to patients.

Early Menopause and Premature Ovarian Insufficiency 

Women who have an early menopause (aged 40–45 years), or who are affected by premature ovarian insufficiency (POI; menopause when aged under 40 years), require a different approach to counselling about risks and benefits. A useful framing may be along the following lines: ‘If we treat you with HRT, we’re really only replacing the hormones that most women would have naturally, so the same figures on risk don’t apply’. NICE acknowledges this difference in relation to POI especially, advising that HRT should be offered to all those with POI (and continued until the average age of natural menopause) unless contraindicated, and that if there are any doubts about diagnosis, a specialist referral should be made. Such a referral would also be sensible if there are contraindications to HRT such as a history of breast cancer, as the counselling in such a situation would be complex. Some women with POI will prefer to use the combined hormonal contraceptive pill instead of HRT; this is also an appropriate way to replace their lost oestrogen, assuming no contraindications.

However, NICE offers few recommendations about early menopause, apart from:

  • recommending referral for psychological support if the woman is experiencing distress
  • suggesting that clinicians consider the risks and benefits of HRT in this group as lying somewhere between those for women experiencing the menopause at a normal age and those with POI.

The BMS suggests that this is a missed opportunity to highlight the long-term effects of the menopause in this group, which was perhaps inevitable because the scope of the guideline was too narrow and did not include consideration of the impact of early menopause on bone, cognition, and cardiovascular health. The BMS encourages clinicians to think of POI and early menopause as a continuum of risk and recommends HRT use in those who experience the menopause aged 40–44 years. The discussion aid largely focuses on those who have their menopause over the age of 45 years, giving information only about breast cancer for those with a menopause between 40 and 44 years and offering no statistics for those with POI.

Summary 

In conclusion, this update gives useful information on the management of GSM (particularly for those who have had breast cancer) and the use of menopause-specific CBT. It also updates figures about the risks and benefits of HRT. The better-informed patient may ask about the disagreements between NICE and the BMS, but many of the absolute risks involved are small, and most of those working in the field would already tend to recommend HRT for those experiencing the menopause below the age of 45 years. Implementation will be helped by adding new links (such as to the new discussion aid) to text-message templates, ensuring that those involved in medicines management are aware of the newer options for treating GSM, and exploring local commissioning of CBT for the menopause.