NICE has released its long awaited guidance on the use of hormone replacement therapy in women (HRT) and it includes a few changes that are likely to see more women being offered it / considering it. I have summarised some key points below. To find out more you will need to speak to your own GP – I can not give individual advice by email.
- HRT should now be considered (along with other approaches) to help women troubled by low mood as a result of the menopause (this is NEW).
- HRT remains the most effective treatment for hot flushes and night sweats caused by the menopause – and should be offered where indicated. It is also the therapy of choice in women with an early menopause (no change)
- There should be less emphasis on the current strategy of often restricting treatment to 5 years. Many women do not need HRT for longer than this, but others do. (NEW emphasis)
- Oestrogen only HRT causes “little or no increase in the incidence of breast cancer”. Combined HRT – which contains both oestrogens and progestogens – is associated with an increase but any increased risk decreases on stopping treatment.
- HRT does not increase the risk of heart attack and stroke in women under 60
- Here is the press release with more details:
Here is the press release with more details:
NICE issues first guideline on menopause to stop women suffering in silence
More than a million women could benefit from the first NICE clinical guideline on diagnosing and managing menopause.
The National Institute for Health and Care Excellence (NICE) has published wide-ranging recommendations for the NHS on the support, information and treatments needed to address the often debilitating symptoms that women suffer. The guideline covers determining if menopause has started, the drug and non-drug treatment options that help with physical and psychological symptoms, and it provides clarity on the benefits and risks of taking HRT (hormone replacement therapy).
The guideline also focuses on the often overlooked needs of women aged under 40 experiencing premature menopause, and women who have menopause triggered as a result of treatment for hormone-dependent cancer or gynaecological conditions.
Menopause is when a woman stops having menstrual periods as she reaches the end of her natural reproductive life. The decrease in oestrogen levels can cause problems like hot flushes and vaginal dryness, and may lead to long-term conditions including cardiovascular disease (CVD) and osteoporosis (brittle bones).
An estimated 1.5 million women – around 80% of those going through menopause – experience some symptoms, which typically continue for around 4 years after the last period. But for around 10% of women, symptoms can last for up to 12 years. The average age for menopause in the UK is 51 but it can vary widely depending on lifestyle and ethnicity, and premature menopause affects 1 in 100 women under the age of 40.
Christine Carson, Programme Director at NICE’s Centre for Clinical Practice said: “This is the first NICE guideline which covers the diagnosis and management of menopause, which women will experience at some stage during their lives. Menopause symptoms may severely affect a woman’s health and quality of life. Women don’t always get the help they need from their GP, practice nurse or hospital specialist to manage their symptoms but this guideline recommends effective treatments which can help. The message to women is clear – talk about the menopause with your clinician if you need advice on your symptoms – it’s very important to discuss the options to find what might help you.”
Professor Mary Ann Lumsden, chair of the expert group which developed the NICE guideline, professor of gynaecology at the University of Glasgow and honorary consultant gynaecologist at Glasgow Royal Infirmary, said: “The NICE recommendations are based on a thorough assessment of all important literature, and are the gold standard in managing menopause. The guideline covers the treatment of symptoms and also looks again at the place of HRT in treating menopausal women. It emphasises that, for most women, HRT is a very effective treatment for several menopausal symptoms, for example hot flushing and also reduces the risk of osteoporotic fracture. The guideline outlines that menopausal women should be informed that the impact of HRT on the risk of breast cancer varies with the type of HRT used as does the risk of cardiovascular disease. Since risk varies from one woman to another, lifestyle factors that might be important should also be discussed. Every woman who is worried about the effects that menopause is having on her life must be given the chance to find if there’s an option that works for her.”
