What is the truth on hormone replacement therapy?
What is the truth on hormone replacement therapy?
What is the truth on hormone replacement therapy? Millions of menopausal women shunned it after study claimed it could cause cancer …but now a new book suggests that report was wrong
- A U.S. study claimed HRT carried a significant risk of breast cancer
- Before the news made headlines, around one in four British women was taking it
- Now a new book claims to have the definitive answer: HRT is safe
Wary of hormone replacement therapy (HRT)? Join the club. Ever since a report by a massive U.S. study called the Women’s Health Initiative (WHI) claimed in 2002 that it carried a significant risk of breast cancer and heart disease, most menopausal women remain scared of taking it.
Before the alarming news made headlines, around one in four British women was taking HRT. The WHI study’s heavily publicised warning sent shockwaves throughout the world. Suddenly a therapy which promised to banish debilitating menopausal symptoms such as night sweats and hot flushes was demonised as a lady-killer.
Prescriptions for HRT more than halved in the ensuing two years in the UK, plummeting from around six million a year to just 2.3 million — where the numbers remain today, according to the British Menopause Society.
Wary of hormone replacement therapy (HRT)? Join the club
Indeed, many patients and doctors remain wary of the health risks associated with taking HRT pills or using patches, which contain a combination of the hormones oestrogen and progesterone.
As a consequence, only one in ten of those going through the menopause is currently prescribed the treatment. According to the British Menopause Society’s latest factsheet, ‘almost a generation of women have mostly been denied the opportunity of improved quality of life during their menopausal years’. This is despite strong guidelines issued three years ago by the UK treatment watchdog NICE, which urged that twice as many women could benefit from HRT.
Why is fear so prevalent? The plain answer is confusion. Menopausal women’s dilemmas about the therapy are fuelled by the constant Punch and Judy effect of research headlines proclaiming ‘HRT is safe’ one day, and ‘HRT is dangerous’ the next.
Now comes a broadside in a new book that claims to have the definitive answer: HRT is safe.
What’s more, it is not just safe for the short-term, to treat women’s menopausal symptoms, but throughout their post-menopausal lives — even for women who have had breast cancer.
The authors — Dr Avrum Bluming, a leading breast cancer specialist, and Dr Carol Tavris, a social psychologist — argue that the original WHI study was flawed as it was based on women who were too old and unhealthy to provide meaningful results. Moreover, they claim that the researchers warped the data to make the results look alarming because they were convinced HRT was harmful and wanted to confirm that hypothesis.
WOMEN TOLD THEY’D BE ‘FEMININE FOREVER’
The WHI study’s results, which were initially published in 2002, killed a dream that had begun six decades before. In the early Forties, chemists discovered how to extract industrial quantities of oestrogen from the urine of pregnant mares.
From this, Ayerst Laboratories in Canada produced the first oestrogen pills. It called the drug Premarin, after ‘pregnant mare’s urine’, and marketed it as a panacea for menopausal symptoms. The idea was that it would make up for the drop in oestrogen which occurs during the menopause and underlies many of its symptoms.
The New York-based gynaecologist Robert Wilson’s bestselling book Feminine Forever boosted demand in the Sixties. He promised that oestrogen would suffuse menopausal women with renewed youth, beauty and a full sex life. Dr Wilson’s son later told The New York Times that Ayerst Laboratories paid his father’s expenses for writing the book.
The optimism was tempered in the Seventies by reports in The New England Journal of Medicine that taking oestrogen raised the risk of endometrial cancer — cancer of the uterus — by up to eight times.
Subsequent studies found this could be prevented by adding the female hormone progesterone (which helps to regulate the menstrual cycle and changes in early pregnancy, but is not produced after a woman’s final period).
Since the early Eighties, women on hormone therapy who have had hysterectomies have mostly been given oestrogen alone, while those who have not receive oestrogen plus progesterone (known as HRT).
Until the millennium there was little cause for concern regarding oestrogen and any link to breast cancer. Studies by the U.S. National Cancer Institute found no statistically significant increased risk of breast cancer in women on Premarin — even those who had taken it for more than 20 years.
