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Researchers from the well-known Women's Health Initiative (WHI) Hormone Therapy Trials recently provided the most comprehensive look at the findings to date.
They are also offering new information from extended follow-up of 27,347 postmenopausal women from the two hormone therapy trials. The comprehensive findings, published in the Oct. 2 edition of The Journal of the American Medical Association (JAMA), include information on a wide range of diseases and quality-of-life outcomes, comparisons of the two hormone therapy trials side-by-side and a full breakdown of results by age and time since menopause onset.
"Our main goal was to provide as much information as possible from the WHI hormone therapy trials to help women and their clinicians make the most informed decisions about hormone therapy use," said JoAnn Manson, MD, DrPH, chief of BWH's Division of Preventive Medicine and first author of the WHI report. "The WHI findings, presented in this new detail, provide the strongest evidence base available to guide clinical decision-making and individualized care."
Launched in the early 1990s, WHI was the largest women's health research program in the nation. It focused on addressing the most common causes of death, disability and poor quality of life in postmenopausal women. The program was comprised of several clinical trials, two of which were the Hormone Therapy Trials (estrogen plus progestin and estrogen alone) and an observational study.
Researchers have found that both forms of hormone therapy treatment increased the risk of stroke, leg blood clots, gallstones and urinary incontinence. Yet they also found benefits, such as the decreased risk of hip and other fractures, diabetes, hot flashes and night sweats. Estrogen plus progestin, but not estrogen alone, increased breast cancer risk. As a result of this research, the WHI trials have led researchers to the conclusion that while hormone therapy is appropriate for some women for short-term management of menopausal symptoms, the findings do not support long-term use for the prevention of chronic disease.
The findings also indicate that the risks of adverse events in younger women are much lower than in older women, and, because menopausal symptoms are more common in younger age groups, the quality-of-life benefits are likely to outweigh the risks for many women who seek treatment for symptoms during the menopause transition.
In an accompanying editorial, BWH President Betsy Nabel, MD, praised the legacy of the WHI, writing, "Twenty-two years following its inception, the WHI is a model for publicly-funded, rigorous, thorough and objective clinical trials that broadly affect human health."
The WHI enrolled women nationwide in its two hormone therapy trials and is sponsored by the National Institutes of Health's National Heart, Lung, and Blood Institute (NHLBI). For more information about the WHI, visit the WHI website at whiscience.org.