Study questions HRT's benefits on quality of life: findings may not be applicable to women with severe postmenopausal symptoms. (Women's Health Initiative).

Combination hormone replacement therapy does not have any clinically meaningful benefits on overall health-related quality of life in postmenopausal women, according to new data from the Women's Health Initiative.

Researchers found no significant effects of estrogen plus progestin on such factors as general health, vitality, social functioning, mental health, depressive symptoms, or sexual satisfaction--reasons why many women had chosen to go on hormone replacement therapy (HRT) in the past.

The study, by Jennifer Hays, Ph.D., of Baylor College of Medicine (Houston), and her associates, was scheduled to appear in the May 8 issue of the New England Journal of Medicine but was released online on March 17 because of its potential therapeutic implications (N. Engl. J. Med. March 17, 2003 [epub ahead of print]).

The new study is not without criticism, however. Some have noted that the study did not include the women who are most likely to take hormones--postmenopausal women with severe symptoms. Of the women in the study who were symptomatic, the frequency and severity of those symptoms were actually quite mild, said Natalie de Vane, spokes-woman for Wyeth Pharmaceuticals, maker of Prempro--the hormone replacement used in the study.

For these women, the benefit of relief of vasomotor symptoms should be balanced against the risks associated with hormone use, Dr. Deborah Grady of the University of California, San Francisco, said in an accompanying editorial.

The new findings follow the early discontinuation of the estrogen-plus-progestin arm of the Women's Health Initiative (WHI) last summer, because results indicated small increases in risks of MI, stroke, venous thromboembolism, and breast cancer associated with HRT use. These risks outweighed potential benefits such as decreased risk of colon cancer and osteoporosis.

In the current study, 16,608 postmenopausal WHI participants were randomly assigned to take either a combination of estrogen and progestin (0.625 mg of conjugated equine estrogen plus 2.5 mg of medroxyprogesterone acetate [Prempro]) or a matching placebo pill. The women completed questionnaires at baseline and again after 1 year. In addition, 1,511 of these women completed the questionnaire again at their third annual visit.