Women's Health Initiative halts HRT study
The hormone replacement therapy (HRT) portion of a large set of clinical trials was ended 3 years early because of a small but unacceptable increase in the rate of breast cancer among the women taking the combination of estrogen 0.625 mg plus progestin 2.5 mg daily for longer than 4 years. The study also showed an increase in heart attack, stroke, and blood clots in the lungs (pulmonary embolism) and legs (deep venous thrombosis).

The full report of this study, conducted by the National Heart, Lung, and Blood Institute (NHLBI), was made available in the July 17, 2002, issue of the Journal of the American Medical Association (JAMA). The following table summarizes the findings of the study.
If 10,000 women took estrogen 0.625 mg plus progestin 2.5 mg daily for 1 year:

 
10,000 women/year
taking placebo
10,000 women/year
taking combination HRT
Difference per year
Breast cancer
30
38
8 more women
with breast cancer
Heart attacks
30
37
7 more women
with heart attacks
Strokes
21
29
8 more women
with strokes
Blood clots
16
34
18 more women
with blood clots
Colorectal cancer*
16
10
6 fewer women
with colorectal cancer
Hip fractures*
15
10
5 fewer women
with hip fractures
*HRT is not indicated for the prevention or treatment of colorectal cancer or hip fractures.

The study did not measure the effect of estrogen when used alone or when used in different doses or by alternative methods of delivery, such as the transdermal patch. It also did not address the short-term risks and benefits of estrogen/progestin when used to treat symptoms of menopause, such as hot flashes and vaginal dryness. A study of the effects of estrogen when used without progestin is ongoing.
This study was released since the topics Menopause and Osteoporosis were updated, and women should consider this new evidence while reading these topics.

Approximately 38% of postmenopausal women in the United States use some form of hormone replacement therapy. Treatment with HRT is approved by the U.S. Food and Drug Administration for treatment of menopausal symptoms, such as hot flashes and vaginal dryness, and prevention of osteoporosis. However, many women take HRT hoping to decrease their risk for other chronic diseases, such as coronary artery disease and stroke.

If you are taking combined estrogen/progestin therapy, the American College of Obstetricians and Gynecologists advises you to discuss your individual situation with your health professional. Your decision about hormone use should take into account why you are taking hormones, how long you have been taking them, and your risk for specific conditions that may benefit or be made worse by hormone use.

The following Web sites provide information to help you assess your individual health needs:
• Additional information about the Women's Health Initiative is available on the NHLBI Web site, www.nhlbi.nih.gov.

• Information about the prevention and early detection of breast cancer is available from the NCI Cancer Information Service Web site, www.cancer.gov.

• Information about menopause and symptoms related to menopause is available from the North American Menopause Society Web site, www.menopause.org.