The impact of clinical trials on the use of hormone replacement therapy. A population-based study.

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 > or =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< or =.0001. When stratified by age, a statistically significant decline in HRT post-WHI occurred in all age groups, with the biggest decline among women > or =55 to 64 (18% to 11%, P< or =.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< or =.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.