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[Emma]

British Menopause Society Statement on HRT dosages
6 November 2024

In the weeks following the BBC One Panorama programme, “The Menopause Industry Uncovered”, which focused on the commercialisation of menopause and exposed the vulnerability of women experiencing menopausal symptoms, the BMS has been contacted by many women regarding their HRT treatment. Some women are now being advised to come off HRT or their HRT is being restricted, dependent upon primary care audit outcomes.
 
The underlying concern relates to the frequency of prescribing high dose estrogen outside of product licence, and in some cases not balanced by an increase in the dose of progestogen where appropriate. The focus of the programme and any concerns generated were not about use of standard dose HRT in women with no contraindications to treatment.
 
BMS, national and international guidance advises that if HRT is given in appropriate doses and care is individualised, the benefits associated with treatment outweigh the risks in otherwise healthy women. Further, some women may require higher doses of estrogen, outside the licensing guidelines, but this should not be regarded as standard practice.
 
There is no evidence to justify stopping HRT at a certain age and dose adjustment should be carried out on individualised clinical grounds. All women using HRT should have an annual review.
 
The BMS has been at the forefront of promoting mid-life women’s heath since the society was established in 1989 and has championed women’s health and menopause management in particular, throughout the historical highs and lows, including the aftermath of the Women’s Health Initiative Study, published in 2002.
 
Patient safety remains our primary concern, with a focus on the provision of specialist peer reviewed guidance in collaboration with other national and international organisations, to optimise women’s health and well-being.

[Emma]

Summary by Emma -
In women who take combined HRT:
1. there is no statistically significant increase of breast cancer mortality.
2. there is no statistically significant increase in ovarian cancer cases.

BMS statement in response to the publication of the updated NICE Menopause guideline (NG23)
7 November 2024

The publication today of the reviewed NICE guideline Menopause: identification and management (NG23) marks an important development in the diagnosis and treatment of menopausal women. It builds selectively on the conclusions and recommendations of the original guideline published in November 2015.

In the intervening nine years the awareness within the medical profession of the diagnosis and management of menopause has significantly improved. The training and education developed for healthcare professionals (HCPs) by the British Menopause Society (BMS), Royal College of Obstetricians & Gynaecologists, Faculty of Sexual & Reproductive Healthcare, Royal College of General Practitioners and the Royal College of Nursing continue to be essential in enabling GPs and other HCPs to treat patients with confidence and respect. NICE endorses that the two fundamental principles acknowledged and practised by all responsible HCPs are individualised care and patient safety.

The BMS recognises that the guideline:

• encourages awareness and provision of accurate information.
• defines that a healthcare professional with an expertise in menopause should be recognised by a professional body such as the British Menopause Society, the Faculty of Sexual and Reproductive Healthcare or the Royal College of Obstetricians and Gynaecologists.
• encourages access to/offering of HRT for management of menopausal symptoms and continues to recommend individualised care.
• emphasises the need to consider the impact of increased dosage of estrogen, and progestogen intake, on the risk of endometrial cancer.
• focusses on different treatment options for genitourinary symptoms of menopause, including women with a history of breast cancer.
• suggests that menopause-specific CBT should be more widely available as an alternative or an adjunct to other treatment options.
• recommends the need for ongoing research.

However, the BMS has considered the following limitations of the guideline:

• The guideline scope did not include reviewing the evidence on the impact of early menopause on bone, cardiovascular and cognitive health in women with early menopause. As a result, the NICE guideline did not include a recommendation on the impact of early menopause on long term health nor as a result of this the benefits of taking HRT to protect against this.

The BMS is of the view that this limitation needs to be considered when interpreting the guideline recommendations on early menopause and should be considered when counselling women with early menopause about the adverse health impacts of early menopause and the role of HRT intake in this context.

• The data on breast cancer risk with HRT in early menopause were based on the 2019 Lancet meta-analysis where HRT users under 45 years of age were compared with postmenopausal women under 45 years of age not on HRT (a group who already have a lower risk of breast cancer compared to age-matched premenopausal women). The clinically meaningful comparator would be age-matched premenopausal women.

The BMS is of the view that POI and early menopause should be regarded as a risk continuum, applying both to POI and women with early menopause under 45 years of age.

• The guideline scope excluded studies where estrogen only and combined HRT were included together, which resulted in exclusion of the combined outcomes of WHI and the Cochrane review. The Cochrane review showed that starting hormone therapy less than 10 years after the menopause had lower mortality and coronary heart disease compared to placebo or no treatment.  Women who started HRT more than 10 years after the menopause were not noted to have an increased risk of mortality or coronary heart disease.

The BMS is of the view that this limitation should be considered when interpreting the guideline recommendations and when counselling women about the impact of HRT intake on the risk of CVD.

• The observational data on the risk of breast cancer with HRT included in the NICE guideline were based on the Lancet meta-analysis, which only included a very small number of women on micronised progesterone. As a result, the guideline could not draw conclusions from this report on the risk of breast cancer with micronised progesterone.  The French E3N data on risk of breast cancer with micronised progesterone were not included in the meta-analysis and as a result were not included in the NICE guideline data analysis. The E3N suggested less increase in the risk of breast cancer with micronised progesterone and dydrogesterone compared with other synthetic progestogens.

The BMS is of the view that this limitation should be considered when interpreting the guideline recommendations and when counselling women about the risk of breast cancer with HRT.
In addition, the BMS identifies two substantive errors in the guideline:

• Ovarian cancer: It is stated that "evidence from an RCT (randomised controlled trial) showed that there were more ovarian cancer cases in people taking combined HRT than in people not taking HRT."

This is incorrect; there was an RCT from the WHI Manson et al 2013, Anderson 2003 which found no significant increase in risk.

• Breast cancer mortality: It is stated that RCT evidence showed that mortality was slightly higher in women who take combined HRT. 

This is factually incorrect as there was no statistically significant increase. It is also stated elsewhere that the breast cancer mortality data were derived from RCTs and a meta-analysis when in fact the mortality data came from a letter in The Lancet.  The meta-analysis did not report on breast cancer mortality.
The final draft of the guideline was made available for consultation in November 2023.  As a key stakeholder, the BMS led robust challenges to the authenticity of some of its interpretations and conclusions.

The BMS will continue to promote high quality care to menopausal women through education and evidence-based medicine.