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Should women take hormonal replacement therapy

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    Should women take hormonal replacement therapy

    This is a very thoughtful, reporting on the recent finding from the Journal of the American Medical Association that women over age 65 who start taking combined hormonal replacement therapy doubled their risk of developing dementia.

    The study points out that 10% of people older than 65 and 50% of those older than 85 years have Alzheimer's disease (AD). Postmenopausal women have a greater risk of developing AD than men. Much animal data suggest that estrogen reduces neuronal loss, stimulates axonal sprouting, and improved brain blood flow. Several previous studies suggested that women who take estrogen have 29-34% lower risks of dementia. However, most of these were retrospective studies while prospective studies did not show similar benefits.

    This particular study published in JAMA seems to be well designed. Involving over 4532 women randomized to either placebo or estrogen+progestin, the study reports that the treatment doubled the risk for dementia in women. The absolute numbers of women who developed dementia were not that much greater, i.e. 40 women that received the hormonal replacement therapy compared to 21 in placebo group. Thus, the absolute risk is low.

    There are two potential weaknesses of this study. First, many of the women started hormonal replacement therapy after menopause has already begun. Second, it is possible that the combination of estrogen and progestin together is partly responsible for the increased risk. On the other hand, the estrogen-progestin combination is what most women are taking when they take hormonal replacement therapy because it reduces the risk of breast cancer.

    Managing hormonal storms

    May 31 2003

    The safety of drugs to ease women's midlife miseries is in question - again. While doctors and patients are confused, lawyers scent opportunity.

    At 21, Aurora Frattali became one of the youngest women in Australia to begin menopause.

    "It was a huge shock," she recalls. "I felt I had lost my femininity, my sexuality. How do you explain to a 21-year-old boy or to a group of friends having coffee that you have something your mother hasn't even been through yet? I felt as if I had been diagnosed as an old woman."

    Frattali, now 27, took her doctor's advice and decided to take hormone replacement therapy. It gives her the best chance of maintaining a healthy uterus to carry a future pregnancy.

    She takes a daily oral dose of combined oestrogen and progestin - the form of HRT that has caused worldwide alarm following the release of American research findings this week. The new findings follow reports last year of HRT's links to breast cancer and heart attacks.

    Frattali has strong medical reasons for her choice. But it was not so long ago that many women - and their doctors - believed HRT to be a fountain of youth. Women took it not only to stop hot flushes but to keep their bones strong, their skin supple, their vaginas moist and their teeth intact. It was also thought to protect against diseases such as Alzheimer's.

    But this week's Journal of the American Medical Association reported that women over the age of 65 who started taking combined HRT doubled their risk of developing dementia.

    The findings by the Women's Health Initiative Memory Study came less than a year after researchers called a halt to related trials that showed that HRT put women at significantly greater risk of breast cancer, heart attacks and blood clots.

    Now the companies that make the drugs are bracing for a mauling of their stock prices, a dive in company profits and a rash of lawsuits. More importantly, millions of women who take HRT are wondering about the safety of the pills they pop daily. And there are broader questions, too: why is it that research about the long-term effects of common drugs is relatively rare? Is it right to treat a natural process such as menopause like a disease to be medicated? And has fear of ageing played too large a role in the widespread use of HRT?

    There are no precise figures on how many women take HRT because they believe it helps them look and feel younger, but in America, in particular, HRT stopped being just a drug for hot flushes long ago.

    There are no precise figures on how many women take HRT because they believe it helps them look and feel younger.

    "There is no doubt that women use it to stave off ageing," says Wulf Utian, emeritus professor of reproductive biology, obstetrics and gynaecology at Case Western Reserve University and founder and executive director of the American Menopause Society.

    "And I can understand that, because there is evidence that HRT can help women feel better. You get a better night's sleep, it helps keep the skin soft, there is good evidence that it is beneficial for the eyes, the teeth, the gums, and, of course, it helps prevent broken bones.

    "And yes, there's no doubt that demand for these treatments has increased massively in recent years, but I wouldn't agree (as some critics of HRT say) that it's all due to marketing. The number of women going through menopause has also increased. Look at the figures: in 1900, there were five million women (in the US) over 50, and by 2000 there were 50 million."

    Australia has 5.9 million women aged over 50, but no figures are available about how many of them take HRT. At the peak of HRT use in the US, some drug companies estimated 38 per cent of menopausal women (or about six million people) were taking their drugs.

    Monash Medical Centre menopause specialist Dr Elizabeth Farrell says research suggests that most women will experience menopausal symptoms such as hot flushes and sleeplessness for two to five years. But a significant proportion - 25 per cent - will have symptoms for more than five years and 10 per cent endure them for more than a decade.

    Figures like these give rise to great profits. That is why most major pharmaceutical companies produce a form of HRT. The clear market leader is Wyeth Pharmaceuticals; HRT accounts for 70 per cent of its sales, worth $US2 billion ($A3 billion) a year.

    When the Women's Health Initiative released its first damaging report on HRT last July, Wyeth's shares took a battering. The company lost $US16 billion, or a quarter of its market capitalisation, in a few hours. Sales of its HRT products plummeted and, by last August, sales of some products had halved.

    Wyeth helped finance the latest research, hoping for good news. Earlier studies had suggested HRT might reduce the risk of Alzheimer's in women, but the study found the opposite. The researchers studied 4500 women aged 65 to 79: half were taking a Wyeth drug called Prempro, and half were taking a placebo. Sixty women were diagnosed with dementia. Of these, 39 (65 per cent) were in the Prempro group, and 21 (35 per cent) were in the placebo group.

