David Baxter PhD
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Hormone therapy regains support, 10 years after study warning of health risks
By Sharon Kirkey, Ottawa Citizen
September 9, 2012
Ten years after a massive U.S. study warned women the world over that hormone therapy posed serious health risks, women are again turning toward hormones to help them cope with menopause, Canadian doctors report.
The cautious return to the very drugs women gave up in droves a decade ago comes as more than a dozen medical bodies, including the Society of Obstetricians and Gynaecologists of Canada, say that new data and a second look at the findings from the landmark Women?s Health Initiative Trial show that the absolute risks of hormones for the relatively young ? women up to age 59 ? are low based on what?s known so far, while starting hormones in older age is associated with greater harm.
A new position statement prepared by an expert panel of the North American Menopause Society, and endorsed by Canada?s obstetricians and gynecologists, concludes that ?recent data support the initiation of HT (hormone therapy) around the time of menopause? for hot flashes and other symptom relief.
?The whole point of this publication is to say to women, ?There is an effective treatment for your symptoms,? ? said Dr. Robert Reid, professor of obstetrics and gynecology and chair of reproductive endocrinology and infertility at Queen?s University in Kingston.
?If you are distressed by them ? if you?re not sleeping and waking up at night and tired at work the next day ? there is an effective treatment that is low risk and highly effective.?
Some say the widely sanctioned recommendations on hormones will lead to wider prescribing of the drugs when important questions remain to be answered: what is the optimal dose and regimen, and how long is it safe for women to stay on hormones? Should hormones really be the first line treatment for hot flashes, or reserved for women whose quality of life is being seriously impaired?
?A lot of effort, a lot of research dollars went into disproving the WHI findings,? said Anne Rochon Ford, executive director of the Canadian Women?s Health Network.
?I?m not implying that all uses of hormone therapy are wrong, that there aren?t instances where it is the best solution for women who are having extreme symptoms,? she said. ?But I think we have to pull back and say, why is this getting so much attention? If half the energy that went into defending and supporting the use of hormone therapy went into the serious study and promotion of healthier alternatives, we?d be in a really different place.?
In Canada, breast cancer rates dropped by nearly 10 per cent among women aged 50 to 69 from 2002 to 2004, the period in which women began abandoning hormones, Canadian researchers reported two years ago.
?It would be a shame if this was reversed,? said Barbara Menzies, an assistant professor in the School of Population and Public Health at the University of B.C.
Reid said it remains controversial whether the drop in breast cancer in many countries, not just Canada, was actually due to the fall-off in hormone use or other factors, such as screening mammography.
He argues that the negative publicity and fallout from the WHI cost a decade of women problems.
Many turned to black cohosh, donqai and other herbal remedies that studies suggest work no better than placebo. Two studies have shown rising rates of osteoporotic fractures. Over the past decade, medical schools have graduated doctors from obstetrics and gynecology and family medicine programs who don?t know how to prescribe hormones, Reid said ? just as record numbers of women in Canada are entering menopause, with the largest demographic from the ?baby boomer? generation turning 50.
?The women who were 40 years old in 2002 (when the first wave of the WHI data was released) weren?t really thinking much about menopause,? Reid said.
?Now we?re starting to see women who are taking a more aggressive approach to their own management,? he said. ?We?re starting to see more women looking for relief. They?ve read or heard about the ineffectiveness of a lot of the alternative therapies, and we?re seeing a lot more women coming in requesting hormone therapy.?
Dr. Jennifer Blake agrees that more women are re-thinking hormones. ?We tend to find them coming asking for hormones after they?ve tried a number of things and after they think, ?Ok, this is getting ridiculous, I?ve suffered long enough. Let?s get on with it,? ? said Blake, a gynecologist at the University of Toronto and Sunnybrook Health Sciences Centre.
