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

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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.