Guideline recommendations include:
In otherwise healthy women aged over 45 years with menopausal symptoms, diagnose the following without laboratory tests: perimenopause based on vasomotor symptoms (hot flushes and night sweats) and irregular periods; menopause in women who have not had a period for at least 12 months and are not using hormonal contraception; menopause based on symptoms in women without a uterus
Offer women HRT for hot flushes and night sweats after discussing risks and benefits
Consider HRT to ease low mood that arises as a result of the menopause, and consider cognitive behavioural therapy (CBT) to alleviate low mood or anxiety
Explain that oestrogen-only HRT has little or no increase in the risk of breast cancer, whilst HRT with oestrogen and progestogen can be associated with an increase in the risk of breast cancer, but any increased risk reduces after stopping HRT
Women with cardiovascular risk factors should not automatically be excluded from taking HRT. Ensure that menopausal women and healthcare professionals involved in their care understand that HRT does not increase cardiovascular disease risk when started in women aged under 60 years, and it does not affect the risk of dying from cardiovascular disease.
Women should be referred to a menopause specialist if there’s no improvement after trying treatments, and a referral considered if a woman has menopausal symptoms but HRT is contraindicated (for example, in women with hormone-sensitive cancer), or the most suitable option is uncertain.
Dr Imogen Shaw, a GP with special interest in gynaecology and NICE guideline developer said: “Women should not feel they have to suffer in silence when menopause is affecting their daily lives at work and at home. The effects of menopause are often misunderstood and underestimated – it can impact on health significantly in both the long term and short term. Menopause can cause unbearable hot flushes and night sweats. Some of my patients describe being woken up several times during the night by hot flushes, and being so drenched in sweat that they have to change the bed linen. Menopause also can result in problems including low mood, brittle bones, urogenital changes that can cause vaginal dryness and urinary tract infections, and it can affect a woman’s sex life.
“For the last decade, some GPs have been worried about prescribing HRT, and women worried about taking it. I hope that this new NICE guideline will empower women to talk to their GP or practice nurse about menopause and provide them with information on the range of options that could help. For health professionals, the guideline should boost their confidence in prescribing HRT, having fully discussed the woman’s individual circumstances with her.”
The recommendations for women at risk of premature menopause (premature ovarian insufficiency) include giving women who are likely to start menopause because of medical or surgical treatment support and information about it before treatment starts, and referring them to a menopause specialist. Premature ovarian insufficiency should be diagnosed in women aged under 40 years based on menopausal symptoms including no or infrequent periods (depending on whether the woman has a womb), and results of two separate blood tests for follicle stimulating hormone (FSH). Management options are a choice of HRT or a combined hormonal contraceptive unless this is contraindicated (for example, in women with hormone-sensitive cancer).
Debbie Keatley, NICE guideline developer with personal experience of sudden menopause caused by breast cancer treatment, said: “The treatment that I had for breast cancer hurtled me into menopause. The problems I experienced included not sleeping because of the night sweats, feeling exhausted and drained. I wasn’t prepared for the long-term effects on my relationship and sex life – I would have liked to have had the chance to discuss this with a specialist. It was very hard to handle this on top of already feeling rotten because of the chemotherapy. I was being treated by an oncologist, so their focus was on how well the cancer treatment was working, not on the terrible symptoms I was also suffering because of the menopause. I had to go back and ask for help to manage the menopause, so it would have been much easier if I could have been referred to a menopause specialist when the symptoms started. So I’m very pleased that the NICE guideline recommends more help for women in my situation. This guideline is good news for women facing a double-whammy of sudden menopause whilst also coping with hormone-dependent cancer or gynaecological surgery, now they won’t have to deal with their symptoms alone.”
Commenting on the NICE guideline, Dr David Richmond, President of the Royal College of Obstetricians and Gynaecologists, said: “This guideline is a milestone for both healthcare professionals and women and will help ensure that the best possible care is provided in the diagnosis and treatment of menopause, a biological stage that every woman experiences to some extent in their lives. For some women, menopausal symptoms can be extremely debilitating and dramatically impact upon their quality of life. Compiled by the leading experts in the field and a comprehensive review of all of the existing evidence, we hope that this guideline will not only support healthcare professionals but also provide women with the necessary information to empower them to make informed decisions about their choice of treatment.”
The guideline, Menopause: diagnosis and management’ is available at www.nice.org.uk/guidance/NG23.
For more information call Dr Tonya Gillis at the NICE press office on 0300 323 0142, or out of hours on 07775 583 813.
