Listen "Finally cracking the HRT code: NICE on the menopause"
Episode Synopsis
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 youcan access here: The Practical GP YouTube Channel: https://youtube.com/@practicalgp?si=ecJGF5QCuMLQ6hrkThe NICE guideline NG23 “Menopause: diagnosis andmanagement” can be found here: https://www.nice.org.uk/guidance/NG23The guidancefrom the Faculty of Sexual & Reproductive Healthcare on contraception forwomen aged over 40 years can be found here:http://www.fsrh.org/pdfs/ContraceptionOver40July10.pdfThe MHRA summary of HRT risks and benefits during current use andcurrent use plus post-treatment from age of menopause up to age 69 years, per1000 women with 5 years or 10 years use of HRT can be found here: https://assets.publishing.service.gov.uk/media/5d680409e5274a1711fbe65a/Table1.pdfThe summary flowchart with examples of preparations can be found here: https://1drv.ms/b/s!AiVFJ_Uoigq0mFjbJIiJs842urJB?e=FcfiJlThumbnail photo: from Freepik: https://www.freepik.com/ Image by LipikStockMedia onFreepik: 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"Imageby LipikStockMedia/a on FreepikIntro / 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 TranscriptHello and welcome, I am Fernando, a GP in the UK. Mrs Brown sees youbecause wants to discuss HRT in detail, including the pros and cons of thevarious preparations available. Do you say?: “of course, ask me anything youwant” 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 themenopause from a Primary Care perspective.Make sure to stay for the entire episode because, at the end, I willalso go through a one-page summary flowchart giving cost effective examples ofvarious 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 ofthe menopause include:· a change in their menstrualcycle · vasomotor symptoms (e.g., hotflushes 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., lowsexual desire).When these symptoms are present, most women willask 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 thefollowing diagnoses without checking FSH:perimenopause in women over 45 with vasomotorsymptoms and irregular periods andmenopause in women over 45:· If they are not usingcontraception and have had no periods for at least 12 months or· based on symptoms alone if thewoman does not have a uterusOf course, diagnosis can be more difficult if they are on hormonaltreatments but still, we should not check FSH if the woman is on combinedhormonal contraception or high-dose progestogen.However, we will consider checking FSH levels to diagnose menopause:· in women aged 40 to 45 withmenopausal symptoms, including a change in their menstrual cycle and· in women under 40 in whom the menopauseis suspected.Once we have made the diagnosis, we will give information about lifestylechanges, 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. CBTWe will also give information about contraception in the perimenopausaland postmenopausal phase. I have put a link to the guidance in the episodedescription but a very simplified summary is that:· CHC should be stopped at 50 andswitch to a safer method· Contraception can be stopped at55 as the risk of pregnancy is extremely low by thenIf the menopause is a result of medical or surgical treatment, we will:· Give information about fertilitybefore that treatment and· We will refer to a menopausespecialistIn terms of managing menopausal symptoms, thissummary 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 andrisks. We will offer a choice of:· oestrogen and progestogen towomen with a uterus or· oestrogen alone to women withouta uterus.We will not routinely offer SSRIs, SNRIs or clonidine as first-linetreatment for vasomotor symptoms alone.We will explain that there is some evidence that isoflavones or blackcohosh may relieve vasomotor symptoms but that:· preparations may vary· their safety is uncertain and· Drug interactions have beenreportedIn terms of psychological symptoms, we will consider HRT to treat menopauserelated low moodAnd also consider CBT to treat menopause related low mood or anxiety Remember that there is no clear evidence for SSRIs or SNRIs for low moodin menopausal women without a diagnosis of depression.We will consider testosterone supplementation for menopausal women withlow sexual desire if HRT alone is not effective. The BNF says that it is not licensed for this indication so seeking specialistadvice before initiation may be advisableFor urogenital atrophy we will offer vaginal oestrogen (including forthose on systemic HRT) and we will continue treatment for as long as needed torelieve symptoms.We will also consider vaginal oestrogen for urogenital atrophy in thosefor whom systemic HRT is contraindicated, after seeking specialist advice.If vaginal oestrogen does not relieve symptoms we will also seekspecialist advice before increasing the doseHowever we will also explain that:· symptoms often come back whentreatment is stopped· that adverse effects fromvaginal oestrogen are very rare and · that they should reportunscheduled vaginal bleeding Moisturisers and lubricants for vaginal dryness can be used alone or inaddition to vaginal oestrogen.And finally we will not offer routine monitoring of endometrialthickness 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 maybe unknown and we will also advise that there is also uncertainty about theappropriate use of St John's wortOnce treatment has been started, we will review patients:· at 3 months to assess the efficacyand tolerability and· annually thereafter unless moreoften is clinically indicatedWe will refer women for specialist advice if:· treatments are ineffective orcause side effects· there are contraindications toHRT or · there is uncertainty about themost suitable treatment optionIn terms of starting and stopping HRT, we will explain that unscheduled vaginalbleeding is a common side effect of HRT within the first 3 months of treatmentbut it should be reported at the 3-month review, or promptly if it occurs afterthe first 3 monthsWhen stopping HRT we will consider the choice of gradually reducing orimmediately stopping treatment explaining that:· gradually reducing HRT may limitrecurrence of symptoms in the short term but that· either approach makes nodifference to their symptoms in the longer termThere are separate guidelines on the treatment ofmenopausal symptoms for women with, or at high risk of, breast cancer, butin general:· we will refer to a menopausespecialist· and ensure that paroxetine andfluoxetine are not given if the patient is on tamoxifenIn terms of long-term