The Women's Health Initiative: A Tale of Two Trials

In 1987, the "grandmother" of hormonal trials tested 875 healthy postmenopausal women from ages 45 to 64. The Postmenopausal Estrogen/ Progestin Interventions (PEPI) trial begun by the National Institutes of Health concluded the best treatment regimen to prevent heart disease would combine estrogen/progesterone therapy for postmenopausal women with a uterus and estrogen alone for women who have had hysterectomies. In 1991, a more ambitious test was launched with 16,808 women, also postmenopausal. The clinical trials were designed to test the effects of postmenopausal hormone therapy, diet modification, and calcium and vitamin D supplements on heart disease, fractures, and breast and colorectal cancer. The negative conclusion sent many women tossing pills and fanning hot flashes. According to Scott Wepfer, RPh, "They spent all that time and money studying the wrong hormones." In his opinion, the researchers "studied the losing arm of the PEPI trial. "It was unscientific and unfair to women across the country." Dr. Randy Yarbrough agrees. "A lot of things about that study were flawed." He concludes people were starting on hormones long after menopausal damage to blood vessels. In regard to breast cancer, he questioned how the study could see a difference in five years when it takes 10 years to form a mass significant enough to show on a mammogram. Besides, "the people on estrogen had less breast cancer than those on nothing. To blame heart trouble or a stroke on hormones really isn't fair." Another concern of the study was the 40 percent dropout rate due to side effects, according to Wepfer. May 2007