Notes to Editors
About the NICE guideline, ‘Menopause: diagnosis and management’
1. The guideline is available at https://www.nice.org.uk/guidance/NG23 from Thursday 12 November.
2. The Information for Patients version of the guideline which also suggests points that women may find helpful to discuss with their doctor or nurse is available at http://www.nice.org.uk/guidance/ng23/informationforpublic.
3. Menopause is the biological stage in a woman’s life that occurs when she stops menstruating and reaches the end of her natural reproductive life. Usually it is defined as starting 1 year after the last menstrual period for women reaching menopause in middle age. The changes associated with menopause occur when the ovaries stop functioning. Menopause occurs after the eggs in the ovaries stop maturing, and the secretion of the sex hormones oestrogen and progesterone stop.
4. As a woman approaches menopause, usually her periods don’t stop suddenly, but can become less regular with gaps of months in between. This phase of irregular periods is called perimenopause, and lasts until one year after her final period, at which point she has reached menopause.
5. As well as a change in their menstrual cycle, women may experience a variety of symptoms associated with menopause, including:
• vasomotor symptoms (for example, hot flushes and sweats)
• musculoskeletal symptoms (for example, joint and muscle pain)
• effects on mood (for example, low mood)
• urogenital symptoms (for example, vaginal dryness)
• sexual difficulties (for example, low sexual desire).
6. Premature menopause (premature ovarian insufficiency) is usually defined as menopause occurring before the age of 40 years, affecting 1 in 100 women. It can occur naturally or as a result of treatment. Early menopause starts before the age of 45 years.
7. The age of menopause varies by ethnicity: studies found that early menopause (between 40 and 45 years of age) affected 3.7% of African–American women, 2.9% of white women, 2.2% of Chinese women and 0.8% of Japanese women.
8. HRT (hormone replacement therapy) is available in oral form (pills) or transdermal form (patches or gel). HRT preparations are either combined oestrogen and progestogen, which is for women who have a womb, or oestrogen only for women without a womb.
9. Transdermal HRT is associated with less risk than oral HRT, and for some conditions oestrogen-only HRT has lower risk than combined oestrogen and progestogen.
10. The menopause guideline references two published NICE guidelines within its recommendations for women with, or at high risk of, breast cancer. Some of the existing published recommendations in these two guidelines follow:
· The NICE guideline ‘Early and locally advanced breast cancer, CG80’ makes a number of recommendations regarding HRT and women with breast cancer in section 1.13, including:
“- Discontinue hormone replacement therapy (HRT) in women who are
diagnosed with breast cancer.
– Do not offer HRT (including oestrogen/progestogen combination) routinely to
women with menopausal symptoms and a history of breast cancer. HRT may,
in exceptional cases, be offered to women with severe menopausal symptoms
and with whom the associated risks have been discussed.
– Offer information and counselling for all women about the possibility of early
menopause and menopausal symptoms associated with breast cancer
See the full recommendations at nice.org.uk/cg80.
· The NICE guideline ‘Familial breast cancer, CG164’ makes a number of recommendations regarding HRT and women at high risk of breast cancer in section 1.7, including:
“ – Women with a family history of breast cancer who are considering taking, or
already taking, HRT should be informed of the increase in breast cancer risk
with type and duration of HRT.
– Advice to individual women on the use of HRT should vary according to the
individual clinical circumstances (such as asymptomatic menopausal
symptoms, age, severity of menopausal symptoms, or osteoporosis).
– HRT usage in a woman at familial risk should be restricted to as short a
duration and as low a dose as possible. Oestrogen-only HRT should be
prescribed where possible.
See the full recommendations at nice.org.uk/cg164.
In addition, the menopause guideline recommends offering menopausal women with, or at high risk of, breast cancer: information on all available treatment options, information that the SSRIs paroxetine and fluoxetine should not be offered to women with breast cancer who are taking tamoxifen; and referral to a healthcare professional with expertise in menopause.
The National Institute for Health and Care Excellence (NICE) is the independent body responsible for driving improvement and excellence in the health and social care system. We develop guidance, standards and information on high-quality health and social care. We also advise on ways to promote healthy living and prevent ill health.
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