Estrogen Therapy: WHI Initiative in Perspective (cont.)
Why should we hold out for large randomized controlled trials? A randomized trial assigns each woman to either EPT or placebo (sugar pill) without her knowing and without the researchers knowing, which therapy she is taking. Unfortunately, we learned from the past that women who take estrogen tend to be healthier in general than women who do not choose to take estrogen. Frequently the reason women who chose to be on estrogen had fewer heart attacks, or less dementia was because they were healthier for other reasons. Women who take estrogen often have healthier diets, more money, more education, lower body weight, and exercise more - things that on their own predict fewer heart attacks or dementia. Therefore, we need to have research in which the women who were taking the EPT were as similar as possible in these health characteristics to the women in the study taking the placebo. Studies in which women can choose to take or not take estrogen are not going to give us the answers we need. Before the WHI, many people thought estrogen would be protective against heart disease, dementia, and stroke, on the basis of studies that were not randomized. Fortunately, the WHI came along to give definite answers. The answers surprised many people.
The First surprise was that the WHI study was stopped early, after just 5.2 years, because there were early signs of increased harm (increase in coronary heart disease, stroke, and blood clots in the lungs) that outweighed the benefits (decreased fractures and colon cancer).
The WHI estimates that out of 10,000 women who take the particular EPT combination over the course of a year, we can expect additional cases of several serious health problems: