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. 2005 Nov;20(11):1026-31.
doi: 10.1111/j.1525-1497.2005.0221.x.

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

Nancy Kim  1 , Cary Gross, Jeptha Curtis, Glen Stettin, Stephen Wogen, Nami Choe, Harlan M Krumholz
Affiliations

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

Nancy Kim et al. J Gen Intern Med. 2005 Nov.

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.

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Figures

FIGURE 1
FIGURE 1
Hormone Replacement Therapy (HRT) Utilization 1998 to 2003. Heart and Estrogen/progestin Replacement Study (HERS), randomized trial of estrogen plus progestin for secondary prevention of coronary heart disease in postmenopausal women; Women's Estrogen for Stroke Trial (WEST), a clinical trial of estrogen replacement therapy after ischemic stroke; Women's Health Initiative (WHI), risks and benefits of estrogen plus progestin in health postmenopausal women principal results from the Women's Health Initiative randomized controlled trial.
FIGURE 2
FIGURE 2
Plot of the observed and predicted percent of hormone replacement therapy (HRT) prescription claims for combined HRT before and immediately after the Women's Health Initiative.
FIGURE 3
FIGURE 3
Plot of observed and predicted percent of HRT prescription claims for unopposed estrogen before and immediately after the Women's Health Initiative.
FIGURE 4
FIGURE 4
Hormone Replacement Therapy (HRT) Utilization, According to Geographic Region. Heart and Estrogen/progestin Replacement Study (HERS), randomized trial of estrogen plus progestin for secondary prevention of coronary heart disease in postmenopausal women; Women's Estrogen for Stroke Trial (WEST), a clinical trial of estrogen replacement therapy after ischemic stroke; Women's Health Initiative (WHI), risks and benefits of estrogen plus progestin in health postmenopausal women principal results from the Women's Health Initiative randomized controlled trial; ENC, East North Central; ESC, East South Central; Mid At, Mid-Atlantic; Mount, Mountain; New Eng, New England; Pacific, Pacific; South At, South Atlantic; WNC, West North Central; WSC, West South Central.
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