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After a decade of studying nearly 40,000 healthy women in the landmark Women's Health Study (WHS), BWH researchers published findings regarding the roles of low-dose aspirin in cancer prevention and vitamin E in cardiovascular disease and cancer prevention in two lead articles this month in the Journal of the American Medical Association.
BWH WHS researchers found regular, low-dose aspirin had no overall effect in preventing cancer, including breast, colorectal and other site-specific cancers, but they did find regular low-dose aspirin therapy may confer some protection against lung cancer. The research showed regular intake of vitamin E supplements did not help prevent cardiovascular disease or cancer.
“A clear 'no' is just as important as a clear 'yes' in preventive medicine,” said Julie Buring, ScD, principal investigator of WHS. This massive, randomized and placebo-controlled clinical trial followed 39,876 participants who were all healthy female health professionals 45 years old or older when the trial began in 1992. Today, WHS findings provide physicians with important results related to the prevention of certain diseases in women.
Nancy Cook, ScD served as the lead investigator on the low-dose aspirin and cancer analyses, and I-Min Lee, MBBS, ScD was the lead investigator of the vitamin E and cardiovascular and cancer analyses.
“As a result of our findings, we do not suggest doctors recommend low-dose aspirin therapy for primary prevention of cancer,” Cook said. WHS analyses could not rule out benefits of higher doses of aspirin, and Cook and her colleagues recommend additional study.
Lee's analyses debunked a common misconception that vitamin E helps prevent cardiovascular disease or cancer in healthy women. “At present, a healthy lifestyle and regular screening for cardiovascular health and cancer are a woman's best choices for disease prevention,” she said.
The study, however, did show that vitamin E reduced cardiovascular mortality rates, a finding that is not consistent with data from other studies prompting WHS researchers to recommend additional exploration.
The National Heart, Lung and Blood Institute and the National Cancer Institute funded WHS, as researchers monitored participants through mail questionnaires and medical records for occurrences of cancer and cardiovascular events such as heart attack and strokes.
“BWH researchers have taken the lead on women's health issues and helped shape some of our basic understanding of disease prevention in women,” said Barbara Bierer, MD, BWH senior vice president of Research. “The contributions emanating from the Women's Health Study are a source of immense pride for this hospital.”
“BWH pioneered the methodology for such large-scale, mail-based trials for interventions safe enough not to require regular clinical visits,” said JoAnn Manson, MD, DrPH, chief of the Division of Preventive Medicine. Other large-scale BWH studies include the Physicians' Health Study, a randomized clinical trial, and the Nurses' Health Study, an observational study directed by Channing Laboratory.
“Our single-institution direction of large-scale, clinical trials by mail is extremely cost-effective, especially when two or more interventions are tested simultaneously as in the WHS,” said Manson, a co-investigator of both the WHS and Physicians' Health Study.
Previously, WHS researchers released groundbreaking findings on low-dose aspirin in relation to cardiovascular disease prevention in the March 31 New England Journal of Medicine. In addition, WHS provides researchers with an almost limitless data set that has yielded approximately 75 other published papers prior to the July 6 JAMA articles.
“We have DNA samples from more than 27,000 of these women providing us with a fabulously rich but scarce resource for more research,” Buring said. Researchers are now studying how aspirin and vitamin E affect other diseases and medical conditions, including diabetes, loss of cognitive function, vision disorders and rheumatoid arthritis.