MANAGEMENT OF MENOPAUSE CLINICAL GUIDELINES Register No: 18009 Status: Public Developed in response to: RCOG guideline: Best Practice 2015 Contributes to CQC 11, 12 Consulted With Post/Committee/Group Date Miss Anita Rao/ Alison Cuthbertson Alison Cuthbertson Sally Larcombe Jan Medici Debbie Anderson Claire Fitzgerald Sarah Moon Clinical Directors for Women s and Children s Directorate Head of Midwifery/ Nursing Sister in Charge of Gynaecological Outpatients Sister in Charge of Gynaecological Outpatients Staff Nurse Gynaecological Outpatients Pharmacy Specialist Midwife for Guidelines and Audit May 2018 Professionally Approved By: Anita Rao Consultant Obstetrician May 2018 Version Number 1.0 Issuing Directorate Women s and Children s Ratified By DRAG Chairman s Action Ratified On 18 th June 2018 Trust Executive Sign Off Date July 2018 Implementation Date 16 th July 2018 Next Review Date May 2021 Author/Contact for Information Mrs Vidya Thakur, Consultant Obstetrician Policy to be followed by (target staff) Gynaecology and Theatre Staff Distribution Method Intranet & Website. Notified on Staff Focus Related Trust Policies (to be read in conjunction with) 04071 Standard Infection Prevention 04072 Hand Hygiene 08086 Clinical Record Keeping Standards Policy 05128 Human Tissue Disposal Document History: Version No: Authored/Reviewed by: Issue Date: 1.0 Vidya Thakur 16 th July 2018 1
INDEX 1. Purpose 2. Background and Definitions 3. Symptoms of Menopause 4. Diagnosing Menopause 5. Diagnosing Premature Menopause 6. Assessment of Menopause 7. Information and Advice 8. Managing the Menopause without HRT 9. Managing the menopause with HRT 10. Referral Process 11. Equality and Diversity 12. Audit and Monitoring 13. Guideline Management 14. Communication 15. References 2
1.0 Purpose 1.1 To streamline the care pathway and services for women who present with menopausal symptoms. 2.0 Background and Definitions 2.1 Menopause is a biological stage in a woman's life when menstruation ceases permanently due to the loss of ovarian follicular activity. It occurs with the final menstrual period and is usually diagnosed clinically after 12 months of amenorrhoea. In the UK, the mean age of the natural menopause is 51 years, although this can vary between different ethnic groups. 2.2 Perimenopause, also called the 'menopausal transition' or 'climacteric', is the period before the menopause when the endocrinological, biological, and clinical features of approaching menopause commence. It is characterized by irregular cycles of ovulation and menstruation and ends 12 months after the last menstrual period. 2.3 Post menopause is the time after a woman has not had a period for 12 consecutive months. 2.4 Premature menopause, also called 'premature ovarian insufficiency' or 'premature ovarian failure', is usually defined as menopause occurring before the age of 40 years. 2.0 Symptoms of Menopause 2.1 Vasomotor symptoms (hot flushes and night sweats) are the most commonly reported symptoms, occurring in about 75% of postmenopausal women, with 25% of these being severely affected. Symptoms may resolve in 2 5 years, but the median duration is 7 years and sometimes longer. 2.2 Other symptoms include mood changes, musculoskeletal symptoms, urogenital symptoms, sleep disturbance, and sexual disorders 3.0 Risk of chronic disease after menopause 3.1 Women with untreated premature menopause and early perimenopause (menopause between the ages of 40 and 45 years) are at increased risk of mortality and serious morbidity, including cardiovascular disease (CVD), cognitive decline, dementia, parkinsonism, and osteoporosis. This increased risk is due to the menopausal decrease in oestrogen levels. 3
3.2 Postmenopausal women are at increased risk of osteoporosis, CVD, stroke, and atrophic changes in the vagina and bladder, due to oestrogen depletion as well as natural ageing. 4.0 Diagnosing Menopause 4.1 Diagnose the following without laboratory tests in otherwise healthy women aged over 45 years with menopausal symptoms: A. Perimenopause if the woman has vasomotor symptoms and irregular periods B. Menopause if the woman has not had a period for at least 12 months C. Menopause based on symptoms in women without a uterus 4.2 Consider using the follicle stimulating hormone (FSH) blood test to diagnose menopause in the following groups of women provided they are not taking combined oestrogen and progestogen contraception or high-dose progestogen, as the diagnostic accuracy of the FSH blood test may be confounded by these treatments: Women aged over 45 years with atypical symptoms Women between 40 45 years with menopausal symptoms, including a change in their menstrual cycle Women younger than 40 years in whom premature menopause is suspected 4.3.1 A pelvic examination should be performed only if clinically indicated and to exclude other possible causes of symptoms. 