NEJM study indicates hormone replacement therapy does not improve quality of life

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March 17, 2003

WORCESTER, Mass.--Researchers with the multi-site Women’s Health Initiative, who in July 2002 reported an unexpected increased risk of invasive breast cancer, coronary heart disease, stroke, and pulmonary embolism among postmenopausal women using a combination hormone replacement therapy, released an additional paper indicating that the combination therapy does not improve quality of life for postmenopausal women, as originally believed. The previous findings, which prompted the National Heart, Lung, and Blood Institute (NHLBI) to halt the major study in July, prompted millions of women to weigh the risks of hormone therapy against the improved quality of life the combination hormones estrogen plus progestin were thought to provide.

The new study, released March 17 on the New England Journal of Medicine’s web site (www.nejm.org), examined quality of life measures--physical function, mental health, energy, sleep, pain, and sexual satisfaction--among 16,600 postmenopausal women in the WHI. Women were surveyed at one and three years of "EplusP" therapy. Very little difference was found between the women receiving a placebo and those receiving the hormones when measured at one year; no difference was found at three years.

"On the group level, there were no significant benefits from estrogen plus progestin therapy," said Judith K. Ockene, PhD, the Barbara Helen Smith Chair in Preventive and Behavioral Medicine and Chief of the Division of Preventive and Behavioral Medicine at the University of Massachusetts Medical School and co-author of the study. "While some individuals may still feel they are benefiting from therapy, this suggests that for the majority of women, there are no benefits to outweigh the serious risks we identified last summer."

Women in the study were asked questions about their general health, mental and physical health, role limitations caused by physical or emotional health problem, bodily pain, energy and fatigue, social functioning, depression, memory, sleep disturbances, and sexual satisfaction. The study used the RAND 36-Item Health Survey, a widely used instrument in health and medical research. The WHI also used validated measures to assess depression, cognitive function, and sleep. Researchers expected quality of life to improve more in younger women (50-54 years of age) who were experiencing hot flashes and night sweats, symptoms that spur many women to seek treatment. In this group, however, there were no such improvements, although they reported a slight improvement in sleep.

The study, it should be noted, does not apply to women taking estrogen alone; the WHI continues to gather data relative to estrogen therapy and is also investigating the effect of all hormone replacement therapies on other conditions, such as diabetes, gallbladder disease and cognitive function.

The WHI involves over 161,000 women who are participating in a set of clinical trials or an observational study at more than 40 sites across the country. Clinical trials in Massachusetts are based at UMass Medical School in conjunction with Fallon Clinic, and at the Brigham and Women’s Hospital. The clinical trials are designed to test promising but unproven treatments for heart disease, breast and colorectal cancer, and osteoporosis. WHI is sponsored by NHLBI in collaboration with four other components of the NIH: the National Cancer Institute; the National Institute of Arthritis and Musculoskeletal and Skin Diseases; the National Institute on Aging; and the Office of Research on Women’s Health.

Originally scheduled to run until 2005, the EplusP component of the WHI studies enrolled between 1993 and 1998 more than 16,600 menopausal women, aged 50 to 79 who had not had a hysterectomy. An important objective of the trial was to examine the effect of estrogen plus progestin on the prevention of heart disease and hip fractures, and any associated change in risk for breast and colon cancer. The adverse effects of estrogen plus progestin applied to all women, irrespective of age, ethnicity, or prior disease status. The study did not address the short-term risks and benefits of hormones for the treatment of menopausal symptoms.

Women enrolled in the EplusP study were randomly assigned to a daily dose of estrogen plus progestin (0.625 mg of conjugated equine estrogens plus 2.5 mg of medroxyprogesterone acetate) or to a placebo. There were noteworthy benefits of EplusP-fewer hip fractures and protection from colon cancer-and the combined hormone is known to prevent endometrial cancer. Specific study findings for the estrogen plus progestin group, compared to placebo, included:

Information about the WHI is available at www.whi.org. or on the NHLBI website at: www.nhlbi.nih.gov.

Contact: Alison Duffy, 508-856-2000