Women’s Health Initiative

September 29, 2011

The National Institutes of Health (NIH) in 1990 established the U.S. Office of Research on Women’s Health. In 1991, this office launched its first national study on women’s health called the Women’s Health Initiative. The Women’s Health Initiative was initiated because there had been insufficient medical research relating to women’s health. Such research is critical because many diseases are unique to women and, therefore, treatments designed specifically for women are needed. Over $625 million was allocated to conduct this 15-year study on health issues affecting postmenopausal women between the ages of 50 and 79 years. The recommended research focus consisted of the study of (a) health disparities between men and women; (b) health issues affecting postmenopausal women for whom few data are available; and (c) health issues affecting women of differing social, economic, and ethnic backgrounds.

The Women’s Health Initiative has a tripartite agenda: (a) Clinical Trials, (b) Observational Studies, and (c) the Community Prevention Study. Together, the NIH and the National Heart, Lung, and Blood Institute conduct the Clinical Trials and the Observational Studies. The Community Prevention Study was carried out by the Centers for Disease Control and Prevention (CDC). The Women’s Health Initiative was designed to focus on breast cancer, colon cancer, rectal cancer, osteoporosis, and heart disease. These diseases are responsible for most of the deaths, disabilities, and the decreased quality of life among postmenopausal women.

Osteoporosis was selected because one out of every six women suffers from hip fractures, and hip fractures occur four times more often in women than in men. As a result, it is a more frequent risk for women than cancer. Second, heart disease is currently the leading cause of death in women. As many as 240,000 women suffer heart attacks due to heart disease. Third, breast cancer kills more than 46,000 women per year, ranking second in cancer deaths among women. Furthermore, over 183,000 cases of breast cancer are diagnosed each year. Fourth, colon and/or rectal cancers kill over 28,000 women each year. Each year 51,000 cases of colon cancer and 16,500 cases of rectal cancer are diagnosed in women. Colon cancer ranks third in cancer deaths among women.

The Clinical Trials involve over 68,000 women who will be studied for 9 years. The major studies under way include Dietary Modification, Calcium/Vitamin D Supplementation, and Hormone Replacement Therapy. The Dietary Modification trial focuses on the impact that high fiber, fruit, vegetable, and low-fat intake have on the prevention of cancers and heart disease. The Calcium/Vitamin D Supplement trial focuses on the impact the supplements have on reducing the risk of osteoporosis, hip fractures, and colon and rectal cancer. The Hormone Replacement Therapy trial focuses on the impact estrogen supplements have on reducing the risk of osteoporosis and colon cancer (terminated in 2002). These trials are being conducted across the nation at 40 clinical centers where women were recruited between 1993 and 1998.

The Observational Study tracks the lifestyles and health of over 100,000 women for 8-12 years. The study focuses on the impact exercise and healthy behaviors have on disease prevention. The last recruitment phase for this study was in 1998.

The Community Prevention Study followed 64,500 women from all social, economic, and ethnic backgrounds. For 5 years this Study was carried out at eight university-based prevention centers. The purpose of the Community Prevention Study was to identify the best local programs that lead to healthy lifestyles among women over the age of 40. Healthy programs such as diet, exercise, smoking cessation, vitamin supplements, mammogram checkups, education, and outreach were evaluated to identify the most effective practices.

Today, the Women’s Health Initiative is still being conducted. However, while still in Clinical Trials, the Hormone Replacement Therapy trial was abruptly terminated. In 2002, the U.S. Food and Drug Administration (FDA) stopped the trial because the research data indicated that the health risks were beginning to outweigh the benefits. An increased incidence of breast cancer, heart attack, stroke, and blood clots in the legs and arms among healthy women outweighed the benefits gained due to reductions in hip fractures and colon cancers. Since these findings were based on women using hormone replacement therapy for more than 3 years, women considering its use for shorter periods of time can still gain some benefits. Therefore, the FDA strongly encourages women to consult their physicians for medical advice.

In conclusion, the Women’s Health Initiative is the first major step toward increasing the medical data on women available to doctors and researchers. This information will help the development of new treatments for heart disease, breast cancer, osteoporosis, and colon and rectal cancer. Although the Hormone Replacement Therapy trial was stopped, much has been learned about the role of estrogen supplements as a treatment for women. Furthermore, the information from the Observational and Community Prevention studies will help our communities promote healthy practices that are effective in disease prevention and improving the quality of life for women.

See Also: Cancer, Clinical trials, Coronary risk factors, Hormone replacement therapy, Osteoporosis and osteopenia, Quality of life, Vitamins

Suggested Reading

  • Bowden, D. J., Hunt, J. R., Kaplan, R. M., Klesges, R. C., Langer, R. D., Mathews, K. A., et al. (1997). Women’s Health Initiative. Why now? What is it? What’s new? American Psychologist, 52, 101-116.
  • Clifford, C., Finnegan, L. P., Harlan, W. R., McGowan, J. A., Pinn, V. W., & Rossouw, J. E. (1995). The evolution of the Women’s Health Initiative: Perspective from the NIH. Journal of the American Medical Women’s Association, 50, 50-55.
  • Hamdy, R. C. (2002). Lessons learned from the Women’s Health Initiative study. Southern Medical Journal, 95(9), 951-965.
  • Liu, J. (1998). The Women’s Health Initiative: Goals, rationale, and current status. Menopausal Medicine, 6(2), 1-4.

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