Recommendations

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 of our recommendations, and has information about safeguarding, consent and prescribing medicines (including 'off-label' use).

1.1 Individualised care

1.1.1 Adopt an individualised approach at all stages of diagnosis, investigation and management of menopause. Follow recommendations in the NICE guideline on patient experience in adult NHS services.

1.2 Diagnosis of perimenopause and menopause

1.2.1 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.

1.2.2 Take into account that it can be difficult to diagnose menopause in women who are taking hormonal treatments, for example for the treatment of heavy periods.

1.2.3 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.

1.2.4 Do not use a serum follicle-stimulating hormone (FSH) test to diagnose menopause in women using combined oestrogen and progestogen contraception or high-dose progestogen.

1.2.5 Consider using a FSH test to diagnose menopause only:

  • in women aged 40 to 45 years with menopausal symptoms, including a change in their menstrual cycle

  • in women aged under 40 years in whom menopause is suspected (see also section 1.6).

1.3 Information and advice

1.3.1 Give information to menopausal women and their family members or carers (as appropriate) that includes:

  • an explanation of the stages of menopause

  • common symptoms (see recommendation 1.3.2) and diagnosis

  • lifestyle changes and interventions that could help general health and wellbeing

  • benefits and risks of treatments for menopausal symptoms

  • long-term health implications of menopause.

1.3.2 Explain to women that as well as a change in their menstrual cycle they 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).

1.3.3 Give information to menopausal women and their family members or carers (as appropriate) about the following types of treatment for menopausal symptoms:

  • hormonal, for example hormone replacement therapy (HRT)

  • non-hormonal, for example clonidine

  • non-pharmaceutical, for example cognitive behavioural therapy (CBT).

1.3.4 Give information on menopause in different ways to help encourage women to discuss their symptoms and needs.

1.3.5 Give information about contraception to women who are in the perimenopausal and postmenopausal phase. See guidance from the Faculty of Sexual & Reproductive Healthcare on contraception for women aged over 40 years.

1.3.6 Offer women who are likely to go through menopause as a result of medical or surgical treatment (including women with cancer, at high risk of hormone-sensitive cancer or having gynaecological surgery) support and:

  • information about menopause and fertility before they have their treatment

  • referral to a healthcare professional with expertise in menopause.

1.4 Managing short-term menopausal symptoms

The recommendations in this section are not intended for women with premature ovarian insufficiency (see recommendations 1.6.6 to 1.6.8 for management of premature ovarian insufficiency).

1.4.1 Adapt a woman's treatment as needed, based on her changing symptoms.

Vasomotor symptoms

1.4.2 Offer women HRT for vasomotor symptoms after discussing with them the short-term (up to 5 years) and longer-term benefits and risks. Offer a choice of preparations as follows:

  • oestrogen and progestogen to women with a uterus

  • oestrogen alone to women without a uterus.

1.4.3 Do not routinely offer selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs) or clonidine as first-line treatment for vasomotor symptoms alone.

1.4.4 Explain to women that there is some evidence that isoflavones or black cohosh may relieve vasomotor symptoms. However, explain that:

  • multiple preparations are available and their safety is uncertain

  • different preparations may vary

  • interactions with other medicines have been reported.

Psychological symptoms

1.4.5 Consider HRT to alleviate low mood that arises as a result of the menopause.

1.4.6 Consider CBT to alleviate low mood or anxiety that arise as a result of the menopause.

1.4.7 Ensure that menopausal women and healthcare professionals involved in their care understand that there is no clear evidence for SSRIs or SNRIs to ease low mood in menopausal women who have not been diagnosed with depression (see the NICE guideline on depression in adults).

Altered sexual function

1.4.8 Consider testosterone[1] supplementation for menopausal women with low sexual desire if HRT alone is not effective.

Urogenital atrophy

1.4.9 Offer vaginal oestrogen to women with urogenital atrophy (including those on systemic HRT) and continue treatment for as long as needed to relieve symptoms.

1.4.10 Consider vaginal oestrogen for women with urogenital atrophy in whom systemic HRT is contraindicated, after seeking advice from a healthcare professional with expertise in menopause.

