Hormone Replacement Therapy Prescribing (314)

• Date of LMP
• Frequency and duration of menses
• Severity and frequency of flushes / sweats
• Sexual difficulties, including vaginal dryness
• Contraception, if required (a women is considered potentially fertile for 2 years after her last menstrual period if she is younger than 50 years of age, and for 1 year if she is over 50 years of age)
• Personal/Family history of breast/ovarian/bowel cancer
• Personal/Family history of DVT/PTE
• Risk factors for CHD/stroke
• Risk factors for osteoporosis [smoking, premature ovarian insufficiency (POI), low BMI, excess alcohol, family history]
• Migraines

• BP/BMI
• Breast/pelvic – only if clinically indicated

Women aged over 45 years, with menopausal symptoms. 

Diagnose the following without laboratory tests:

• 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.
  
  

Women aged under 40 years and those aged 40 to 45 years, with menopausal symptoms, including a change in their menstrual cycle, 

• Consider a pregnancy test
• Consider using FSH to diagnose menopause.
  Note: Do not use this test if women are using oestrogen-containing hormonal contraception

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

• information about menopause and fertility before they have their treatment
• for more complex cases consider referral to a healthcare professional with expertise in menopause.

• Pregnancy
• Abnormal vaginal bleeding which has not been investigated
• Known or suspected breast, endometrial or oestrogen sensitive cancer
• Untreated endometrial hyperplasia
• Recurrent VTE
• Active or recent (≤1 year) arterial thromboembolic disease (e.g. angina, MI) •Untreated hypertension
• Active liver disease with abnormal LFTs
• Porphyria cutanea tarda – oestrogen is an exacerbating factor

• Migraines with aura
• Previous idiopathic VTE or women currently on anticoagulant therapy
• Any woman who wishes to discuss alternatives to HRT
• Any woman with unclear risks or who wishes a 2^nd opinion

• Hot flushes and night sweats — regular exercise, weight loss (if applicable), wearing lighter clothing, sleeping in a cooler room, reducing stress, and avoiding possible triggers (such as spicy foods, caffeine, smoking, and alcohol).
• Sleep disturbances — avoiding exercise late in the day and maintaining a regular bedtime.
• Mood and anxiety disturbances — adequate sleep, regular physical activity, and relaxation exercises.
• Cognitive symptoms — exercise and good night-time routine e.g. avoidance of blue light emitting devices in bed.

The  intention  is  always  to  use  the  lowest  effective  dose  that  achieves  symptom control.   HRT can be given orally or transdermally (patches or gel) and is available as oestrogen-only preparations (for women without a uterus) and combined oestrogen-progestogen preparations (for women with an intact uterus - oestrogen alleviates symptoms whilst progestogen provides endometrial protection). 

The choice of formulation will depend on the woman’s preference, however transdermal preparations may be appropriate if;

• The woman prefers this route
• Symptom control is poor with oral treatment
• Oral treatment causes GI side effects
• The woman is taking a hepatic enzyme-inducing drug
• The woman has a bowel disorder which may affect absorption of oral treatments
• The woman has lactose sensitivity (most HRT tablets contain lactose)
• The woman is diabetic
• The woman has an increased risk of VTE

If in any doubt, refer to a specialist menopause clinic.

After commencing therapy, review at 3 months, and once stabilised, an annual review by the primary care physician is advised.  After commencing or changing any regime, women should be advised to persist with that regime for 6 months to permit minor side-effects to settle and to assess response to therapy. 

Cyclical preparations (also called sequential HRT) should be used for those women with menstrual cycles or those who are within 1 year of their last cycle.  

Continuous combined preparations provide oestrogen and progestogen throughout the cycle. These are best reserved for those women where 12 months have elapsed since the last menses or in women commencing HRT over the age of 54 years.  Irregular bleeding is more likely to be a problem if a continuous combined preparation is commenced too early.

Subtotal hysterectomy:

There is always the possibility of residual endometrium. In these cases, a combined preparation should be used.  Discuss with a Consultant or refer to a specialist menopause clinic if unopposed oestrogen is considered.

Previous hysterectomy for endometriosis:

These cases should be considered individually. Unopposed oestrogen or continuous combined preparations can be prescribed. 

Levonorgestrel-IUS already in situ:

The IUS is licensed for endometrial protection as part of the HRT regime. Any oestrogen preparation which is suitable for the woman can be prescribed. Mirena® currently has a four year license for this indication; however FRSH guidance now states that 5 year use is acceptable.

Previous endometrial ablation:

These women must be assumed to have residual endometrium and should be treated as per those with an intact uterus.

Premature Ovarian Insufficiency (POI):

These women should take sex steroid replacement, with a choice of combined HRT or combined hormonal contraceptive (CHC), until the average age of the natural menopause (51years). There is no evidence that HRT increases the risk of breast cancer or cardiovascular disease in these women.  

Spontaneous ovulation can occur in 5-10% of these women, HRT is not contraceptive, therefore additional contraception (if not using CHC as HRT) is required if conception is to be avoided.

This  may  be  used  in  women  with  localised  symptoms  such  as vaginal dryness and dyspareunia.  Topical oestrogens can be used without systemic progestogens.  Vagifem® low dose (10µg) has a license for long-term use. Please refer to the management of vulval-vaginal atrophy (VVA) guideline.

Venous thromboembolism (VTE)
There is an increased risk of VTE with oral HRT preparations.  There is no increased risk associated with transdermal HRT given at standard therapeutic doses.

Coronary heart disease (CHD) and stroke See HRT and Cardiovascular Disease guideline.

Type 2 diabetes

HRT (either orally or transdermally) is not associated with an increased risk of developing type 2 diabetes.

Breast cancer

• The baseline risk of breast cancer for women around menopausal age in the UK varies from one woman to another.
• HRT with oestrogen alone is associated with little or no increase in the risk of breast cancer.
• HRT with oestrogen and progestogen can be associated with an increase in the risk of breast cancer – see NICE guidance for table.
• Any increase in risk of breast cancer is related to treatment duration and reduces after stopping HRT.
• HRT does not affect the risk of dying from breast cancer.

Dementia

The likelihood of HRT affecting the risk of dementia is unknown.

NICE found some evidence that isoflavones and black cohosh may relieve vasomotor symptoms compared with placebo; however, the results should be interpreted with caution because the variety of herbal preparations used in studies may differ significantly.  Women who wish to discuss these options should be referred to a specialist menopause clinic.

• Menopause and You GGC Patient Information Leaflet
• Menopause Matters (menopausematters.co.uk) — provides information on the menopause, menopausal symptoms, and treatment options.
• The Daisy Network (daisynetwork.org.uk) — a nationwide support group for women who have suffered a premature menopause.
• The British Menopause Society at http://www.thebms.org.uk/