New non-hormonal hot flush medication – Fezolinetant

Fezolinetant (Veoza)

The long awaited game changing medication for hot flushes is now available in UK

Veoza is not a hormone treatment, so it is suitable for women for whom hormone replacement therapy is not safe, or who wish to avoid hormones.

Those of us who care for breast cancer survivors have been watching in eager anticipation the promise of the initial pilot studies, and now extensive trials have finalised and confirmed the safety and effectiveness of Fezolinetant , branded as Veoza in reducing the severity and frequency of hot flushes and sweats. Official approval for its use was given earlier this month and the pharmacies will begin to have it available by the end of this week. It is a prescription drug, and will initially only be available privately. This is because it has to be assessed by the National Institute for Health and Care Excellence (NICE) before it can be approved for use in the NHS. It is expected that even with a push to have it approved that it will take about eighteen months before we can prescribe it on the NHS.

Neurokinin B receptor Agonist Veoza (Fezolinetant) has the potential to revolutionise the treatment of women who have significant flushes and sweats and who cannot take hormone replacement therapy. For those of us who want to know how it works, Veoza is a non-hormonal menopause drug that acts directly on the brain to prevent hot flushes. It works by blocking a brain protein called neurokinin-3 that plays a unique role in regulating body temperature in menopausal women.
Hot flushes, also called vasomotor symptoms, affect about 85 % of women going through the menopause. Women can suddenly and overwhelmingly feel hot, which often has an impact on their quality of life, exercise, sleep and productivity. We know that hot flushes last on average for seven years, for some women they last a couple of years but there are some women for whom they last a lifetime.

Despite the enormous numbers of women affected, for decades there have been few safe and effective treatment options. Hormone replacement therapy (HRT) is the most effective, but this is unsuitable for women with a history of breast, ovarian or uterine cancer. Some women experience side-effects or would prefer a non-hormonal alternative.

The British Menopause Society considers the advent of Veoza a very exciting advance and as a menopause specialist I am so pleased to be able now to prescribe for you.

This medication will help with vasomotor symptoms, it has very few minor side effects and there are only a very few drugs with which it may interact. In the trials it was noted to take very speedy effect, within days, and it is convenient to take once a day.

I can see it being hugely useful for my cancer survivors, and also for women who wish to avoid hormones who have persistent hot flushes. The studies looked at women between 40 and 65, and we will need more evidence to guide us if we want to use it for older women.

Like the BMS, I am very excited to start to use Veoza, please call 020 8861 1221 to make an appointment for my menopause clinic on Friday mornings or email [email protected]

Jane Woyka

Dr Woyka clinics rescheduled from August 2023

Unfortunately our own Dr Woyka has to have an operation towards the end of July and will not be able to see patients until September 2023 at the earliest.

Regular patients can see our other great doctors at the practice who will be covering her sessions, but Menopause clinics have been postponed.

If you have a menopause related query these should still be able to be answered by the team covering. For more information do please email us on [email protected]

Celebrate World Menopause Day 2022

Upcoming YouTube Premiere – to celebrate World Menopause Day

To celebrate World Menopause Day, British Menopause Society has again partnered with ITN Business to bring an exclusive video Premiere Tuesday 18 October at 12.00

The link to the YouTube Premiere is here https://youtu.be/0mxjD7D27jc

Menopause: Continuing the Conversation, hosted by Louise Minchin, showcases menopause news stories and misinformation, to nutrition, workplace policies and why HRT isn’t for everyone.

Menopause HRT drug supply issues

Dear menopause patients,

I am really sorry there are supply issues with some of  the transdermal products specifically oestrogel and  now sandrena

The alternative non oral oestrogen comes in patch form, one squirt of oestogel is equivalent to a 25 mcg patch

Most patches last 3-4 days, they include evorel, estradot, generic etradiol, all of which come in  25-100mcg strengths.

You would continue to use your usual progestogen as prescribed (utrogestan usually)

Please see link to the BMS website

British Menopause Society update on HRT supply – British Menopause Society (thebms.org.uk)

Best wishes

Dr Jane Woyka

Menopause casting call

Dear Patients,

I have received a request from a TV company which is casting for an online series about the menopause and is looking for women to take part. It’s for a well-known lifestyle brand.

I am sharing the below flyer for any of my patients who may be interested and would like to share their experience.