5.0 Diagnosing Premature Menopause 5.1 The diagnosis of premature menopause should take into account the woman s clinical history (for example previous medical or surgical treatment) and family history. 5.2 A. Diagnose premature menopause in women younger than 40 years based on: Menopausal symptoms, including no or infrequent periods (taking into account whether the woman has a uterus) and Elevated follicle stimulating hormone (FSH) levels on 2 blood samples taken 4 6 weeks apart. Do not use a serum FSH test to diagnose menopause in women using combined oestrogen and progestogen contraception or high-dose progestogen, as the diagnostic accuracy may be confounded by these treatments. B. If there is doubt about the diagnosis of premature menopause, consider anti-müllerian hormone testing after seeking specialist advice. Do not diagnose premature menopause on the basis of a single blood test 4
Do not routinely use anti-müllerian hormone testing to diagnose premature menopause. C. A pelvic examination should be performed only if clinically indicated and to exclude other possible causes of symptoms. 6.0 Assessment of Menopause 6.1 Assess her symptoms and their severity. This helps determine: The most suitable treatment (hormonal, non-hormonal, or non-pharmacological). The severity of the symptoms and the extent to which they are affecting the woman's quality of life. 6.2 Assess her risk of cardiovascular disease (CVD): Women with, or at increased risk of, CVD should have their cardiovascular risk factors managed. 6.3 Assess her risk of osteoporosis: Discuss the woman's expectations: Ask why she has consulted (for example concern regarding the cause of the symptoms). Ask if she would like treatment for her symptoms. 6.4 Investigations and examinations are not routinely indicated before starting hormone replacement therapy, unless: There is a sudden change in menstrual pattern, intermenstrual bleeding, postcoital bleeding, or postmenopausal bleeding arrange an urgent 2-week referral if a gynaecological cancer is suspected There is a personal or family history of venous thromboembolism consider arranging a thrombophilia screen, bearing in mind that a negative thrombophilia screen does not mean the woman is not at risk. There is a high risk of breast cancer consider referring for mammography. The woman has arterial disease or other risk markers for arterial disease a lipid profile may be useful. The woman has history, symptoms, or family history of gynaecological disease considers a pelvic examination. 5
7.0 Information and Advice 7.1 Information and advice as follows: An explanation of the stages of menopause. The common symptoms of the menopause. Available treatments for menopausal symptoms, including hormone replacement therapy (HRT), non-hormonal treatments (such as antidepressants), and nonpharmacological treatments (such as cognitive behavioural therapy [CBT] and relaxation techniques). The risks possible adverse effects, benefits, and expected duration of treatment with HRT. Advice on bone health (especially for women diagnosed with premature menopause). Advice on the importance of keeping up to date with nationally recommended health screening, including: The NHS Breast Screening Programme that is offered every 3 years to women aged 50 years or over. The Cervical Screening Programme which is available for all women aged 25 years and over with a frequency of routine 3-yearly recall between 25 49 years of age, then 5-yearly recall until aged 65 years. Advice on contraception, including that HRT does not provide contraception and that a woman 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. 7.2 Information on support groups, such as: Menopause UK (www.menopauseuk.org) a network of groups and organizations which represent and support women affected by menopause. Menopause Matters (www.menopausematters.co.uk) provides information on the menopause, menopausal symptoms, and treatment options. The Daisy Network (www.daisynetwork.org.uk) a nationwide support group for women who have suffered a premature menopause. 7.3 Give advice on lifestyle modifications to reduce menopausal symptoms. For example: 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). 6
