Menopause & HRT prescribing guidance

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Presentation

Diagnosis of menopause should be based on the woman’s symptoms and age. Healthy women over 45 years with menopausal symptoms, diagnose without laboratory tests if the woman has:

  • vasomotor symptoms and irregular periods.
  • not had a period for at least 12 months.
  • had a hysterectomy and has symptoms
  • had a bilateral salpingo-oopherectomy (BSO) at any age

FSH level over 30 units/L is diagnostic of ovarian decline. Fluctuations of FSH in perimenopause limit its value. FSH should not be done if taking combined oestrogen and progestogen contraception.     

      Consider checking FSH if the woman is:

  • between 40 to45 years with menopausal symptoms, including a change in menstrual cycle.
  • younger than 40 years in whom premature ovarian insufficiency (POI) is suspected.

Consider HRT to manage menopause symptoms including vasomotor symptoms, psychological symptoms (including low mood that arises as result of menopause), altered sexual function and urogenital atrophy.

For most women with disruptive symptoms, the benefits of HRT are likely to outweigh the risks if they are below the age of 60 years or within 10 years of menopause. There is no arbitrary limit for as long as it is felt that benefits of symptom control and improvement in quality of life continue to outweigh any risks.

In women with POI or BSO, systemic HRT is strongly recommended, if there are no contraindications, until at least the average age of natural menopause (51 years in the UK) to prevent the early onset of osteoporosis, CVD, cognitive decline and to maintain sexual function.

HRT may be appropriate for prevention of osteoporosis related fractures in women below the age of 60 years or within 10 years of menopause in symptomatic women or for the prevention of osteoporosis in women who are at higher risk.

HRT is 1st line treatment for menopause related mood disorders. There is no clear evidence that SSRIs or SNRIs ease low mood in menopausal women who have not been diagnosed with depression.

Management

British Menopause Society: https://thebms.org.uk/

HRT Prescribing

Has Uterus

Consider contraceptive needs until age 55. Mirena IUS will provide contraception, control of menstrual bleeding and endometrial  protection for use with estrogen only HRT

No Uterus

Urogenital atrophy only

Perimenopausal (Less than1 year after LMP)

Post-menopausal (More than 1 year after LMP)

Estrogen Only

 

Low dose topical vaginal

estradiol or estriol

Combined sequential HRT:

 

Continuous estrogen with cyclical progestogen for 10-14 days in 28 day cycle, giving cyclical progestogen withdrawal bleed.

 

Consider changing to continuous combined HRT after 1 to2 years or from age 54 years

 

Continuous combined HRT:

Continuous estrogen and progestogen (cycle free)

 

Prescribe continuous combined

estrogen & progestogen

- If history of severe endometriosis & occasionally after subtotal hysterectomy

- seek specialist advice

 

Can also be added alongside

systemic HRT

Contraindications

Caution

Seek specialist advice

Current, past, or suspected breast cancer.

Known or suspected estrogen-sensitive cancer.

Undiagnosed abnormal vaginal bleeding.

 Untreated endometrial hyperplasia.

Current venous thromboembolism (deep vein thrombosis or pulmonary embolism), unless the woman continues on anticoagulant treatment.

Active or recent arterial thromboembolic disease (for example angina or myocardial infarction).

Untreated hypertension.

Active liver disease with abnormal liver function tests.

A personal or first degree relative with any history of venous thromboembolism (whether provoked or unprovoked)

 

Migraines (transdermal preparation starting low dose is advised with dose gradually increased to control symptoms)

Duration of treatment

No arbitrary limits should be placed on the dose or duration of usage of HRT as decisions should be made on an individualised basis after discussing the benefits and risks with each patient. In addition to the potential increased risks of breast cancer and VTE, they should also be considered in the context of the overall benefits obtained from using HRT including symptom management and improved quality of life as well as the cardiovascular and bone protective effects associated with HRT.

Risks

Venous thromboembolism (VTE)

The risk of VTE is increased by oral HRT, particularly in the first year of use. Background risk is 1.7 per 1000 women aged over 50.

The risk associated with transdermal HRT is no greater than baseline population risk.

Consider transdermal HRT if woman has VTE risk factors including BMI greater than30.

If high risk of VTE, including family history, consider referring to specialist service.

Cardiovascular disease (CVD)

The risk of coronary heart disease and stroke for women around menopause varies according to their own risk factors.

