Women have been oversold HRT for decades
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Version 0 of 1. On my desk I keep a copy of Feminine Forever, a book promoting hormone replacement therapy (HRT), published in 1966, by Robert A Wilson. On the front, it proclaims that it is “a fully documented discussion of one of medicine’s most revolutionary breakthroughs – the discovery that the menopause is a hormone deficiency disease, curable and totally preventable and that every woman, no matter what her age, can safely live a fully sexed life for her entire life”. I keep this book to remind me of a few things. One, that it is possible to be very, dramatically wrong in medicine – especially when you are very sure of yourself. Two, that when you make big promises, you should have robust, unbiased and powerful data to support them. Three, that when medicine tries to suggest that a new large section of the population – on this occasion, that all women over menopausal age – are “diseased”, one had better look to see who is behind that claim, and why. And last, hype around new medical products are, sadly, nothing new. As a junior doctor more than two decades ago, I attended meetings (which had sandwiches, pens and soft drinks supplied by drug companies, I am sorry to say) where HRT was promoted as not just the dream solution to all menopausal symptoms – but the way to prevent cardiovascular disease, dementia, stress incontinence, hair loss, the need for dentures, and osteoporosis. There were even claims made that it could prevent depression and supposedly restore a sex life back to ecstatic peaks. Wilson suggested that women should start hormone replacement in their mid-30s, claimed that “the myth that oestrogen is a causative factor in cancer has been proven to be entirely false” and that it would generate “youthful appearance and vigorous energy”, else poor ladies would simply “crumble in ruin”. It took until 2002 for it to emerge that Wilson was being funded by Wyeth, a major manufacturer of HRT – a fact not disclosed in the book. HRT is still widely recommended for treatment of menopausal symptoms – particularly hot flushes and night sweats – but with the mantra of “informed choice”. Properly informed choice needs accurate information. The initial promises made that HRT could reduce future cardiovascular disease were based on observational studies. Observational studies, though, are highly prone to bias, wrong conclusions, and thus bad information. High-quality, reliable, clinical data is best generated by double-blind, randomised controlled trials that compare groups, with the only difference being the drug under test, and careful attention to monitoring benefits and harms. One such trial, the Hers study, published in 1998, found that recurrent cardiovascular disease wasn’t prevented by HRT. Then – to shock, surprise and dismay – the Women’s Health Initiative Study, published in 2002, found that the risk of cardiovascular disease was in fact increased with HRT, not decreased. For 10,000 people-years of taking HRT, there were 15 more heart attacks or strokes, eight more pulmonary emboli – blood clots to the lungs – and eight more breast cancers. Last week, an analysis published in the Lancet found that for every 1,000 women using HRT for five years, there is one extra case of ovarian cancer – a slightly higher risk than seen in previous studies. This pattern in medicine is recurrent and depressing: low-quality studies are used to drive the creation of a new diagnostic label – according to Feminine Forever that’s all women over the age of 30 who didn’t want to “crumble”. Then, having told millions of people that they are diseased, a treatment is offered – even if inadequately studied, especially in the long-term, and without powerful enough studies capable of finding unanticipated harms. This is followed by widespread use of said newly popular product, often driven by overblown pharmaceutical or media hype. It is only much later that high-enough-quality studies are done which call into question the original hypothesis – and which find out that the premise was either false, or actively harmful. This week another study was also published which found that, of women who have frequent hot flushes and sweats due to the menopause, the average duration of symptoms was just over seven years. It seems that the length of time that symptoms go on for has been underestimated by doctors (but not women, if anyone had listened) – thanks to a historical lack of quality studies on such basic knowledge. And isn’t it the basics that we need to get right first, so that we can advise women properly? In the past few years there has been a widening of non-hormonal treatments for menopausal symptoms – including the SSRI group of antidepressants, which provide modest improvement only, and with the typical antidepressant side-effects. But here’s the thing. There is increasing evidence that group and guided cognitive behavioural therapy – both for women who have had a menopause due to breast cancer treatment, and women who had typically problematic hot flushes and night sweats – improves mood and quality of life, and decreases the frequency of night sweats. So it’s not just drugs that can work – women can be helped to control their own symptoms. But there is no big publicity campaign for CBT. Clearly the menopause is disabling for some women, and inconvenient or minimally disruptive for others. We need high-quality information about our choices, and honesty about what we don’t know and aren’t sure of. The menopause has been made a disease and opened a marketing opportunity, and the resulting misinformation has served us all badly. |