Effects of Estrogen plus Progestin on Health-related Quality of Life

March 2003

Findings Summary

The purpose of the Women’s Health Initiative Hormone Program was to study the health benefits and risks of hormones for postmenopausal women. In July 2002, we asked women in the Estrogen plus Progestin part of the program to stop taking their study pills. For women taking estrogen plus progestin, the overall risks (breast cancer, heart attacks, stroke, and blood clots) outweighed the benefits (fewer fractures and colorectal cancers). These results were published in the Journal of the American Medical Association (JAMA) and have prompted new guidelines for the use of these combined hormones. Women are now being told to take hormones only for symptom relief.
One of the questions not addressed in the JAMA paper was whether taking estrogen plus progestin does improve women’s quality of life. These data have now been analyzed and appear on-line in the New England Journal of Medicine issue for Monday, March 17.
The 16,608 postmenopausal women 50 to 79 years old in the Estrogen plus Progestin study received either a daily hormone pill or a placebo pill. Researchers collected information about the participants’ quality of life when they joined the study and after one year. They also collected data from a random subgroup of 1,511 women at three years.
Quality of life is a measure of how someone’s health affects perceived well-being and ability to function (physically, mentally and socially). To assess quality of life, WHI participants answered questions about their general health, physical functioning, bodily pain, energy, social functioning, mental health, depression, sleep disturbances, sexual satisfaction, and symptoms associated with menopause.
The results showed there were no clear benefits for those taking estrogen plus progestin on any of the quality of life measures. There were no significant improvements on perceptions of general health, energy, social functioning, mental health, depression, or sexual satisfaction. There were slight improvements in women's physical functioning, bodily pain, and sleep disturbances at one year. These effects were very small, however. The average increase in physical functioning, for example, was less than one point on a 100-point scale. Most women would not notice such small differences in every-day life, nor would these effects outweigh the risks of estrogen plus progestin hormones for heart attack, stroke, blood clots, and breast cancer.
Researchers then analyzed the data from younger women (50-54 years of age) who reported having hot flashes and night sweats -- the symptoms that cause some women to seek treatment. There were no improvements in quality of life for these 574 women except a small improvement (1 point on a 20-point scale) in sleep disturbance.
These results do not apply to women who are taking estrogen-alone. This part of the WHI Hormone Program is still continuing, and the results are not yet known.This information has been superceded by the 2004 Hormone Program Update.
These results also may not apply to the women who seek medical care for menopausal symptoms. Participants in the WHI study volunteered to be assigned to either the combined hormone group or a placebo group. Women who were not willing to be in the placebo group did not participate in the WHI.
Future WHI publications will address a variety of other conditions--like diabetes, ovarian cancer, dementia and cognitive function--that estrogen plus progestin may impact in favorable or unfavorable ways.