1.4.11 If vaginal oestrogen does not relieve symptoms of urogenital atrophy, consider increasing the dose after seeking advice from a healthcare professional with expertise in menopause.

1.4.12 Explain to women with urogenital atrophy that:

  • symptoms often come back when treatment is stopped

  • adverse effects from vaginal oestrogen are very rare

  • they should report unscheduled vaginal bleeding to their GP.

1.4.13 Advise women with vaginal dryness that moisturisers and lubricants can be used alone or in addition to vaginal oestrogen.

1.4.14 Do not offer routine monitoring of endometrial thickness during treatment for urogenital atrophy.

Complementary therapies and unregulated preparations

1.4.15 Explain to women that the efficacy and safety of unregulated compounded bioidentical hormones are unknown.

1.4.16 Explain to women who wish to try complementary therapies that the quality, purity and constituents of products may be unknown.

1.4.17 Advise women with a history of, or at high risk of, breast cancer that, although there is some evidence that St John's wort may be of benefit in the relief of vasomotor symptoms, there is uncertainty about:

  • appropriate doses

  • persistence of effect

  • variation in the nature and potency of preparations

  • potential serious interactions with other drugs (including tamoxifen, anticoagulants and anticonvulsants).

Review and referral

1.4.18 Discuss with women the importance of keeping up to date with nationally recommended health screening.

1.4.19 Review each treatment for short-term menopausal symptoms:

  • at 3 months to assess efficacy and tolerability

  • annually thereafter unless there are clinical indications for an earlier review (such as treatment ineffectiveness, side effects or adverse events).

1.4.20 Refer women to a healthcare professional with expertise in menopause if treatments do not improve their menopausal symptoms or they have ongoing troublesome side effects.

1.4.21 Consider referring women to a healthcare professional with expertise in menopause if:

  • they have menopausal symptoms and contraindications to HRT or

  • there is uncertainty about the most suitable treatment options for their menopausal symptoms.

Starting and stopping HRT

1.4.22 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 recommendations on endometrial cancer in the NICE guideline on suspected cancer).

1.4.23 Offer women who are stopping HRT a choice of gradually reducing or immediately stopping treatment.

1.4.24 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.

Women with, or at high risk of, breast cancer

1.4.25 For advice on the treatment of menopausal symptoms in women with breast cancer or at high risk of breast cancer, see section 1.13 of the NICE guideline on early and locally advanced breast cancer and section 1.7 of the NICE guideline on familial breast cancer.

1.4.26 Offer 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

  • referral to a healthcare professional with expertise in menopause.

1.5 Long-term benefits and risks of hormone replacement therapy

Venous thromboembolism

1.5.1 Explain to women that:

  • the risk of venous thromboembolism (VTE) is increased by oral HRT compared with baseline population risk

  • the risk of VTE associated with HRT is greater for oral than transdermal preparations

  • the risk associated with transdermal HRT given at standard therapeutic doses is no greater than baseline population risk.

1.5.2 Consider transdermal rather than oral HRT for menopausal women who are at increased risk of VTE, including those with a BMI over 30 kg/m2.

1.5.3 Consider referring menopausal women at high risk of VTE (for example, those with a strong family history of VTE or a hereditary thrombophilia) to a haematologist for assessment before considering HRT.

Cardiovascular disease

1.5.4 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

  • does not affect the risk of dying from cardiovascular disease.

1.5.5 Be aware that the presence of cardiovascular risk factors is not a contraindication to HRT as long as they are optimally managed.

1.5.6 Using tables 1 and 2, explain to women that:

  • the baseline risk of coronary heart disease and stroke for women around menopausal age varies from one woman to another according to the presence of cardiovascular risk factors

  • HRT with oestrogen alone is associated with no, or reduced, risk of coronary heart disease

  • HRT with oestrogen and progestogen is associated with little or no increase in the risk of coronary heart disease.

1.5.7 Explain to women that taking oral (but not transdermal) oestrogen is associated with a small increase in the risk of stroke. Also explain that the baseline population risk of stroke in women aged under 60 years is very low (see table 2).