The presence of CVD risk factors is not a contraindication to HRT if they are optimally managed.

HRT initiated before the age of 60 or within 10 years of the menopause is likely to be associated with a reduction in coronary heart disease and cardiovascular mortality.

Oral (not transdermal) estrogen is associated with a small increased risk of stroke when started in women over the age of 60 years.

Breast cancer

 

Lifestyle risk factors to discuss with patients: https://thebms.org.uk/wp-content/uploads/2016/04/WHC-UnderstandingRisksofBreastCancer-MARCH2017.pdf

 

Vaginal estrogen is not associated with an increase risk.

Estrogen-only HRT is associated with little or no increased risk of breast cancer.

Estrogen and progestogen combined HRT can be associated with an increased risk of breast cancer after 5 years use, over the age of 50, but this is less than other lifestyle risk factors for breast cancer (eg obesity, alcohol intake)

Any increase in risk reduces after stopping.

Mortality is not increased.

Ovarian cancer

HRT use may be associated with a small increased risk of ovarian cancer with both estrogen only and combined HRT but the risk falls after cessation of HRT.

Diabetes

HRT has been shown to decrease incidence of risk of developing type 2 diabetes as well as improving glycaemic control.

Consider HRT for the same indications as a non diabetic woman.

Seek specialist advice if co-morbidities

Cervical cancer

There is no association between cervical cancer & HRT

Endometrial cancer

In women with a uterus, use of unopposed estrogen is associated with an increase risk of endometrial hyperplasia and endometrial cancer

Colorectal cancer

Data suggests a reduced risk of colorectal cancer with use of combined HRT.

Side Effects

generally settle within 3 months

Estrogenic

Breast tenderness

Nipple sensitivity

Bloating

Leg cramps

Nausea/heartburn

Headaches

Progestogenic

PMS type symptoms

Mood changes

Breast tenderness

Bloating

Headaches

Mood changes

Acne/greasy skin

Fluid retention

How to ameliorate side effects

Lower dose

Change route ie from oral to transdermal

Change type of progestogen

Change route eg oral to transdermal

Change regimen - consider long cycle HRT or continuous

combined HRT

Consider Mirena IUS to provide progestogen

Bleeding Problems may occur in the 1st 3 months of starting HRT or on changing preparations.

Consider causes eg compliance, drug interactions, GI or other absorption problems, pelvic pathology.

-           Heavy or prolonged bleeding: increase or change type of progestogen or reduce oestrogen dose.

-           Bleeding early in progestogen phase: increase dose of progestogen or change type.

-           Painful bleeding: change type of progestogen.

-           Irregular bleeding: change regimen or increase progestogen.

Consider Mirena IUS which will  provide bleeding control & reduce risk of endometrial hyperplasia

Refer to Gynaecology (Fast Track) if persistent bleeding despite management above or new bleeding after 1 year amenorrhoea with or without HRT

Alternative & Complementary Therapies

Hormone replacement therapy (HRT) is established as the most effective treatment for menopausal vasomotor symptoms and is thus recommended as the first-line choice for women requiring pharmacological management. However, alternatives may need to be considered for women with contraindications or do not wish to take HRT. NICE advise that women with or at high risk of breast cancer should be offered information on all available treatment options.

Lifestyle measures

Evidence suggests that regular sustained aerobic exercise such as swimming or running improve several common menopause-related symptoms (infrequent high-impact exercise should be avoided as it can make symptom worse)

Avoidance or reduction of alcohol and caffeine intake may help to reduce the severity and frequency of vasomotor symptoms

Cognitive behavioural therapy (CBT)

https://www.womens-health-concern.org/help-and-advice/factsheets/cognitive-behaviour-therapy-cbt-menopausal-symptoms/

Recommended treatment option for anxiety experienced during the peri and post-menopause and can improve hot flush perception and reduce stress and sleep problems.

Non Hormonal prescribed treatments

 

NICE Guidelines (2015) recommend that women should not routinely be offered antidepressants as first-line treatment for vasomotor symptoms alone. SSRIs should not be offered for vasomotor symptoms unless HRT cannot be given.