Best wishes

Jane Woyka

 

Stopping HRT

Women shouldn’t be advised to stop taking HRT after any arbitrary time limit,’ say the National Institute for Health and Care Excellence (NICE) guidelines that help healthcare professionals provide the best and safest care at the menopause. Yet the myth that you should stop HRT after five years is still one of the most common reasons why women stop taking HRT. This is often because their doctors refuse to continue to prescribe it, in the mistaken belief that taking HRT has a maximum five-year safety limit, regardless of a woman’s age or why she’s taking it.

Many women stop treatment after only a few weeks. The NICE guidelines advise that healthcare professionals should: ‘explain to women what the menopause is, why they are being prescribed hormones, and what benefit they will have. They also need to know what side effects they may experience and that bleeding is very common in the first few months and not a reason to stop.’ Unfortunately, many women take HRT for only a very short time, often not long enough to see any benefit, indicating that they haven’t been given a good-enough explanation.

Do you still need it?

It’s natural to wonder if you still need HRT. I often find that women have had their own trial period off HRT, and these are often the women who are adamant that they don’t want to stop as they felt so awful without it. In practice, I often find women have stopped because they ran out, forgot to take it on holiday or, increasingly, because they had difficulty getting a GP appointment. The recent supply shortages have also caused problems, with many women stopping HRT because they were unable to get their patches or usual formulations

There may be medical reasons to stop, perhaps because a woman is diagnosed with breast, uterine (womb) or ovarian cancer. Women who have had a heart attack or stroke are often advised to stop, although some cardiologists and menopause specialists will allow them to continue using non-oral treatments. Women who are about to have major surgery are also currently advised to stop
taking oral oestrogen six weeks before surgery; non-oral treatments can be continued up to three days before surgery, although we always advise you to discuss this with your anaesthetist first.

Women are often worried that there may be an age limit; many rely on their HRT to help them function at work, particularly now the state pension age is 67. For some unlucky few, hot flushes can persist for decades, and we have patients in their 90s who are still on HRT.

Doctors know that the long-term health benefits continue for at least as long as women stay on HRT, and some women never want to stop. We do recommend using the lowest dose of HRT that’s effective; it seems a little oestrogen goes a longer way as we age, and older women should use transdermal (across the skin) products that have no increased risk of blood clots.

How to stop

If you and your healthcare professional have decided that you should stop HRT, we suggest trying a lower dose for three to six months first (unless you have been advised to stop immediately because of a new medical condition such as breast cancer). NICE tells us that there’s no long -term difference between stopping gradually or stopping abruptly, but weaning off HRT is less likely to cause rebound symptoms.

Reducing the dose means reducing the ‘daily’ dose; oestrogen is broken down in your body quite quickly, so don’t cut down by taking your medicine on alternate days, as this will cause fluctuations in your oestrogen levels.

If you’re using patches, you can ask for a lower strength or simply cut the patch in half down the middle. If you wish to reduce your HRT even more slowly, taking a third or a quarter off your patch will work too. Pharmacists may tell you this makes the preparation unlicensed, but it works extremely well!

If you’re using a gel, you can reduce the number of pumps. If you’re using one pump only, you can squirt out a whole dose and use only half of it.

If your HRT is in tablet form, there’s likely to be a low-dose formulation, or you could cut the tablet in half using a tablet cutter. A 0.5 mg strength of tablet is the lowest effective dose.

These directions work very well for oestrogen-only and standard oestrogen/progestogen combinations. If you’re stopping sequential treatment, we would recommend you finish the 28-day cycle to avoid early bleeding. If you’re taking utrogestan, simply stop taking it when you finish the oestrogen part.

Going back on HRT

If you decide to restart HRT, you should be able to return to your usual treatment straightaway, unless you’ve been off it for some time. If this is the case, you should return to a lower dose at first, after discussing this with your healthcare professional. We don’t recommend that you stop and start HRT repeatedly, as there’s a small slight increase in the risk of stroke in women in the first six months of stopping treatment.

Women who are taking HRT because they had an early menopause are strongly encouraged to continue HRT at least until the expected age of the menopause (and as long as they wish afterwards). Women who have a risk of breast cancer because of a family history, or who carry the faulty breast cancer gene, are advised to stop treatment at 50.

Topical vaginal oestrogen

Topical vaginal oestrogens are not, in my view, hormone replacement, as they’re not absorbed into the bloodstream. These are available as pessaries, creams, a ring and a gel. They protect against urine and vaginal infections, help with all forms of bladder problems, maintain sexual responsiveness and comfort and improve vaginal dryness and all aspects of vaginal health. I consider these as important as face creams, except they’re for the vagina, and should never be stopped.

