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Hormone
Treatment Is Called Harmful
Menopause
Study Cites Health Risks
By
Susan Okie
Washington
Post Staff Writer
Wednesday,
July 10, 2002; Page A01
A
landmark scientific study has found that giving hormones to healthy
menopausal women does more harm than good, a finding that overturns
doctors' long-held beliefs about the treatment's benefits and creates
new uncertainty for millions of women.
The
stunning findings from the federally funded Women's Health
Initiative (WHI), released yesterday, appear to dash the longstanding
hope that taking the hormones estrogen and progestin after menopause
would help women live healthier lives.
A
study of the two-hormone combination was stopped three years early
when it was found to increase the risk for breast cancer. In
addition, women on the treatment suffered more heart attacks, more
strokes and more life-threatening blood clots than those given a placebo.
Although
the hormones had some benefits -- reducing the frequency of hip
fractures and of colon cancer -- the WHI's study of more than 16,000
women found that those pluses were outweighed by the increased risk
of breast cancer, heart disease and circulatory disorders.
"Considering
that millions of American women might consider taking estrogen plus
progestin . . . that could translate into tens of thousands of cases
of breast cancer or cardiovascular disease over several years,"
said Jacques Rossouw, acting director of the WHI.
Of
approximately 50 million postmenopausal women in the United States,
about 14 million are taking hormone treatment, either to relieve
common menopausal symptoms or in the hope of preventing osteoporosis
or other chronic diseases. A number of recent studies have cast doubt
on the value of long-term hormone therapy, but the long-awaited WHI
study is the first large clinical trial to measure the treatment's
impact on healthy women.
Experts
said women who are taking the hormones should not panic, but should
consult with their doctors about whether to continue. Several said
women who take the two hormones to relieve hot flashes and other
symptoms of menopause should use the treatment as briefly as
possible, and those wishing to prevent osteoporosis should probably
choose alternatives to hormones.
The
study found that breast cancer risk did not rise significantly until
the fourth year of treatment, but that women's risk of heart attacks
and blood clots increased as soon as they began taking hormones.
"There's
really no safe period," Rossouw said.
The
WHI study had been testing a combination of estrogen and progestin.
About 6 million U.S. women take the two hormones, according to WHI
researchers. Another 8 million U.S. women who have had hysterectomies
take only estrogen.
For
women taking only estrogen, the balance of risks and benefits
remains uncertain. Researchers said no increase in breast cancer risk
has been seen in a WHI study evaluating the use of estrogen alone,
and they plan to continue that study until 2005.
It
is unclear whether the adverse effects of the hormone combination
used in the WHI study -- sold as Prempro -- are the same in users of
other forms of estrogen and progestin, since other products have not
been as extensively studied. However, researchers said manufacturers
will need to show the other hormone products don't carry the same risks.
"It's
up to the Food and Drug Administration now to decide whether they're
going to change the package insert and change what [hormone
manufacturers] can advertise," Rossouw said.
Women
in the study, who were between 50 and 79 years old, were randomly
prescribed the hormone combination or a placebo and their health was
monitored for an average of 5.2 years. The women and their doctors
were not told which treatment was being taken.
There
was no difference in death rates between the two groups. However,
women on the hormone treatment had a 26 percent higher incidence of
breast cancer, a 29 percent higher incidence of heart attacks, a 41
percent higher incidence of strokes and twice as many blood clots in
the lungs and leg veins as those taking the placebo. In contrast, the
hormone-treated women had 37 percent fewer hip fractures and a 34
percent lower rate of colon cancer.
The
study found that the frequency of these effects in hormone users did
not differ by age, ethnic group or prior health status.
For
an individual woman, the risk of suffering a serious adverse effect
of hormone treatment is low, researchers said. For instance, among
10,000 women taking the two hormones for one year, there would be
seven more heart attacks, eight more strokes, eight more lung blood
clots, eight more breast cancers, six fewer colon cancers and five
fewer hip fractures than among a comparable group not on the
treatment. So far the study has not identified which women are at
highest risk of adverse effects, but researchers said they are still
analyzing the data.
Estrogen
is the most effective treatment for the hot flashes and night sweats
that are common during menopause, although drugs in the family
chemically related to Prozac have been found to help. In women who
have not had a hysterectomy, estrogen is usually given with progestin
because when given alone, it greatly increases the risk of cancer of
the lining of the uterus.
About
3 of 4 women experience menopausal symptoms, but in 50 percent to 75
percent of sufferers they last a year or less. In about one-third of
sufferers, they persist for up to five years, and in a small
percentage, they last longer, said gynecologist Margery Gass,
president-elect of the North American Menopause Society.
Researchers
said that for women with severe symptoms, short-term hormone
treatment is reasonable.
The
results of the WHI study "really do reemphasize the need for
women [taking hormones] to have ongoing discussions with their
physicians," said Victoria Kusiak, vice president for clinical
affairs of Wyeth Pharmaceuticals, which makes Prempro. "It's
particularly important to have those conversations when a woman is
considering therapy beyond four years," the point at which the
study showed an increase in breast cancer risk.
For
women with osteoporosis, the drugs alendronate and risendronate have
been shown to reduce hip fractures and are good alternatives to
hormone treatment, said Rebecca Jackson, an associate professor of
internal medicine at Ohio State University. Another drug, raloxifene,
has not been shown to prevent hip fractures but does prevent
osteoporosis and reduces the risk of breast cancer.
Women
in the WHI study have been informed of the results by mail and have
been asked to stop their medications. Diane, a 66-year-old
participant who lives in Rockville, said she joined the study six
years ago and guessed, because of breast tenderness, that she was
taking hormones. She learned the study results on Monday from WHI
researchers at George Washington University Hospital.
"As
[it] began to sink in, I was a little overwhelmed," she said.
"I don't think I was scared -- 'apprehensive' might be a better
word. I haven't yet had a chance to discuss it with my doctor to see
whether he thinks I should continue to take it anyway."
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