MONDAY, March 17, 2003 (HealthDayNews) -- Women in the Women's Health Initiative (WHI) study who were taking the hormones estrogen and progestin showed no improvement in their quality of life.
This report, the second released by the WHI since health risks prompted the National Institutes of Health to pull the plug on the study last year, will appear in the May 8 issue of The New England Journal of Medicine. The journal released the study early because of its "potential therapeutic implications."
Ironically, the new finding comes on the heels of an announcement by the U.S. Food and Drug Administration that it has just approved a low-dose version of Prempro, a pill containing both progesterone and estrogen.
"[Estrogen plus progestin] did not help quality of life in our participants," says study author Jennifer Hays, one of the chief investigators for WHI. "We had 16,608 women and we asked them questions about physical and emotional and social health, depression, sleep, sexual satisfaction and memory. And we really couldn't find any appreciable benefit."
While some experts are wondering if hormone replacement therapy (HRT) has any role to play in the health of postmenopausal women, others feel the new findings are misleading.
"The WHI was not designed to test quality of life," says Dr. Steven Goldstein, a professor of obstetrics and gynecology at New York University School of Medicine in New York City. "The women were chosen 10 years ago when they thought estrogen and progestin prevented heart disease. [That's one of the reasons] two-thirds of the women were 60 to 79 years old and not recently menopausal and not overly symptomatic. Women entering this trial don't need a boost in quality of life."
The WHI was halted in July 2002 after researchers realized that women taking the combination of estrogen plus progestin were at a higher risk for heart attacks, stroke and breast cancer. Although the women also had a lower risk of colorectal cancer and osteoporotic fractures, the benefits clearly did not outweigh the risks.
For the purposes of this latest study, 16,608 postmenopausal women aged 50 to 79 were randomly assigned to take either estrogen plus progestin or a placebo. Quality of life was assessed at the beginning, again at one year and, in a subgroup of 1,511 women, at three years. Most of the women enrolled did not have menopausal symptoms.
No matter which way you looked at it, the hormones had little effect on quality of life, the researchers say.
"We did it several different ways. We put in the age and whether or not they had symptoms, such as hot flashes and night sweats, and none of that made a difference," Hays says. "We did a separate analysis of 574 women in the study who were 50 to 54 at the beginning who all reported moderate to severe night sweats or hot flashes. And the only measure that showed any improvement at all was on sleep. There was a 5 percent improvement in sleep."
Some 2,000 women reported moderate to severe symptoms when they started the study. Those in the treatment arm experienced an overall improvement in symptoms of about 77 percent. This sounds good until you compare it with the 52 percent improvement in symptoms experienced by the placebo group. The remaining 25 percent difference may also reflect "the natural history of menopause," Hays says. "If you can wait it out, you will get better."
"I think it's the end [of estrogen and progestin treatment] for the majority of women who are postmenopausal," Hays says. "But there are probably a group of women who these results do not apply to."
And those are the women who would not join a trial like this because they wouldn't want to risk going into a placebo group.
"We found that 20 percent of women in the U.S. and Europe seek medical treatment for hormones, so we may presume that about 20 percent are really suffering and would not have participated in this trial," Hays says. "We don't want to invalidate the experience of those women. We didn't measure change in a group like that because we didn't have them in the study."
Still, Hays adds, the vast majority of women with menopausal symptoms get better without treatment.
What's a menopausal woman to do without combination hormone treatment?
"Keeping yourself active physically and mentally is probably the most powerful treatment that you can find for quality-of-life improvements, and it doesn't raise risk of heart attack, stroke and breast cancer," Hays says.
More information
For more on the Women's Health Initiative, visit the National Heart, Lung, and Blood Institute.
For more on menopause, check out the North American Menopause Society.