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 sleep hygiene. 8.0 Managing the Menopause without HRT 8.1 Advise on lifestyle modification to reduce menopausal symptoms. 8.2 If lifestyle modifications are ineffective, consider one of the following: 8.3 Prescribe non-hormonal and/or non-pharmacological treatments for symptom relief: For vasomotor symptoms, consider a 2-week trial of fluoxetine (20 mg daily), citalopram (20 mg daily), or venlafaxine (37.5 mg twice a day). Note that the use of antidepressants for treating menopausal symptoms is off-label. For vaginal dryness, prescribe a vaginal lubricant or moisturizer, such as Replens MD. For sexual dysfunction, seek specialist advice regarding the use of testosterone supplementation (off-label use). Obtain (and document) informed consent before prescribing testosterone for this indication. For psychological symptoms, such as mood disturbance, anxiety, and depression, consider self-help groups, cognitive behavioural therapy (CBT), or antidepressants. Note that there is no clear evidence for antidepressants to ease low mood in menopausal women who have not been diagnosed with depression. For more information, see the CKS topics on Depression and Generalized anxiety disorder Refer the woman to a healthcare professional with expertise in menopause. Advise the woman to return if her symptoms persist or worsen. For women considering complementary therapies, explain that the quality, purity, and constituents of these products may be unknown. Although there is some evidence that isoflavones and black cohosh may relieve vasomotor symptoms, their safety is unknown and different preparations may vary. 8.4 Review the woman at 3 months, then annually thereafter unless there are clinical indications for an earlier review (such as treatment ineffectiveness or adverse effects). At the review: Assess efficacy and tolerability of treatment(s). Reinforce information and lifestyle advice. 7
If the woman is symptom-free on treatment, consider a trial withdrawal of the antidepressant treatment after 1 2 years of treatment. Advise that symptoms may recur once treatment is stopped. The use of vaginal moisturizers and lubricants may be continued indefinitely. 8.5 Refer the woman to a healthcare professional with expertise in menopause if treatments do not improve menopausal symptoms. 9.0 Managing the menopause with HRT 9.1 If a woman chooses to use hormone replacement therapy (HRT), following a discussion on the risks, possible adverse effects, and benefits, and there are no contraindications to its use: 9.2 Advise on lifestyle modifications to reduce menopausal symptoms. 9.3 Prescribe the most suitable type of HRT based on her symptoms: For vasomotor symptoms: In woman with a uterus, offer an oral or transdermal combined (oestradiol plus progestogen) HRT preparation. In women without a uterus, offer an oral or transdermal oestrogen-only preparation. In women diagnosed with premature menopause, offer sex steroid replacement with a choice of HRT or a combined oral contraceptive (unless contraindicated) For effects on mood, offer a choice of oral or transdermal HRT preparations as above. Consider referring the woman for a trial of cognitive behavioural therapy (CBT) to alleviate low mood and anxiety. For urogenital symptoms, manage according to the specific symptom: For women with urogenital atrophy (including those already using systemic HRT), offer low-dose vaginal oestrogen. Continue treatment for as long as needed to relieve symptoms. For women with vaginal dryness, advise that moisturisers and lubricants can be used alone or in addition to vaginal oestrogen. For sexual dysfunction, seek specialist advice regarding the use of testosterone supplementation (off-label use). Obtain (and document) informed consent before prescribing testosterone for this indication. For women considering complementary therapies, explain that the quality, purity, and constituents of these products may be unknown. 8
Although there is some evidence that isoflavones and black cohosh may relieve vasomotor symptoms, their safety is unknown and different preparations may vary. 9.4 Advise women with premature menopause that they should not use HRT as a contraceptive.. 9.5 Review the woman at 3 months, then annually thereafter unless there are clinical indications for an earlier review (such as treatment ineffectiveness or adverse effects). At the review: 9.6 Assess efficacy and tolerability of treatment(s). If low-dose vaginal oestrogen does not relieve symptoms, consider increasing the dose after seeking specialist advice from a healthcare professional with expertise in menopause. 9.7 Reinforce information and lifestyle advice 9.8 If HRT was started in the perimenopause, discuss the option of changing the treatment regimen and/or reducing the dose of oestrogen in the HRT (with longer duration of treatment). 9.9 Be aware that HRT may need to be stopped immediately in certain circumstances 9.10 Consider referring the woman to a healthcare professional with expertise in menopause if: Treatment is ineffective. They have ongoing troublesome adverse effects. There are 'red flag' symptoms such as unexplained bleeding arrange an urgent 2- week referral if a gynaecological cancer is suspected. 9.11 For vasomotor symptoms, most women require 2 5 years of HRT, but some women may need longer. This judgement should be made on a case-by-case basis with regular attempts to discontinue treatment. Symptoms may recur for a short time after stopping HRT. 9.12 Topical (vaginal) oestrogen may be required long term. Regular attempts (at least annually) to stop treatment are usually made. Symptoms may recur once treatment has stopped. 9.13 Women with premature menopause usually take HRT up to the average age of the natural menopause (51 years), after which the need for HRT should be reassessed. Some women will still be symptomatic. 9
