Finally cracking the HRT code: NICE on the menopause

This episode makes reference to guidelines produced by the "National Institute for Health and Care Excellence" in the UK, also referred to as "NICE". Please note that the content on this channel reflects my professional interpretation/summary of the guidance and that I am in no way affiliated with, employed by or funded/sponsored by NICE. My name is Fernando Florido and I am a General Practitioner in the United Kingdom. In this episode I will go through the NICE guideline on “Menopause: diagnosis and management” or NICE guideline NG23. I will summarise the guidance from a Primary Care perspective only. I am not giving medical advice; this video is intended for health care professionals; it is only my interpretation of the guidelines and you must use your clinical judgement. There is a YouTube version of this and other videos that you can access here: The Practical GP YouTube Channel: https://youtube.com/@practicalgp?si=ecJGF5QCuMLQ6hrk The NICE guideline NG23 “Menopause: diagnosis and management” can be found here: https://www.nice.org.uk/guidance/NG23 The guidance from the Faculty of Sexual & Reproductive Healthcare on contraception for women aged over 40 years can be found here: http://www.fsrh.org/pdfs/ContraceptionOver40July10.pdf The MHRA summary of HRT risks and benefits during current use and current use plus post-treatment from age of menopause up to age 69 years, per 1000 women with 5 years or 10 years use of HRT can be found here: https://assets.publishing.service.gov.uk/media/5d680409e5274a1711fbe65a/Table1.pdf The summary flowchart with examples of preparations can be found here: https://1drv.ms/b/s!AiVFJ_Uoigq0mFjbJIiJs842urJB?e=FcfiJl Thumbnail photo: from Freepik: https://www.freepik.com/ Image by LipikStockMedia on Freepik: ahref="https://www.freepik.com/free-photo/beautiful-woman-50-years-old-enjoys-yoga-she-is-meditating-by-cupping-her-palms-front-her-with-her-eyes-closed-she-dreams-personal-one-close-up-shot_23935463.htm#page=2&query=menopause&position=9&from_view=search&track=sph&uuid=9a84a386-a034-42ca-ac20-add7c2fb2d27"Image by LipikStockMedia/a on Freepik Intro / outro music: Track: Halfway Through — Broke In Summer [Audio Library Release] Music provided by Audio Library Plus Watch: https://youtu.be/aBGk6aJM3IU Free Download / Stream: https://alplus.io/halfway-through Transcript Hello and welcome, I am Fernando, a GP in the UK. Mrs Brown sees you because wants to discuss HRT in detail, including the pros and cons of the various preparations available. Do you say?: “of course, ask me anything you want” or do you go? ….. If you are in the second group then you know exactly how I feel. So, today, we will go through the NICE guideline on the diagnosis and management of the menopause from a Primary Care perspective. Make sure to stay for the entire episode because, at the end, I will also go through a one-page summary flowchart giving cost effective examples of various preparations available which you will also be able to download So, let’s jump into it. And let’s start by saying that possible symptoms of the menopause include: · a change in their menstrual cycle · vasomotor symptoms (e.g., hot flushes and sweats) · musculoskeletal symptoms (e.g., joint and muscle pain) · effects on mood (e.g., low mood) · urogenital symptoms (e.g., vaginal dryness) and · sexual difficulties (e.g., low sexual desire). When these symptoms are present, most women will ask for a blood test to check if they are menopausal. Is this really necessary? Well, most of the time, it isn’t. Because NICE says that we can make the following diagnoses without checking FSH: perimenopause in women over 45 with vasomotor symptoms and irregular periods and menopause in women over 45: · If they are not using contraception and have had no periods for at least 12 months or · based on symptoms alone if the woman does not have a uterus Of course, diagnosis can be more difficult if they are on hormonal treatments but still, we should not check FSH if the woman is on combined hormonal contraception or high-dose progestogen. However, we will consider checking FSH levels to diagnose menopause: · in women aged 40 to 45 with menopausal symptoms, including a change in their menstrual cycle and · in women under 40 in whom the menopause is suspected. Once we have made the diagnosis, we will give information about lifestyle changes, and benefits and risks of treatments, giving information about: · hormonal treatment, e.g. HRT · non-hormonal treatment, e.g. clonidine · non-pharmaceutical treatment, e.g. CBT We will also give information about contraception in the perimenopausal and postmenopausal phase. I have put a link to the guidance in the episode description but a very simplified summary is that: · CHC should be stopped at 50 and switch to a safer method · Contraception can be stopped at 55 as the risk of pregnancy is extremely low by then If the menopause is a result of medical or surgical treatment, we will: · Give information about fertility before that treatment and · We will refer to a menopause specialist In terms of managing menopausal symptoms, this summary is not intended for women with premature ovarian insufficiency, that