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Menopause

About

What is covered

This interactive flowchart covers the diagnosis and management of menopause. It includes women in perimenopause and postmenopause, and the particular needs of women with premature ovarian insufficiency and women with hormone-sensitive cancer (for example, breast cancer).
Menopause is a 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 having occurred when a woman has not had a period for 12 consecutive months (for women reaching menopause naturally). The changes associated with menopause occur when the ovaries stop maturing eggs and secreting oestrogen and progesterone.

Updates

Updates to interactive flowchart

8 February 2017 Menopause (NICE quality standard 143) added.

Your responsibility

Guidelines

The recommendations in this interactive flowchart represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take these recommendations fully into account, alongside the individual needs, preferences and values of their patients or service users. The application of the recommendations in this interactive flowchart is not mandatory and does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.
Local commissioners and/or providers have a responsibility to enable the interactive flowchart to be applied when individual health professionals and their patients or service users wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this interactive flowchart should be interpreted in a way that would be inconsistent with compliance with those duties.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

Technology appraisals

The recommendations in this interactive flowchart represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, health professionals are expected to take these recommendations fully into account, alongside the individual needs, preferences and values of their patients. The application of the recommendations in this interactive flowchart is at the discretion of health professionals and their individual patients and do not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.
Commissioners and/or providers have a responsibility to provide the funding required to enable the recommendations to be applied when individual health professionals and their patients wish to use it, in accordance with the NHS Constitution. They should do so in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

Medical technologies guidance, diagnostics guidance and interventional procedures guidance

The recommendations in this interactive flowchart represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, healthcare professionals are expected to take these recommendations fully into account. However, the interactive flowchart does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
Commissioners and/or providers have a responsibility to implement the recommendations, in their local context, in light of their duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations. Nothing in this interactive flowchart should be interpreted in a way that would be inconsistent with compliance with those duties.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

Person-centred care

People have the right to be involved in discussions and make informed decisions about their care, as described in your care.
Making decisions using NICE guidelines explains how we use words to show the strength (or certainty) of our recommendations, and has information about prescribing medicines (including off label use), professional guidelines, standards and laws (including on consent and mental capacity), and safeguarding.

Short Text

Everything NICE has said on diagnosing and managing menopause and premature ovarian insufficiency in an interactive flowchart

What is covered

This interactive flowchart covers the diagnosis and management of menopause. It includes women in perimenopause and postmenopause, and the particular needs of women with premature ovarian insufficiency and women with hormone-sensitive cancer (for example, breast cancer).
Menopause is a 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 having occurred when a woman has not had a period for 12 consecutive months (for women reaching menopause naturally). The changes associated with menopause occur when the ovaries stop maturing eggs and secreting oestrogen and progesterone.

Updates

Updates to interactive flowchart

8 February 2017 Menopause (NICE quality standard 143) added.

Sources

NICE guidance and other sources used to create this interactive flowchart.
Menopause: diagnosis and management (2015) NICE guideline NG23
Menopause (2017) NICE quality standard 143

Quality standards

Quality statements

Diagnosing perimenopause and menopause

This quality statement is taken from the menopause quality standard. The quality standard defines clinical best practice for diagnosing and managing menopause and should be read in full.

Quality statement

Women over 45 years presenting with menopausal symptoms are diagnosed with perimenopause or menopause based on their symptoms alone, without confirmatory laboratory tests.

Rationale

In otherwise healthy women over 45, perimenopause and menopause can be diagnosed based on clinical history alone. In this age group, laboratory tests, particularly follicle-stimulating hormone (FSH), do not help with the diagnosis because hormone levels fluctuate during the perimenopause. Knowing these levels will not change management. Other laboratory tests, for example, blood count or thyroid function tests, may still be needed if non-menopausal causes of symptoms are suspected. Reducing the number of unnecessary tests will reduce stress for women, lead to potential cost savings and empower healthcare professionals to make a clinical diagnosis and provide reassuring support and advice based on their clinical experience.