Table 1 Absolute rates of coronary heart disease for different types of 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 1000 1 )

Current HRT users

Treatment duration <5 years

Treatment duration 5–10 years

>5 years since stopping treatment

Women on oestrogen alone

RCT estimate2

6 fewer

(-10 to 1)

No available data

No available data

6 fewer

(-9 to -2)

Observational estimate3

6 fewer

(-9 to -3)

No available data

No available data

No available data

Women on oestrogen + progestogen

RCT estimate2

5 more

(-3 to 18)

No available data

No available data

4 more

(-1 to 11)

Observational estimate3

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.

1 Results from Weiner 2008 were used for the baseline population risk estimation.

2 For women aged 50–59 years at entry to the RCT.

3 Observational estimates are based on cohort studies with several thousand women.

Table 2 Absolute rates of stroke for different types of 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 1000 1)

Current HRT users

Treatment duration <5 years

Treatment duration 5–10 years

>5 years since stopping treatment

Women on oestrogen alone

RCT estimate2

0

(-5 to 10)

No available data

No available data

1 more

(-4 to 9)

Observational estimate3

3 more

(-1 to 8)

No available data

No available data

No available data

Women on oestrogen + progestogen

RCT estimate2

6 more

(-2 to 21)

No available data

No available data

4 more

(-1 to 13)

Observational estimate3

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.

1 Results from Weiner 2008 were used for the baseline population risk estimation.

2 For women aged 50–59 years at entry to the RCT.

3 Observational estimates are based on cohort studies with several thousand women.

Type 2 diabetes

1.5.8 Explain to women that taking HRT (either orally or transdermally) is not associated with an increased risk of developing type 2 diabetes.

1.5.9 Ensure that women with type 2 diabetes and all healthcare professionals involved in their care are aware that HRT is not generally associated with an adverse effect on blood glucose control.

1.5.10 Consider HRT for menopausal symptoms in women with type 2 diabetes after taking comorbidities into account and seeking specialist advice if needed.

Breast cancer

1.5.11 Using table 3, explain to women around the age of natural menopause that:

  • the baseline risk of breast cancer for women around menopausal age varies from one woman to another according to the presence of underlying risk factors

  • HRT with oestrogen alone is associated with little or no change in the risk of breast cancer

  • HRT with oestrogen and progestogen can be associated with an increase in the risk of breast cancer

  • any increase in the risk of breast cancer is related to treatment duration and reduces after stopping HRT.

Table 3 Absolute rates of breast cancer for different types of 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 1000 1 )

Current HRT users

Treatment duration <5 years

Treatment duration 5–10 years

>5 years since stopping treatment

Women on oestrogen alone

RCT estimate2

4 fewer

(-11 to 8)

No available data

No available data

5 fewer

(-11 to 2)

Observational estimate3

6 more

(1 to 12)4

4 more

(1 to 9)

5 more

(-1 to 14)

5 fewer

(-9 to -1)

Women on oestrogen + progestogen

RCT estimate2

5 more

(-4 to 36)

No available data

No available data

8 more

(1 to 17)

Observational estimate3

17 more

(14 to 20)

12 more

(6 to 19)

21 more

(9 to 37)

9 fewer

(-16 to 13)5

HRT, hormone replacement therapy; RCT, randomised controlled trial

For full source references, see Appendix M in the full guideline.

1 Office for National Statistics (2010) breast cancer incidence statistics.

2 For women aged 50–59 years at entry to the RCT.

3 Observational estimates are based on cohort studies with several thousand women.

4 Evidence on observational estimate demonstrated very serious heterogeneity without plausible explanation by subgroup analysis.

5 Evidence on observational estimate demonstrated very serious imprecision in the estimate of effect.

Osteoporosis

1.5.12 Give women advice on bone health and discuss these issues at review appointments (see the NICE guideline on osteoporosis: assessing the risk of fragility fracture).

1.5.13 Using table 4, explain to women that the baseline population risk of fragility fracture for women around menopausal age in the UK is low and varies from one woman to another.

1.5.14 Using table 4, explain to women that their risk of fragility fracture is decreased while taking HRT and that this benefit:

  • is maintained during treatment but decreases once treatment stops

  • may continue for longer in women who take HRT for longer.

