New scientific support for hormone replacement therapy to relieve menopausal symptoms in women has been welcomed by doctors and support groups.
HRT replaces declining hormones in women as they age, by topping up oestrogen and progesterone that are no longer produced in sufficient levels during the menopause.
The drugs can alleviate symptoms such as hot flushes, night sweats, brain fog and mood swings.
However, in the US their use plummeted up to 80 per cent following a 2002 Women's Health Initiative (WHI) study linking HRT with an increased risk of heart disease, stroke, blood clots and breast cancer.
Research assessed 161,000 women in the US, but subsequent analysis found the risk-benefit ratio of taking HRT was dependent on other factors, such as age and when the woman started the menopause.
The 2002 study focused on women who were, on average, 63 and 10 years post-menopause, a group already susceptible to cardiovascular issues.
Two decades on and the medical dogma that HRT is harmful for all women has receded following an intervention by the US Department of Health and Human Services (HHS) and Food and Drug Administration (FDA).
After a comprehensive review of scientific literature, the FDA has removed black box warnings from HRT packaging, the most serious type of guidance issued for medications that may cause death or serious injury.
“Every single part of a woman's body depends on oestrogen to operate at its best – including the brain, bones, heart and muscles,” said Alicia Jackson, health director of the US government’s Advanced Research Projects Agency.
“The removal of the black box warning, based on the best science and data, is an incredible step forward to empower millions of women to live longer, healthier lives.”
The FDA is not seeking to remove the boxed warning for endometrial cancer for systemic oestrogen-alone products. Drugs prescribed by the FDA are prescribed in the UAE and all over the world.
Loss of confidence
The decision has been welcomed by medics, who said millions of women who lost confidence in the drugs could now return to HRT to help deal with debilitating menopause symptoms.
The FDA’s labelled recommendation will be to start HRT when the menopause begins, within 10 years, or before the age of 60. As well as removing boxed warnings, the FDA is also approving two new drugs to expand menopause treatment options.
A generic version of Premarin (conjugated oestrogens), is the first HRT approval in more than 30 years, and will be more affordable than similar branded drugs. Approval has also been granted for a non-hormonal treatment for moderate to severe menopause symptoms, offering a proven option for women unsuitable for HRT.
Dr Aysha Salam, a specialist in obstetrics and gynaecology, at Aster Hospital Mankhool, in Dubai, said many doctors are recommending early treatment in perimenopause.
“Unlike the WHI study's single method, HRT can now be tailored to individual needs, considering symptoms, medical history and risk,” said Dr Salam. “HRT is the most effective way to control menopausal symptoms while also giving other health benefits.
“It is safe to use for most women in their fifties, or for the first 10 years after the onset of menopause. The added risk for blood clots, stroke and breast cancer while taking HRT is very small, and similar to that for many other risk factors such as being overweight.”
Despite the overall benefits, some women should remain cautious, Dr Salam said.
“Women with a history of hormone-sensitive cancers, such as certain types of breast cancer, are generally advised against HRT due to the potential for stimulating cancer cell growth and recurrence,” she said.
“Similarly, individuals with a history of venous thromboembolism or active liver disease face increased risks with the delivery of HRT drugs, necessitating alternative treatment strategies or careful monitoring.”
Women under 60 who initiate HRT within 10 years of the onset of menopause have a reduction in all-cause mortality and fractures, research has shown, while women may also reduce their risk of cardiovascular diseases by half, Alzheimer’s disease by a third, and bone fractures by up to 60 per cent.
Dr Bibiana Singh, a consultant in obstetrics and gynaecology at Medcare Women and Children Hospital, said doctors remained cautious when prescribing HRT.
“HRT will continue to be recommended only after a detailed and comprehensive gynaecological evaluation,” she said.
“Before initiating any treatment, women must undergo a full set of investigations, including a breast ultrasound, mammogram, pelvic ultrasound, and a pap smear.
“These assessments allow the doctor to identify any underlying concerns or risks that could influence treatment safety.”
Menopause advocacy groups said removing black box labelling was a welcome move, but said there are more alternative treatments available now for women reticent to take HRT.
“The decision to remove the black box warning makes a lot of sense,” said Ann Marie McQueen, founder of Hotflash inc, a global platform providing evidence, expert and experience-based information for more than 60,000 women.
“The risks are very low, but doctors remain concerned because the narrative from the FDA and those announcing it is that it's risk-free, but that's not really the case.
“If you have a history of hormone sensitive breast cancer, blood clots, or if you have already developed cardiovascular disease, there's really a nuanced conversation to be had.
“Some women might still be scared or concerned this new wave of attention and awareness is so incredibly pro hormone therapy. It almost makes it seem like every woman should be on hormone therapy when it's really a very individual decision.”
Alternative therapies
Alternative therapies have proven effective in addressing menopause symptoms. One of those is pycnogenol, a pine bark extract in the Mediterranean thought to improve blood vessel function, helping to regulate body temperature and decrease oxidative stress.
Ms McQueen said a lot of women are prepared to seek alternatives to HRT.
“I'm very sensitive to hormones and when I did try progesterone, it didn't really work for me,” she said.
“I'm feeling pretty good at 55, but I also know there's a lot of women that I see in my community around the world who think hormone therapy will solve everything, but it’s not a magic bullet.
“Everyone should have access and get the options they want, but it's really important to get to the bottom of what's going on with you.”