9.14 Offer women who wish to stop HRT a choice of gradually reducing or immediately stopping treatment 9.15 Gradually reducing or immediately stopping HRT makes no difference to their symptoms in the longer term. 9.16 Gradually reducing HRT may limit recurrence of symptoms in the short-term. 9.17 Symptoms of urogenital atrophy often come back when treatment with vaginal oestrogen is stopped. 10.0 Referral Process 10.1 Women with complex medical history requesting HRT, please refer to the local menopause/hrt lead. 10.2 This pathway will ensure that medical practitioners who object to termination of pregnancy will not be involved in the management of these women and thus the care of these women will not be affected by dissenters to the process. 11.0 Equality and Diversity 11.1 Mid Essex Hospital Services NHS Trust is committed to the provision of a service that is fair, accessible and meets the needs of all individuals. 12.0 Audit and Monitoring 12.1 Audit of compliance with this guideline will be considered on an annual audit basis in accordance with the Clinical Audit Strategy and Policy (register number 08076), the Corporate Clinical Audit and Quality Improvement Project Plan and the Maternity annual audit work plan; to encompass national and local audit and clinical governance identifying key harm themes. The Women s and Children s Clinical Audit Group will identify a lead for the audit. 12.2 The findings of the audit will be reported to and approved by the Multi-disciplinary Risk Management Group (MRMG) and an action plan with named leads and timescales will be developed to address any identified deficiencies. Performance against the action plan will be monitored by this group at subsequent meetings. 12.3 The audit report will be reported to the monthly Directorate Governance Meeting (DGM) and significant concerns relating to compliance will be entered on the local Risk Assurance Framework. 12.4 Key findings and learning points from the audit will be submitted to the Clinical Governance Group within the integrated learning report. 12.5 Key findings and learning points will be disseminated to relevant staff. 10
13.0 Guideline Management 13.1 As an integral part of the knowledge, skills framework, staff are appraised annually to ensure competency in computer skills and the ability to access the current approved guidelines via the Trust s intranet site. 13.2 Quarterly memos are sent to line managers to disseminate to their staff the most currently approved guidelines available via the intranet and clinical guideline folders, located in each designated clinical area. 13.3 Guideline monitors have been nominated to each clinical area to ensure a system whereby obsolete guidelines are archived and newly approved guidelines are now downloaded from the intranet and filed appropriately in the guideline folders. Spot checks are performed on all clinical guidelines quarterly. 13.4 Quarterly Clinical Practices group meetings are held to discuss guidelines. During this meeting the practice development midwife can highlight any areas for further training; possibly involving workshops or to be included in future skills and drills mandatory training sessions 14.0 Communication 14.1 A quarterly maternity newsletter is issued and available to all staff including an update on the latest guidelines information such as a list of newly approved guidelines for staff to acknowledge and familiarise themselves with and practice accordingly. 14.2 Approved guidelines are published monthly in the Trust s Staff Focus that is sent via email to all staff. 14.3 Approved guidelines will be disseminated to appropriate staff quarterly via email. 14.4 Regular memos are posted on the Guideline and Audit notice boards in each clinical area to notify staff of the latest revised guidelines and how to access guidelines via the intranet or clinical guideline folders. 14.5 Approved guidelines will be disseminated to appropriate staff quarterly via email. 14.6 Regular memos are posted on the Risk Management notice boards in each clinical area to notify staff of the latest revised guidelines and how to access guidelines via the intranet or clinical guideline folders. 15.0 References National Institute for Clinical Excellence (2015) Menopause: diagnosis and management. NICE; NG23; November. Royal College of Obstericians and Gynaecologists (2006) Alternatives to HRT for symptoms of the menopause. RCOG: May. National Institute for Clinical Excellence (2017) Menopause. Quality Standard (QS143). NICE: February. 11