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Arch Neurol. 2006 Jul;63(7):945-50.

Effects of ultra-low-dose transdermal estradiol on cognition and health-related quality of life.

Author information

  • 1Department of Psychiatry, University of California, San Francisco, CA 94121, USA. kristine.yaffe@ucsf.edu

Abstract

BACKGROUND:

Several small trials and many observational studies suggest that estrogen treatment in postmenopausal women improves cognition, but 2 large randomized trials have shown harm. The effect of an ultra-low- dose of unopposed transdermal estradiol on cognition and health-related quality of life is unknown.

OBJECTIVE:

To investigate the effect of unopposed ultra-low-dose transdermal estradiol on cognitive function and quality of life in postmenopausal women.

DESIGN:

Randomized, placebo-controlled, double-blind trial with 2-year follow-up. The main outcome of the trial was change in bone density. Changes in cognitive function and quality of life were preplanned secondary outcomes of the trial.

SETTING:

Nine clinical centers in the United States.

PARTICIPANTS:

Postmenopausal women (N = 417), aged 60 to 80 years, with a normal bone density for age and an intact uterus.

INTERVENTION:

A weekly transdermal patch that delivers estradiol, 0.014 mg/d (n = 208), or placebo (n = 209).

MAIN OUTCOME MEASURES:

Seven standardized cognitive tests (a total of 10 scores) administered at baseline and years 1 and 2 to test global cognitive function, verbal and visuospatial memory, language, executive function, and semantic memory. The 36-Item Short-Form General Health Survey was administered to assess health-related quality of life in physical and mental domains. The sample size provided 80% power to detect a standardized effect of 0.29 SD, a small-to-moderate difference.

RESULTS:

Baseline characteristics were similar in the 2 treatment groups. At 2 years of follow-up, we found no statistically significant differences between treatment groups in change on any of the cognitive test scores or on the 36-Item Short-Form General Health Survey (P > .12 for all). There was no consistent evidence that the effect of treatment on change in cognitive or 36-Item Short-Form General Health Survey scores depended on the level of baseline endogenous estradiol.

CONCLUSION:

Postmenopausal treatment with ultra-low-dose unopposed transdermal estradiol for 2 years had no effect on change in cognitive function or in health-related quality of life over 2 years of treatment.

PMID:
16831962
[PubMed - indexed for MEDLINE]
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