The Hormone Therapy Controversy: What Makes Reliable Evidence

For nearly two decades, the main evidence for hormone therapy was based on evidence from observational studies such as the Nurses’ Health Study. In 1985, researchers from the Nurses’ Health Study confirmed that postmenopausal women who took estrogen had lower levels of heart disease than women who had never taken the hormone. These influential results helped fuel the rise in hormone prescriptions in the 1980s and 1990s. But in 2002, in a surprising change, researchers in a randomized clinical trial called the Women’s Health Initiative reported that hormone therapy actually increased the risk of heart disease and stroke in postmenopausal women. Almost overnight, the recipes for hormonal treatments collapsed. Yet millions of women who abruptly stopped or refused treatment remained confused and fearful. At the center of the controversy over hormone therapy was the fact that two different research approaches, observational studies and randomized experiments, yielded diametrically opposite results, again raising the question of reliable evidence. Case number 2005.0

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