Estrogen, Progestin “Combo” Does Not Improve Quality of Life

Combination hormone therapy does not improve quality of life for postmenopausal women, according to the Women’s Health Initiative study in the March 17 online edition of the New England Journal of Medicine.

The paper is the second released by the WHI since July 2002, when researchers reported that the combination of estrogen and progestin increased a woman’s risk of heart attack, breast cancer and stroke. These findings prompted the National Institutes of Health to halt the study nearly three years early.

“There was no benefit to being in the combination hormone group in terms of general health, energy, mental health, depression, memory or sexual functioning after one year,” said Jennifer Hays, Ph.D., lead author of the study and director of the Center for Women’s Health at Baylor College of Medicine.

An accompanying editorial by Deborah Grady, M.D., of the University of California at San Francisco, says “there is no role for hormone therapy in the treatment of women without menopausal symptoms.”

Women who take hormone therapy for hot flashes should weigh the health risks, she said.

A total of 16,608 postmenopausal women 50 to 79 years old were randomly assigned to receive daily estrogen plus progestin or placebo.

Researchers collected information about the participants’ quality of life after one year, and from a smaller subgroup of 1,511 women at three years. Participants were asked questions about their general health, mental and physical health, role limitations associated with their physical or emotional health, bodily pain, energy and fatigue, social functioning, depression, memory, sleep disturbances, and satisfaction with sexual functioning.

Quality of life is a measure of how an individual’s health affects his or her ability to function. The WHI used the RAND 36-Item Health Survey, a commonly used instrument in health and medical research, and other measures to assess depressive symptoms, cognitive functioning, and sleep.

Even among the youngest women who had moderate to severe symptoms, the only benefit was a 5 percent improvement in sleep disturbances after one year.

The study results do not apply to women who are taking estrogen-alone, as this arm of the WHI is still continuing. These results also may not apply to the approximately 20 percent who seek medical treatment for menopausal symptoms, Hays said. Since participants in the WHI voluntarily agreed to either receive the combination hormone therapy or a placebo, women who were unwilling to be randomly assigned to the placebo group did not participate.

“The WHI results show that for most women, combination estrogen and progestin therapy is not going to make a difference in their lives, and won’t make a major difference in how women feel,” Hays said. “The study indicates if you are taking this just because you think you might be missing out on something if you don’t, you should stop.”

The New England Journal of Medicine released the article early via the Internet because of its “potential therapeutic implications.” The article will appear in the May 8 print edition.

For additional information, see the March 17 issue of Findings, Baylor College of Medicine’s online research newsletter at http://www.bcmfindings.net.

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©2006 Texas Medical Center

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