Guidance on the management of menopause

The guidance below is largely based on the 2015 NICE publication (NG23): Menopause: diagnosis and management. Further advice and support is also available to healthcare professionals, via the British Menopause Society website.

The 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. This is not usually abrupt, but a gradual process during which women experience perimenopause before reaching postmenopause. Usually it is defined as having occurred when a woman has not had a period for 12 consecutive months (for women reaching menopause naturally).

As well as a change in their menstrual cycle women may experience a variety of symptoms associated with menopause such as hot flushes and sweats, low mood, vaginal dryness, low sexual desire etc.

Most women (8 out of 10) experience some symptoms, typically lasting about 4 years after the last period, but continuing for up to 12 years in about 10% of women. Prolonged lack of oestrogen affects the bones and cardiovascular system and postmenopausal women are at increased risk of a number of long-term conditions, such as osteoporosis.

The information described below is not intended for women with premature ovarian insufficiency. Refer to NICE guideline 23 for further details on the management of menopause occurring before the age of 40 years.

Diagnosis

Laboratory tests are rarely required to diagnose perimenopause or menopause in women aged over 45 and should not be taken.

Follicle-stimulating hormone (FSH) fluctuates considerably over short periods of time during the years leading up to menopause and so blood levels are not a helpful addition to what is a clinical diagnosis.

If a woman is aged over 45 years and has not had a period for at least 12 months, or has vasomotor symptoms and irregular periods (or just symptoms if she doesn't have a uterus), this is adequate information to diagnose menopause and perimenopause respectively.

FSH tests should not be used to diagnose menopause in those taking combined oestrogen and progestogen contraception or high-dose progestogen because these affect FSH measurements.

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.

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, or in women aged under 40 years in whom menopause is suspected.

Managing short-term menopausal symptoms

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

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

Review each treatment for short-term menopausal symptoms at 3 months to assess efficacy and tolerability. Thereafter annually unless there are clinical indications for an earlier review.

Vasomotor symptoms

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

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.

Psychological symptoms

Consider HRT to alleviate low mood; cognitive behavioural therapy (CBT) may also be considered to alleviate low mood or anxiety that arise as a result of the menopause.

There is no clear evidence for SSRIs or SNRIs to ease low mood in menopausal women who have not been diagnosed with depression.

Urogenital atrophy

Urogenital atrophy results in multiple symptoms such as vaginal dryness, vaginal irritation, a frequent need to urinate and urinary tract infections.

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

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

Consider vaginal oestrogen for women with urogenital atrophy in whom systemic HRT is contraindicated, after seeking specialist advice.

Consider increasing the dose after seeking specialist advice if symptoms are not relieved from initial treatment with vaginal oestrogen.

Explain to women that symptoms often come back when treatment is stopped; adverse effects from vaginal oestrogen are very rare; any unscheduled vaginal bleeding should be reported to their GP.

Vaginal oestrogen preparations to be used in the relief of vaginal atrophy can be found here 7.2.1 Preparations for vaginal and vulval changes.

Women with, or at high risk of, breast cancer

  • The SSRIs paroxetine and fluoxetine should not be offered to women with breast cancer who are taking tamoxifen
  • Menopausal women with, or at high risk of, breast cancer should be referred to a specialist gynaecologist

Refer also to NICE clinical guideline 80: Early and locally advanced breast cancer: diagnosis and treatment, and NICE clinical guideline 164: Familial breast cancer: classification, care and managing breast cancer and related risks in people with a family history of breast cancer.

Risks and benefits of HRT

It is important to provide information on the benefits and risks of HRT to help women make an informed choice about which treatment to use for menopausal symptoms.

The benefits and risks for HRT have been summarised, and are described below. Refer also to individual product Summary or Product Characteristics (SPCs) and MHRA Drug Safety Update (September 2007).

Tables and further information used to support the explanation of risk to women are available via NICE guideline 23, the BNF, and the British Menopause Society website.

For the treatment of menopausal symptoms, the benefits of short-term HRT outweigh the risks in the majority of women, especially in those aged under 60 years.

For healthy women without symptoms, the risk: benefit of HRT is generally unfavourable.

HRT increases the risk of venous thromboembolism, stroke, endometrial cancer (reduced by a progestogen), breast cancer, and ovarian cancer; there is an increased risk of coronary heart disease in women who start combined HRT more than 10 years after menopause.

HRT does not prevent coronary heart disease or protect against a decline in cognitive function and it should not be prescribed for these purposes. Experience of treating women over 65 years with HRT is limited.

