Return to Englemed contents
| Chat page | Submit your comments here | Books on women's health | See archive reports of the 1997 controversy |
The massive study, dubbed the WISDOM project, was to have involved some 16,000 women in Britain, Australia and New Zealand.
But its fate was sealed when American researchers halted their own study of HRT amid evidence linking it to a slight increase in serious illness.
The project was also hampered by slow progress in finding enough women to take part following its launch three years ago.
An independent committee, commissioned by the British Medical Research Council, set to work to review the future of WISDOM following the announcement of the American conclusions in July.
Researchers said that women who were already in the project should consult with their doctors about whether they wanted to continue taking HRT.
Researcher Professor Ray Fitzpatrick, of the Oxford University, UK, said: "When the WISDOM trial began recruiting in 1999, there were important questions about the risks and benefits of taking HRT long term that needed to be answered. But since then new findings have provided evidence in relation to those questions.
"There is strong evidence that taking HRT long term increases the risks of some diseases such as breast cancer and decreases the risks of others such as osteoporosis. However, there is no trial evidence that HRT protects women from cardiovascular disease and it may even increase their risk in the short term."
While HRT has suffered setbacks in recent weeks, the new findings suggest that the treatment may offer substantial protection against endometrial cancer.
Researchers at Sheffield University, UK, studied more than 500 post-menopausal women for their research, reported in the British Medical Journal.
The women were given the combined oestrogen-progestogen HRT over a period of five years and the condition of the endometrium was examined, through biopsy, three times during the research.
The researchers, led by Professor Michael Wells, said that 21 women had abnormalities in the endometrium at the start of the study - but these disappeared after nine months of HRT. And no cases of endometrial cancer developed during the research.
The researchers conclude: "Women who take daily combined HRT may actually be better protected against endometrial cancer than women who do not use any form of hormone replacement therapy."
All Reports Copyright: Englemed Health News at http://www.internationalmedicalnews.com
The latest findings come from a study of more than 44,000 women who were taking part in a breast cancer detection project.
They come hard on the heels of research linking a combination therapy - oestrogen-progestin - with a range of ill-effects including breast cancer and stroke.
The new findings, also reported in the Journal of the American Medical Association, show that women who have used oestrogen-only therapy for 20 years may face a trebled risk of developing ovarian cancer.
The risk was increased by 60 per cent for all women who took the therapy.
However the researchers could find no link between combination, oestrogen-progestin, therapy with the cancer.
The researchers, led by Dr James Lacey, of the US National Cancer Institute, Bethesda, Maryland, USA, report that a total of 329 women in the study developed ovarian cancer. Some 16 of these had been taking oestrogen therapy for 20 years or longer.
Writing in the same journal, Dr Kenneth Moller, of Tufts University, Boston, Massachusetts, USA, says: "Oestrogen replacement therapy certainly is not the panacea it once appeared.
"Physicians counselling women about HRT must consider the unique needs of each patient and attempt to weigh the benefits and risks on an individual basis."
But another expert, Dr John Curtin, of New York University, USA, said short-term use of the therapy seemed to carry a small risk.
He said: "Women should not panic. This new study raises definite concerns about ovarian cancer when oestrogen therapy is used over a long period of time - 10 or more years.
"There appears to be minimal risk associated with short-term use, possibly five years or less. Altogether, I would caution against using oestrogen long-term in patients who still have their ovaries.
Manufacturers and some experts defended HRT - pointing out that the overall risks faced by users were small and that menopausal women could gain substantial short-term benefits.
Other critics of the US research said it only studied one product, an oestrogen-progestin combination.
Some 16,000 women were taking part in the US study, the Women's Health Initiative - but after five years have been told to stop taking the product because of the growing risk of serious illness.
The latest findings were reported yesterday in the Journal of the American Medical Association.
Novogyne Pharmaceuticals, makers of an HRT skin patch, argued that its side-effects might well be different to that experienced from the use of a pill.
The company's director of medical affairs, Dr Fran Dapas, said: "It is also important to keep in mind that the majority of women start HRT to treat menopausal symptoms such as hot flushes, night sweats, associated sleep disturbances, and vaginal dryness, and discontinue hormone treatments after the symptoms subside.
"The WHI did not address or challenge HRT as the most effective treatment method for menopausal symptoms, nor did it raise health concerns when used for short-term treatment, meaning shorter than five years."
In the UK, Professor David Purdie, from the Centre for Metabolic Disease at Hull Royal Infirmary, said: "No British women should stop taking HRT on the basis of these results and if she is at all concerned she should discuss it with her doctor."
Malcolm Whitehead, director of the Amarant Trust, said: "This particular combination is not available here or in Europe, but similar ones are, and if you are having long-term treatment you should go to your doctor and talk about the risks and whether you should continue."
