BETHESDA, Md--Data on a single slide presented in November, 1994, led quickly to a key change in the hormone arm of the Women's Health Initiative (WHI), sponsored by the National Institutes of Health.
As a result, any women in the program who still had her uterus faced no grave worries when she heard about findings from the Postmenopausal Estrogen/Progestin Interventions (PEPI) study. WHI investigators had already stopped giving unchallenged estrogen to women with intact uteruses.
PEPI researchers found that a daily 0.625 mg dose of conjugated equine estrogens(Drug information on estrogens) significantly increased a woman's chances of developing endometrial hyperplasia. However, no risk was found among women in the study who took the estrogen in combination with either medroxyprogesterone(Drug information on medroxyprogesterone) acetate or micronized progesterone(Drug information on progesterone) (JAMA Feb. 7, 1996).
Findings Spotted at 1994 Meeting
Although many physicians did not learn of the PEPI hyperplasia findings until their formal publication, WHI researchers spotted indications of potential problems for their study in a slide displayed during a report at the American Heart Association's 1994 scientific meeting that described preliminary results from PEPI.
WHI's hormone study seeks to learn the overall risks and benefits of such treatments on women's health, particularly the effectiveness of estrogen in preventing coronary heart disease and osteopor-osis and its possible role in breast cancer.
Originally, the hormone trial, which begin enrolling postmenopausal participants in September, 1993, randomly assigned women to one of three groups: estrogen alone, an estrogen-progestin combination, or placebo. WHI officials modified that protocol as a result of the early findings from PEPI.
At the 1994 Heart meeting, one slide shown at the PEPI presentation gave rates of adenomatous and atypical hyperplasia. "Those were significantly high for us to sit up and take notice," Dr. Jacques Rossouw, WHI's Lead Project Officer, said in an interview with Oncology News International.