Study: HRT has little effect on quality of life

New treatments needed, physician says

Research has indicated that women have risked their health by long-term use of hormone replacement therapy. Now new research says the therapy seems to have little benefit in aiding quality-of-life measures either.

Both sets of findings are taken from a study that was part of the federally funded Women’s Health Initiative (WHI). The study involved 16,608 postmenopausal women ages 50-79 years with an intact uterus. The women either received the combination hormone replacement therapy, 0.625 mg conjugated equine estrogens plus 2.5 mg medroxyprogesterone acetate, or placebo.

Researchers conducted the first study to assess whether long-term use of the combination hormone therapy would reduce the risk of coronary heart disease in postmenopausal women. This study was stopped more than three years early (after an average follow-up of 5.2 years) because of an increased risk of invasive breast cancer.

The trial also found that increases in coronary heart disease, stroke, and pulmonary embolism in study participants (compared to women taking placebo) exceeded the benefits of the drug. The benefits included fewer cases of hip fractures and colon cancer.

The most recent study was conducted to determine the effect of hormone therapy on health-related quality of life. To do this, quality-of-life measures were collected at baseline and at one year in all women and at three years in a subgroup of 1,511 women.

No quality-of-life benefits at three years

The results showed that randomization to estrogen plus progestin resulted in no significant effects on general health, vitality, mental health, depressive symptoms, or sexual satisfaction. The use of estrogen plus progestin was associated with a statistically significant but small and not clinically meaningful benefit in terms of sleep disturbance, physical functioning, and bodily pain after one year. At three years, there were no significant benefits in terms of any quality-of-life outcomes.

Among women ages 50-54 years with moderate-to-severe vasomotor symptoms at baseline, estrogen and progestin improved vasomotor symptoms and resulted in a small benefit in terms of sleep disturbance but no benefit in terms of the other quality-of-life outcomes.

A physician not related to the research states the results bluntly in an editorial accompanying the study findings. "Postmenopausal therapy with estrogen and progestin results in increased risks of disease, does not make asymptomatic women feel better, does not improve cognition. There is no role for hormone therapy in the treatment of women without menopausal symptoms," says Deborah Grady, MD, MPH. Grady is professor of epidemiology and biostatistics, professor of medicine, and vice chair of the department of epidemiology and biostatistics at the University of California San Francisco (UCSF). Grady also is director of the UCSF Women’s Health Clinical Research Center and the UCSF Women’s Health Faculty Development Program.

"Women with vasomotor symptoms must weigh the risks associated with treatment against the benefit of symptom relief," she continues. "Vasomotor symptoms occur in about two-thirds of women and are very distressing in 10% to 20%. We clearly need to identify new treatments that are highly effective and safe."

The results of the study will be published in the May 8 issue of the New England Journal of Medicine. Because of the study’s importance, however, the journal made the research available on-line March 17.