Menopause - Obsolete

Introduction

The following is based on NICE Guideline NG23 (November 2015) which has been summarised below by Dr Rachel Brown, GPSI in gynaecology.

Useful Tools for clinicians can also be found on the British Menopause Society website.

Menopause occurs on average at 51y, but early onset (before 40 y) happens in approximately 1 %.

Menopausal symptoms can be difficult to recognise and it is important to consider this diagnosis as they can have a significant impact on quality of life. Mood changes, memory and concentration loss ,vaginal dryness and dysuria ,lack of interest in sex, headaches, joint and muscle stiffness can occur in combination or individually and can occur on the background of normal cycles (perimenopause). 

Useful leaflets and a short film for patients are available in the Resources section at the bottom of this page.

Diagnosis

The following advice regards making a diagnosis is taken from NICE guidelines:

• Women over 45 years presenting with menopausal symptoms should be diagnosed with perimenopause or menopause based on their symptoms alone, without confirmatory laboratory tests. Diagnosis of peri-menopause is based on vasomotor symptoms and irregular periods. Menopause is defined as those women who have not had a period for 12 months and are not using hormonal contraception or menopause based on symptoms in women without a uterus. Checking FSH levels in these groups is not recommended.

• 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.

• In women under 45, offer two FSH levels, six weeks apart, on day 2-6 of their menstrual cycle, or a random day if not menstruating, to diagnose menopause (as per NICE and ESHRE guidance). 

  • If FSH levels are above the normal range please trial HRT, discuss health effects of an early menopause and investigate for potential causes (such as autoimmune). These women can be referred to the menopause clinic for this discussion / investigations if the practice does not have a health care practitioner with an interest in menopause.

  • If FSH levels are normal, investigate for other causes of her symptoms. If no other cause can be found, discuss the pros and cons of a 3-month trial of HRT. If this provides symptom control a diagnosis of early menopause can be provided and investigations for causes of this and a discussion relating to the health effects completed. If HRT does not improve symptoms, and oestrogen levels show good absorption, stop HRT and re-assess for other causes.

Hormone Replacement Therapy

Please see BNSSG MENOPAUSE GUIDELINES AND HRT PRESCRIBING PATHWAY in the Formulary section of Remedy

Unscheduled vaginal bleeding on HRT

Please see the Abnormal Vaginal Bleeding page of Remedy for information on managing this and when and how to refer if indicated.

Menopause symptoms questionnaire and HRT choices

The BNSSG Menopause Working Group have developed a Menopause Symptoms Questionnaire based on the Greene Climacteric scale. Patients can complete the questionnaire prior to a menopause appointment to allow the patient and local GP/clinician to prepare and to guide HRT choices.

Risk can be presented as either relative or absolute; relative risk often gives rise to greater anxiety, especially with breast cancer and VTE. The use of risk charts to demonstrate absolute risk can be helpful.eg British Menopause Society website or NICE NG23. 

Unlicensed bioidentical hormone therapies (“natural hormone therapies”) are perceived by patients to be lower risk and are not available on the NHS. Bioidentical therapies claim to be safe because they are of natural plant origin but there is no evidence to support these claims.

Bioidentical HRT has been available on the NHS for some years. Unlike many COPs which use synthetic ethinyl oestradiol, the 17-β oestradiol found in most HRT options is bioidentical to ovarian oestrogen, and can be administered as a patch, gel, tablet, or implant. The only exception is the equine-derived conjugated oestrogens found in some therapies. Note that these are not contraceptive.

Route of administration

Oral drugs are most commonly prescribed. NICE NG23 recommends that women with significant CVD risk should use transdermal oestrogen. The transdermal route also allows for a more natural delivery, using lower doses while maintaining efficacy through greater dosing flexibility. Oral micronised natural progesterone also has favourable safety data, which showed no significant increase in breast-cancer risk compared with non-users.

Tailor the dose

Often the lowest available dose is prescribed, at the expense of symptom relief or long-term health benefits. The goal of therapy is to establish a dose that effectively treats symptoms, and also offers bone protection. Standard doses, as recommended in the British National Formulary, are suitable for women around the age of the menopause. Hence women under 40 years of age often need higher doses to achieve symptom relief or to ensure adequate bone protection. This higher dosage needs to be maintained until the average age of the menopause, 51 years, and brings no known associated increase in risks. Conversely, symptomatic women over 60 years initiating HRT may need to be started on suboptimal transdermal doses due to the higher VTE risk observed in the first year. The dose may be slowly increased over time until therapeutic symptom relief is achieved.

Topical oestrogen

Vaginal oestrogen used either concurrently or on its own, can effectively alleviate many vaginal atrophy symptoms. Vaginal oestradiol tablets or cream may be considered for long-term use due to low systemic absorption; there is little concern regarding endometrial stimulation. Topical oestrogens are very safe and can be used by most women with vaginal symptoms alone and adverse effects are very rare. The only absolute contraindications are active breast cancer and undiagnosed vaginal bleeding. The systemic absorption of oestrogen from recommended doses of topical oestrogens over 1 year contains the same dose as taking a single tablet of oral HRT.  It is unlikely to affect the endometrium and additional progestogens are not necessary. Maximum benefit with these products is usually achieved after around 1–3 months but it can take up to 1 year in some women. Treatment with topical oestrogen should be continued for as long as needed to relieve symptoms as symptoms will often return after treatment is stopped. Systemic oestrogen restores normal vaginal pH levels, thickens and revascularises the epithelium, and also increases vaginal lubrication;however, around 10–25% of women who take systemic HRT will have urogenital symptoms that persist. These women can safely be given vaginal local oestrogen in addition to taking HRT.