is, women aged under 40 For vasomotor symptoms we will offer HRT after discussing benefits and risks. We will offer a choice of: · oestrogen and progestogen to women with a uterus or · oestrogen alone to women without a uterus. We will not routinely offer SSRIs, SNRIs or clonidine as first-line treatment for vasomotor symptoms alone. We will explain that there is some evidence that isoflavones or black cohosh may relieve vasomotor symptoms but that: · preparations may vary · their safety is uncertain and · Drug interactions have been reported In terms of psychological symptoms, we will consider HRT to treat menopause related low mood And also consider CBT to treat menopause related low mood or anxiety Remember that there is no clear evidence for SSRIs or SNRIs for low mood in menopausal women without a diagnosis of depression. We will consider testosterone supplementation for menopausal women with low sexual desire if HRT alone is not effective. The BNF says that it is not licensed for this indication so seeking specialist advice before initiation may be advisable For urogenital atrophy we will offer vaginal oestrogen (including for those on systemic HRT) and we will continue treatment for as long as needed to relieve symptoms. We will also consider vaginal oestrogen for urogenital atrophy in those for whom systemic HRT is contraindicated, after seeking specialist advice. If vaginal oestrogen does not relieve symptoms we will also seek specialist advice before increasing the dose However we will also explain that: · symptoms often come back when treatment is stopped · that adverse effects from vaginal oestrogen are very rare and · that they should report unscheduled vaginal bleeding Moisturisers and lubricants for vaginal dryness can be used alone or in addition to vaginal oestrogen. And finally we will not offer routine monitoring of endometrial thickness during treatment with vaginal oestrogen. In terms of complementary therapies we will explain that the efficacy, safety, quality and purity of unregulated compounded bioidentical hormones may be unknown and we will also advise that there is also uncertainty about the appropriate use of St John's wort Once treatment has been started, we will review patients: · at 3 months to assess the efficacy and tolerability and · annually thereafter unless more often is clinically indicated We will refer women for specialist advice if: · treatments are ineffective or cause side effects · there are contraindications to HRT or · there is uncertainty about the most suitable treatment option In terms of starting and stopping HRT, we will explain that unscheduled vaginal bleeding is a common side effect of HRT within the first 3 months of treatment but it should be reported at the 3-month review, or promptly if it occurs after the first 3 months When stopping HRT we will consider the choice of gradually reducing or immediately stopping treatment explaining that: · gradually reducing HRT may limit recurrence of symptoms in the short term but that · either approach makes no difference to their symptoms in the longer term There are separate guidelines on the treatment of menopausal symptoms for women with, or at high risk of, breast cancer, but in general: · we will refer to a menopause specialist · and ensure that paroxetine and fluoxetine are not given if the patient is on tamoxifen In terms of long-term benefits and risks of HRT, there is an MHRA summary of HRT risks and benefits that we can refer to explain the absolute rates per 1000 women with 5 years or 10 years use of HRT. It is a useful one-page resource and I have included a link to this table in the episode description. But in summary, let’s go through the different possible risks. In terms of venous thromboembolism we will explain that: · the risk of VTE is increased by oral HRT · that the risk is greater for oral than transdermal preparations and · that the risk of transdermal HRT is no greater than baseline Therefore we will consider transdermal rather than oral HRT if the woman is at increased risk of VTE, including those with a BMI over 30 But we will consider haematology referral if the patient is at high risk, e.g.: · if there is a strong family history of VTE or thrombophilia For cardiovascular disease we will explain that HRT: · does not increase CVD risk if aged under 60 and · that it does not affect the cardiovascular mortality And we must remember that cardiovascular risk factors are not a contraindication to HRT as long as they are optimally managed. So we will explain that: · the baseline CVD risk varies depending on risk factors · that HRT with oestrogen alone is associated with no, or reduced, risk of coronary heart disease · and that HRT with oestrogen and progestogen is associated with little or no increase in the risk of coronary heart disease But we will also explain that oral oestrogen is associated with a small increase in the risk of stroke but that the baseline risk under 60 is very low We will indicate that HRT does not increase the risk of developing type 2 diabetes and does not have an adverse effect on glucose control but we will consider comorbidities and specialist advice before giving HRT in type 2 diabetes In terms or breast cancer