Hormone therapy revisited: What about quality of life?

Last year, the Women’s Health Initiative (WHI) brought an early end to its trial of estrogen and progestin (Prempro) in 16,608 postmenopausal women. Researchers found that the hormone combination increased risk of heart attacks, strokes, blood clots, and breast cancer. Since then, many women have come off the drug, and doctors no longer prescribe it widely for disease prevention.

Yet despite the risks, some women have been reluctant to abandon long-term hormone therapy because they feel it boosts their quality of life. Women report that it improves sleep, energy, concentration, sexuality, and mood. But a recent analysis of data collected during the WHI’s combined hormone trial shows that the therapy significantly improves the lives of only one fairly small group of women—those with moderate to severe hot flashes.

Hormones’ limited quality-of-life benefits

For this part of the study, women filled out a questionnaire before they started taking their pills—either Prempro or a placebo—and again one year later. They answered questions about their general health, physical and emotional functioning, pain, energy level, sleep quality, sexual satisfaction, and cognitive functioning. They also rated hot flash severity, mood swings, memory, and the ability to concentrate.

After one year, the women taking Prempro had slightly better physical functioning, less sleep disturbance, and less pain than women on placebo—but only by about 1 or 2 points on a 100-point scale. After three years, even those slight differences disappeared.

For participants ages 50 to 54 who had reported moderate to severe hot flashes at the beginning of the study, there was a 5% improvement in sleep for those taking Prempro—but no other meaningful quality-of-life advantages over placebo. Of the 12% of all participants who reported moderate to severe hot flashes, about three-quarters of those who took Prempro had fewer hot flashes after one year. But so did more than half of the women taking a placebo pill.

The authors conclude that for most postmenopausal women, the quality-of-life benefits offered by hormone therapy aren’t robust enough to outweigh the risks associated with it. The study was published in the May 8, 2003, New England Journal of Medicine.

Study may not apply to everyone

There are some limitations to the WHI data. In particular, the data may under-represent women whose hot flashes are very severe because these women were discouraged from participating in the trial, although they were not excluded. Also, the average age of study participants was 63, and most women who start hormone therapy are younger. So data from this large randomized trial don’t necessarily apply to all women.

Another limitation of the study is that cognitive testing may not have been sensitive enough to detect all brain changes. The study’s measure of sexual functioning was also limited because women were asked only to rank their satisfaction on a four-point response scale.

What it means for you

About 20% of women seek help for hot flashes at menopause; some report drenching sweats, severe palpitations, anxiety, and confusion. Unless you have severe hot flashes, the WHI investigators conclude that hormone therapy is unlikely to affect your general functioning, energy level, sleep, mood, or sexual satisfaction in any significant way. For those who do, hormone therapy may be worth the increased risk in heart attack, blood clot, or breast cancer. It is also the standard of care for women with premature menopause due to certain medical conditions.

June 2003 Update

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