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December 6, 1995

The Postmenopausal Estrogen/Progestin Interventions Trial

Author Affiliations

Englewood, Colo

JAMA. 1995;274(21):1675. doi:10.1001/jama.1995.03530210029021

To the Editor.  —With all due respect to the numerous institutions and conscientious physicians who participated in the Postmenopausal Estrogen/Progestin Interventions (PEPI) trial research project,1 there is a serious shortcoming that must be addressed. Those of us who practiced medicine in the 1970s and 1980s became unhappily aware of the incidence of premalignant and malignant endometrial lesions induced by unopposed estrogen. This was amply confirmed by the literature, and the entire enterprise of estrogen replacement fell into disrepute until concomitant progestin therapy was added.2-5In the face of this knowledge, the addition of an unopposed estrogen arm to the PEPI project needlessly exposed patients to a foreseeable harm that, in fact, the published outcome demonstrated to have occurred. Despite the precaution of periodic endometrial biopsies, major surgical interventions became necessary.Minimal risks may be accepted by an informed subject, but only if there is no other way to

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