Two studies that were
part of the Women's Health Initiative, sponsored by the National Heart, Lung,
and Blood Institute (NHLBI), part of the National Institutes of Health (NIH),
have been stopped because of potential health risks to the participants. The
clinical trials were designed to test the effects of postmenopausal hormone
therapy on heart disease, bone fractures, and breast and colorectal cancers.
One of the studies
included postmenopausal women receiving estrogen combined with progestin. The
study found increases in breast cancer, cardiovascular disease, stroke, and
blood clots in study participants who were taking this combination compared with
women taking placebo pills. This study was stopped in July 2002.
The other NHLBI study,
which was stopped in February 2004, involved women taking estrogen alone. After
careful review of the data, NIH concluded that estrogen alone did not
significantly affect risk of either heart disease or breast cancer compared with
placebo. However, similar to the estrogen-plus-progestin combination, estrogen
alone increased the risk of stroke.
Both of the
postmenopausal hormone therapies tested in the studies demonstrated some
benefits, including a decrease in the risk of hip fracture. The combination
therapy also resulted in fewer cases of colon cancer. However, on balance the
harm was greater than the benefit, and these therapies should not be used to
prevent chronic disease. The women in these studies are now participating in a
follow-up phase, which should last until 2007.
Alternatives to
Hormones
Many women may now be
considering using alternatives to conventional HT to relieve menopausal symptoms
and to lower the risk of conditions such as osteoporosis and heart disease.
According to a 1997 study conducted by the North American Menopause Society,
more than 30% of women use acupuncture, natural estrogen(s), herbal
supplements, or so-called plant estrogens (phytoestrogens). At this time,
there is not enough scientific evidence to determine whether these therapies are
beneficial. In addition, we do not have sufficient information to show whether
these therapies are as safe or safer than conventional drugs being used for
menopausal symptoms, osteoporosis, or heart disease.
Botanical products
containing or acting like estrogens may provide some of the benefits of estrogen
in relieving menopausal symptoms. For example, studies have suggested that soy
food products can benefit women with mild hot flashes. Some limited research
provides conflicting results on the safety and effectiveness of herbal
products--such as ginseng, black cohosh, and dong quai--that are marketed
for menopausal symptoms. Currently, there is research on several botanicals that
have shown promise for reducing menopausal symptoms, including black cohosh,
red clover, hops, dong quai, flax seed, and dietary soy.
Through this research,
we hope to learn more about the mechanism of action as well as the safety and
effectiveness of these botanical products. Studies are needed to define the
possible benefits of these botanical products in promoting bone, heart, and
brain health, as well as the potential risks of increasing breast, endometrial,
or other cancers in diverse populations of postmenopausal women.
Advice To Consumers
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Postmenopausal women
should consult their health care provider about their personal risks and
benefits of using HT, as well as the use of alternative therapies. Certain
lifestyle changes including quitting smoking, eating well, and exercising
regularly can also offer benefits and should be considered for promoting
healthy aging and reducing the risk of heart disease.
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Alternative
therapies may or may not be helpful in relieving menopausal symptoms. More
research is needed to define the benefits and risks.
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Herbal therapies may
have adverse side effects or exhibit harmful interactions with other
medications. Consumers should always discuss their use of herbs and dietary
supplements with their health care provider.
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The cost of
alternative therapies such as dietary supplements is usually not covered by
insurance.
More Information &
Resources
Botanicals