Table 4 Absolute rates of any fragility fracture for 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 estimate1

23 fewer

(-10 to -33)3

25 fewer

(-9 to -37)4

No available data

No available data

Observational estimate2

16 fewer

(-15 to -18)5

15 fewer

(-11 to -17)5

18 fewer

(-15 to -20)5

2 more

(-19 to 27)6

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.

1 For women aged 50–59 years at entry to the RCT.

2 Observational estimate is based on cohort studies with several thousand women.

3 Baseline population risk = 69 per 1000 women (follow-up: 3.43 years).

4 Baseline population risk = 78 per 1000 women (follow-up: 3.71 years).

5 Baseline population risk = 15.4 per 1000 women (follow-up: 2.8 years).

6 Baseline population risk = 106 per 1000 women (follow-up: 5 years).

Dementia

1.5.15 Explain to menopausal women that the likelihood of HRT affecting their risk of dementia is unknown.

Loss of muscle mass and strength

1.5.16 Explain to women that:

  • there is limited evidence suggesting that HRT may improve muscle mass and strength

  • muscle mass and strength is maintained through, and is important for, activities of daily living.

1.6 Diagnosing and managing premature ovarian insufficiency

Diagnosing premature ovarian insufficiency

1.6.1 Take into account the woman's clinical history (for example, previous medical or surgical treatment) and family history when diagnosing premature ovarian insufficiency.

1.6.2 Diagnose premature ovarian insufficiency in women aged under 40 years based on:

  • menopausal symptoms, including no or infrequent periods (taking into account whether the woman has a uterus) and

  • elevated FSH levels on 2 blood samples taken 4–6 weeks apart.

1.6.3 Do not diagnose premature ovarian insufficiency on the basis of a single blood test.

1.6.4 Do not routinely use anti-Müllerian hormone testing to diagnose premature ovarian insufficiency.

1.6.5 If there is doubt about the diagnosis of premature ovarian insufficiency, refer the woman to a specialist with expertise in menopause or reproductive medicine.

Managing premature ovarian insufficiency

1.6.6 Offer sex steroid replacement with a choice of HRT or a combined hormonal contraceptive to women with premature ovarian insufficiency, unless contraindicated (for example, in women with hormone-sensitive cancer).

1.6.7 Explain to women with premature ovarian insufficiency:

  • the importance of starting hormonal treatment either with HRT or a combined hormonal contraceptive and continuing treatment until at least the age of natural menopause (unless contraindicated)

  • that the baseline population risk of diseases such as breast cancer and cardiovascular disease increases with age and is very low in women aged under 40

  • that HRT may have a beneficial effect on blood pressure when compared with a combined oral contraceptive

  • that both HRT and combined oral contraceptives offer bone protection

  • that HRT is not a contraceptive.

1.6.8 Give women with premature ovarian insufficiency and contraindications to hormonal treatments advice, including on bone and cardiovascular health, and symptom management.

1.6.9 Consider referring women with premature ovarian insufficiency to healthcare professionals who have the relevant experience to help them manage all aspects of physical and psychosocial health related to their condition.

Terms used in this guideline

Compounded bioidentical hormones Unregulated plant-derived hormonal combinations similar or identical to human hormones that are compounded by pharmacies to the specification of the prescriber.

Fragility fracture 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.

Low mood Mild depressive symptoms that impair quality of life but are usually intermittent and often associated with hormonal fluctuations in perimenopause.

Menopause 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.

Menopausal women This includes women in perimenopause and postmenopause.

Perimenopause 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. The perimenopause is also known as the menopausal transition or climacteric.

Postmenopause The time after menopause has occurred, starting when a woman has not had a period for 12 consecutive months.

Premature ovarian insufficiency 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.

Urogenital atrophy 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.

Vasomotor symptoms 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.

You can also see this guideline in the NICE pathway on menopause.

To find out what NICE has said on topics related to this guideline, see our web page on menopause.



[1] At the time of publication (November 2015), testosterone did not have a UK marketing authorisation for this indication in women. The prescriber should follow relevant professional guidance, taking full responsibility for the decision. Informed consent should be obtained and documented. See the General Medical Council's Prescribing guidance: prescribing unlicensed medicines for further information.

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