Hormone replacement therapy (HRT)--in the form of estrogen plus progestin--did not improve the quality of life of women participating in a landmark HRT trial that was halted last summer, researchers from the federal Women's Health Initiative (WHI) have concluded. The researchers ended the treatment of women early after finding that those who took the estrogen-progestin combination were at increased risk for breast cancer, heart attacks and stroke.
Now, researchers have found that the same women also did not experience significant improvements in their general health, vitality, mental health, depressive symptoms or sexual satisfaction while on HRT. There was, however, a small but not clinically meaningful improvement in sleep disturbance, physical functioning and bodily pain.
The findings were released in March and are published in this month's New England Journal of Medicine (Vol. 348, No. 19). Psychologist Jennifer Hays, PhD, of the Baylor College of Medicine in Houston led the study, and psychologists Judith K. Ockene, PhD, Robert L. Brunner, PhD, and Sally A. Shumaker, PhD, are co-authors.
The psychologists and their colleagues gathered data from 16,608 women 50 to 79 years old, who were randomized into a placebo or HRT group at baseline, and after the first year; data were also collected from a random subgroup of 1,511 in the third year.
Because many women seek HRT treatment to reduce vasomotor symptoms, the researchers also examined a subset of 574 women who were 50-54 years old and reported having hot flashes and night sweats. These women also reported no improvements in quality of life, except for a small decrease in sleep disturbances.
The researchers note that since the study only included women who were willing to be possibly randomized to placebo, the sample may not be representative of all postmenopausal women. Additionally, the results only apply to women with uteruses taking the estrogen-progestin combination. WHI, which is funded by the National Institutes of Health's National Heart, Lung and Blood Institute, is continuing a study of women without uteruses who are taking an estrogen-only replacement therapy.