Quality measures

Structure
Evidence of local arrangements to ensure that women over 45 years presenting with menopausal symptoms are diagnosed with perimenopause or menopause based on their symptoms alone, without confirmatory laboratory tests.
Data source: Local data collection.
Process
Proportion of women over 45 years diagnosed with perimenopause and menopause whose diagnosis is based on their symptoms alone, without confirmatory laboratory tests.
Numerator – the number in the denominator whose diagnosis is based on their symptoms alone, without confirmatory laboratory tests.
Denominator – the number of women over 45 years diagnosed with perimenopause or menopause.
Data source: Local data collection.
Outcome
a) Proportion of women over 45 years with menopause who felt reassured by their healthcare professional about their diagnosis.
Data source: Local data collection.
b) Number of laboratory tests to confirm a diagnosis of menopause in women over 45 years.
Data source: Local data collection.

What the quality statement means for different audiences

Service providers (primary and secondary care and community services) ensure that systems are in place for women over 45 years to be diagnosed with perimenopause or menopause based on their menopausal symptoms alone, without confirmatory laboratory tests.
Healthcare professionals (such as GPs, practice nurses and healthcare professionals with expertise in menopause) do not use laboratory tests to confirm a diagnosis of perimenopause or menopause in women over 45 years, but base the diagnosis on menopausal symptoms alone.
Commissioners (clinical commissioning groups and NHS England) ensure that they commission services in which women over 45 years are diagnosed with perimenopause or menopause based on their menopausal symptoms alone, without confirmatory laboratory tests.
Women over 45 who visit their GP or practice nurse with common symptoms of the menopause are not offered unnecessary blood tests, but have their symptoms assessed by the doctor or nurse to see whether they have started the menopause or will start the menopause soon. Common symptoms of the menopause include hot flushes, night sweats, mood changes, and no periods or the occasional period.

Source guidance

Menopause (2015) NICE guideline NG23, recommendation 1.2.1

Definitions of terms used in this quality statement

Menopausal symptoms
Menopausal symptoms include the following:
  • no or infrequent periods (taking into account whether the women has a uterus)
  • hot flushes
  • night sweats
  • mood changes
  • memory and concentration loss
  • vaginal dryness
  • lack of interest in sex
  • headaches
  • joint and muscle stiffness.
[Adapted from NICE’s guideline on menopause, context section and recommendations 1.2.1 and 1.3.2]
Diagnosed
Diagnose the following without laboratory tests in otherwise healthy women aged over 45 years with menopausal symptoms:
  • perimenopause based on vasomotor symptoms 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.
[NICE’s guideline on menopause, recommendation 1.2.1]
Laboratory tests
FSH tests should not be routinely considered when diagnosing menopause in women aged over 45 years with menopausal symptoms.
[Adapted from NICE’s guideline on menopause, recommendation 1.2.5]
Do not use the following laboratory and imaging tests to diagnose perimenopause or menopause in women aged over 45 years:
  • anti-Müllerian hormone
  • inhibin A
  • inhibin B
  • oestradiol
  • antral follicle count
  • ovarian volume.
[NICE’s guideline on menopause, recommendation 1.2.3]

Diagnosing premature ovarian insufficiency

This quality statement is taken from the menopause quality standard. The quality standard defines clinical best practice for diagnosing and managing menopause and should be read in full.

Quality statement

Women under 40 years presenting with menopausal symptoms have their levels of follicle-stimulating hormone (FSH) measured.

Rationale

An early diagnosis of premature ovarian insufficiency can mean these women get treatment and access to specialised services sooner. This is particularly important because this group of women have higher morbidity and mortality during menopause than women over 45 years. Although in women under age 40 menstrual history is often the first indication of premature ovarian insufficiency, persistently elevated FSH levels are needed to confirm the diagnosis in this age group. Changes in menstrual history can also suggest other conditions, for example, pregnancy or polycystic ovarian syndrome, and these should also be considered when making a diagnosis. Women with untreated premature ovarian insufficiency (particularly surgical menopause) are at increased risk of developing osteoporosis and cardiovascular disease.

