Copyright 2005 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.2005
Col and colleagues1 provide an excellent example of the use of a clinical decision model to target short-term hormone therapy (HT) for the treatment of menopausal symptoms in light of recent data from the Women’s Health Initiative trial. However, while the decision model focuses on rare but serious adverse effects of short-term HT, it fails to account for less serious but more common adverse effects requiring medical attention. For example, Anderson and colleagues2 report that, among women not scheduled for routine endometrial biopsy as part of the Women’s Health Initiative study protocol, 33% of those assigned to HT had an endometrial biopsy, compared with 6% among those assigned to placebo (P<.001). Of women receiving at least 1 endometrial biopsy, 38% (13% overall) had more than 1 biopsy in the HT group, compared with 16% (1% overall) in the placebo group. Similarly large differences in rates of transvaginal uterine ultrasound examinations were reported: 12.8% (HT group) vs 4.1% (placebo group) for at least 1 procedure, and 3.5% (HT group) vs 0.7% (placebo group) for more than 1 procedure.2(p1746) This translates into a risk ratio of 5.8 for 1 or more endometrial biopsies and 3.1 for 1 or more transvaginal uterine ultrasound examinations. Focusing on the breast effects observed in the Women’s Health Initiative, Chlebowski and colleagues3(p3248) conclude that “even short-term estrogen plus progestin use resulted in a substantial increase in abnormal mammograms requiring medical evaluation” (emphasis added).
Ohsfeldt RL. Common Adverse Effects of Short-term Hormone Therapy. Arch Intern Med. 2005;165(5):587-588. doi:10.1001/archinte.165.5.587-c