In 1992, a 22-year study by New York University, which randomly assigned 168 postmenopausal female mental institution inmates to receive either HRT or a placebo, reported that 11.5 per cent of the women taking the placebo developed breast cancer. The Obstetrics & Gynecology journal reported that the women on HRT remained free of the disease.
Then, in July 2002, came the bombshell. A press release reported that the WHI study, a major clinical trial of the risks and benefits of HRT in more than 16,000 healthy postmenopausal women, had been halted early due to an increased risk of breast cancer.
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The WHI researchers said they had abandoned the trial in order to save participants’ lives.
An ensuing announcement in the Journal of the American Medical Association said that the WHI study was stopped not only because of the increased risk of breast cancer, but also of heart disease, stroke, and pulmonary embolism (a potentially fatal blood clot in an artery running from the heart to the lungs).
It was the first huge prospective study, where thousands of women were randomly selected to take either hormones or unwittingly take a placebo, then followed for years.
This is the ‘gold standard’ of research. If you simply compare women who chose to take hormones with those who chose not to, the results can’t show whether HRT makes women sicker or if it is simply that sicker women take HRT.
THEN CAME THE BOMBSHELL. . .
The news made headlines across the world. The BBC declared: ‘HRT linked to breast cancer.’ Millions of women dumped their pills.
But according to Dr Bluming and Dr Tavris, the WHI study announcement — and the headlines — were utterly wrong. The WHI study researchers, they say, were pursuing a ‘campaign of fear’.
In their new book, Oestrogen Matters, they argue that the WHI study’s finding that HRT increased the risk of breast cancer was not ‘statistically significant’. The figures indicated a 26 per cent increase in the risk of breast cancer. But the study acknowledged this increase ‘almost reached nominal statistical significance’ — the numbers were not firm enough to prove a strong link. It may have been coincidental instead. Why report this when it might be spurious?
Garnet Anderson, the WHI study co-principal investigator and statistician justified her decision in a press release at the time, saying: ‘Because breast cancer is so serious an event, we set the bar lower to monitor for it. We pre-specified that the change in cancer rates did not have to be that large to warrant stopping the trial.’
Dr Bluming and Dr Tavris claim that this should be interpreted as: ‘We set the bar low enough to monitor for non-significant results if we could squeak out any.’
They add that the WHI study’s participants were not representative of menopausal women. The volunteers’ average age was 63 — and thus many were at an age when their breast cancer risk naturally increases. But the conclusions were applied to women entering the menopause in their 50s.
Dr Bluming and Dr Tavris also say that the women studied were not representative of healthy women. Nearly half were current or past smokers. More than a third had been treated for high blood pressure. And 70 per cent were overweight or obese.
All these factors put them at risk of cancer or heart disease. The pair add that the WHI study’s investigators have subsequently pulled back on their findings. They claim that in 2006, in an update regarding this same cohort of women, the WHI study researchers reported in the journal Maturitas that they now found no increased risk of breast cancer among those same women taking HRT.
But the U.S. government’s Office on Women’s Health does not agree with this. This March its updated guidance reinforced the WHI study’s finding that postmenopausal women taking HRT have an increased risk of breast cancer. ‘One of the most important outcomes of the WHI study was the sharp decline in breast cancer in 2003 after the WHI study results were released in 2002, when many women stopped taking hormone therapy,’ its website says.
‘Today, [the U.S. medicines watchdog] the FDA urges women who take hormone therapy to take the lowest helpful dose for the shortest amount of time.’
STUDY THAT TURNED WOMEN AGAINST IT
Hormone replacement therapy (HRT) was launched in the Fifties, promising a safe way for women to avoid menopausal symptoms and remain ‘feminine forever’.
But in 2002, the U.S. Women’s Health Initiative (WHI) study, involving more than 16,000 women, was halted prematurely when those taking HRT showed an increased incidence of breast cancer.
The announcement by the WHI study sparked shock headlines, and in the UK, around four million women tore up their prescriptions. The number of HRT prescriptions fell from six million a year to just 2.3 million, where they remain today.