Quality measures

Structure
Evidence of local arrangements to ensure that women under 40 years presenting with menopausal symptoms have their FSH levels measured.
Data source: Local data collection.
Process
Proportion of women under 40 years presenting with menopausal symptoms who have their FSH levels measured.
Numerator – the number in the denominator who have their FSH levels measured.
Denominator – the number of women under 40 years presenting with menopausal symptoms.
Data source: Local data collection.
Outcome
a) Proportion of women with premature ovarian insufficiency who had a positive experience of the diagnostic process.
Data source: Local data collection.
b) Average time to diagnosis of premature ovarian insufficiency from first presenting with menopausal symptoms for women under 40 years.
Data source: Local data collection.
c) Incidence of premature ovarian insufficiency.
Data source: Local data collection.

What the quality statement means for different audiences

Service providers (primary and secondary care and community services) ensure that systems are in place for women under 40 presenting with menopausal symptoms to have their FSH levels measured.
Healthcare professionals (such as GPs, practice nurses and healthcare professionals with expertise in menopause) base a diagnosis of premature ovarian insufficiency on symptoms and elevated FSH levels in women under 40 who present with menopausal symptoms.
Commissioners (clinical commissioning groups and NHS England) ensure that they commission services in which women under 40 presenting with menopausal symptoms have their FSH levels measured.
Women under 40 who visit their GP or practice nurse with common symptoms of the menopause are offered blood tests for hormone levels to find out whether they have premature menopause (also known as premature ovarian insufficiency). The sooner a diagnosis is made, the sooner any treatment of symptoms can start.

Source guidance

Menopause (2015) NICE guideline NG23, recommendation 1.6.2

Definitions of terms used in this quality statement

Premature ovarian insufficiency
Menopause occurring before the age of 40 years, which is also known as premature ovarian failure or premature menopause. It can occur naturally or as a result of medical or surgical treatment.
[NICE’s guideline on menopause, terms used in the guideline]
Menopausal symptoms
Symptoms include the following:
  • no or infrequent periods (taking into account whether the women has a uterus)
  • hot flushes
  • night sweats
  • mood changes
  • memory and concentration loss
  • vaginal dryness
  • lack of interest in sex
  • headaches
  • joint and muscle stiffness.
[Adapted from NICE’s guideline on menopause, context section and recommendations 1.3.2 and 1.6.2]
Measuring FSH
Two blood samples taken 4 to 6 weeks apart.
[NICE’s guideline on menopause, recommendation 1.6.2]

Managing premature ovarian insufficiency

This quality statement is taken from the menopause quality standard. The quality standard defines clinical best practice for diagnosing and managing menopause and should be read in full.

Quality statement

Women with premature ovarian insufficiency are offered hormone replacement therapy (HRT) or a combined hormonal contraceptive.

Rationale

Women with premature ovarian insufficiency should be offered sex steroid replacement with either HRT or a combined hormonal contraceptive unless contraindicated (for example, because of hormone-sensitive cancer). Without treatment, these women can experience the effects of menopause for most of their adult life. This can lead to reduced quality of life and an increased risk of developing osteoporosis and cardiovascular disease, which can lead to early mortality.

Quality measures

Structure
Evidence of local arrangements to ensure that women with premature ovarian insufficiency are offered HRT or a combined hormonal contraceptive.
Data source: Local data collection.
Process
Proportion of women with premature ovarian insufficiency who receive HRT or a combined hormonal contraceptive.
Numerator – the number in the denominator receiving HRT or a combined hormonal contraceptive.
Denominator – the number of women with premature ovarian insufficiency.
Data source: Local data collection.
Outcome
a) Health-related quality of life for women with premature ovarian insufficiency.
Data source: Local data collection.
b) Long-term health effects (for example, osteoporosis or cardiovascular disease) in women with premature ovarian insufficiency.
Data source: Local data collection.

