Lindsey Randell "adores" being on Premarin, the most commonly used form of hormone replacement therapy (HRT). But she is trying to stop taking the prescription drug that has changed her life for the better. She is one of hundreds of thousands of fiftysomething women at the centreof one of the most controversial, though little noted, disputes in medicine today.
Maintaining pre-menopausal levels of oestrogen and progesterone in her 59-year-old body improves Randell's mood and her sense of wellbeing as well as her hair and skin. Until three years ago, doctors routinely encouraged such women to take HRT, at first to avoid menopausal symptoms and then to go on to enjoy a better quality of life. Above all, HRT, whether delivered as a pill, patch, implant or gel, was seen as fending off some serious diseases of old age, including osteoporosis and heart disease, a benefit widely agreed to outweigh the small increase in the known risk of developing blood clots or breast cancer.
Three years ago, however, two clinical trials of Premarin, published within 12 months of each other, changed everything. The results produced alarming headlines - about HRT generally rather than specifying Premarin. Within weeks, sales of HRT preparations halved as millions of women abandoned drugs that were suddenly seen as potential killers.
The Women's Health Initiative (WHI), a large US study, was halted abruptly in 2002 when scientists warned that HRT increased the risk of stroke and had no impact on heart disease. Less than a year later the British Million Women Study (MWS) reported that the risk of breast and ovarian cancer was unacceptably high. Within a week of the MWS, new guidance was issued by the Government's Chief Medical Officer, telling doctors to prescribe HRT only "for the shortest possible time and the lowest possible dose for the relief of menopausal symptoms".
For Randell, the findings were worrying. She had low levels of oestrogen since her early 40s and had tried different types of HRT before finding a combined dose of oestrogen and progestogen that, she says, "put me in control".
Following the government guidance, however, she was advised to come off the drug. "I tried halving the dose and felt so awful that I went back on the full dose," she says. Now, she's trying again, reducing the dose week by week - believing that while she'd like to keep on taking the pills, she's probably better off not relying on potentially risky drugs.
Yet doctors remain divided over the rationale behind the advice on HRT users. GPs, the main prescribers of HRT, have largely, albeit reluctantly, stuck by the government's advice. "We may regret the fact that we now have little to offer women during and after the menopause but we can't ignore the fact that there has been a sea-change," says Professor Mayur Lakhani, chairman of the council of the Royal College of General Practitioners.
"There's no evidence now to show that HRT is useful except to deal with hot flushes around the time of the menopause and there appear to be substantial risks. We now know there are no long-term benefits from HRT. I would very rarely prescribe HRT for longer than 12 months."
Talk to specialists, however, and the view is entirely different. At the British Menopause Society's annual meeting in Edinburgh this month, specialists in HRT were unanimous in condemning the two studies on HRT as "unreliable", as well as the government advice.
"The WHI and MWS studies were widely criticised when they were published and further analysis of the WHI trial has shown its findings can be largely discounted when considering HRT for women with menopausal symptoms," says Dr Heather Currie, associate specialist gynaecologist at Dumfries and Galloway Royal Infirmary.
"WHI studied women who started taking HRT in their 60s, almost certainly at too high a dose and still found risks in less than 0.3 per cent of the women. The MWS was an observational study that was very poorly designed and significantly over-estimated the risk of breast cancer. The reports of these studies vastly exaggerated the risks of HRT."
What worries specialists is that media coverage appears to be skewed to bad news about HRT. One of many recent papers to be "virtually ignored by the media", according to Dr John Stevenson, a HRT specialist at Imperial College and the Royal Brompton Hospital in London, was a review of the literature by the International Consensus Group on HRT, published in March 2006 in the journal Human Reproduction.
"We found that 99 per cent of the women in the WHI and MWS study were taking HRT without any harm," says Stevenson, who was the study's lead author. "Quite contrary to the impression that most people have, we found substantial evidence that HRT is of major benefit to many women and we recommend that it should be the first line treatment for the prevention of hip fractures and osteoporosis."
Dr Stevenson says women and their doctors have been unnecessarily terrified by alarmist reports of the studies. "It does seem as though the regulatory authorities have misinterpreted the evidence and the result is a huge disadvantage to the health and well-being of post-menopausal women."
So what should women do? Experts suggest that Premarin, the combined oestrogen and progestogen HRT that was used in the WHI study, is probably safe for the majority of women. But other combinations of hormones are also available.
Vaginal oestrogen can also be taken to prevent the "hugely under-reported and under-treated" problem of post-menopausal vaginal dryness, she says.
There is some evidence to support the use of herbal remedies, including red clover and a pollen extract, Femal. Most medics say further research is needed on their effectiveness and safety, however. Earlier this week (Wednesday 20th) the Government's Herbal Medicines Advisory Committee issued a warning that black cohosh, another popular menopausal remedy, can cause rare but serious liver disorders.
Another option is to seek advice from a gynaecologist with an interest in managing menopause - as Lindsey Randell has now done. She has not yet made up her mind whether to give up on HRT.
ASKING FOR ADVICE
Norma Goldman, a pharmacist who runs the Menopause Exchange, tel: +44 (0)20 8420 7245, says women need to follow their doctors’ advice but urges them to also take advantage of independent information on HRT that is widely available.
Useful sources include: www.menopausematters.co.uk, a Scottish-based website with contributions from experts in menopause management, led by Dr Heather Currie, which currently gets more than 1m hits a month; www.yorkshiremenopause.co.uk, led by James Walker, Professor of Obstetrics and Gynaecology at St James University Hospital, Leeds. This site is aimed at health professionals as well as the public.
