Journal of General Internal Medicine

, Volume 20, Issue 11, pp 1026–1031

The impact of clinical trials on the use of hormone replacement therapy

A population-based study

Authors

    • Section of General Internal MedicineYale University School of Medicine
    • The Robert Wood Johnson Clinical Scholars ProgramYale University School of Medicine
  • Cary Gross
    • Section of General Internal MedicineYale University School of Medicine
    • The Robert Wood Johnson Clinical Scholars ProgramYale University School of Medicine
    • The Yale-New Haven Hospital Center for Outcomes Research and Evaluation
  • Jeptha Curtis
    • Section of Cardiovascular MedicineYale University School of Medicine
  • Glen Stettin
    • Medco Health Solutions Inc.
  • Stephen Wogen
    • Medco Health Solutions Inc.
  • Nami Choe
    • Medco Health Solutions Inc.
  • Harlan M. Krumholz
    • The Robert Wood Johnson Clinical Scholars ProgramYale University School of Medicine
    • The Yale-New Haven Hospital Center for Outcomes Research and Evaluation
    • Section of Cardiovascular MedicineYale University School of Medicine
    • Department of Medicine and the Section of Health Policy and AdministrationYale University School of Medicine
    • Department of Epidemiology and Public HealthYale University School of Medicine
Original Articles

DOI: 10.1111/j.1525-1497.2005.0221.x

Cite this article as:
Kim, N., Gross, C., Curtis, J. et al. J GEN INTERN MED (2005) 20: 1026. doi:10.1111/j.1525-1497.2005.0221.x

Abstract

BACKGROUND: The last 5 years of trial data demonstrate the ineffectiveness of hormone replacement therapy (HRT). The impact of these trials on age-specific HRT use, HRT discontinuation, and regional HRT variation has not been evaluated extensively.

OBJECTIVE: To characterize the relation between HRT trial dissemination and age-specific HRT use, HRT discontinuation, and regional HRT variation before and after the trials’ publication.

DESIGN: Using the Medco Health database, we analyzed HRT prescription filling, discontinuation, and regional variation among women ≥55 years from May 1998 to May 2003.

MEASUREMENTS AND MAIN RESULTS: Approximately 340,000 women were eligible for Medco benefits each month. Within 3 months of the Women’s Health Initiative (WHI), HRT prescriptions declined from 12.5% to 9.4%, P≤.0001. When stratified by age, a statistically significant decline in HRT post-WHI occurred in all age groups, with the biggest decline among women ≥55 to 64 (18% to 11%, P≤.0001). Among HRT users, we found statistically significant increases in discontinuation in 2002 (67%) compared with 2001 (53%, P<.0001). Prior to the WHI there was substantial regional variation in HRT use, with the West South Central and mid-Atlantic having the highest and lowest proportions, respectively (19% vs 6%, P≤.0001). Despite a relative decline in HRT use of 25% to 42% across all regions, substantial geographic variation remained.

CONCLUSIONS: Hormone replacement therapy use decreased significantly immediately post-WHI, suggesting that trial results can have a rapid effect on practice. Marked regional variation in HRT use persisted after the WHI, suggesting that local practice patterns exert a strong effect on clinical behavior even after new evidence is available.

Key Words

hormone replacement therapyestrogenclinical trialsWomen’s Health Initiative
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Copyright information

© Society of General Internal Medicine 2005