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Investigators Reaffirm Short-Term HRT for Younger Women

Investigators Reaffirm Short-Term HRT for Younger Women

The conclusion that hormone therapy is not recommended for the prevention of chronic disease, but may remain a reasonable option for the short-term management of menopausal symptoms for younger women has been reaffirmed by Women’s Health Initiative (WHI) Hormone Trials investigators. This conclusion was reached after investigators reviewed data from the trial and the extended post-trial follow-up period.

The update and overview presents for the first time the extended follow-up data and highlights findings related to conditions that affect quality of life. The paper also provides the most comprehensive look at the trials’ findings to date, with more detail on individual disease-specific outcomes, side-by-side comparisons of estrogen-alone and estrogen plus progestin, and a full breakdown of results by age and over time.

The WHI, which is sponsored by the National Institutes of Health’s National Heart, Lung, and Blood Institute (NHLBI), followed women during a 13-year period.

“The combination of the 6 to 7 years of intervention combined with the extended post-intervention follow-up make these hormone therapy medications among the best studied medications in medical history,” said Dr. JoAnn Manson, a principal investigator for the WHI; chief of the division of preventive medicine at Brigham and Women’s Hospital; and professor of medicine at Harvard Medical School, Boston. “There are very few other treatments with this much information about the balance of benefits and risks over such a long period of time that include such a long post-intervention phase. The ultimate goal of this paper and the analysis is to help women and their health care providers make informed decisions.”

Of the 27,247 women who participated in the original WHI Hormone Trials—16,608 with an intact uterus in the trial of estrogen plus progestin and 10,739 without a uterus in the trial of estrogen alone—81% agreed to continue follow-up after the planned end of the trials. The WHI compared the rates of developing coronary heart disease (including a heart attack), stroke, breast cancer, blood clots in the lungs, colorectal cancer, endometrial cancer, hip fracture, and death among women who were assigned to hormones versus women who were assigned to placebo study pills.

Those chronic diseases and deaths were combined in a global index to provide an overall measure of the balance of harm and benefit. The WHI researchers also studied several other important outcomes, including dementia, other cancers, other fractures, diabetes, gallbladder disease, urinary incontinence, and quality-of-life outcomes such as hot flashes, night sweats, sleep disturbances, mood and depression, breast tenderness, and joint pain.

Rates of overall illnesses (any one of the major illnesses studied) and death were 12% higher in women taking estrogen plus progestin than in women taking placebo pills during the trial. In absolute numbers, there were 20 more major illnesses or deaths per year for every 10,000 women taking estrogen plus progestin compared with the same number of women taking placebo. After women stopped taking the estrogen plus progestin therapy, there were no effects on overall illness and death. These results were the same in each age group but absolute numbers of additional illnesses and deaths were low in women aged 50 to 59 years (12 more for every 10,000 women per year). The results are based on a trial period of 5.6 years with an average of 3 years of actual hormone use and then no hormone use for 8 or more years.

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