We are nearing the 20 year mark of the landmark study the Women’s Health Initiative (WHI) in Wisconsin. One question has been on my mind. What has been the impact of the Women’s Health Initiative on Wisconsin women’s health over these past 20 years? I contacted Dr. Jane E. Kotchen from the Medical College in Milwaukee to learn how these clinical trials changed the health care of women these past years.
In 1995 an extensive clinical trial began with a specific focus on our older women of Wisconsin through the Women’s Health Initiative study. “The Women’s Health Initiative changed the paradigm of how older women are treated medically,” explained Dr. Jane Kotchen. “The risks
and benefits of hormone replacement therapy required a long term study.” The National Institute of Health commenced these crucial trials in 1991 by setting up 40 centers nationwide to complete the studies. Mortality, disability and frailty would be studied in 161,808 healthy
postmenopausal women across the nation.
Wisconsin Women Join the Clinical Trails
“The study began in Wisconsin with recruitment of women. Wisconsin women were very responsive to joining the study,” said Dr. Kotchen. “One percent of age eligible women participated in the study. Eight thousand women were involved within the Madison and Milwaukee areas.” Dr. Kotchen explained, “In order to reduce factors that might influence the research results, the women in our studies were the same age, had the same number of children and were of the same economic background.”
Cardiovascular heart disease has been the leading cause of death in postmenopausal women with breast cancer the second leading cause of death. With these two diseases at the forefront of the study, the WHI clinical trials concentrated on three main questions
1. Does hormone therapy reduce the risk of cardiovascular disease and breast cancer?
2. Does a low fat diet reduce the risk of cardiovascular disease and breast cancer?
3. Does adding calcium and vitamin D to a diet reduce the risk of fractures?
“Women with hysterectomies made one group of our clinical trials and women with a uterus made up the other group,” said Dr. Kotchen. “These women were given either a hormone replacement or a placebo (a substance with no therapeutic effect).” The double blind study randomly assigned either the hormone or the placebo to women.
During the low fat diet study, women were randomized into the usual eating pattern or a low-fat diet. Women in the calcium/vitamin D study were randomized to calcium (1000 mg/d) and vitamin D (400 IU/d) supplements or a placebo.
Another part of this amazing study on women’s health was the Observational Study. In Wisconsin 160,000 women were tracked anywhere from 8 to 12 years by completing surveys regarding their health. These women had no lifestyle or medication changes.
What are the conclusions of the WHI research?
“The findings from the studies were huge!” said Dr. Kotchen. “We found that there was more risk with hormone replacement therapy. The recommendation for hormone replacement therapy changed and now a woman should be given the lowest dose of hormone for the shortest amount
of time possible.” The study revealed:
- Hormone replacement therapy does not reduce cardiovascular disease.
- Hormone replacement therapy increased the risk of breast cancer.
- Low fat diet results were not conclusive.
- Calcium and vitamin D do reduce fractures in older women.
The National Institute of Health reported other important data from the nationwide trails (http://www.nhlbi.nih.gov/whi/).
- The number of women who developed breast cancer was higher in women taking
estrogen plus progestin.
- The numbers of women who developed heart attacks, strokes, or blood clots in the lungs
and legs were higher in women taking estrogen plus progestin.
- For women taking this estrogen plus progestin combination, the risks (increased breast
cancer, heart attacks, strokes, and blood clots in the lungs and legs) outweigh the benefits
(fewer hip fractures and colon cancers).
- Estrogen therapy alone revealed a slightly greater risk of dementia including Alzheimer’s
WHI Provided Other Vital Studies for Wisconsin Women
“The WHI allowed us to have ancillary studies on older women’s health. We studied how
hormones affect cognitive function with MRIs. Eye disease, especially macular degeneration,
was a focus of one study. Women provided blood samples which have been stored to complete
genetic studies on the predisposition of disease. Again, Wisconsin women were very happy to do
this,” noted Dr. Kotchen. “Currently we are completing a home visit study on African American
women to obtain data on life and longevity after cancer.”
Status of Wisconsin Women Today
Dr. Kotchen shared her insights on the health of Wisconsin women today. “Overall women
living longer have made gains, but smoking is definitely still a problem. In the 1960’s women
had a 2.7x higher chance of having lung cancer while between the years 2000 and 2010 the risk
has gone up to a 25.7x higher chance. The women who stopped smoking during the trials
improved their health. Two areas of great interest will be obesity and diabetes (Type II) and how
women will be affected by these diseases in the future.”
Keep Supporting Women’s Health
The Women’s Health Initiative provided us with comprehensive data on how to keep women
healthy thus leading to changes by health providers. We need to keep supporting women’s health
studies in Wisconsin.
Because it all begins with a healthy woman…
Sue Ann Thompson is founder and president of the Wisconsin Women’s Health Foundation
(WWHF), a statewide non-profit organization whose mission is to help Wisconsin women and
their families reach their healthiest potential. WWHF provides programs and conducts forums
that focus on education, prevention, and early detection; connects individuals to health
resources; produces and distributes the most up-to-date health education and resource
materials; and, awards grants and scholarships to women health researchers and related
community non-profits. To learn more, visit wwhf.org or call 1-800-448-5148.