Top Tips for Women who are going through cancer and experiencing early menopause

  • If your cancer treatment is likely to cause an early menopause do ask to be referred to a menopause specialist ideally before you have the treatment
  • Having an early menopause isn’t good for your health, your life expectancy is reduced by 2 years, you have an increased risk of heart disease, you are more likely to develop osteoporosis, there is an impact on the collagen structures including pelvis, skin, hair, you are likely to develop vaginal dryness, your libido may well be affected and some aspects of your memory function may also be affected. These long term health disadvantages can be reversed by taking appropriate treatment.
  • Ask for a DEXA bone density test. Take Vitamin D.  Plenty of sunshine and lots of weight-bearing exercise.
  • Having an early menopause affects fertility. Egg production ceases and in most situations your only option for having a baby would be egg donation.
  • Early menopause affects your sexual health. Loss of oestrogen in the vaginal area makes it less responsive and the impact of reduced oestrogen on your brain directly affects your libido.   Talk to your partner.  Ask for referral to a counsellor.
  • Early menopause means less oestrogen in the vulva and vagina areas. This often causes dryness, soreness, loss of responsivity as well as generalised discomfort.   You may experience more frequent urine infections.   There are lots of things on the market to help you, go and find a good moisturiser such as Regale or Replens.   Always use a lubricant when having sex.   KY Jelly is not a lubricant that’s for doctors doing examinations but there are lots of lovely products like Yes, Silk and other excellent products.   Look after your vulva and vagina with the same attention as you would look after your skin and face.   Almost everybody can use topical oestrogens which will improve matters greatly particularly if used in combination with the moisturisers and lubricants.   Topical oestrogen is not absorbed in the blood stream and is usually not detectable but makes a huge difference to the local tissues.   Patients taking aromatase inhibitors are the one group of women who should not use topical oestrogens but almost every other cancer patient can use a topical oestrogen safely.
  • Consider hormone replacement therapy. If your menopause has come too early you are at risk from the long term health issues mentioned above.   You may also have symptoms like hot flushes, night sweats, sleep disturbance which can all be resolved by taking hormone replacement therapy.   All the long term health disadvantages of being rendered early menopause can be reversed by being on hormone replacement.   Women who have had what we term hormone dependent cancers will not be prescribed oestrogen replacement therapy. ( These include most patients with breast cancers, patients with later stage cancers of the womb (although stage 1A endometrial cancers can have oestrogen therapy) and some sorts of ovarian cancer) But all other sorts of cancers, bowel cancers, cervical cancers, leukaemia etc patients are suitable for hormone replacement therapy and should indeed be prescribed oestrogen replacement.
  • Natural remedies abound but none have been shown to reverse the long-term health disadvantages of early menopause. Don’t forget however natural remedies doesn’t necessarily mean safer remedies and some herbal treatments like Black Cohosh, St John’s Wort can interact with other medications and are generally not to be recommended.
  • So try HRT if your cancer permits, as most do, if not please adopt healthy lifestyle with plenty of sunshine, weight-bearing exercise, a good well-balanced healthy diet including dairy products, fruit, vegetables.

Non hormonal treatments for menopausal symptoms

The majority of women experience a natural menopause (sometimes called the ‘change of life’) when their periods finish, usually around the age of 51 years. During the years when women are having periods, the ovaries produce eggs and the female hormones estrogen and progesterone. As women approach the menopause, there are few remaining eggs in the ovaries and those that remain are less likely to develop. Fewer eggs are released and less of the hormones are produced, until the ovaries finally stop working and periods stop. Sometimes the menopause is accompanied by uncomfortable symptoms. These symptoms are caused by fluctuating and lower levels of estrogen.

In a recent survey 95% of women said they would try alternative therapies before HRT because they think they are more natural and because they are worried about health risks of HRT. NICE guidelines have used carefully weighed evidence-based evaluations of the effectiveness of alternative treatments compared with placebo (no treatment) and also with conventional forms of HRT

Women should receive an individualised approach at all stages of their care, to help them make decisions based on the evidence given to them.  Healthcare professionals are tasked with providing an explanation of the stages of the menopause and women should receive an explanation about what to expect. These include changes in the menstrual cycle and the symptoms which may be experienced such as hot flushes and night sweats, musculo-skeletal problems, mood changes (different from depression), uro-genital symptoms and sexual difficulties. There will be changing symptoms at different stages and this too needs to be recognised.