However, the UK authorities, such as the treatment watchdog NICE, now recommend the number of women being prescribed the therapy should be double this.
The WHI study has since been somewhat dogged by controversy, with HRT supporters claiming that its results were skewed to make HRT look dangerous.
Nevertheless, some authorities, such as the U.S. Preventive Services Task Force, still suggest post-menopausal women should shun the treatment.
Breast cancer is not the only raised risk, says the Office on Women’s Health. It adds that the WHI study also found an increased danger of heart disease, stroke and blood clots.
Again, Dr Bluming and Dr Tavris disagree. They argue that the WHI study claimed that HRT increased the risk of heart problems, but in fact that risk only occurred during the first year of treatment, and only among women who were more than 20 years post-menopause.
They add that breast cancer levels among women generally were already dropping before the WHI study.
should more be taking hrt?
The pair also argue that in 2007, the WHI study investigators revised their findings and concluded women who started HRT in the first ten years after menopause actually reduced their risk of coronary artery disease.
As for the WHI study’s claims that oestrogen increases the risk of strokes, Dr Bluming and Dr Tavris say that the WHI study used an extremely broad definition of stroke, which included transient, subtle symptoms that went away in a day or two with no aftermath.
Dr Bluming is candid about his personal bias. ‘I am convinced of the immense benefits of HRT,’ he says. ‘Women should be taking HRT as it is likely to make them healthier for longer. There’s no question in my mind that oestrogen matters.’
Nevertheless, serious questions remain in the HRT debate. In December last year, the U.S.’s leading authority on preventive medicine declared that women who have already gone through the menopause should avoid HRT as ‘the potential benefits (such as preventing osteoporosis) are outweighed by the harms (breast cancer and heart disease risk)’.
In its evidence review, the U.S. Preventive Services Task Force considered results from 18 clinical trials including more than 40,000 women, as well as using follow-up data from the WHI trials.
Its negative conclusion seems a world away from the current UK position from NICE — that twice as many British women should be taking HRT as do so presently.
Other crucial research evidence must be considered. In their book Dr Bluming and Dr Tavris glaringly omit to mention a major 2016 study that was conducted by experts at the UK’s Institute of Cancer Research and published in the British Journal of Cancer.
These researchers monitored more than 39,000 women over a six-year period. They found that those who were on HRT had a 2.7 times higher risk of breast cancer than those not taking hormones.
This risk increased with length of use. Women who had used HRT for more than 15 years were 3.3 times more likely to develop breast cancer than non-users.
The study is particularly strong because of its meticulous methodology. Unlike many previous HRT investigations, the researchers updated information on women’s use of HRT over time with follow-up questionnaires.
This avoided errors caused when women who had stopped using HRT after entering a study are still counted as ‘current users’, or when women who had started using HRT after entering the study are still counted as ‘never users’.
The result should be put into careful context. According to the Institute of Cancer Research’s estimates, 34 women in 1,000 would get breast cancer on HRT — 20 more than among the group who do not take the drugs.
What’s more, the women’s risk returned to normal around a year or two after they stopped taking HRT.
Baroness Delyth Morgan, chief executive of the charity Breast Cancer Now, has said: ‘Some women will feel HRT to be a necessity. But in order to minimise the risk of breast cancer . . . it is recommended that the lowest effective dose is used for the shortest possible time.’
That is the polar opposite of taking HRT as early as possible and never stopping, as Dr Bluming suggests.
And unfortunately it brings us no clearer to a definitive answer. But it does point us towards a definitive, albeit unsatisfactory, conclusion.
What we all want from our scientists, our doctors, our media reports, is crystal- clear clarity. But where HRT is concerned, there is none.
This is not least because HRT affects individual women’s bodies in such different ways that a definitive one-size-fits-all conclusion cannot be made.
Instead, it is down to each woman to decide what it means to them, considering their personal symptoms and known family health risks.
So says Professor Anthony Swerdlow, an epidemiologist who led the Institute of Cancer Research study. He advises: ‘Each should consider that the therapy has benefits, but they should also factor in all the known risks. It is a matter for them to decide, in collaboration with advice from a professional such as their GP.’