In Australia Professor Henry Burger, of Prince Henry's Institute for Medical Research, said: "First of all, absolutely no need to panic.
"No need to throw the tablets down the toilet or throw them at your doctor, as some people might wish to do. Discuss your individual reasons for being on the therapy and what other options you might have, but certainly don't make any decisions in the next 24 or 48 hours."
Thousands of women are this week being told to stop taking the therapy because of the aggravated risks.
The trial was testing the benefits of the combined oestrogen-progestin treatment for healthy, menopausal women.
As well as relieving the symptoms of the menopause, it had been hoped it would protect the heart and protect against brittle bone disease.
But the latest analysis of the trial - which has run for five years - shows a 29 per cent increase in heart attacks and a 41 per cent increase in strokes and a doubling of venous blood clots among women taking the therapy.
The risk of breast cancer - long linked to HRT - was found to be increased by 26 per cent.
Only colorectal cancer and hip fractures were prevented - rates of the cancer by 37 per cent and fractures by a third.
Overall death rates, however, were not increased by the therapy.
Researchers stressed that the overall risks faced by the age group who had been taking the treatment remained low.
And a separate study of oestrogen therapy - which is being given to women who have had a hysterectomy - is continuing.
The results of the study were published on-line tonight by the Journal of the American Medical Association.
The British charity Cancer Research UK said the findings confirmed the results of research undertaken by its predecessor, the Imperial Cancer Research Fund, five years ago.
Dr Lesley Walker, the charities director of cancer information, said: "This is clearly an important study and confirms the results of previous work on breast cancer undertaken by Cancer Research UK.
"Women need to be aware of the risk of breast cancer and the newly identified risk of cardiovascular disease found in this study when they weigh up the pros and cons of HRT with their doctors."
Dr Claude Lenfant, director of the US National Heart, Lung and Blood Institute - which supervised the research - said: "We have long sought the answer to the question: does postmenopausal hormone therapy prevent heart disease and, if it does, what are the risks?
"The bottom-line answer is that this combined form of hormone therapy is unlikely to benefit the heart. The cardiovascular and cancer risks of oestrogen plus progestin outweigh any benefits - and a 26 percent increase in breast cancer risk is too high a price to pay, even if there were a heart benefit.
"Menopausal women who might have been candidates for oestrogen plus progestin should now focus on well-proven treatments to reduce the risk of cardiovascular disease, including measures to prevent and control high blood pressure, high blood cholesterol, and obesity."
Not only could the treatment cause breast cancer but it could also reduce the effectiveness of screening, according to surgeon Mike Dixon, of the Edinburgh Breast Unit, Scotland, UK.
Writing in the British Medical Journal, Mr Dixon warns that the long term effect of HRT on women over the age of 50 is only now becoming clear.
HRT increased the density of the breast - hampering the effectiveness of mammography, he said.
This could "undermine" the ability of national screening programmes to reduce the rate of deaths from breast cancer.
Recent research showed "significantly" higher levels of risk of cancer among women who took combined hormone preparations compared with those who only use oestrogen.
"The challenge for clinicians is to control menopausal symptoms while limiting these unwanted effects," he said.
The findings, in the Journal of the American Medical Association, come after a 14 year study by Dr Carmen Rodriguez and colleagues with the American Cancer Society, Atlanta, USA.
They also show that women face a doubled risk of death from the cancer for up to 15 years after they stop taking therapy.
The research examined 211,581 postmenopausal women who had enrolled in the American Cancer Society's Cancer Prevention Study II between 1982 and 1996 to establish whether or not there was an association between the use of postmenopausal HRT and ovarian cancer mortality.
None of the women had a history of cancer, hysterectomy, or ovarian surgery. A total 46,260 (22 per cent) of the participants had used HRT, including 11,024 who were users at baseline - the start of the study - and 35,236 who were former users. In the 14 years' follow up, researchers recorded 944 ovarian cancer deaths.
"In this population, postmenopausal oestrogen use for ten or more years was associated with increased risk of ovarian cancer mortality that persisted up to 29 years after cessation of use," the authors write.
"The risk of death was approximately doubled in women who had used oestrogens for ten or more years within the 15 years prior to enrollment.
"This large prospective study supports the hypothesis that HRT increases the risk of fatal ovarian cancer. The association was related to both duration and recency of hormone use," they said.
Annual age-adjusted ovarian cancer death rates per 100,000 women were 64.4 for baseline users with ten or more years of use, 38.3 for former users with ten or more years of use, and 26.4 for those who had never had the treatment.
Women who were using HRT at the start of the research had 51 per cent higher death rates from ovarian cancer than those who never used HRT. Among former oestrogen users, the risk was 16 per cent higher.
Dr Harmon Eyre, chief medical officer of the American Cancer Society, said: "More studies will be needed to confirm these results and also to look at the effect on mortality of combined therapy or HRT as it is commonly called, against the effect of unopposed oestrogen therapy.