Your doctor or nurse should help you explore the lifestyle changes which will improve your general health and well-being and explore the long-term implications of the menopause. They should be able to provide information about the different treatments including the benefits and risks of treatments and the evidence for their effectiveness.

Women who have breast cancer or are at high risk of breast cancer should receive care and advice from a healthcare professional with expertise in the menopause.

Many women will elect to take no treatment for their symptoms, some do not wish to take hormones and for others HRT is not advisable.

NICE use some different techniques to measure the effectiveness of different therapies.  A network meta-analysis (NMA) allows lots of different treatments to be compared by how well they worked in relation to another treatment.  An NMA compared placebo (no treatment)  acupuncture, sham acupuncture, oestrogen alone, estrogen and progestogen, non-oral estrogen plus progestogen, tibolone,  gabapentin, Selective Serotonin Reuptake Inhibitors (SSRI) and Selective Norepinephrine Reuptake Inhibitors (SNRI), Isoflavones, Chinese herbal medicine, black cohosh, multi botanicals and cognitive behavioural therapy  (CBT).

One of the powerful messages coming from the NICE Guidelines is that herbal remedies which are not regulated by a medicine authority should not be considered safer, as there is so much  variety in their effectiveness and potency and that there may be significant side effects.  The same warning is given for bio-identical hormones which are compounded and again not regulated or subject to quality control

Complementary and alternative treatments

Cognitive behavioural therapy (CBT)

The good news is that CBT can alleviate low mood and anxiety which arise as a result of the menopause, and now we realise CBT can also improve hot flushes and sweats.  The North American Menopause Society (NAMS) recommends a CBT approach that combines relaxation techniques, sleep hygiene and learning to take positive healthy attitude to a menopause challenge.  CBT is now a recommended treatment option for anxiety experienced during the peri and post-menopause. A CBT approach which is theory based can improve hot flush perception and reduce stress and sleep problems. There are two-way interactions between mood and hot flushes as 10% of women are more likely to be depressed during the menopause.   There is a fact sheet (written by Professor Myra Hunter, Kings College London) on the Women’s Health Concern website which provides guidance on cognitive behavioural therapy almost in a self-help format for women to access directly

Herbal treatments

Guidelines recommend that you look for the THR logo standing for traditional herbal medicines.  These products have been approved and you can be sure that the product has the correct dosage, is of high quality and has suitable product information.  The NICE guidelines also recommend that many available herbal medicines have unpredictable dose and purity and some herbal medicines have significant drug interactions.

Black Cohosh:

This North American traditional herb can help hot flushes although never as well as HRT.  Black cohosh does not help with anxiety or low mood, but black cohosh can interact with other medicines and there are unknown risks regarding safety

St John’s Wort:

Again the good news is that St John’s Wort was shown to have benefit in relieving vasomotor symptoms, particularly in women with a history of, or at high risk of breast cancer.  However, like black cohosh, it does interact with other drugs which again makes it a drug we have concerns about, including its reliability regarding dose effectiveness and safety profiles. Women on tamoxifen must not take St John’s Wort as it makes the tamoxifen ineffective.

Other herbal treatments including Ginseng and Chinese herbal medicines are not shown to improve hot flushes, anxiety or low mood.

Isoflavones and soya products (plant substances found in the diet including red clover supplements)   

Phytoestrogens (isoflavones) can form a large part of dietary intake in certain ethnic groups; these women should continue their normal diet.   There are very many studies looking at the effectiveness of these food substances, but the results are variable and generally show little value. They are not recommended in patients with breast cancer.

Acupuncture

Studies showed no difference in women who received acupuncture compared with those who received sham acupuncture, but there is a very high placebo effect with both sham and real acupuncture.

Non hormonal prescribed treatments

Selective Serotonin Re-uptake Inhibitors (SSRI) [fluoxetine, paroxetine, citalopram, sertraline] and the Serotonin Noradrenaline Re-uptake Inhibitor/Selective Serotonin Re-uptake Inhibitors (SSRI-SNRI) [venlafaxine ]

Historically SSRI and SNRIs are recognised for their effects on depression and anxiety, and some of these medicines can improve hot flushes in some women. Paroxetine 10 mg seems to be the most effective, even at low dose and is now a recognised (licensed) treatment for menopausal hot flushes in the USA.  Other SSRIs which may be helpful include citalopram and fluoxetine.  Venlafaxine is also an option and is the preferred treatment for breast cancer survivors taking Tamoxifen and at 75mg there can be reduction in hot flushes with improvement in fatigue, mental health and sleep disturbance.  SSRIs and SSRI/ SNRIs can have associated significant side effects, such as dry mouth, nausea, constipation and appetite problems which are commoner at higher dosage, and reduction in libido is often experienced, a very unwanted extra effect for menopausal women. SSRIs should not be offered for vasomotor symptoms unless HRT cannot be given.  Those women taking tamoxifen should not take fluoxetine or paroxetine, as again it makes the tamoxifen ineffective.

