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The U.S. Food and Drug Administration has launched a national campaign to
help educate women about the pros and cons associated with the use of estrogen
therapy, also known as hormone replacement therapy (HRT).
For decades, physicians have prescribed HRT to help women manage symptoms
associated with menopause and to help prevent osteoporosis and heart disease.
But a large study focusing on the effects of long-term HRT consisting of
combination estrogen/progestin showed that while it can be effective for
managing menopausal symptoms, it does not offer protection against the
development of diseases and conditions known to occur at higher rates after
menopause. In fact, compared with women not using HRT for five years or more,
those who did had a higher number of:
- breast cancers
- strokes
- heart attacks
- blood clots in the legs and lungs.
HRT was, however, associated with a decrease in the number of colorectal
cancers and hip fractures. The results come from a study overseen by the Women’s
Health Initiative, a research program undertaken to address the most common
causes of death, disability and poor quality of life in postmenopausal women.
The causes are cardiovascular disease, cancer, and osteoporosis.
The study, which began in 1999 and slated to run until 2005, was halted in
July 2002 when preliminary results revealed the negative consequences associated
with combination HRT therapy. More than 16,000 healthy women were enrolled in
the trial.
HRT therapy can consist of estrogen alone, or estrogen with progesterone.
Progestin is added to estrogen for any woman on HRT with an intact uterus,
because without the hormone, the risk of uterine cancer is increased.
Menopause and disease risks
Menopause is characterized by the gradual decline and eventual end to the
production by the ovaries of the hormones estrogen and progesterone. These
hormones drive the female reproductive system. Decline in estrogen production
usually begins several years before a woman experiences her last menstrual cycle
(period). When production stops altogether, fertility and menstruation cease.
Around the time menopause occurs, a woman’s risk of developing certain
medical conditions increases. These include heart disease and breast cancer. The
rate of bone loss (osteoporosis) also increases. HRT, it was believed, could
help protect women against these conditions or slow the rate at which they
developed.
The general age range for menopause occurrence is 40 to 58, although most
women experience it around age 50. Common menopause changes include irregular
periods, hot flashes, sleep disturbances, and vaginal dryness.
10 million women
According to the FDA, more than 10 million American women use menopausal and
hormone therapies. Of these, approximately 6 million use estrogen plus progestin,
according to the National Heart, Lung and Blood Institute. The reasons for using
combination therapy include relief from menopausal symptoms, following the
advice of physicians or to promote long-term health.
Given the findings from the Women’s Health Initiative, the FDA recommends
that women who wish to use hormone therapy for hot flashes or vaginal dryness or
to prevent bone loss should take the lowest dose for the shortest duration
possible.
FDA’s advice to women
Estrogens provide valuable therapy for many women, but serious risks are
associated with their use; therefore postmenopausal women who use or are
considering using estrogen or estrogen with progestin treatments should
discuss with their physicians whether the benefits outweigh the risks.
For hot flashes and symptoms of vulvar and vaginal atrophy, these products
are the most effective approved therapies.
Estrogens and progestins should be used at the lowest doses for the
shortest duration to reach treatment goals, although it is not known at what
dose there may be less risk of serious side effects.
Background on the Women’s Health Initiative Study
The WHI study included 16,000 women ages 50 to 79, with a uterus, taking
Prempro (estrogen/progestin) or a placebo.
In July 2002, one "arm" of the study was halted because it showed
that the overall health risk (especially of cardiovascular disease and breast
cancer) from taking estrogens with progestin was greater than the benefits of
lowering the risk of colon cancer and bone fractures.
The study showed that, for every 10,000 women taking estrogen with
progestin for one year, there may be seven more cases of heart disease, eight
more strokes, eight more blood clots to the lungs (13 more in the limbs) and
eight more cases of breast cancer, while there may be six fewer cases of colon
cancer and five fewer hip fractures.
Education "kit"
The main tools of the HRT education campaign are a menopause and
hormone-therapy fact sheet, and a "purse guide" that provides
questions for discussion with a health professional. These materials will be
available in both English and Spanish from the National Women's Health
Information Center, online, at www.4woman.gov.
Visit the following web sites for more information:
Women’s Health Initiative - http://www.nhlbi.nih.gov/whi/index.html
The National Women’s Health Information Center - http://www.4woman.gov/
The North American Menopause Society - http://www.menopause.org/
U.S. Food and Drug Administration - http://www.fda.gov
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