Unlike older generations, millions of women are entering menopause while they?re still active in the workforce, ?and they?re very concerned about how they?re functioning,? Blake said. Symptoms of menopause can include hot flashes, mood swings, out-of-control of emotions, aches and pains, dry eyes, dry mouth, night sweats and changes in sex drive.
But equal numbers of women remain terrified of hormones, Blake said. ?They don?t know who to believe.?
This much is true: When researchers put an early and abrupt halt to one part of the Women?s Health Initiative Trial in July 2002, the announcement was a bombshell.
The trial, which involved nearly 17,000 women ages 50 to 79, was prematurely stopped after researchers concluded that the risks of a combination estrogen-plus-progestin regimen outnumbered the benefits.
After five years of follow-up, for every 10,000 women each year, those taking the combination therapy had a 26-per-cent increased risk of breast cancer compared with women not taking hormones (38 cases on combination therapy, versus 30 on placebo). They had a 41- per- cent increased risk of stroke (29 cases on combination therapy and 21 on placebo); a 29-per-cent increased risk of heart attack (37 cases versus 30); and a doubling in the rates of blood clots in the legs or lungs (34 on combination therapy and 16 on placebo.)
Many doctors told women to go off hormones. Women were told to use fans or cold face cloths for hot flashes.
But the study focused primarily on older women. The average age of women going into the study was 63. The findings were initially extrapolated to all postmenopausal women, no matter their age.
When researchers took a second look at the data in 2007, trying to tease out whether age and timing mattered, a different picture emerged: the risk of heart disease was higher in women who were 20 or more years past menopause (70 or older). Meanwhile, younger women (50 to 59), or women who began taking hormones within the first 10 years of menopause, had a lower risk of coronary heart disease. They also had a lower risk of dying than women on placebos, and no increased risk of stroke.
?No one expected that there would be a different response by age ? that?s not typical for most drugs,? said Dr. Margery Gass, executive director of the North American Menopause Society.
Until then, hormones had been heavily pushed for all women, because earlier studies had shown a 40-per-cent decrease in heart disease. In the year 2000, the medical guidelines were recommending hormone therapy for every woman indefinitely, whether she had symptoms or not, ?because it was assumed that there was going to be a cardiovascular benefit, a bone benefit, a cognition benefit, and that had not really been established,? Gass said.
The study wasn?t about hot flashes. It was designed to answer a fundamental question: Should hormone therapy be used by the majority of women to keep them healthy forever?
When the results first came out, there were near-panic headlines. Hormone prescriptions plummeted.
But as time went on, ?we gained better understanding that the side effects are more pronounced in older women who are using hormone therapy, rather than younger women right at the time of menopause,? Gass said.
The WHI did find that women who took the combination hormones for more than five years had an increase in risk of breast cancer ? according to Reid, less than one-tenth of a percentage point absolute increase. ?It?s no different than the risk if women drink alcohol or fail to exercise or become obese in the menopause.
?If you drink two glasses of wine each night, you?ve got a higher risk of breast cancer than you do if you take hormones beyond five years,? he said.
Overall, an individual woman?s level of risk from hormones depends on her medical history, age and the number of years since menopause began, Gass says.
Estrogen alone appears to carry fewer risks than combination therapy. With estrogen-plus-progestin, the risk of breast cancer shows up earlier, Gass said.
Her group isn?t recommending hormones for all women. ?There are still women who should think seriously about not taking hormones,? she stressed, including women who have had breast cancer or a history of blood clots. Hormones can also cause breast tenderness, bloating, bleeding and other side effects ?that a lot of women just don?t want to tolerate,? Gass said.
But, in the aftermath of the WHI, the assumption among many doctors was that no woman should be using hormones for any reason, full-stop, she said.
?We felt it was timely to say, look, major organizations and groups of practising clinicians who are highly involved in women?s health agree that, for most women who have symptoms, it?s really quite safe to use hormones for a short amount of time, with very small risk of side effect.?
