The Hormone Conundrum
An abrupt end to a major menopause study leaves women as confused as ever
Seven years ago, Mary Lazarus read an ad in her local paper asking for volunteers for a clinical trial of hormone replacement therapy. It was part of the federally funded Women's Health Initiative, and the scientists were looking for postmenopausal women at least 50 years old. "I wanted to do it," says Lazarus, of Millbrae, Calif. "There was so little information on women's health." So she signed up.
Lazarus was just 50 at that time, but she had been taking estrogen since her hysterectomy at age 46. Her gynecologist prescribed the pills to relieve her severe hot flashes and night sweats. To be included in the landmark, 161,000-woman WHI study, she had to go cold turkey for several months to wash her body clean of estrogen. "I got all my symptoms back," she says, but it was a price she was willing to pay for potential payoff ahead.
Those hopes all but came to an end last week when Lazarus opened a letter from officials at the National Institutes of Health. The letter said they were prematurely stopping the estrogen study, which had enrolled 11,000 women. "We have stopped the study in the interest of safety of the study participants," said Barbara Alving, director of the WHI, at a briefing last week. The NIH believes that, based on the data so far, estrogen does not provide the reduction in heart disease that was anticipated and hoped for. Indeed, estrogen therapy is apparently increasing some health risks, especially the risk for stroke. The study did not increase the chance of heart disease or breast cancer, though a separate study revealed a trend toward increased risk of cognitive impairment and dementia. The actual data will be released in April.
This was the second bombshell from the WHI in its long-awaited review of hormone therapy, once believed to be a cure-all for aging women. The first exploded in July 2002, when the NIH stopped the combined estrogen plus progestin trial--the treatment most commonly used by menopausal women who have not had a hysterectomy. The end came after a mountain of data revealed that women on HRT had more invasive breast cancers, heart disease, strokes, and blood clots. That study's positive findings--a reduction in hip fractures and colorectal cancer--did not outweigh the added harm. A New England Journal of Medicine report last week contained a mixed message about HRT and colorectal cancer risk, while another report--showing twice the risk of dementia in the HRT group--cast an even darker shadow over the whole idea of hormone therapy for women. Before the WHI, observational studies of women choosing to take estrogen (usually alone, later combined with progestin) appeared to show that hormones were a fountain of youth. Indeed, hormone pills were credited with reducing heart disease, bone fractures, atherosclerosis, and overall mortality, including deaths from seemingly unrelated causes like accidents and homicide. Hormones were also said to improve mood, skin, hair, sex drive, concentration, and memory. These studies often conflicted on the possibility that estrogen increased the risk of cancer and stroke.
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