The Case for Hormone Therapy




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The Case for Hormone Therapy

By Tara Parker-Pope, The Wall Street Journal
October 21, 2003

Menopause hormones have been battered by recent studies highlighting their potential dangers. Here's why women might still want to take them.

[Personal Health] Last summer, millions of middle-aged and older women woke up to some shocking news: The daily menopause hormones they had come to depend on to even their mood and body temperature, to help them sleep, improve their sex lives, protect their bones and possibly prevent heart disease and Alzheimer's, seemed to have turned against them.

Doctors conducting a major study of the popular estrogen-progestin combination known as Prempro had suddenly halted the research, citing higher rates of breast cancer and heart problems among Prempro users. In the months that followed, millions of women threw away their hormone pills as an unrelenting barrage of "new" studies warned about the dangers of hormone therapy in general.

But lost amid the headlines and the hysteria was something crucial: the facts.

The fact that nearly all of the revelations came from the same single study of 16,600 women known as the Women's Health Initiative. The fact that significant questions remain about the type of hormones used, the age of the women who participated and the statistical strength of the data mined from the research.

And the fact that many doctors subsequently concluded that the study told them very little, if anything, about the typical woman who enters their office seeking relief from the symptoms of menopause. As a result, these doctors -- and many of the WHI researchers themselves -- believe that despite the fears the study raises about breast cancer, heart attacks, strokes and dementia, it's still reasonable and even wise for women to consider taking the drugs anyway.

"What can we really draw from this study?" asks Alan M. Altman, an assistant professor of obstetrics at Harvard Medical School who, like many doctors on both sides of the debate, has accepted speaking fees from drug firms. "One of the things we can't say is that it means hormones aren't good for you. That's unfortunately the connotation that's been attached to it."

While the extent to which women should consider hormone therapy remains controversial, even those who led the WHI study now concede many people have overreacted to the results.

"There may be an element of going overboard," says Harvard professor JoAnn E. Manson, chief of preventive medicine at Brigham and Women's Hospital in Boston and lead author on the WHI's heart report. "I think it's going too far for the study to be interpreted as saying hormone therapy has absolutely no role in clinical practice any longer."

Where It Began

To make sense of the WHI study today, you have to understand the thinking at the time work on the study began in 1991. As is the case now, everyone back then pretty much agreed that hormones helped ease the symptoms of menopause and probably increased the risk of breast cancer and blood clots. But at the time, many doctors also believed the drugs protected a woman from all sorts of health problems, particularly heart disease.

The thinking was that all the supposed added protection against chronic disease far outweighed the risks. As a result, estrogen and progestin combinations were commonly prescribed to women who didn't have any symptoms, including those who were years past menopause. And many women were advised to stay on hormones for years or even their lifetime.

The main evidence in support of hormone therapy came from an ongoing study of more than 48,000 nurses, which in 1991 showed almost a 50% reduction in heart-attack rates among women who used hormones. The study wasn't conclusive, but the idea that hormones would protect women's hearts made sense, because it was known that heart disease sets in a full decade later in women than in men, presumably because a woman's natural estrogen lends some extra fortification against heart disease.

And so the Women's Health Initiative set out to see whether hormones really did protect women from developing heart problems and other chronic disease. Armed with $628 million from the National Institutes of Health, researchers at 40 sites around the country in 1993 began recruiting women for the WHI, which was expected to end in 2005.

Two Hurdles

The study, though, contained two huge hurdles that, in retrospect, severely limited its usefulness. The biggest challenge: studying health problems that typically afflict older women. If the study had too many young women, it would take years for them to get old enough to generate enough "events" like heart attacks and fractures to provide a statistically meaningful analysis.

Another problem was finding enough women willing to risk receiving a placebo. Women with severe menopause symptoms -- such as hot flashes and night sweats -- were specifically discouraged from enrolling in the study because they probably would know almost immediately whether they were getting a sugar pill instead of the real thing.