Hormone therapy: Does it boost quality of life?
New research from the Women’s Health Initiative (WHI) indicates that for many postmenopausal women, combined hormone therapy does not have a clinically significant effect on their health-related quality of life.1
"Our conclusion is that for most women, long-term use of hormones will not have a significant impact on their quality of life — perceived physical and emotional functioning — and the health risks remain," says lead author Jennifer Hays, PhD, director of the Center for Women’s Health and associate professor in the department of medicine at Baylor College of Medicine, both in Houston.
Clinicians continue to sort out the findings following the 2002 cessation of the estrogen/progestin arm of the WHI trial. The study was halted after data showed that the overall health risk, particularly of cardiovascular disease and breast cancer, from taking estrogens with progestin was greater than the benefits of lowering the risk of colon cancer and bone fractures.2
In the trial, a total of 16,608 postmenopausal women 50-79 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.
Study findings indicate that combination hormone users had no benefit over placebo recipients on any of the quality of life outcomes, including general health, vitality, mental health, depressive symptoms, or sexual satisfactions. At one year, combination hormone use was associated with statistically significant, but not clinically significant, benefits in sleep disturbance, physical functioning, and body pain. After three years, results were not significant.
How do you proceed?
With the findings from the large-scale trial now in hand, clinicians are deliberating on how to apply them in their care of peri- and postmenopausal women.
"This study has little relevance to the woman most likely to initiate hormone therapy; i.e., the woman with menopausal symptoms," comments Susan Wysocki, RNC, NP, president and chief executive officer of the Washington, DC-based National Association of Nurse Practitioners in Women’s Health.
The population of women studied were an average of 63 years old, Wysocki points out. Nearly 64% of the women studied in the treatment and placebo groups were 10 or more years past menopause, she observes.
"Secondly, women who reported moderate to severe menopausal symptoms were discouraged from entering the trial," says Wysocki. "Only 12.7% of the treatment group and 12.2% of the placebo group had moderate to severe vasomotor symptoms at baseline."
According to Hays, the study has the following limitations:
- Scientists only enrolled
women who were willing to be randomly placed on hormones or a placebo.
"Since about 20% of women seek treatment for menopause, and up to 75% of women in the past were noncompliant with hormone therapy, we believe our results still apply to the majority of postmenopausal women," states Hays.
- The study does not focus
on perimenopausal women.
Hot flashes peak during the year in which a woman has her last menstrual period; about 65%-85% of women have hot flashes during that period, observes Hays. Quality of life may be more impacted during perimenopause, she notes.
- The data apply only
to combination (estrogen plus progestin) hormone therapy.
The estrogen-only arm of the WHI is ongoing, and the data for that study will not be analyzed until the study is completed, states Hays. The analysis is scheduled for May 2005, she reports. (CTU will report on that analysis when it is complete.)
Remember that the WHI is not a study of the impact of short-term hormone use on symptoms in perimenopausal women, notes Hays. When the WHI initially was designed in the early 1990s, hormones typically were prescribed for indefinite or lifelong use for symptom relief, as well as to prevent cardiovascular disease and osteoporosis, she points out. It is only since the Food and Drug Administration revised its guidelines in January 2003 that estrogen plus progestin use has been limited to short-term use for symptoms, says Hays.
Get fingertip information on the latest in hormone therapy research from the following resource:
• The Cleveland-based North American Menopause Society offers updates on scientific literature, as well as information for clinicians and consumers, on its web site, www.menopause.org. The site offers free abstracts of the society’s monthly journal, Menopause, and web-based access of such publications as its Menopause Guidebook. Resource links and scientific news also are included at the site.
1. Hays J, Ockene JK, Brunner RL, et al. Effects of estrogen plus progestin on health-related quality of life. N Engl J Med 2003; Mar 17 [epub ahead of print].
2. Writing Group for the Women’s Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: Principal results from the Women’s Health Initiative randomized controlled trial. JAMA 2002; 288:321-333.