risk, we will make it clear that: · the baseline risk varies according to risk factors · that HRT with oestrogen alone is associated with little or no change in the risk · that HRT with oestrogen and progestogen can be associated with an increase in the risk of breast cancer but · that any increase in the risk is related to treatment duration and it goes down after stopping HRT When discussing osteoporosis, we will give women advice on bone health and inform them that the risk of fragility fracture around menopausal age is low and varies from one woman to another. We will say that their risk of fragility fracture is reduced while taking HRT and that this benefit: · remains during treatment but decreases once HRT stops and · that it may continue for longer for those who take HRT for longer We will tell patients that the effect of HRT on the risk of dementia is unknown And that: · HRT may improve muscle mass and strength · And that Being active helps maintain muscle mass and strength We will now touch on the diagnosis and management of premature ovarian insufficiency And we will diagnose premature ovarian insufficiency under 40 years of age based on: · menopausal symptoms (including no or infrequent periods) and · elevated FSH levels on 2 samples taken 4–6 weeks apart We will not diagnose premature ovarian insufficiency on a single blood test and we will not routinely check anti-Müllerian hormone to diagnose it If there is doubt about the diagnosis, we will seek specialist advice For their management we will consider referral but we may also offer a choice of HRT or a combined hormonal contraceptive unless contraindicated We will explain: · the importance of hormonal treatment either with HRT or a combined hormonal contraceptive until at least the age of natural menopause · that the baseline population risk of diseases such as breast cancer and cardiovascular disease increases with age and is very low in women aged under 40 · that HRT may have a beneficial effect on blood pressure when compared with a combined oral contraceptive · that both HRT and combined oral contraceptives offer bone protection and · that HRT is not a contraceptive If hormonal treatment is contraindicated we will give advice on bone and cardiovascular health. Now, as promised, let’s have a look at our one-page summary flowchart, giving you some cost-effective examples of preparations that we can use. Obviously, these will change from time to time so keep an eye on your local formulary too. You can download this flowchart by clicking on the link in the episode description. And we will start with the transdermal options remembering that they should be the first-choice route particularly for women with high risk factors, including a BMI over 30, as they are unlikely to increase the risk of VTE or stroke, unlike the oral preparations. Examples of oestrogen only preparations for women with no uterus, we have twice weekly patches like evorel and estradot with their different strengths as well as gels and sprays like oestrogel, sandrena and lenzetto. We may also use these preparations for women with a uterus if we avoid endometrial hyperplasia and the increased risk of endometrial cancer by giving progestogenic opposition with a levonorgestrel IUS or Mirena Coil or micronized progesterone like utrogestan capsules. As an example of sequential combined HRT causing a monthly bleed for women with a uterus, we have twice weekly Evorel sequi patches Continuous period free combined HRT, is not suitable in the perimenopause or within 12 months of the last menstrual period and an example would be twice weekly evorel contipatches We will now look at the oral options. And an example of an oestrogen only oral preparation is Elleste Solo with two different strengths Examples or oral sequential combined HRT offering a monthly bleed are femoston and elleste duet also with their two different strengths And examples of period free oral continuous combined HRT preparations, again not suitable in the perimenopause or within 12 months of the last menstrual period we have femoston conti and its low dose version, indivina, kliofem and elleste duet conti. Second line preparations would be bijuve and tibolone but researching the pros and cons of these last two may be advisable We also have a few boxes about low oestrogen options, for example for women 60 or over like evorel 25 patch and oestrogel as unopposed oestrogens or, as continuous combined preparations, femoston conti with 0.5mg of oestradiol or kliovance. We also have a reminder about addressing lifestyle factors and optimally managing conditions like hypertension and diabetes. And also, that herbal medicines are not available on prescription and they are largely unregulated products lacking consistency. And for urogenital atrophy we can use ovestin cream, vagirux vaginal tablets, imvaggis pessaries, estring vaginal rings and blissel gel And finally, of course, we have over the counter vaginal moisturisers such as replens MD and Yes VM We have come to the end of this episode. Remember that this is not medical advice and it is only my summary and my interpretation of the guideline. You must always use your clinical judgement. Thank you for listening and goodbye.