Defining the Future
The story behind the landmark women's health study that is creating exciting breakthroughs
"You have to go to several meetings" before you're even assigned to a group, says Lorraine Sandoval-Vigil, 69, a college counselor and retired high school principal in Watsonville, Calif., who joined to help her partner, who was battling breast cancer, switch to a low-fat diet. "They kept asking, are you sure you want to do this, because it's such a long period of time." After blood tests, a medical history, and a physical exam, qualified women chose the hormone therapy, low-fat diet, or both--and a computer randomly assigned them to the experimental or placebo group. At the one-year mark, women were invited to join the calcium and vitamin D study.
Women who weren't able to participate in the clinical trials joined about 93,000 others in the observational study, which monitored women as they went about their daily lives. It didn't involve swallowing pills or a low-fat diet, but it was a commitment nonetheless. After an initial physical checkup, the women were followed for about eight years. They filled out an annual 10-page survey detailing their health, diet, and lifestyle. Tracking down 93,000 women as they traveled, retired, moved, and remarried was a challenge, but by the end of the study, 94 percent of the original participants were still faithfully turning in their surveys. Because it wasn't a clinical trial, researchers were able to cast a wide net, scanning the histories for clues that led to coronary heart disease, stroke, a range of cancers, osteoporosis-related fractures, and diabetes (box, Page 68).
The hormone trial was perhaps the most anticipated project, as it dwarfed all other hormone studies ever undertaken. More than 16,000 women who still had their uteruses were assigned to either an estrogen and progestin pill or to a placebo. An additional 11,000 women who did not have a uterus took estrogen alone or a placebo. The trial was randomized and double blind, meaning neither the participants nor the clinic staff knew which women were on the hormone or the placebo.
Some 49,000 women were enrolled in the low-fat trial, a diet many experts thought could help prevent breast and colorectal cancer. Half of the women were told to cut their fat intake to 20 percent of total calories and to eat at least five daily servings of fruit and vegetables and six of grains. The remainder had no dietary restrictions whatsoever. The dieters met in groups with WHI nutritionists, who taught them how to count fat grams.
Before enrolling in the trial, Maisie Partridge of Roswell, Ga., thinks she was eating about 70 grams of fat a day. That became intolerable after her nutritionist showed her the amount of fat in the typical hamburger and fries. "They used that horrible white fat, Crisco, to illustrate, and by the time they were finished, they had a plate full of fat," says Partridge. The retired marketing specialist cut her diet to 32 grams of fat a day and lost 30 pounds in six months. Since then, she hasn't looked back, preferring simple poached salmon or chicken with fresh vegetables from her garden to her previous fare.
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