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The Women’s Health Initiative (WHI), a landmark study involving 40 centers nationwide—including BWH—has reached conclusive results three years ahead of schedule. One component of the study, the combined estrogen and progestin trial, has been stopped early due to an increased risk of breast cancer and because, overall, the risks outweigh the benefits. While some benefits were identified, results of the large, multi-centered trial studying the risks and benefits of combined estrogen and progestin in healthy post-menopausal women also found increases in coronary heart disease, stroke and pulmonary embolism in study participants.
These findings will be published in the July 17 issue of The Journal of the American Medical Association (JAMA).
“The bottom line from the study is that this combined form of estrogen plus progestin does not protect the heart and, overall, the risks outweigh the benefits after five years of use,” said JoAnn Manson, MD, WHI principal investigator and chief of Preventive Medicine at BWH. “Women world-wide have been seeking these answers for decades, and this study will help women make more informed choices about their health.”
The findings target only women who have not had a hysterectomy and were treated with a combination of estrogen and progestin. A separate study of estrogen alone in women who had a hysterectomy does not appear to pose an increased risk of breast cancer so far and is continuing without change.
The Women's Health Initiative is one of the largest studies of its kind ever undertaken in the United States. It involves more than 161,000 American women, ages 50-79, participating in clinical trials or observational studies.