Gamma aminobutyric acid (gabapentin) and pregabalin.

Gabapentin can improve flushes and sweats. Side effects include sleepiness, dizziness, weight gain and dry mouth and increase with higher dosage. A small dose is commenced and increased gradually, according to the effect on symptoms and side effects. Some patients like this medication as it improves sleep, but others find it very sedating in the day as well. Since April 2019 both these drugs have been reclassified as controlled medicines which have strict prescribing rules which will discourage  their use.

Clonidine:

Clonidine is the only non-hormonal drug licenced for use for hot flushes in the UK. Clonidine 25mcg is prescribed twice daily for 2 weeks increased to a maximum of 50mcg three times a day.   Studies of its effectiveness are contradictory although a few women may have significant benefit. At higher doses clonidine causes sleep disturbance in at least 50 percent of users. It must be withdrawn gradually as suddenly can cause rebound high blood pressure   as an anti-hypertensive, clonidine may not be suitable for patients with a baseline low blood pressure.

Treatments for breast cancer survivors    

Most women diagnosed and treated for breast cancer will live with their cancer, rather than die from it.   More research is needed into the safety of possibly using estrogen-based therapies for some of these women, particularly in receptor negative patients, but for the moment most clinical guidelines will not recommend estrogen based treatments. The North American Menopause Society (NAMS) looked for solid evidence of a few therapies that work so as not to waste patients’ time experimenting with things that really don’t work. NAMS recommends SSRIs, SNRIs, Gabapentin, Pregablin, Clonidine, CBT and clinical hypnosis.   The UK NICE guidelines (November 2015) indicate that SSRIs, SNRIs and Gabapentin are no better than placebo and that Paroxetine and Fluoxetine may reduce the efficacy of Tamoxifen.   For breast cancer survivors, one NICE guideline recommends Clonidine, Venlafaxine and Gabapentin might be tried, although the NICE 2015 Guideline indicates that only St John’s Wort may improve symptoms, although not recommended because of serious drug interactions. Isoflavones, red clover and black cohosh are not recommended for breast cancer survivors by any of the International bodies.

It is important to recognise that all this information is “evidence-based”, which means it is not hearsay or factoid, but supported by powerful scientific evidence.

Few complementary and alternative treatment options have proven evidence of effectiveness, but although many options do not stand up to scrutiny from a robust and evidence-based perspective, there will be individual women who will benefit from some of these treatments.

It is most important to have an individualised approach from your practitioner. We are realising more and more that the powerful placebo effect from almost every menopause intervention (which can be at the 50-60 percent level)   may be due to improved brain chemical messengers which are generated because you believe in the treatment option.

Your healthcare professional should help you pick through the different treatment options to help identify which ones may be the best for you. This guidance is evidence based but not looking at the individual and it is possible you might be one of the two percent who responds extremely well to Isoflavones or Gabapentin.  You should ask to discuss any ongoing problems with a menopause specialist.

Useful contacts

British Acupuncture Council

63 Jeddo Road , London, W12 9HQ

Tel: 020 8735 0400

Website: www.acupuncture.org.uk

British Reflexology Association

Monks Orchard, Whitbourne, Worcester WR6 5RB

Tel: 01886 821 207

Website: www.britreflex.co.uk

Complementary Medical Association

Tel: 0845 129 8434

Website: www.the-cma.org.uk

International Federation of Professional Aromatherapists

82 Ashby Road, Hinckley Leicestershire, LE10 1SN

Tel: 01455 637987

Website: www.ifparoma.org

National Institute of Medical Herbalists

Clover House, James Court, South Street, Exeter, Devon EX1 1EE

Tel: 01392 426022

Website: www.nimh.org.uk

Society of Homeopaths

11 Brookfield, Duncan Close, Moulton Park Northampton NN3 6WL

Tel:  01604 817890

Website: www.homeopathy-soh.org