"But if these current results do hold up, then we will have to list ovarian cancer among the health risks associated with 10 years or more of oestrogen use."
The controversial new findings suggest that a woman on HRT has no better chance of beating the cancer than any other woman with the disease.
This flies in the face of earlier research which has suggested that women who take the therapy tend to develop less serious forms of breast cancer than other women.
The new research, published in the British Medical Journal, comes days after a major study linked a high risk of breast cancer with taking a form of combined hormone replacement therapy.
Researchers in Glasgow, Scotland, studied more than 1,100 women aged between 50 and 64 who underwent routine breast screening over a five year period and who developed breast cancer. 166 of the women were taking HRT.
Using one measure the researchers found that about 60 per cent of the HRT women and the non-HRT women had a good chance of surviving the cancer.
And about nine per cent of each group had a poor chance.
Last June American researchers claimed that women on HRT had a doubled chance of getting relatively low-risk forms of breast cancer.
But the researchers, from the North Glasgow Hospitals University NHS Trust, write: "Our results do not support the commonly held view that women using hormone replacement therapy develop tumours with favourable prognostic features.
"Our numbers are small, and further studies are needed."
The new research for the first time distinguishes between combined hormone treatments and those that consist solely of the female hormone oestrogen - and finds that combined treatments carry a much increased risk.
Writing in the Journal of the American Medical Association, researchers said the breast cancer danger was limited to women currently taking therapies and those who had taken them in the previous four years.
The findings, from a massive study of more than 46,000 post-menopausal women, show that those taking a combination of oestrogen and progestin had a 40 per cent increased risk of contracting breast cancer.
Researchers from the US National Cancer Institute in Rockville, Maryland, USA, found more than 2,000 cases of breast cancer amongst all the women over a 15-year period.
The found that women who had taken a simple oestrogen therapy faced a 20 per cent increased risk of getting the cancer - but this only applied to lean women. The risk increased by one per cent for each year of treatment.
In contrast the risk rose by eight per cent for each year that a women used a combined HRT.
The conclusions take into account other factors such as the frequency with which women underwent breast screening and the age of menopause.
Researcher Dr Catherine Schairer said the findings seemed consistent with other research linking the development of breast cancer to recent HRT and to lean women.
In general oestrogen only treatment is given to women who have had a hysterectomy while most others have the combined treatment.
Other recent research has suggested that women who develop breast cancer after taking HRT contract less deadly forms of the illness and are more likely than others to survive it.
But writing in the same journal, experts say the medical profession may have come to rely too much on HRT to prevent brittle bone disease and heart disease - when better diet and fitness might achieve the same objective.
Dr Walter Willett, of Harvard Medical School, Massachusetts, USA, said the risks from HRT were immediate while the benefits might not be seen for a decade or more.
"Although post-menopausal hormone use has important benefits, the study highlights the potential hazards and uncertainties that accompany such use," he writes.
"The commonly held belief that ageing routinely requires pharmacological management has unfortunately led to neglect of diet and lifestyle as the primary means to achieve healthy ageing.
"Now is an appropriate time to reassess this emphasis."
But it is linked to relatively rare, treatable forms of the cancer, the study of more than 37,000 women found.
Women on long term HRT face a 2.6 increased risk of developing this kind of cancer, according to a report in the Journal of the American Medical Association.
In the first five years of treatment, the risk is 1.8 times increased.
The finding follows a British study reported in December which showed that women on HRT tended to contract a treatable form of breast cancer - and at the time researchers suggested HRT might actually offer protection against the deadlier forms of disease.
And in 1997 a major UK study, reported in The Lancet, found that overall HRT use increased the cancer risk by 2.3 per cent a year.
The doctors who conducted the latest research, led by Professor Monica Morrow, of Northwestern University, Chicago, USA, write: "If HRT use selectively increases the risk of less commonly occurring tumours with a good prognosis, then the overall risks and benefits of hormone use in the population should be reexamined."
But in a separate article in the same journal, experts from the University of Maryland, USA, says there is still an "absence of convincing evidence" of a link between HRT and breast cancer.
Users of HRT seemed safe from breast cancer but faced increased peril from cancer of the lining of the womb, according to the report in The Lancet.
Doctors in Finland studied nearly 8,000 women aged between 57 and 72 of whom nearly 1,000 used HRT.
They found women who took HRT were 79 per cent less likely than others to suffer stroke, heart disease or a fatal heart attack.
But their risk of contracting endometrial cancer, a much rarer disease, increased four-fold.
The researchers, led by Professor Leif Sourander, of Turku, Finland, say they could not find a significant difference in the risk of breast cancer.
And, as a contribution to seasonal oddities, the journal also reports a claim that men's height may vary - very slightly - according to when they are born.
The researchers found that men born in April were 2.2mm taller than those born in December.