Estrogen: To be or Not to be?

Vietnamese

On February 29, 2004, the National Institutes of
Health (NIH) announced a halt to the estrogen
alone study (one-a-day 0.625mg conjugated
estrogen, brand name Premarin) conducted by the
Women’s Health Initiative.  This study trial
involved a large number of healthy women
between the ages 50-79 in many clinics throughout
USA.  The trial was aimed at studying the long-
term effect of estrogen on heart
disease.                            

The reason for stopping the trial, as reported by the NIH, is that the
data collected so far is sufficient to indicate that estrogen alone
appears to have no effect on heart disease.  At the same time,
estrogen alone appears to decrease the risk of hip fracture but
increase the risk of stroke at a rate similar to the estrogen-progestin
trial in 2002. In that study, women taking estrogen plus progestin
had 8 more strokes per year for every 10,000 women than those
taking the placebo.

In July 2002, the estrogen-plus-progestin trial was stopped after 5.6
years of follow-up because of an increase in the risk of breast cancer.
 The study also suggested that the risks of breast cancer, coronary
heart disease, stroke, and blood clots outweighed the benefits on hip
fracture and colorectal cancer.  In this study, since the participating
women still had a uterus, they were given a combined hormone
therapy of estrogen plus progestin (0.625 mg of conjugated
estrogens plus 2.5 mg of medroxyprogesterone acetate).

The difference between the two treatments is important because
estrogen alone is taken by 5.6 million women in the U.S, a lot more
than the estrogen-progestin combination (2 million).

The Food and Drug Administration (FDA) said that it plans to assess
the latest results to determine if additional labeling changes for
postmenopausal hormone therapy are needed.

What does this mean to the rest of us, especially women who are
currently taking hormone replacement therapy or planning on being
on estrogen therapy?

FDA urges these women and their healthcare providers to regularly
discuss hormone therapy benefits and risks. Women should be aware
that postmenopausal hormone therapy has never received approval
for prevention of heart disease, or cognitive disorders such as
Alzheimer's disease or memory loss.  FDA mandates that estrogen
should only be used for the relief of moderate to severe
postmenopausal symptoms such as hot flashes.  When used to treat
moderate to severe symptoms of vaginal dryness or atrophy, FDA
urges physicians to prescribe topical products first.  For
postmenopausal osteoporosis, FDA recommends that estrogen
should be considered only for women at significant risk for
osteoporosis and for whom non-estrogen treatments are
inappropriate or ineffective.

And as a general rule, whenever estrogen therapy is given, FDA
recommends the lowest dose in the shortest duration of therapy
possible.


April 1, 2004
ASHInfo Health Review

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