Considerations when prescribing HRT

Starting, stopping and reviewing HRT prescriptions

Every decision to start HRT should be made individually, giving the woman all the information they need. The decision to prescribe HRT should be based on a thorough evaluation of the potential benefits and risks of treatment (see above). The lowest effective dose should be used for the shortest possible time for symptom control. Increases in dosage should only be made according to an inadequate response.

The British Menopause Society recommends that if HRT is to be used in women over 60 years of age, lower doses should be started, preferably with a transdermal route of administration.

HRT relieves menopausal symptoms. In most cases, 2-3 years therapy is sufficient, but some patients may need longer; this judgement should be made on a case-by-case basis with regular attempts to discontinue. Symptoms may recur for a short time after stopping HRT.

Review women commenced on HRT (or whose HRT prescription has changed) after 3 months to assess efficacy and tolerability. Once a woman is established on HRT, treatment should be reviewed at least annually. At this time alternative treatments for osteoporosis should also be considered.

Estradiol levels are rarely indicated. If it is thought necessary to perform such tests, please seek advice from the biochemistry laboratory or a specialist as to which test to use.

See the BNF for reasons where HRT should be stopped (pending investigation and treatment)

Offer women who are stopping HRT a choice of gradually reducing or immediately stopping treatment. Gradually reducing HRT may limit recurrence of symptoms in the short term but makes no difference to their symptoms in the longer term. A gradual reduction is possible by reducing the dose or using an "alternative day" regimen to tail off the prescription.

HRT choice

For women without a uterus, oestrogen-only therapy is appropriate, however, in endometriosis, endometrial foci may remain despite hysterectomy and the addition of a progestogen should be considered in these circumstances. For women with a uterus, oestrogen plus progestogen is recommended. A progestogen should be added to reduce the risk of cystic hyperplasia of the endometrium and possible transformation to cancer.

The choice of HRT for an individual depends on an overall balance of indication, risk, and convenience. A woman with a uterus normally requires oestrogen with cyclical progestogen for the last 12 to 14 days of the cycle or a preparation which involves continuous administration of an oestrogen and a progestogen. Cyclical HRT usually results in regular withdrawal bleeding towards the end of the progestogen.

Continuous combined preparations or tibolone are not suitable for use in the perimenopause or within 12 months of the last menstrual period; women who use such preparations may bleed irregularly in the early stages of treatment—if bleeding continues endometrial abnormality should be ruled out and consideration given to changing to cyclical HRT. Continuous combined preparations should be reserved for women who do not want withdrawal bleeding.

NICE guidance recommends that unscheduled vaginal bleeding is a common side effect of HRT within the first 3 months of treatment for women with a uterus, which should be reported at the 3-month review appointment, or promptly if it occurs after the first 3 months; this follows recommendations on endometrial cancer in the guideline on suspected cancer.

Prior to prescribing, patients may wish to know that conjugated oestrogens (Premarin®, Prempak-C® and Premique®) are derived from urine of farmed horses.

Remind peri-menopausal women that HRT is not a contraceptive and that contraceptive precautions are still necessary.

Choice of formulation

Formulary oral and transdermal HRT preparations can be found here 6.4.1 Female sex hormones and their modulators

Vaginal oestrogen preparations to be used in the relief of vaginal atrophy can be found <here (link)>. Guidance relating to the use of vaginal preparations can be found in the Section 'Managing short-term menopausal symptoms'.

Oral therapies have a lower acquisition cost in comparison to transdermal preparations. They are often well tolerated and are an appropriate first choice for many patients.

Oral HRT is ingested and metabolised in the liver. While undergoing first pass metabolism it affects the clotting cascade, thus increasing a woman's tendency towards thrombosis. Transdermal oestrogens are absorbed directly into the bloodstream, thus having less effect on the coagulation factors in the liver. Consideration should be given to transdermal rather than oral HRT preparations for menopausal women who are at increased risk of venous thromboembolism.

Complementary therapies and unregulated preparations

The efficacy and safety of unregulated compounded bioidentical hormones (unregulated plant-derived hormonal combinations) are unknown. The quality, purity and constituents of products may be unknown.

There is an association between black cohosh and a risk of liver toxicity, with some isolated reports of serious liver damage. The Medicines and Healthcare products Regulatory Agency (MHRA) say that all black cohosh products should carry a warning about possible liver toxicity. Different preparations may vary, and interactions with other medicines have been reported. NICE states that although there is some evidence that isoflavones or black cohosh may relieve vasomotor symptoms, women should be informed that multiple preparations are available and their safety is uncertain.

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 and persistence of effect
  • variation in the nature and potency of preparations
  • potential serious interactions with other drugs (including tamoxifen, anticoagulants, anticonvulsants and other antidepressants)

Contact your local Medicines Information Department for further information regarding interactions.

 

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