What the quality statement means for different audiences

Service providers (primary and secondary care) ensure that systems are in place for women with premature ovarian insufficiency to be offered HRT or a combined hormonal contraceptive.
Healthcare professionals (such as GPs, practice nurses and healthcare professionals with expertise in menopause) offer HRT or a combined hormonal contraceptive to women with premature ovarian insufficiency unless contraindicated (for example, in women with hormone-sensitive cancer).
Commissioners (clinical commissioning groups and NHS England) ensure that they commission services in which women with premature ovarian insufficiency are offered HRT or a combined hormonal contraceptive.
Women with early menopause (also known as premature ovarian insufficiency) are offered either HRT or the combined contraceptive pill to help relieve their symptoms if these treatments are suitable for them.

Source guidance

Menopause (2015) NICE guideline NG23, recommendation 1.6.6

Definitions of terms used in this quality statement

Premature ovarian insufficiency
Menopause occurring before the age of 40 years, which is also known as premature ovarian failure or premature menopause. It can occur naturally or as a result of medical or surgical treatment.
[NICE’s guideline on menopause, terms used in the guideline]

Reviewing treatments for menopausal symptoms

This quality statement is taken from the menopause quality standard. The quality standard defines clinical best practice for diagnosing and managing menopause and should be read in full.

Quality statement

Women having treatment for menopausal symptoms have a review 3 months after starting each treatment and then at least annually.

Rationale

A review 3 months after starting a treatment for menopausal symptoms ensures that changes to dosage or formulation can be made if there are persistent side effects such as bloating, nausea and breast discomfort. Once treatment is established, further review is needed to assess new or pre-existing health problems, to carry out basic health checks (for example, measuring weight and blood pressure), and to inform and engage women in national screening programmes. Review should take place at least once a year, but may be needed more often if there are clinical indications for this. For most women, the symptoms of menopause respond well to treatment. However, for some whose symptoms do not improve or side effects are troublesome, review will identify if they need to be referred for help and support from a healthcare professional with specialist training and expertise.

Quality measures

Structure
Evidence of local arrangements to ensure that women having treatment for menopausal symptoms have a review 3 months after starting each treatment and then at least annually.
Data source: Local data collection.
Process
a) Proportion of women having treatment for menopausal symptoms who have a review 3 months after starting treatment.
Numerator – the number in the denominator who have a review 3 months after starting treatment.
Denominator – the number of women having treatment for menopausal symptoms.
Data source: Local data collection.
b) Proportion of women receiving treatment for menopausal symptoms who have an annual review within 12 months of the 3-month review or last annual review.
Numerator – the number in the denominator who have an annual review within 12 months of the 3-month review or last annual review.
Denominator – the number of women receiving treatment for menopausal symptoms.
Data source: Local data collection.

What the quality statement means for different audiences

Service providers (primary care) ensure that women having treatment for menopausal symptoms have a review 3 months after starting each treatment and then at least annually.
Healthcare professionals (such as GPs and practice nurses) ensure that they offer women a review 3 months after starting each treatment for menopausal symptoms, and then at least annually.
Commissioners (clinical commissioning groups and NHS England) ensure that they commission services in which women having treatment for menopausal symptoms have a review 3 months after starting each treatment and then at least annually.
Women having treatment to help with symptoms of the menopause have a review 3 months after starting each treatment, and then have a review at least once a year. The aim of a review is to check that the treatment is working and that side effects are not a problem.

Source guidance

Menopause (2015) NICE guideline NG23, recommendation 1.4.19

Definitions of terms used in this quality statement

Menopausal symptoms
Symptoms include the following:
  • hot flushes
  • night sweats
  • mood changes
  • memory and concentration loss
  • vaginal dryness
  • lack of interest in sex
  • headaches
  • joint and muscle stiffness.
[Adapted from NICE’s guideline on menopause, context section and recommendation 1.3.2]

Information for women having treatment likely to cause menopause

This quality statement is taken from the menopause quality standard. The quality standard defines clinical best practice for diagnosing and managing menopause and should be read in full.