Original source article: Hormone therapy regains support, 10 years after study warning of health risks
By Sharon Kirkey, Ottawa Citizen
September 9, 2012
Ten years after a massive U.S. study warned women the world over that hormone therapy posed serious health risks, women are again turning toward hormones to help them cope with menopause, Canadian doctors report.
The cautious return to the very drugs women gave up in droves a decade ago comes as more than a dozen medical bodies, including the Society of Obstetricians and Gynaecologists of Canada, say that new data and a second look at the findings from the landmark Women?s Health Initiative Trial show that the absolute risks of hormones for the relatively young ? women up to age 59 ? are low based on what?s known so far, while starting hormones in older age is associated with greater harm.
A new position statement prepared by an expert panel of the North American Menopause Society, and endorsed by Canada?s obstetricians and gynecologists, concludes that ?recent data support the initiation of HT (hormone therapy) around the time of menopause? for hot flashes and other symptom relief.
?The whole point of this publication is to say to women, ?There is an effective treatment for your symptoms,? ? said Dr. Robert Reid, professor of obstetrics and gynecology and chair of reproductive endocrinology and infertility at Queen?s University in Kingston.
?If you are distressed by them ? if you?re not sleeping and waking up at night and tired at work the next day ? there is an effective treatment that is low risk and highly effective.?
Some say the widely sanctioned recommendations on hormones will lead to wider prescribing of the drugs when important questions remain to be answered: what is the optimal dose and regimen, and how long is it safe for women to stay on hormones? Should hormones really be the first line treatment for hot flashes, or reserved for women whose quality of life is being seriously impaired?
?A lot of effort, a lot of research dollars went into disproving the WHI findings,? said Anne Rochon Ford, executive director of the Canadian Women?s Health Network.
?I?m not implying that all uses of hormone therapy are wrong, that there aren?t instances where it is the best solution for women who are having extreme symptoms,? she said. ?But I think we have to pull back and say, why is this getting so much attention? If half the energy that went into defending and supporting the use of hormone therapy went into the serious study and promotion of healthier alternatives, we?d be in a really different place.?
In Canada, breast cancer rates dropped by nearly 10 per cent among women aged 50 to 69 from 2002 to 2004, the period in which women began abandoning hormones, Canadian researchers reported two years ago.
?It would be a shame if this was reversed,? said Barbara Menzies, an assistant professor in the School of Population and Public Health at the University of B.C.
Reid said it remains controversial whether the drop in breast cancer in many countries, not just Canada, was actually due to the fall-off in hormone use or other factors, such as screening mammography.
He argues that the negative publicity and fallout from the WHI cost a decade of women problems.
Many turned to black cohosh, donqai and other herbal remedies that studies suggest work no better than placebo. Two studies have shown rising rates of osteoporotic fractures. Over the past decade, medical schools have graduated doctors from obstetrics and gynecology and family medicine programs who don?t know how to prescribe hormones, Reid said ? just as record numbers of women in Canada are entering menopause, with the largest demographic from the ?baby boomer? generation turning 50.
?The women who were 40 years old in 2002 (when the first wave of the WHI data was released) weren?t really thinking much about menopause,? Reid said.
?Now we?re starting to see women who are taking a more aggressive approach to their own management,? he said. ?We?re starting to see more women looking for relief. They?ve read or heard about the ineffectiveness of a lot of the alternative therapies, and we?re seeing a lot more women coming in requesting hormone therapy.?
Dr. Jennifer Blake agrees that more women are re-thinking hormones. ?We tend to find them coming asking for hormones after they?ve tried a number of things and after they think, ?Ok, this is getting ridiculous, I?ve suffered long enough. Let?s get on with it,? ? said Blake, a gynecologist at the University of Toronto and Sunnybrook Health Sciences Centre.