 

 

https://www.sps.nhs.uk/wp-content/uploads/2019/11/UKMi_QA_Hot-flushes_antidepressants_updateOct2019.pdfhttps://www.sps.nhs.uk/articles/what-non-hormonal-alternatives-to-antidepressants-are-available-for-the-management-of-menopausal-hot-flushes/

 

 

https://www.sps.nhs.uk/wp-content/uploads/2019/11/UKMi_QA_Hot-flushes_antidepressants_updateOct2019.pdfhttps://www.sps.nhs.uk/articles/what-non-hormonal-alternatives-to-antidepressants-are-available-for-the-management-of-menopausal-hot-flushes/

 

https://thebms.org.uk/wp-content/uploads/2020/07/02-BMS-TfC-Prescribable-alternatives-to-HRT-July2020-01B.pdf

 

Selective Serotonin Re-uptake Inhibitors (SSRI) [fluoxetine, paroxetine, citalopram, sertraline] and the Serotonin Noradrenaline Re-uptake Inhibitor/Selective Serotonin Re-uptake Inhibitors (SSRI-SNRI) [venlafaxine]: can have associated significant side effects, such as dry mouth, nausea, constipation and appetite problems, and reduction in libido.

 

Those women taking tamoxifen should not take fluoxetine or paroxetine, as it makes the tamoxifen ineffective.

 

Venlafaxine is the preferred treatment for breast cancer survivors taking tamoxifen and at 75mg there can be reduction in hot flushes with improvement in fatigue, mental health and sleep disturbance.

 

Clonidine: the only non-hormonal drug licensed for use for hot flushes in the UK. NICE Menopause Guidelines recommend women should not routinely be offered clonidine as first-line treatment for vasomotor symptoms alone. Although evidence indicates efficacy in reducing hot flushes, the side effects of clonidine (e.g. hypotension, sedation, dry mouth, dizziness) limit its clinical use

 

Gamma aminobutyric acid (gabapentin): can improve flushes and sweats. Improves sleep, but others find it very sedating in the day as well (unlicensed)

 

Herbal Treatments

 

There is limited evidence that herbal remedies may relieve vasomotor symptoms. Explain to women who wish to try complementary therapies that the quality, purity and constituents of products may be unknown. Also, they may have significant drug interactions and unknown risks regarding safety.

St John’s Wort 

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

  • appropriate doses  
  • persistence of effect  
  • variation in the nature and potency of preparations 
  • serious interactions with other drugs (including tamoxifen (makes it less effective), anticoagulants and anticonvulsants). 

Isoflavones and soya products

There are very many studies looking at the effectiveness of these food substances, but the results are variable and generally show little value. They are not recommended in patients with breast cancer.

Acupuncture

Studies show a very high placebo effect

Referral

Refer via SCI Gateway to Menopause Clinic, Highland Sexual Health:

  • Premature ovarian insufficiency. It is likely that most women below40 years will need referral to specialist clinic.
  • Complex medical history
  • Safety concerns of HRT
  • Persistent treatment problems eg side effects, lack of efficacy including persistent genitourinary symptoms and sexual problems
  • History of hormone dependent cancer and patients with BRCA gene
  • Patient request

Further information for healthcare professionals

BMS (British Menopause Society) Guidance: https://thebms.org.uk/publications/tools-for-clinicians/

Clinical Knowledge Summaries Menopause October 2015: http://cks.nice.org.uk/menopause

NICE Menopause Guidance 2015 : https://www.nice.org.uk/guidance/ng23

National Osteoporosis Society: https://theros.org.uk/

Patient information

Women’s Health Concern (patient arm of British Menopause Society): https://www.womens-health-concern.org/help-and-advice/factsheets/

Menopause Matters: www.menopausematters.co.uk

Early menopause group: www.daisynetwork.org.uk

NICE Menopause—Information for the public: www.nice.org.uk/guidance/ng23/ifp/chapter/menopause

Abbreviations

BRCA gene – BReast CAncer gene

BSO – bilateral salpingo-oopherectomy

CBT – cognitive behavioural therapy

CVD - cardiovascular disease

FSH – follicle stimulating hormone

GI - gastrointestinal

HRT – hormone replacements therapy

IUS – intra-uterine system

LMP – last menstrual period

POI – premature ovarian insufficiency

SNRI – serotonin-noradrenaline reuptake inhibitor

SSRI – selective serotonin reuptake inhibitor

VTE – venous thromboembolism

Last reviewed: 31 August 2020

Next review: 31 August 2023

Author(s): Obstetric and Gynaecology Review Group

Version: 8

Approved By: TAM Subgroup of ADTC

Reviewer Name(s): Obstetric and Gynaecology Review Group

Document Id: TAM182