This article was written by one of The Food Medic team; London-based GP Nirja Joshi.
Hormone replacement therapy (HRT) will reportedly be made available over the counter in the UK to support women going through the menopause. Understandably this has raised a lot of questions and we thought it would be a good opportunity to share what we know so far.
What is HRT?
HRT stands for Hormone Replacement Therapy HRT is a treatment option for women who suffer with symptoms during the menopause. The menopause can cause varying symptoms in women, ranging from hot flushes, disturbed sleep, vaginal dryness, mood swings and anxiety. HRT is currently only available in the UK following a consultation with your doctor (1). Women may require HRT during the menopause (if they have not had a period for 12 months), or the perimenopause (the time leading up to the menopause).
What is changing?
The government has made a commitment to improving inequalities within women’s health in the UK (2). Women have often had to endure terrible symptoms which have impacted their work and home lives. However, the proposal which is currently being discussed by the Medicines and Healthcare products Regulatory Agency (MHRA) is to trial having a vaginal oestrogen preparation over the counter in pharmacies. The aim of this is to improve access to HRT which has been notoriously difficult in the past.
The proposal is that “Gina-10”, which is a vaginal oestrogen tablet, could be made available to buy over the counter in pharmacies (2). The tablet could be offered to women over the age of 50 who have not had a period in over 12 months. The Commission on Human Medicines has suggested it would be safe to have this medication available over the counter. The Commission on Human Medicines (CHM) advises ministers on the safety, efficacy and quality of medicinal products. The MHRA is currently conducting a consultation with GPs, pharmacists and members of the public on their opinion on the subject. “The MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.” (2)
Before any medicines would be available, pharmacists would be given access to training materials as well as safety checklists to ensure that the medication is given appropriately and safely. (2)
What options do women with menopausal symptoms have?
HRT is one option which attempts to help address the hormonal changes which occur with menopause. During this time, a woman’s oestrogen levels drop, which leads to a variety of symptoms. HRT works by redressing the hormonal balance and helping to alleviate these symptoms. HRT can be delivered through various means, oral tablets, gels to use on your skin, patches or vaginal preparations – as in this situation (1).
Aside from HRT, many women choose to use other treatments for menopausal symptoms. Herbal treatments are commonly used (3), however, these treatments can cause side effects or interact with other medication, and hence, if you choose to use a herbal remedy, please consult your GP first. There is a misconception that herbal remedies are not ‘strong’, however, some can impact your liver function, and others interact with medication and hence a discussion with a medical professional is advised. St John’s Wort, typically used to help with symptoms relating to low mood, can interfere with the metabolism of other medications in your liver. Black Cohosh used to help the impact of low oestrogen, can cause stomach upset, headaches and rashes. It is important to remember that herbal medicines will not be monitored for strength and dose, hence effects, and side effects may vary.
There are of course, lifestyle changes (3) which can help with the menopause such as wearing lighter clothing to help with hot flushes, exercise and nutrition can boost mood and improve sleep. Some women are prescribed other medications such as antidepressants which can address anxiety, depression as well as vasomotor symptoms (hot flushes).
Do you need vaginal oestrogen?
Vaginal oestrogen can be helpful for women with particular symptoms such as vaginal dryness, which is sometimes referred to as ‘vaginal atrophy (4)’. Vaginal oestrogens do not absorb well into your bloodstream, and hence do not have the effect, or indeed side effect profile of other types of HRT which can affect your whole body (4).
Every woman’s experience of menopause is different and it is important to recognise which treatment would be best aligned to your symptoms.
Is this the right direction of travel for women’s health?
The MHRA has recently licensed the Progesterone Only Pill (POP) as contraception which can be bought over the counter (5). This is a progressive step in terms of action to equalise the access to contraception. In order to have this level of approval, the safety data on the POP had to be investigated to ensure that the medication was safe to take over the counter. The same process will need to be done for HRT. HRT is not available over the counter at present, and the timeframe of which this may become a reality is unclear (2).
Minister for Women’s Health, Maria Caufield has said that a UK-wide Menopause taskforce has been created to help address the issues faced by women in the UK experiencing menopausal symptoms (2).
What is the safety data on HRT?
In the past, doctors have been more cautious prescribing HRT due to concerns regarding safety and the risk of breast cancer. Studies in the 1990s, including the ‘Million Women Study’, suggested two main concerns, potential increased risk of breast cancer with prolonged use, and potential increased risk of heart disease (6). This dramatically reduced the uptake of HRT amongst women, the usage of HRT declined in the UK by 66%, and current data shows that this has not changed since those studies. More recently, the significance of these studies has been questioned as it looked at women over 60 and those with high BMI, hence it is difficult to look at the direct risk from HRT. However, the risk of breast, ovarian cancer and blood clots does remain, but will depend on what type of HRT, at what age you take it, the duration of treatment and your pre-existing risk factors. Aside from treatment of traditional menopausal symptoms, HRT also has the potential to reduce a woman’s risk of osteoporosis and fractures (6). HRT should certainly be considered with a discussion with your doctor if menopausal symptoms are affecting your life. The vaginal oestrogen being considered for over the counter usage does not have the same risk profile as other medications, for example, those taken by mouth, which can have more systemic effects on the body (2).
What to do next?
Menopausal symptoms can have a devastating impact on some women. Therefore, I would strongly encourage any woman with symptoms which are impacting on their life to seek help from their GP for treatment.
As explained, there are several different options to consider, HRT, non-HRT based prescription medication, lifestyle changes and herbal treatments. Each woman’s preference will vary depending on your symptoms, and your personal preference. Before speaking to your GP, I suggest reading about the options available to consider what types of treatment you may prefer.
- NHS. Hormone Replacement Therapy (HRT) [Internet]. HRT. 2019 [cited 2022 Feb 2]. Available from: https://www.nhs.uk/conditions/hormone-replacement-therapy-hrt/
- Medicines and Healthcare products Regulatory Agency. Views sought on making first local vaginal HRT product available without need for prescription [Internet]. 2022 [cited 2022 Feb 10]. Available from: https://www.gov.uk/government/news/views-sought-on-making-first-local-vaginal-hrt-product-available-without-need-for-prescription
- NHS. Alternatives to HRT [Internet]. 2021 [cited 2022 Feb 10]. Available from: https://www.nhs.uk/conditions/hormone-replacement-therapy-hrt/alternatives/
- National Institute for Clinical Excellence. ESTRADIOL [Internet]. British National Formulary. [cited 2022 Feb 10]. Available from: https://bnf.nice.org.uk/drug/estradiol.html
- Medicines and Healthcare products Regulatory Agency. Progestogen-only contraceptive pills will be available for the first time from pharmacies without prescription, increasing choice for women in the ways in which they can access contraception. [Internet]. First progestogen-only contraceptive pills to be available to purchase from pharmacies. 2021 [cited 2022 Feb 10]. Available from: https://www.gov.uk/government/news/first-progesterone-only-contraceptive-pills-to-be-available-to-purchase-from-pharmacies
- Women’s Health Concern. HRT: Benefits and risks [Internet]. 2020 [cited 2022 Feb 10]. Available from: https://www.womens-health-concern.org/help-and-advice/factsheets/hrt-know-benefits-risks/