Quality statement

Women who are likely to go through menopause as a result of medical or surgical treatment are given information about menopause and fertility before they have their treatment.

Rationale

Some medical or surgical treatments can affect fertility and induce menopause. Women should be given information so that they know about these long-term consequences of treatment. Women who go through menopause as a result of medical or surgical treatment may be younger than women having natural menopause, and so are less likely to know about menopausal symptoms. Awareness of symptoms ensures that women access treatment and services as soon as they need them. This is important because these women are at higher risk of psychological and physical morbidity.

Quality measures

Structure
Evidence of local arrangements to ensure that women who are likely to go through menopause as a result of medical or surgical treatment are given information about menopause and fertility before they have their treatment.
Data source: Local data collection.
Process
Proportion of women having medical or surgical treatment that is likely to cause the menopause who are given information about menopause and fertility before they have their treatment.
Numerator – the number in the denominator who are given information about menopause and fertility before they have their treatment.
Denominator – the number of women who have medical or surgical treatment that is likely to cause the menopause.
Data source: Local data collection.
Outcome
Women having medical or surgical treatment that is likely to cause the menopause are aware of the symptoms of menopause.
Data source: Local data collection.

What the quality statement means for different audiences

Service providers (secondary care) ensure that systems are in place for women who are likely to go through menopause as a result of medical or surgical treatment to be given information about menopause and fertility before they have their treatment.
Healthcare professionals (such as secondary care consultants) ensure that before treatment they give information about menopause and fertility to women who are likely to go through menopause as a result of medical or surgical treatment.
Commissioners (clinical commissioning groups) ensure that they commission services in which women who are likely to go through menopause as a result of medical or surgical treatment are given information about menopause and fertility before they have their treatment.
Women having treatment or surgery that is likely to cause the menopause are given information about menopause and effects on fertility before they have their treatment. This is so that they have all the information they need before deciding to go ahead with the treatment. Treatments that are likely to cause the menopause include chemotherapy and radiotherapy to treat cancer, and surgery that involves the ovaries.

Source guidance

Menopause (2015) NICE guideline NG23, recommendation 1.3.6

Definitions of terms used in this quality statement

Medical or surgical treatment
Treatments that are likely to cause menopause include:
  • radiotherapy and chemotherapy for cancer
  • gynaecological surgery that involves the ovaries.
[Adapted from NICE’s guideline on menopause, recommendation 1.3.6]
Information
Information should include:
  • risk of impaired or loss of fertility
  • risk of early menopause
  • common menopausal symptoms
  • longer-term health implications of menopause
  • contraceptive advice.
[Adapted from NICE’s guideline on menopause, recommendations 1.3.1 and 1.3.5, and full guideline]

Equality and diversity considerations

All information should be culturally appropriate and accessible to women with additional needs, such as physical, sensory or learning disabilities, and to women who do not speak or read English. Interpreters and advocates should be provided if needed.

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Implementation

NICE has produced resources to help implement its guidance on:

Information for the public

NICE produces information for the public that summarises, in plain English, the recommendations that NICE makes to healthcare and other professionals.
NICE has written information for the public explaining its guidance on each of the following topics.

Pathway information

Your responsibility

Guidelines

The recommendations in this interactive flowchart represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take these recommendations fully into account, alongside the individual needs, preferences and values of their patients or service users. The application of the recommendations in this interactive flowchart is not mandatory and does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.
Local commissioners and/or providers have a responsibility to enable the interactive flowchart to be applied when individual health professionals and their patients or service users wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this interactive flowchart should be interpreted in a way that would be inconsistent with compliance with those duties.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

Technology appraisals

The recommendations in this interactive flowchart represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, health professionals are expected to take these recommendations fully into account, alongside the individual needs, preferences and values of their patients. The application of the recommendations in this interactive flowchart is at the discretion of health professionals and their individual patients and do not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.
Commissioners and/or providers have a responsibility to provide the funding required to enable the recommendations to be applied when individual health professionals and their patients wish to use it, in accordance with the NHS Constitution. They should do so in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