He wishes to avoid the Punch and Judy conflicts that have dogged HRT research.
‘I stand by our study,’ he says. ‘But I have no problem with people having different views; it is perfectly reasonable to have doubts about the evidence.’
Ultimately, HRT is a woman’s choice. Unfortunately, it is one that scientific research fails to make any simpler — or any easier.
IT’S KEPT ME YOUNG FOR FORTY YEARS
Marian Munroe, 94, a retired private detective and widowed mother-of-three from the West Midlands, has no plans to stop taking HRT, despite her GP’s advice
When should women start hormone replacement therapy (HRT), and when should it be stopped? You might expect that after having hormone therapies on the market for nearly 70 years, the answers would be clear-cut.
Instead the subject is mired in conflicting advice. The U.S. Food and Drug Administration declares that women should only take ‘the lowest dose that helps and for the shortest time you need to take it’. This is echoed by experts at British charity, Breast Cancer Now.
But UK watchdog NICE’s guidelines make no explicit recommendation on starting or finishing. In favour of a longer duration, it says: ‘Risk of fracture [due to osteoporosis] is decreased while taking HRT.
‘This benefit may continue for longer in women who take HRT for longer’.
In favour of a short duration, it says: ‘Any increase in the risk of breast cancer is related to treatment duration and reduces after stopping HRT’.
Adding to the confusion, the NHS says ‘there is no limit’ on how long you can take HRT, but advises talking to a GP about ‘the duration of treatment they recommend’.
In his new book (see main article) Dr Avrum Bluming, a breast cancer specialist, argues that women may benefit best by starting HRT even before their menopause, and taking it for as long as they live.
‘Many women begin having menopause-related symptoms — such as insomnia, muscle pains, and heart palpitations — even when they are still menstruating,’ says Dr Bluming. ‘HRT can benefit them too.’
He points to several studies that show HRT may have beneficial effects on the heart for women who start taking hormones early, because oestrogen ‘promotes healthy blood vessels and may help delay the formation of clot-forming cholesterol plaques’.
However, HRT ‘probably has no protective effect on women who begin later, in their mid-60s,’ and it is ‘potentially risky for women who begin taking it in their 60s, at least for the first year, especially if they have pre-existing coronary artery disease’.
As for discontinuing HRT, Dr Bluming cites a 1993 analysis of previous research, in The New England Journal of Medicine, which showed that women taking HRT had significantly lower incidence of osteoporosis and hip fractures.
Short, long, early or late? It’s down to who you ask — and ultimately it’s down to you.
While some women wouldn’t touch HRT, here we tell the story of one who’s been on it happily for 40 years.
Marian Munroe, 94, a retired private detective and widowed mother-of-three from the West Midlands, has no plans to stop taking HRT, despite her GP’s advice. She says:
I’m convinced if I stopped taking HRT I’d become an old lady overnight. I’m sure it’s the reason I feel as well as I do.
I’m out twice a day walking my little dog, I do the garden all myself — mowing the lawn, hoeing the weeds, cutting down trees — and I still drive, whizzing about in my little car.
I’ve got a good social life, too, going to the theatre and opera, and I love to travel. I walked the Great Wall of China in my 80s.
I started taking HRT in my 50s. I’m lucky in that I didn’t really have a menopause in the way so many women describe it — my periods just stopped one day — but a nurse suggested HRT anyway. I’ve been on it ever since, with no side-effects.
I remember reading the research in 2002 that found a link with breast cancer, but by that point I’d already been on it such a long time. I was fighting fit, so I wasn’t worried.
About 18 months ago, my doctor did say he wanted me to come off it, but I told him: ‘I’d rather have a short life and a merry one.’ And so he agreed to keep prescribing it.
It doesn’t fix everything — I feel the cold a bit these days, and my appetite isn’t what it was. But I meet people 20 years younger than me and they seem so old: they’ve stopped driving, they have to get people to do the housework, and they have such an old outlook.
I’m sure it’s nothing to do with me — it’s the medication. People are staggered when I tell them my age. HRT has always been my little secret, but the secret’s out now!
Interview: JENNIE AGG
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