benefits and risks of HRT, thereis an MHRA summary of HRT risks and benefits that we can refer to explain theabsolute rates per 1000 women with 5 years or 10 years use of HRT. It is auseful one-page resource and I have included a link to this table in theepisode 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 byoral HRT · that the risk is greater fororal than transdermal preparations and · that the risk of transdermal HRTis no greater than baseline Therefore we will consider transdermal rather than oral HRT if the womanis at increased risk of VTE, including those with a BMI over 30But we will consider haematology referral if the patient is at highrisk, e.g.:· if there is a strong familyhistory of VTE or thrombophiliaFor cardiovascular disease we will explain that HRT:· does not increase CVD risk ifaged under 60 and · that it does not affect thecardiovascular mortalityAnd we must remember that cardiovascular risk factors are not acontraindication to HRT as long as they are optimally managed. So we will explain that:· the baseline CVD risk variesdepending on risk factors· that HRT with oestrogen alone isassociated with no, or reduced, risk of coronary heart disease· and that HRT with oestrogen andprogestogen is associated with little or no increase in the risk of coronaryheart diseaseBut we will also explain that oral oestrogen is associated with a smallincrease 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 type2 diabetes and does not have an adverse effect on glucose control but we will considercomorbidities and specialist advice before giving HRT in type 2 diabetesIn terms or breast cancer risk, we will make itclear that:· the baseline risk variesaccording to risk factors· that HRT with oestrogen alone isassociated with little or no change in the risk · that HRT with oestrogen andprogestogen can be associated with an increase in the risk of breast cancer but· that any increase in the risk isrelated to treatment duration and it goes down after stopping HRTWhen discussing osteoporosis, we will give women advice on bone healthand inform them that the risk of fragility fracture around menopausal age islow and varies from one woman to another.We will say that their risk of fragility fracture is reduced whiletaking HRT and that this benefit:· remains during treatment butdecreases once HRT stops and · that it may continue for longerfor those who take HRT for longerWe will tell patients that the effect of HRT on therisk of dementia is unknownAnd that:· HRT may improve muscle mass andstrength· And that Being active helpsmaintain muscle mass and strengthWe will now touch on the diagnosis and managementof premature ovarian insufficiencyAnd we will diagnose premature ovarian insufficiency under 40 years ofage based on:· menopausal symptoms (includingno or infrequent periods) and· elevated FSH levels on 2 samplestaken 4–6 weeks apartWe will not diagnose premature ovarian insufficiency on a single bloodtest and we will not routinely check anti-Müllerian hormone to diagnose itIf there is doubt about the diagnosis, we will seek specialist adviceFor their management we will consider referral butwe may also offer a choice of HRT or a combined hormonal contraceptive unlesscontraindicatedWe will explain:· the importance of hormonaltreatment either with HRT or a combined hormonal contraceptive until at leastthe age of natural menopause · that the baseline populationrisk of diseases such as breast cancer and cardiovascular disease increaseswith age and is very low in women aged under 40· that HRT may have a beneficialeffect on blood pressure when compared with a combined oral contraceptive· that both HRT and combined oralcontraceptives offer bone protection and· that HRT is not a contraceptive If hormonal treatment is contraindicated we will give advice on bone andcardiovascular 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 localformulary too. You can download this flowchart by clicking on the link in theepisode description.And we will start with the transdermal options remembering that theyshould 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 orstroke, unlike the oral preparations.Examples of oestrogen only preparations for women with no uterus, wehave twice weekly patches like evorel and estradot with their differentstrengths as well as gels and sprays like oestrogel, sandrena and lenzetto. Wemay also use these preparations for women with a uterus if we avoid endometrialhyperplasia and the increased risk of endometrial cancer by givingprogestogenic opposition with a levonorgestrel IUS or Mirena Coil or micronizedprogesterone like utrogestan capsules.As an example of sequential combined HRT causing a monthly bleed forwomen with a uterus, we have twice weekly Evorel sequi patchesContinuous period free combined HRT, is not suitable in theperimenopause or within 12 months of the last menstrual period and an examplewould be twice weekly evorel contipatchesWe will now look at the oral options. And an example of an oestrogen only oral preparation is Elleste Solowith two different strengthsExamples or oral sequential combined HRT offering a monthly bleed arefemoston and elleste duet also with their two different strengths And examples of period free oralcontinuous combined HRT preparations, again not suitable in the perimenopauseor within 12 months of the last menstrual period we have femoston conti and itslow dose version, indivina, kliofem and elleste duet conti. Second linepreparations would be bijuve and tibolone but researching the pros and cons ofthese last two may be advisableWe also have a few boxes about low oestrogen options, for example forwomen 60 or over like evorel 25 patch and oestrogel as unopposed oestrogens or,as continuous combined preparations, femoston conti with 0.5mg of oestradiol orkliovance. We also have a reminder about addressing lifestyle factors and optimallymanaging conditions like hypertension and diabetes.And also, that herbal medicines are not available on prescription andthey are largely unregulated products lacking consistency. And for urogenital atrophy we can use ovestin cream, vagirux vaginaltablets, imvaggis pessaries, estring vaginal rings and blissel gelAnd finally, of course, we have over the counter vaginal moisturiserssuch as replens MD and Yes VMWe have come to the end of this episode. Remember that this is notmedical advice and it is only my summary and my interpretation of theguideline. You must always use your clinical judgement. Thank you for listening and goodbye.
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