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Changes in the Use of Postmenopausal Hormone Therapy after the Publication of Clinical Trial Results

Jennifer S. Haas, MD, MSPH; Celia P. Kaplan, DrPh, MA; Eric P. Gerstenberger, MS; and Karla Kerlikowske, MD
[+] Article and Author Information

From Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts; University of California, San Francisco, San Francisco, California; and the San Francisco Veterans Affairs Medical Center, San Francisco, California.


Acknowledgments: The authors thank John Orav, PhD, for statistical advice.

Grant Support: By a National Cancer Institute–funded Breast Cancer Surveillance Consortium cooperative agreement (U01CA63740).

Potential Financial Conflicts of Interest: None disclosed.

Requests for Single Reprints: Jennifer Haas, MD, MSPH, Division of General Medicine and Primary Care, Brigham and Women's Hospital, 1620 Tremont Street, Boston, MA 02120-1613; e-mail, jhaas@partners.org.

Current Author Addresses: Dr. Haas: Division of General Medicine and Primary Care, Brigham and Women's Hospital, 1620 Tremont Street, Boston, MA 02120-1613.

Dr. Kaplan: University of California, San Francisco, 3333 California Street, Box 0856, San Francisco, CA 94143.

Mr. Gerstenberger: Division of General Medicine and Primary Care, Brigham and Women's Hospital, 1620 Tremont Street, Boston, MA 02120-1613.

Dr. Kerlikowske: San Francisco Veterans Affairs Medical Center, 4150 Clement Street, VAMC (111A1), San Francisco, CA 94121.

Author Contributions: Conception and design: J.S. Haas.

Analysis and interpretation of the data: J.S. Haas, C.P. Kaplan, E.P. Gerstenberger, K. Kerlikowske.

Drafting of the article: J.S. Haas.

Critical revision of the article for important intellectual content: J.S. Haas, C.P. Kaplan, E.P. Gerstenberger, K. Kerlikowske.

Final approval of the article: J.S. Haas, C.P. Kaplan, E.P. Gerstenberger, K. Kerlikowske.

Provision of study materials or patients: K. Kerlikowske.

Statistical expertise: E.P. Gerstenberger.

Obtaining of funding: K. Kerlikowske.

Administrative, technical, or logistic support: J.S. Haas, K. Kerlikowske.

Collection and assembly of data: K. Kerlikowske.


Ann Intern Med. 2004;140(3):184-188. doi:10.7326/0003-4819-140-3-200402030-00009
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Background: The recent publication of clinical trial results has led to a dramatic shift in the evidence about postmenopausal hormone therapy.

Objective: To examine whether the publication of clinical trial results, specifically the Heart and Estrogen/progestin Replacement Study (HERS) in 1998 and the Women's Health Initiative (WHI) in 2002, has influenced the use of hormone therapy among postmenopausal women.

Design: Observational cohort (1997 to 2003).

Setting: San Francisco Mammography Registry, San Francisco, California.

Participants: Postmenopausal women between the ages of 50 and 74 years without a personal history of breast cancer who underwent mammography (151862 mammograms).

Measurements: Self-reported current use of hormone therapy.

Results: Among menopausal women who had mammography, it was estimated that 41% were currently using hormone therapy in 1997. Before the publication of HERS, the use of hormone therapy was increasing at a rate of 1% (95% CI, 0% to 2%) per quarter. After the publication of HERS, use decreased by 1% (CI, −3% to 0%) per quarter. In contrast, the publication of the WHI in 2002 was associated with a more substantial decline in the use of hormone therapy of 18% (CI, −21% to −16%) per quarter. Similar associations were observed for most subgroups of women, including women older than 65 years of age; women with a previous hysterectomy; and women who described their race or ethnicity as white, African American, Latina, Chinese, or Filipina.

Conclusions: The release of the HERS data was temporally associated with a modest decline in the use of hormone therapy. In contrast, the release of the principal findings from the WHI was associated with a more substantial decline in use by postmenopausal women. The reason for the differences in decline may relate to the fact that the WHI results were widely publicized or were more applicable to most postmenopausal women because the WHI study was performed in healthy women.

Figures

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Figure.
Rates of hormone therapy use among postmenopausal women, 1997 to 2003

The first vertical line represents the publication date of the Heart and Estrogen/progestin Replacement Study (HERS ) in August 1998. The second vertical line represents the publication date of the Women's Health Initiative (WHI) in July 2002. Circles represent unadjusted rates of current hormone therapy use for each month between January 1997 and May 2003. Lines represent the adjusted change in hormone therapy use for 3 time periods: before the publication of HERS, after the publication of HERS, and before and after the publication of the WHI. Change in hormone therapy use is adjusted for age, race or ethnicity, history of childbirth, family history of breast cancer, history of breast biopsy, previous hysterectomy, and median income for the ZIP code of residence.

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Summary for Patients

Changes in the Use of Postmenopausal Hormone Replacement Therapy after the Publication of Study Results

The summary below is from the full report titled “Changes in the Use of Postmenopausal Hormone Therapy after the Publication of Clinical Trial Results.” It is in the 3 February 2004 issue of Annals of Internal Medicine (volume 140, pages 184–188). The authors are J.S. Haas, C.P. Kaplan, E.P. Gerstenberger, and K. Kerlikowske.

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