Correspondence
More on the Women's Health Initiative
N Engl J Med 1994; 330:1619-1620June 2, 1994
- Article
To the Editor:
Although I support the Women's Health Initiative, I also believe that the risks of participation in the study should be communicated clearly to members of the public and their health care providers. This study will examine the effects of diet and hormone replacement on the risks of coronary heart disease, osteoporosis, and breast cancer. Drs. Eaker and Hahn (Jan. 6 issue)1 nicely summarize the death rates associated with heart disease and the incidence of hip fracture in women who take estrogen as compared with those who do not take estrogen. They conclude that “the existing epidemiologic data indicate that participation in the [Women's Health Initiative] trial will result in a small net favorable effect attributable to estrogen replacement.” However, they trivialize the increased incidence of breast and endometrial cancer associated with estrogen therapy2,3.
That there is a 30 percent increase in the incidence of breast cancer after 15 years of estrogen use needs to be communicated to our patients. Although these cancers may not result in the death of the affected women, they are surely more than just a nuisance. If a breast cancer 1 cm or more in diameter develops in a woman, she will require a mastectomy or lumpectomy with radiation and will need adjuvant therapy. Surely this is more than an inconvenience and will dramatically change the woman's life and that of her family.
If endometrial cancer develops while a woman is receiving estrogen-replacement therapy, she will require a total abdominal hysterectomy and bilateral salpingo-oophorectomy. The emotional and physical impact of this surgical procedure must not be underestimated.
The Women's Health Initiative is an important study. It will answer questions about the relation of hormone replacement and diet to heart disease, cancer, and osteoporosis in women. However, before they enroll in this landmark study, our patients deserve a chance to give truly informed consent, which should include the provision of information on the incidence of cancer associated with estrogen replacement, not just the death rates.
3 ReferencesCarolyn D. Runowicz, M.D.
Albert Einstein College of Medicine, Bronx, NY 104611
Eaker E ,Hahn RA . Women's Health Initiative. N Engl J Med 1994;330:70-71
Full Text | Web of Science | Medline2
Brinton LA, Hoover RN, Endometrial Cancer Collaborative Group
Web of Science | Medline3
Steinberg KK ,Thacker SB ,Smith SJ , et al. A meta-analysis of the effect of estrogen replacement therapy on the risk of breast cancer. JAMA 1991;265:1985-1990
CrossRef | Web of Science | Medline
Author/Editor Response
The authors reply:
To the Editor: In our letter, we do not trivialize the importance of breast or endometrial cancer that may occur after years of exposure to estrogen-replacement therapy. Breast cancer powerfully affects the lives of many women and their families. Endometrial cancer may also result in major surgery and physical and emotional sequelae. Instead, we emphasize the importance of informing patients and their physicians of the relative overall benefit of enrollment in the estrogen-replacement group of the Women's Health Initiative clinical trial, as compared with participation in the placebo group.
Among the 7500 women in the estrogen-replacement group, we estimate annual increases of 2.1 deaths from breast cancer and 1.2 deaths from endometrial cancer and annual decreases of 25.6 deaths from heart disease and 14.7 cases of hip fracture; among the 10,500 women in the placebo group, we estimate an annual decrease of 3 deaths each from breast and endometrial cancer and annual increases of 26 deaths from coronary heart disease and 11 additional hip fractures. The overall benefit of participation in the Women's Health Initiative study results from the substantial protective effect of estrogen against heart disease and hip fracture, both of which are common among women in the age group to be studied.
Since our letter appeared, a decision analysis has been published indicating that after 25 years of estrogen use the number of deaths from coronary heart disease would decrease by 567 and the number of hip fractures would decrease by 75 in a hypothetical cohort of 10,000 women.1 There would be 39 more deaths from breast cancer and 29 more deaths from endometrial cancer. Thus, 25 years of estrogen-replacement therapy in 10,000 women would be expected to prevent 574 deaths. In addition, the women using estrogen for 25 years would gain 3951 quality-adjusted years of life (in which the value of life with the disease in question is assumed to be 80 percent that of life without the disease), as compared with women not using estrogen.
Analyses of this type can be useful for physicians and their patients, to help guide clinical decisions about the use of postmenopausal hormones.
1 ReferencesElaine D. Eaker, Sc.D.
Marshfield Medical Research Foundation, Marshfield, WI 54449-4148Robert A. Hahn, Ph.D., M.P.H.
Centers for Disease Control and Prevention, Atlanta, GA 303331
Gorsky RD ,Koplan JP ,Peterson HB ,Thacker SB . Relative risks and benefits of long-term estrogen replacement therapy: a decision analysis. Obstet Gynecol 1994;83:161-166
Web of Science | Medline
