A breakthrough drug could transform the lives of millions of women undergoing the menopause, cutting hot flushes and night sweats by nearly three quarters.
The results, unveiled yesterday by British scientists, suggest the new drug could become an alternative treatment for the menopause. The Imperial College London team say the daily pills provide hope for the many women who do not want to take HRT because of safety concerns. They said countless women ‘suffer in silence’ because of a lack of treatment options – a problem which could be solved by the new drug.
Their NHS-funded trial of the drug – which for now is known only by the code name MLE4901 – showed taking the pills reduced the number of hot flushes or night sweats by an average 73 per cent, and also cut their severity and impact. Study leader Professor Waljit Dhillo of Imperial, who presented the paper at the Endocrine Society annual conference in the US yesterday, said: ‘For day to day living and work, that’s a significant impact on quality of life.
‘If we can reduce flushing by 73 per cent it’s a game-changer for those patients.’
The menopause, which commonly strikes women in their late 40s and early 50s, is triggered when the body stops making it the oestrogen hormone. This change causes a wide range of symptoms, including mood swings, joint pain and lack of concentration. But hot flushes and night sweats are the most common symptoms, affecting 70 per cent of women going through the menopause. For many women, hot flushes are little more than an uncomfortable inconvenience. But for some, frequent severe episodes can lead to clothes and bed sheets drenched in sweat, as well as relentless waking from sleep which has a knock-on impact on their daily life.
Hormone replacement therapy – or HRT – for decades has been the go-to treatment for the menopause, tackling the symptoms by providing oestrogen as the body stops producing it. But many women go without the drug because their doctors are reluctant to prescribe it.
The number of women taking HRT plummeted after scares in in the early 2000s raised fears of side effects, including breast and ovarian cancer. Many are instead are left to deal with the symptoms unaided – or put on antidepressants, which come with their own problems, or unproven herbal remedies such as black cohosh or red clover.
The new treatment approaches the problem in a different way to HRT, therefore avoiding the side effects that women are worried about. MLE4901 works by blocking a receptor in the brain linked to hot flushes. This means it only works for the one symptom – rather than the broad approach of HRT – but because hot flushing is the most common symptom of the menopause experts say it could benefit many women.
For day to day living and work, that’s a significant impact on quality of life. ‘If we can reduce flushing by 73 per cent it’s a game-changer for those patients
Professor Waljit Dhillo of Imperial College London
The trial on 28 menopausal women, each of whom were experiencing seven or more hot flushes a day, saw remarkable results. The drug, taken every day for four weeks, reduced the average number of flushes by nearly three quarters.
The team is now embarking on a much larger trial with many more women, but estimate it could be available in Britain within five years.
Professor Dhillo added: ‘A lot of women are choosing not to take HRT because it is oestrogen-based. This new drug is a pill which blocks the NK3 receptor, so it won’t have the side effects associated with oestrogen. These are exciting findings which could be practice-changing.’
Co-author Dr Julia Prague said: ‘For millions of women their menopausal symptoms are intolerable, so many are suffering in silence because it is a taboo subject and treatment options are limited. It was so exciting to see the lives of those who participated in the study become transformed when their flushes improved once taking the new drug. They could sleep through the night, and be less embarrassed in the daytime; they told me they felt “human again”.’
Elaine Barker, aged 61, one of the participants in the study, said: ‘I heard about this study and was interested in taking part. ‘I felt that if the study worked it would be of use to menopausal women now, and for future generations.
‘I was a sufferer still of daily and nightly hot flushes and anything that could improve the quality of my life would be worthwhile. When taking the tablets my flushes noticeably reduced and I woke less often at night and my quality of sleep improved.’
The study was funded by the National Institute for Health Research – the research arm of the NHS – and the Medical Research Council.
Mary Ann Lumsden, senior vice president of the Royal College of Obstetricians and Gynaecologists, said: ‘Hot flushes are the most common symptom of the menopause in the western world; experienced by three out of four menopausal women, with 20 per cent severely affected.
‘This new study, which suggests the effectiveness of MLE4901 in reducing the frequency and severity of hot flushes, is welcome news for women going through the menopause and an exciting development for healthcare professionals. However, it is a small, short term trial, and much further research is needed.’
‘The most effective treatment to date has been HRT, however, evidence shows vitamin E supplements and some antidepressants may help ease hot flushes in some women. Women are also recommended to cut out coffee and tea, stop smoking, keep the room cool using a fan, spray their face with cold water, wear loose clothing, and cut down on alcohol.’