Vaginal moisturisers

Yes! vaginal moisturiser is on the BNSSG formulary for vaginal atrophy in post-menopausal women with oestrogen sensitive conditions for whom topical oestrogens are not suitable i.e. patients with a history of breast or endometrial cancer.  Vaginal moisturisers remain non-formulary for any other indication/patient cohort. 

Progestogen for endometrial protection

Progestogens should always be prescribed for uterine protection against endometrial hyperplasia and risk of malignancy. These must always be combined with oestrogen, either sequentially(for 12 days of the month) for the perimenopause or continuously after 12 months of amenorrhoea. If there is a history of progestogenic side-effects reported with prior use of the COCP or PMS then natural progesterone can be better tolerated. Androgenic progestogens (e.g. norethisterone) are more likely to cause PMS-type side-effects. With PMS-type side-effects, a low-dose regimen may be more suitable.

Depression or anxiety associated with the menopause

Depression and anxiety are common presentations of the perimenopause and also later on in the menopause. Severe menopausal depression may also follow a history of premenstrual syndrome (PMS) and postnatal depression. The new evidence supporting the use of HRT, especially in the perimenopause, and the fact that the risks associated with HRT do not generally apply to women under the age of 50 years should encourage earlier use of HRT in this group.

Testosterone

Testosterone gel for use in the menopause is restricted and currently an Amber drug on the BNSSG formulary.

Patients who meet the following criteria should be considered for referral to a gynaecologist (via eRS) to consider initiation of treatment:

1. Low libido causing distress and

2. Ongoing symptoms despite Optimised oestrogen and progesterone HRT and

3. Either early menopause (45 years and under) or surgical menopause (bilateral oophorectomy) and

4. Testosterone levels below the normal range (0.3 or less).

Use of testosterone gel for women outside of this indication / cohort is non-formulary and should not be prescribed in primary care. 

Choice of HRT

The BNSSG formulary has a useful page listing the different types of HRT available.

The British Menopause Society also has a useful HRT guide

Contraception and the menopause

Many perimenopausal women also suffer with menorrhagia, and may still require contraception. The IUS is a good option and being low-dose local progestogen it may also benefit women with PMS.

Although not licensed within HRT use, it is possible to use the POP in conjunction with a combined HRT. The POP cannot be used without HRT progestogen as it does not provide adequate endometrial protection. Contraceptives containing endogenous oestradiol, rather than ethinyl oestradiol, may be suitable for symptomatic perimenopausal women requiring contraception.

Referral

Most patients with menopause can be managed in primary care.

The British Menopause Society suggests referral should be considered in the following scenarios:

• Persistent side effects
• Poor symptom control
• Complex medical history
• Past history hormone dependent cancer

Consider using Gynaecology Advice and Guidance via eRS if specific advice is required.

Referrals should be made via eRS to gynaecology, or if there if there are bleeding problems with red flags then consider a 2WW gynaecology referral.

UHBW Complex Menopause Clinics

Referrals to the specialist menopause clinic reopened on 1st May 2023. Refer via eRS to the Menopause Clinic,

The complex menopause clinic runs one Tuesday morning at Weston General Hospital and four Friday mornings at St Michael’s Hospital per month.

Referral Criteria for Complex Menopause Clinic

• Ongoing symptoms despite medical treatment or treatment side effects
• Consideration for Testosterone treatment.
  • Lack of libido or treatment resistance AFTER systemic HRT optimised. Pre-referral tests required (8-10am SHBG, testosterone and oestradiol).
• Pre-operative menopause counselling for risk–reducing hysterectomy or bilateral salpingo-oophrectomy (BRCA / Lynch): no personal history of cancer
• Medical co-morbidities such as:
  • IHD
  • Connective tissue diseases
  • Epilepsy
  • Thrombotic risk factors
  • Liver disease
• Uncertainty about most suitable treatment options such as:
  • Endometriosis / fibroids
  • Migraines
  • Progesterone sensitivity
• Premature Ovarian Insufficiency
  • See remedy page for POI for pre-referral tests required

Menopause Oncology Clinic 

The menopause oncology clinic is open to referrals. Most of these patients will be referred from secondary care oncology, but referrals are also open to primary care if the criteria below are met:

• Women with symptoms of menopause and a history of cancer
  • Please include receptor status, grade and stage of cancer
• Women < 45 years who are amenorrhoeic for 6 months or more following anti-cancer treatment
  • Take FSH x2 six weeks apart
• Women of any age taking anti-oestrogen therapy and menopausal symptoms
  • Include medication list

Refer via eRS to the Menopause Clinic from 01/05/23

Resources

Patient Resources

• Bristol Menopause Toolkit - perimenopause and HRT leaflets -  this link has leaflets from the University of Bristol on Perimenopause and HRT available in English, Arabic, Punjabi, Somali and Urdu.
• Cycle of Change - a short film about the peri-menopause produced by a Bristol base charity. There are also interviews with people who have lived experience.

Efforts are made to ensure the accuracy and agreement of these guidelines, including any content uploaded, referred to or linked to from the system. However, BNSSG ICB cannot guarantee this. This guidance 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, in accordance with the mental capacity act, and informed by the summary of product characteristics of any drugs they are considering. Practitioners are required to perform their duties in accordance with the law and their regulators and nothing in this guidance should be interpreted in a way that would be inconsistent with compliance with those duties.

Information provided through Remedy is continually updated so please be aware any printed copies may quickly become out of date.