Medical technologies guidance, diagnostics guidance and interventional procedures guidance

The recommendations in this interactive flowchart represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, healthcare professionals are expected to take these recommendations fully into account. However, the interactive flowchart does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
Commissioners and/or providers have a responsibility to implement the recommendations, in their local context, in light of their duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations. Nothing in this interactive flowchart should be interpreted in a way that would be inconsistent with compliance with those duties.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

Person-centred care

People have the right to be involved in discussions and make informed decisions about their care, as described in your care.
Making decisions using NICE guidelines explains how we use words to show the strength (or certainty) of our recommendations, and has information about prescribing medicines (including off label use), professional guidelines, standards and laws (including on consent and mental capacity), and safeguarding.

Supporting information

Explain to women with a uterus that unscheduled vaginal bleeding is a common side effect of HRT within the first 3 months of treatment but should be reported at the 3-month review appointment, or promptly if it occurs after the first 3 months (see what NICE says on endometrial cancer in suspected cancer recognition and referral).
Offer women who are stopping HRT a choice of gradually reducing or immediately stopping treatment.
Explain to women that:
  • gradually reducing HRT may limit recurrence of symptoms in the short term
  • gradually reducing or immediately stopping HRT makes no difference to their symptoms in the longer term.
Absolute rates of coronary heart disease for different types of hormone replacement therapy (HRT) compared with no HRT (or placebo), different durations of HRT use and time since stopping HRT for menopausal women
Difference in coronary heart disease incidence per 1000 menopausal women over 7.5 years (95% confidence interval) (baseline population risk in the UK over 7.5 years: 26.3 per 1000Results from Weiner 2008 were used for the baseline population risk estimation. )
Current HRT users
Treatment duration <5 years
Treatment duration 5–10 years
>5 years since stopping treatment
Women on oestrogen alone
RCT estimateFor women aged 50–59 years at entry to the RCT.
6 fewer (–10 to 1)
No available data
No available data
6 fewer (–9 to –2)
Observational estimateObservational estimates are based on cohort studies with several thousand women.
6 fewer (–9 to –3)
No available data
No available data
No available data
Women on oestrogen + progestogen
RCT estimate
5 more (–3 to 18)
No available data
No available data
4 more (–1 to 11)
Observational estimate
No available data
No available data
No available data
No available data
HRT, hormone replacement therapy; RCT, randomised controlled trial
For full source references, see Appendix M in the full guideline.
Absolute rates of stroke for different types of hormone replacement therapy (HRT) compared with no HRT (or placebo), different durations of HRT use and time since stopping HRT for menopausal women
Difference in stroke incidence per 1000 menopausal women over 7.5 years (95% confidence interval) (baseline population risk in the UK over 7.5 years: 11.3 per 1000Results from Weiner 2008 were used for the baseline population risk estimation. )
Current HRT users
Treatment duration <5 years
Treatment duration 5–10 years
>5 years since stopping treatment
Women on oestrogen alone
RCT estimateFor women aged 50–59 years at entry to the RCT.
0 (–5 to 10)
No available data
No available data
1 more (–4 to 9)
Observational estimateObservational estimates are based on cohort studies with several thousand women.
3 more (–1 to 8)
No available data
No available data
No available data
Women on oestrogen + progestogen
RCT estimate
6 more (–2 to 21)
No available data
No available data
4 more (–1 to 13)
Observational estimate
4 more (1 to 7)
No available data
No available data
No available data
HRT, hormone replacement therapy; RCT, randomised controlled trial
For full source references, see Appendix M in the full guideline.
Absolute rates of breast cancer for different types of hormone replacement therapy (HRT) compared with no HRT (or placebo), different durations of HRT use and time since stopping HRT for menopausal women
Difference in breast cancer incidence per 1000 menopausal women over 7.5 years (95% confidence interval) (baseline population risk in the UK over 7.5 years: 22.48 per 1000Office for National Statistics (2010) breast cancer incidence statistics. )
Current HRT users
Treatment duration <5 years
Treatment duration 5–10 years
>5 years since stopping treatment
Women on oestrogen alone
RCT estimateFor women aged 50–59 years at entry to the RCT.
4 fewer (–11 to 8)
No available data
No available data
5 fewer (–11 to 2)
Observational estimateObservational estimates are based on cohort studies with several thousand women.
6 more (1 to 12)Evidence on observational estimate demonstrated very serious heterogeneity without plausible explanation by subgroup analysis.
4 more (1 to 9)
5 more (–1 to 14)
5 fewer (–9 to –1)
Women on oestrogen + progestogen
RCT estimate
5 more (–4 to 36)
No available data
No available data
8 more (1 to 17)
Observational estimate
17 more (14 to 20)
12 more (6 to 19)
21 more (9 to 37)
9 fewer (–16 to 13)Evidence on observational estimate demonstrated very serious imprecision in the estimate of effect.
HRT, hormone replacement therapy; RCT, randomised controlled trial
For full source references, see Appendix M in the full guideline.
Absolute rates of any fragility fracture for hormone replacement therapy (HRT) compared with no HRT (or placebo), different durations of HRT use and time since stopping HRT for menopausal women
Difference in any fragility fracture incidence per 1000 menopausal women (95% confidence interval) (see footnotes for information on baseline population risk and length of follow-up time over which absolute risk difference is calculated)
Current HRT users
Treatment duration <5 years
Treatment duration 5–10 years
>5 years since stopping treatment
Women on any HRT
RCT estimateFor women aged 50–59 years at entry to the RCT.
23 fewer (–10 to –33)Baseline population risk = 69 per 1000 women (follow-up: 3.43 years).
25 fewer (–9 to –37)Baseline population risk = 78 per 1000 women (follow-up: 3.71 years).
No available data
No available data
Observational estimateObservational estimate is based on cohort studies with several thousand women.
16 fewer (–15 to –18)Baseline population risk = 15.4 per 1000 women (follow-up: 2.8 years).
15 fewer (–11 to –17)
18 fewer (–15 to –20)
2 more (–19 to 27)Baseline population risk = 106 per 1000 women (follow-up: 5 years).
HRT, hormone replacement therapy; RCT, randomised controlled trial
For full source references, see Appendix M in the full guideline.
Absolute risks calculated by using the baseline population risk in the control arm for each analysis, following GRADE methodology.