    But, as Utian says: "You have to read the results carefully. The idea of this study was to answer a question: if you give HRT to women over the age of 65, can you prevent dementia? And this study proved, no, you can't.

    "But the average age of the women in that study was 71, and the average HRT patient is 45 or 50. So you can't say, well, older women who take HRT are at greater risk of dementia, and then apply those results to women who are 45.

    "But, you know, in media reports, these messages often don't get through. Women get very frightened. They have stopped taking HRT."

    And some of them really need it, he says. There are women who have many extreme flushes a day. "They will be sitting at a meeting and suddenly get an intense hot flush; they can't concentrate. I've heard stories of women who broke into a flush during a business meeting; they looked like they were hiding something, and the deal collapsed. These women feel awful."

    Australian specialists, too, have been quick to hose down alarm. Farrell, 55, has been taking low-dose HRT herself for three years to counter hot flushes and constant wakefulness at night. She argues that the dementia-related study did not reflect the daily reality of clinical practice. Most women who seek help from their doctor are much younger than 65 and begin HRT on low, tailored doses. She says it is rare for doctors to prescribe HRT for 60-year-olds, because most women have finished menopause by then. If they have osteoporosis, they are usually given alternative treatments.

    But the two bouts of research have divided doctors and left many GPs, in particular, uncertain about what advice they should give women.

    Professor Susan Davis, research director of the Jean Hailes Foundation, says that while GPs are very clear about how and when to treat something like high blood pressure, they are less confident when it comes to menopausal symptoms. "They're totally overwhelmed and confused," she says.

    Has the furore made doctors more wary? Henry Burger, the emeritus director of Prince Henry's Research Institute, says he once would have prescribed HRT for heart disease prevention. Now, he says firmly, he would not.

    Is HRT too widely prescribed? "I've heard of people who went to their doctor, and they say: 'How long ago did your periods stop? You ought to be on hormones', without any other discussion," he says. "And I totally disagree with (their doctor's) view."

    A harsher critic is the convenor of the Women's Health Network, Dr Helen Keleher. She says Australian doctors' keenness to dismiss the latest HRT study - by arguing its subjects were too old and would not be on that combination of drugs in Australia - is another example of women being patronised and not given enough information about their health.

    But patients must also be aware of the need for the buyer to beware, says Dr Leslie Cannold, of the Centre for Applied Philosophy and Public Ethics at Melbourne University. She says consumers often misunderstand what doctors mean when they say there is no evidence to suggest a drug is not safe. This often means only that it has not been tested for the condition being discussed, or that the results are inconclusive.

    Cannold says consumers also need to be aware of the connection between doctors and drug companies, which spend a lot of money marketing and promoting their products through forums like free overseas conferences.

    "HRT is a drug for a new disease. It is only recently, by and large, that menopause was not considered a medical problem. It was just a different patch in a woman's life. But then it was medicalised and the drug companies came up with drugs to solve the 'problem'."

    To lay people, it can seem startling that side effects of common drugs that have been around for decades are only just being discovered. But consumer advocates, ethics commentators and medical experts generally agree that it is not possible to design a study capable of picking up every possible individual response to a drug.

    Dr Di Palmer, head of the menopause clinic at the Royal Women's Hospital, says it would be too time-consuming and costly to subject everything to comprehensive, long-term studies like that of the Women's Health Initiative. "If we expect all companies to do something like the WHI study, we would have no medicines," she says.

    But the Australian Consumers Association is critical that drugs are rarely monitored after they hit the market. Health policy officer Martyn Goddard says doctors report less than 1 per cent of adverse effects.

    He says governments have to take the initiative for independent long-term research and demands that companies contribute some of the funding.

    Where does all this leave women? Many feel so much better on HRT that giving it up does not seem like a reasonable option.

    Lyn Parkin, 60, who has been taking HRT for 12 years, says: "I want to enjoy my life. Who's to say that if I reach 80, I might have dementia symptoms anyway?"

    For those less sanguine, a first resort might be the health food shop. Professor Ian Brighthope, president of Australia's Complementary Health Care Council, says sales of complementary medicines to treat menopausal symptoms have leapt 15 to 20 per cent in the wake of research scares. More women are also likely to take up other natural ways of managing symptoms: changes to diet, exercise and caffeine intake.

    But for those who feel damaged through negligence, the resort will be the legal system. It is unclear how effective that might be. Michael O'Meara, of Kenneth B. Moll and Associates in Chicago, filed a class action after the first reports about HRT were published, but said this week that the firm was not pursuing it "for now".

    "We had thousands of inquiries from all over the world, including Australia, and there are cases that stick out: women who have blood clots, with no history of it in the family, or women who suddenly developed breast cancer. And we are still looking at individual cases," O'Meara says.

    "But it's tough to make a class action, in a situation like this. You have to find a group of women, who all have the same disease, who took the same drug, over the same period of time, and then prove that the HRT caused their cancer. But I mean, you try telling that to 600 women with breast cancer. They want you to proceed, and in the court of public opinion, I'd say they'd win. But it's difficult to do in a court of law."

    Meanwhile, the official bottom line from medical bodies in America and Australia is the same: hormones should be taken at the lowest possible dose, for the shortest possible time, to deal with one problem only - the symptoms of menopause.

    Even the companies that make the drugs now say women should not take HRT for long periods, to gain better quality of life or in pursuit of eternal youth.

    "You know, people have always searched for the silver bullet that will stop the ageing process," Utian says.

    "The ancient Egyptians were doing it; everyone has done it. Of course women hoped HRT was the answer. But before a woman decides to take it, she should do what we always tell women to do: see your doctor, and ask him, is this right for me?"