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Hormone Therapy’s Future Put in Doubt

Times Staff Writers

A major study of 16,000 women has found that hormone replacement therapy does not improve the quality of life for post-menopausal women, a finding that may sound the death knell for widespread use of a treatment once thought to be a panacea for women’s ailments.

Last year, a related study indicated that the risk of heart disease and cancer associated with the use of combined estrogen-progestin treatment outweighed potential benefits, but many women continued to take the drugs because they believed it made them feel better overall.

The new study, however, overturns those beliefs. Although hormone replacement therapy can help alleviate menopausal symptoms such as hot flashes, the study found it provided no improvement in emotional stability, cognitive function, sleep and sexual satisfaction -- some of the factors that have led many women to continue the therapy long after menopause. In the study, quality-of-life measures were just as high for women taking a placebo as for those taking the drugs, the researchers found.

“There is no role for hormone therapy in the treatment of women without menopausal symptoms,” said Dr. Deborah Grady of UC San Francisco, who wrote an editorial accompanying the report, which will be published in the New England Journal of Medicine in two months. The report was released early because of its medical importance.

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“The average woman will not experience an improvement in her quality of life by taking this pill,” added Dr. Jennifer Hayes of the Baylor College of Medicine, who led the study.

Hayes said that women can use the therapy to reduce the symptoms of menopause, but that they should use the lowest possible dose and stop taking the drugs as soon as possible.

Proponents remained unswayed by the new evidence, however. “That’s not true, it’s not true,” said Marie Lagano, founder and president of the American Menopause Foundation in New York City. “We’ve met women who have been on hormone therapy for 20 years. They look great and feel great, and have no intentions of stopping hormone therapy.”

Dr. Alan Altman of Harvard Medical School added: “Any health-care provider who has treated post-menopausal women over the past 25 years knows that the clear benefit of individualized hormone replacement therapy to quality of life is indisputable.”

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Hayes countered, however, that “the perception of the benefits has far outstripped the research documenting those benefits.”

Before the Women’s Health Initiative study began, she said, researchers believed that hormone therapy was beneficial to the heart and that the study would reveal how that benefit compared with the risks of therapy. What they found instead was a risk to the heart.

In this study as well, the team was expecting to find a benefit. “We were really surprised when we looked at the results,” Hayes said. “But we shouldn’t be surprised to get such answers when this is the first time the question has been addressed.”

Some women reacted strongly to the new results. “I really feel bandied about by these studies,” said Claudette Sutherland, a 63-year-old actress and writer in the San Fernando Valley who has been taking hormones since she turned 50. “In fact, I’m not trusting the studies, because there is so much conflict in them.”

Maria Robertson, a 54-year-old teacher in the San Gabriel Valley, added that “it is very annoying to think that you have gone through taking something that wasn’t going to make any difference.” She said a lot of women were scared after last year’s report came out. “This time, I think more women are going to be angry than scared.”

The new study is important because of the large number of women who potentially may use the treatment. Up to 20% of American women suffer such severe hot flashes and other symptoms of menopause that they seek medical treatment.

Since the early 1960s, most of those women have received hormone replacement therapy. But there is another large group of women who have received the treatment long past menopause because of their belief in its benefits for improving bone density, cardiac health and their general well-being

The Women’s Health Initiative, which included about 27,000 women, was organized in the early 1990s to determine the potential benefits. One leg of the trial involving the estrogen-progestin combination was terminated three years early when researchers determined that the risks of heart disease, stroke and breast cancer outweighed the potential benefits. The new study is based on those women. A second leg, still ongoing, looks at the potential benefits of estrogen alone in women who have had their uterus removed.

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The estrogen-progestin study enrolled 16,608 post-menopausal women, ages 50 to 79, who were randomly assigned to receive daily doses of either the hormones or a placebo. Hayes noted that the researchers encountered difficulty in enrolling women with severe symptoms because the women did not want to take a chance on receiving a placebo.

The researchers examined quality of life on a standard, widely used rating scale. All participants were reassessed after one year and most after three years.

“There wasn’t anything of major benefit in terms of any of these measures,” Hayes said.

About 2,000 of the women reported moderate to severe menopausal symptoms. The study found that the symptoms improved in 77% of the women receiving hormones, but also in 52% of women in the placebo group. “That may be a placebo effect, but it may also be the natural history of menopause,” she said.

“Did the change in symptoms translate into changes in function, in the way the women felt?” she added. “We would have to say no.”

Dr. Susan Love of UCLA, a longtime critic of hormone replacement therapy, was pleased that science is finally getting answers about the hormones’ effects. “We should be cheering that we’re finally getting some data” instead of blindly accepting claims of efficacy, she said. “There may be a small group of women really suffering from hot flashes and night sweats where short-term use of hormones may be worth it,” she noted. “But, in general, the notion that taking hormones post-menopausally will improve the quality of your life across the board is really not true.”

A spokesman for Wyeth Pharmaceuticals, the primary manufacturer of the drugs, disagreed. “We believe that the findings ... are not likely to have clinical meaning for symptomatic menopausal women,” Doug Petkus said.

He noted that the vast majority of women in the study scored high on quality-of-life measures at the beginning of the study and “it is unlikely that any intervention would have substantially increased them.”

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Times staff writer Shari Roan contributed to this report.


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