Until recently, most postmenopausal women were encouraged to take hormone replacement therapy (HRT), usually a combination of estrogen and progesterone. HRT was believed to reduce the risk of osteoporosis -induced fracture and coronary heart disease , and to control hot flashes and night sweats, among other possible benefits.

Then, in the summer of 2002, the Women’s Health Initiative (WHI), a large, randomized clinical trial investigating the risks and benefits of HRT for the prevention of disease was stopped early when it found that HRT caused small increases in the risk of heart attack , stroke , blood clots, and breast cancer . HRT appeared to slightly decrease the risk of hip fracture and colon cancer , but these benefits were outweighed by the risks.

Still, many menopausal and postmenopausal women—and their physicians—continue to believe that HRT can help improve their overall quality of life by elevating their mood, sharpening their minds, enhancing their sexual functioning, and controlling their hot flashes and other disturbing menopausal symptoms.

In a study released early by the New England Journal of Medicine , to be published in their May 8, 2003 issue, researchers report that HRT did not have any clinically meaningful benefit on general health, vitality, mental health, depressive symptoms, sexual satisfaction, sleep quality, physical functioning, cognitive functioning, or bodily pain. Only women experiencing moderate to severe hot flashes and night sweats derived any meaningful benefit from HRT.

About the Study

The researchers analyzed data from 16,608 postmenopausal women, aged 50 to 79 years, with an intact uterus, who were enrolled in the double-blind, placebo-controlled Women’s Health Initiative (WHI) trial. 8506 women were randomly assigned to receive a daily dose of HRT (0.625 milligrams (mg) estrogen plus 2.5 mg progesterone) and 8102 received a placebo.

The study participants were seen in the clinic at six months, 12 months, and then annually. They were assessed in the following quality of life measures:

  • Physical functioning
  • Social functioning
  • Bodily pain
  • Vitality (energy and fatigue)
  • Emotional and mental health
  • Social interactions
  • Depression
  • Sleep disturbance
  • Sexual functioning and satisfaction
  • Cognitive functioning
  • Menopausal symptoms
    • Hot flashes
    • Night sweats
    • Mood swings
    • Forgetfulness
    • Difficulty concentrating

The Findings

After one year, there were no significant differences between the HRT group and placebo group in terms of general health, vitality, mental health, depressive symptoms, cognitive functioning, or sexual satisfaction.

HRT produced small, but statistically significant benefits in terms of sleep disturbance, physical functioning, and bodily pain after one year. However, these effects were not clinically meaningful. And, at three years, there were no significant differences between the HRT group and placebo group in terms of any quality of life outcomes.

The researchers performed a sub-analysis on women who had reported moderate to severe hot flashes and nigh sweats at the beginning of the trial. Of these women, 1072 were taking HRT and 974 were taking a placebo. The researchers found that at one year, 76.7% of the women taking HRT had improvement in the severity of hot flashes, compared to 51.7% of women in the placebo group. In addition, 71.0% of the HRT group had improvement in the severity of night sweats compared to 52.8% of women taking the placebo. These differences were statistically significant.

There were a few important limitations to this study. First, the WHI trial was designed to study the risks and benefits of HRT on the prevention of disease, not the effects of HRT on menopausal symptoms. Second, the majority (82%) of women enrolled in WHI did not have menopausal symptoms. And finally, although 12% did report moderate-to-severe symptoms, the fact that these women were willing to be randomly assigned to take placebo might mean their symptoms were not very bothersome.

How Does This Affect You?

Though there were some significant benefits of HRT in this study, the researchers largely dismissed them as “not clinically meaningful,” questioning whether women would experience them as an actual benefit.

The results of this study, taken together with previous negative results from this and other trials, strongly imply that women without significant menopausal symptoms should seriously considering not using HRT. The only important benefit of HRT revealed by this study was for the relief of moderate to severe hot flashes and night sweats. Women who do experience these symptoms should bear in mind that menopausal symptoms usually diminish within a few months or years.

If you are currently taking HRT, do not discontinue without discussing it with your doctor first. At that time, you may also wish to consider alternative treatments to control your symptoms such as selective serotonin reuptake inhibitors (Prozac, Zoloft) or other antidepressants, isoflavones (found in soy) or black cohosh , an herbal remedy.