Panel Rejects Routine
Use of HRT
Finds risks too great
to recommend for chronic ailments
A US
health panel has given a failing grade to hormone replacement therapy
as a routine treatment for chronic ailments, saying whatever benefit
the treatment provides is outweighed by its risks.
The announcement by the
US Preventive Services Task Force follows by five
months the suspension of a major federally funded study of hormone
replacement therapy.
The task force said it
could not recommend the combination of estrogen and progestin to
women with chronic problems like heart disease, osteoporosis, and
memory trouble.
"On average, it's not
a good deal," said task force chairman Dr. Alfred Berg, a family
medicine specialist at the University of Washington in Seattle.
"Some women may find a
strong benefit and the potential harms modest and would still go
ahead," he adds. "This policy permits individual shared decision
making."
The panel did not rule
out the possibility that women who have had a hysterectomy might
benefit from taking estrogen alone—since their risk of uterine
cancer from the hormone is negated—but it said the evidence
so far was inconclusive.
Nor did the task force
look at the benefits of taking hormones to relieve the symptoms
of menopause, such as vaginal dryness, insomnia, and hot flashes.
And it found no conclusive evidence that soy-derived estrogen can
prevent brittle bones due to osteoporosis or reduce the risk of
heart and blood vessel problems.
Berg said women who are
already taking HRT should pay as much attention to the new recommendations
as those considering starting the treatment.
The guidance is in line
with the current wisdom about the value of hormone replacement therapy,
which has been shaped significantly by recent events.
Earlier this year, researchers
halted a major trial of estrogen plus progestin treatments for postmenopausal
women after determining that the combination increased the risk
of stroke, blood clots, and invasive breast cancer. Those taking
the common combination hormone therapy, as part of the Women's Health
Initiative, experienced a 29 percent higher rate of coronary heart
disease problems than those taking a placebo.
Stroke rates were 41 percent
higher in women receiving both hormones, and the rate of blood clots
doubled. Invasive breast cancer rates were 26 percent higher. And
total cardiovascular disease increased by 22 percent.
Another arm of the trial,
exploring the benefits of estrogen therapy alone, was allowed to
continue.
On the positive side,
the task force concluded that estrogen and progestin treatment does
increase bone density and probably cuts the risk of fractures in
women. The panel also saw "fair" evidence that the drugs can lower
the odds of colorectal cancer.
But those benefits were
undermined by evidence that hormone replacement therapy (HRT) triggered
more heart and vessel problems, breast cancer, and other undesirable
side effects. For every 10,000 women who take the two hormones for
a year, there would be seven extra heart attacks or other episodes
of heart disease, eight extra strokes, eight more cases of lung
clots, and eight additional cases of invasive breast cancer, the
panel said.
Meanwhile, the treatment
would lead to six fewer cases of colorectal cancer and five fewer
hip fractures.
Women who decide not to
take HRT for chronic conditions are not necessarily stranded in
a treatment-free desert, experts said. Effective alternatives exist
to prevent several of the ailments reviewed by the task force, including
osteoporosis and heart disease.
However, for other health
problems, like colorectal cancer and dementia, the options are not
there yet, Berg said.
Until half of the Women's
Health Initiative was halted, roughly 17 million American women
were taking HRT. That number has dropped, though by how much is
not clear.
If the recommendations
of the preventive services task force do not sway physicians' prescribing
practices, another force might. At least one large malpractice insurer,
COPIC, of Denver, Colo., now requires its physicians to obtain informed
consent signatures from women receiving HRT.
"It's unusual," said Dr.
Paul Miller, a Denver bone expert covered by COPIC. "I don't have
to do this form for anything else."
If other insurers follow
suit, said Miller, it would be the "nail in the coffin" for hormone
replacement therapy, scaring women off the drugs. That, he added,
would not be warranted, even with the results so far from the Women's
Health Initiative.
Miller and other experts
have pointed out that the suspended trial included women older than
the typical age of onset for menopause—their average age was
63, while menopause usually happens around age 50. The risks and
benefits in early menopausal women may be different, he said.
Always consult your physician
for more information.
Online
Resources
(Our Organization is not
responsible for the content of Internet sites.)
American
College of Obstetricians and Gynecologists
Annals
of Internal Medicine
Journal
of the American Medical Association (JAMA)
National
Heart, Lung, and Blood Institute
National
Institutes of Health
National
Osteoporosis Foundation
US
Department of Health and Human Services
US
Food and Drug Administration (FDA)
US
Preventive Services Task Force
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November 2002
US
Health Panel Gives Failing Grade to HRT as a Routine Treatment for
Chronic Ailments
Experts
Admit They Don't Have All the Answers on HRT
Online
Resources
In Other Women's Health
News:
Experts
Admit They Don't Have All the Answers on HRT
Experts who gathered for
a conference earlier this October on what lies ahead for hormone
replacement therapy (HRT) admit that they still do not have all
the answers, but expect more information in the coming months.
The two-day workshop,
sponsored by the National Institutes of Health,
was held in Bethesda, Md. The meetings were filled with presentations
discussing the Women's Health Initiative (WHI) study, other studies
of hormone therapy, and the industry's view.
On some points, everyone
agrees, says Dr. Barbara Alving, deputy director of the National
Heart, Lung, and Blood Institute, who helped organize the
sessions. "Everyone agrees that hormone therapy is acceptable for
the relief of menopausal symptoms," she says. "Hormone therapy is
still the first choice for women with severe vasomotor symptoms
of menopause."
But short-term use—generally
defined as five years—is preferred, she adds.
"Long-term use of hormone
therapy should not be given for prevention of heart disease," Alving
says, citing another area of agreement. While experts used to think
hormone therapy helped reduce the risk of heart disease, the WHI
clearly shows it does not—and actually raises risk slightly.
Women who abandon hormone
therapy but are at high risk for osteoporosis, the low bone density
that can lead to fractures, must take steps to prevent bones from
getting more fragile, Alving says. Women should ask their physician
about alternatives to hormone therapy, such as the new bone-building
drugs, to prevent osteoporosis, she says.
For women who have decided
to discontinue hormone therapy, Alving says the general consensus
is to taper down the dose rather than quit "cold turkey." This may
help in reducing or keeping hot flashes at bay.
If hot flashes are a continuing
problem after hormone therapy is discontinued, Alving says, many
physicians now prescribe the SSRI class of drugs, such as Effexor
(venlafaxine) or Paxil (paroxetine).
Soy protein and primrose
oil, previously believed to combat hot flashes, have both proven
to be disappointing, Alving says.
What's next from researchers?
"There will be quality-of-life analyses, and more detailed analyses
in relation to cancer risk," Alving says. More analysis of hormone
therapy and mental functioning is expected, as well as analysis
of hormone therapy and quality of life, she says.
For women anticipating
that a new study will reverse the WHI study results, Alving says
that will not happen. The new evaluations, she says, will reinforce
the data already presented.
One other message is clear,
she says. "There isn't a magic pill that will take care of all of
this [hot flashes, heart disease risk, etc]. " Women need to "take
care of their bones, lose weight if they need to, and exercise."
For a copy of the WHI
study report, go to the Journal of the American Medical
Association (JAMA). To see the statement released by another
leading group, visit the American College of Obstetricians
and Gynecologists.
Always consult your physician
for more information.
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