Why it was a mistake to stop prescribing HRT to menopausal women

It took a loud public outpouring about menopause symptoms to reverse the impact of two flawed but influential studies warning against hormone replacement therapy

Female sign made from medicine pills

Menopause is a fact of life for women. On average, women in Ireland become menopausal at 51. At that stage, they will have gone 12 consecutive months without having a period.

They will likely have experienced perimenopause in the years leading up to that point. Starting in a woman’s mid-40s, it’s caused by declining levels of the female hormones oestrogen and progesterone, manifesting in symptoms ranging from hot flushes and night sweats to disrupted sleep, brain fog, and painful sex.

Replenishing the levels of oestrogen and progesterone can help alleviate symptoms, but many women are unaware of this because of hormonal replacement therapy’s (HRT) chequered history following reports based on two large-scale studies released more than 20 years ago.

“HRT was first prescribed in the 1940s and was widely used as a treatment for menopausal symptom control until the early 2000s,” says Dr Brenda Moran, menopause specialist and joint leader of the Complex Menopause Clinic at Cork University Maternity Hospital.

“Two studies emerged around that time, the large-scale Women’s Health Initiative (WHI) in the US and the Million Women’s Study in the UK, which suggested that HRT increased the risk of conditions such as breast cancer, clots, and stroke. Regulatory bodies then recommended that women take it only for short periods of time if they had to take it at all.”

As a result, doctors stopped prescribing HRT and menopausal women had little option but to suffer through their symptoms.

It has since emerged that the findings of the WHI, which garnered the most headlines at the time, were flawed. They were based on the effects of HRT on women who were already past menopause, not those who were experiencing menopausal symptoms at the time of treatment.

“The US study involved post-menopausal women in their mid-60s and older who didn’t have symptoms,” says Dr Brian Kennedy, founder of HRT Prescribers, a support group for medics that prescribe HRT.

“The women we generally see presenting with symptoms in their late 40s and early 50s, the ones usually prescribed HRT, were excluded from the study.”

Doctors have also criticised the design of the Million Women’s Study. For example, women who already had cancer or suspected cancer weren’t excluded from participation, which made the study’s conclusions unreliable.

Research carried out in the intervening years has demonstrated it was a mistake to stop prescribing HRT to menopausal women.

“Long-term data now shows a reduction in cardiac events in women who start HRT in the 50- to 60-year-old age group, which is the usual HRT cohort.

“A 2017 study showed no increase in cardiovascular events, cardiovascular mortality, cancer mortality or any kind of mortality in women who start HRT in any age group, including older women,” says Moran.

The latest research proves that HRT is a safe intervention for most women struggling with menopausal symptoms. “It’s the most effective method of providing symptom relief and can improve quality of life for women who are suffering,” says Kennedy.

Myriad symptoms

It can be difficult to anticipate how varied the symptoms of menopause can be. “Most are familiar with hot flushes and night sweats,” says Kennedy.

“But there are oestrogen receptors in the brain, the joints, and all over the body. Therefore women can get random symptoms like a sore tongue, fainting, numb hands and feet, low mood, and forgetfulness.”

HRT has the potential to address these symptoms. “There’s no other therapy or medication that can help with multiple menopausal symptoms the way HRT can,” says Moran.

It can also have other benefits. Along with reducing the risk of cardiovascular events, Moran refers to research demonstrating that oestrogen delivered through HRT helps to maintain and improve bone density and another study linking progesterone to a lower risk of endometrial cancer.

That’s not to say that taking HRT is entirely risk-free. “There’s a small risk of breast cancer with increasing duration of progesterone use,” says Moran. “But it’s less than the risk attributable to being overweight or drinking more than two units of alcohol a day. Observational studies suggest an extremely small risk of ovarian cancer and oral oestrogen is linked to a small increased risk of clots and stroke.”

According to Kennedy, these risks are especially pertinent to women with a history of hormone-sensitive cancers, women who have had a stroke or heart attack or severe active liver disease.

Many menopausal women never need to consider taking HRT. They may be among the 20% who experience minimal symptoms, or their symptoms may have little impact on their lives. “HRT is a discretionary treatment and it’s not necessary if a woman is coping well with menopause,” says Kennedy.

Women who are struggling with menopausal symptoms are advised by their doctors to weigh up the pros and cons of taking HRT. “In terms of the modern HRT products commonly prescribed for women today, the benefits far outweigh the risks,” says Kennedy. “Women are living longer and must deal with issues like osteoporosis and cardiovascular disease in old age. HRT arguably helps reduce the impact of these conditions along with alleviating symptoms.”

Forms of HRT

As our awareness of HRT has changed over the past two decades, so too has the range of HRT products. “Twenty years ago, women were offered a form of oral oestrogen derived from horse urine and progesterone products that were more potent and synthetic than the bioidentical products available today,” says Kennedy.

These HRT products come in different forms. Oestrogen can be administered as a tablet or via the skin as a patch, gel, or spray, while progesterone can be taken as a tablet, vaginal pessary or via an intra-uterine coil.

But these products come at a high cost. “Depending on the products women are taking, HRT can cost from €35 to €75 per month,” says Moran.

It’s a price menopausal women consider worth paying, as demand for these products is rising in Ireland. In 2022, Estradot, one of the leading producers of oestrogen patches, increased its supply to Ireland by 117% since 2020.

“HRT has come full circle,” says Kennedy. “It was hugely popular pre-millennium. Many GPs became reluctant to prescribe it due to the studies associating it with adverse outcomes for women. But following the Davina McCall documentary and the Joe Duffy [ Liveline] show [in 2021], the demand for HRT has risen again and doctors now practice an individualised approach that prescribes HRT for women who need it.”

• Dr Brenda Moran and Dr Brian Kennedy are speakers at the National Menopause Summit at City Hall, Cork, on Friday, October 20.