Unlike older generations, millions of women are entering menopause while they?re still active in the workforce, ?and they?re very concerned about how they?re functioning,? Blake said. Symptoms of menopause can include hot flashes, mood swings, out-of-control of emotions, aches and pains, dry eyes, dry mouth, night sweats and changes in sex drive.
But equal numbers of women remain terrified of hormones, Blake said. ?They don?t know who to believe.?
This much is true: When researchers put an early and abrupt halt to one part of the Women?s Health Initiative Trial in July 2002, the announcement was a bombshell.
The trial, which involved nearly 17,000 women ages 50 to 79, was prematurely stopped after researchers concluded that the risks of a combination estrogen-plus-progestin regimen outnumbered the benefits.
After five years of follow-up, for every 10,000 women each year, those taking the combination therapy had a 26-per-cent increased risk of breast cancer compared with women not taking hormones (38 cases on combination therapy, versus 30 on placebo). They had a 41- per- cent increased risk of stroke (29 cases on combination therapy and 21 on placebo); a 29-per-cent increased risk of heart attack (37 cases versus 30); and a doubling in the rates of blood clots in the legs or lungs (34 on combination therapy and 16 on placebo.)
Many doctors told women to go off hormones. Women were told to use fans or cold face cloths for hot flashes.
But the study focused primarily on older women. The average age of women going into the study was 63. The findings were initially extrapolated to all postmenopausal women, no matter their age.
When researchers took a second look at the data in 2007, trying to tease out whether age and timing mattered, a different picture emerged: the risk of heart disease was higher in women who were 20 or more years past menopause (70 or older). Meanwhile, younger women (50 to 59), or women who began taking hormones within the first 10 years of menopause, had a lower risk of coronary heart disease. They also had a lower risk of dying than women on placebos, and no increased risk of stroke.
?No one expected that there would be a different response by age ? that?s not typical for most drugs,? said Dr. Margery Gass, executive director of the North American Menopause Society.
Until then, hormones had been heavily pushed for all women, because earlier studies had shown a 40-per-cent decrease in heart disease. In the year 2000, the medical guidelines were recommending hormone therapy for every woman indefinitely, whether she had symptoms or not, ?because it was assumed that there was going to be a cardiovascular benefit, a bone benefit, a cognition benefit, and that had not really been established,? Gass said.
The study wasn?t about hot flashes. It was designed to answer a fundamental question: Should hormone therapy be used by the majority of women to keep them healthy forever?
When the results first came out, there were near-panic headlines. Hormone prescriptions plummeted.
But as time went on, ?we gained better understanding that the side effects are more pronounced in older women who are using hormone therapy, rather than younger women right at the time of menopause,? Gass said.
The WHI did find that women who took the combination hormones for more than five years had an increase in risk of breast cancer ? according to Reid, less than one-tenth of a percentage point absolute increase. ?It?s no different than the risk if women drink alcohol or fail to exercise or become obese in the menopause.
?If you drink two glasses of wine each night, you?ve got a higher risk of breast cancer than you do if you take hormones beyond five years,? he said.
Overall, an individual woman?s level of risk from hormones depends on her medical history, age and the number of years since menopause began, Gass says.
Estrogen alone appears to carry fewer risks than combination therapy. With estrogen-plus-progestin, the risk of breast cancer shows up earlier, Gass said.
Her group isn?t recommending hormones for all women. ?There are still women who should think seriously about not taking hormones,? she stressed, including women who have had breast cancer or a history of blood clots. Hormones can also cause breast tenderness, bloating, bleeding and other side effects ?that a lot of women just don?t want to tolerate,? Gass said.
But, in the aftermath of the WHI, the assumption among many doctors was that no woman should be using hormones for any reason, full-stop, she said.
?We felt it was timely to say, look, major organizations and groups of practising clinicians who are highly involved in women?s health agree that, for most women who have symptoms, it?s really quite safe to use hormones for a short amount of time, with very small risk of side effect.?
Original source article: Hormone therapy regains support, 10 years after study warning of health risks