Glossary

unregulated plant-derived hormonal combinations similar or identical to human hormones that are compounded by pharmacies to the specification of the prescriber
fractures that result from mechanical forces that would not ordinarily result in fracture (such as a fall from a standing height or less). Reduced bone density is a major risk factor for fragility fractures, which occur most commonly in the spine, hip and wrist
hormone replacement therapy
mild depression symptoms that impair quality of life but are usually intermittent and often associated with hormonal fluctuations in perimenopause
a 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 having occurred when a woman has not had a period for 12 consecutive months (for women reaching menopause naturally). The changes associated with menopause occur when the ovaries stop maturing eggs and secreting oestrogen and progesterone
the time in which a woman has irregular cycles of ovulation and menstruation leading up to menopause and continuing until 12 months after her final period (also known as menopausal transition or climacteric)
menopause occurring before the age of 40 years (also known as premature ovarian failure or premature menopause). It can occur naturally or as a result of medical or surgical treatment
thinning and shrinking of the tissues of the vulva, vagina, urethra and bladder caused by oestrogen deficiency. This results in multiple symptoms such as vaginal dryness, vaginal irritation, a frequent need to urinate and urinary tract infections
menopausal symptoms such as hot flushes and night sweats caused by constriction and dilatation of blood vessels in the skin that can lead to a sudden increase in blood flow to allow heat loss. These symptoms can have a major impact on activities of daily living

Paths in this pathway

Pathway created: November 2015 Last updated: March 2017

© NICE 2017

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