Effects of estrogen therapy on postmenopausal sleep quality regardless of vasomotor symptoms: a randomized trial

Abstract

Objective To determine the effects of estrogen therapy on objective sleep quality in insomniac postmenopausal women without severe vasomotor symptoms and/or recognized hot flushes during sleep.

Study design Randomized, double-blinded, placebo-controlled trial, parallel design (ClinicalTrials.gov Identifier: NCT01501422).

Methods Forty insomniac postmenopausal women with no severe vasomotor symptoms and/or recognized hot flushes during sleep were randomized into 2 months’ treatment with a 50-μg transdermal estradiol patch or placebo. Sleep quality was determined objectively with wrist actigraphy. Sleep efficiency, total sleep time, wake up after sleep onset and number of awakenings were compared before and after treatment. The Insomnia Severity Index (ISI) and Epworth Sleepiness Scale (ESS) questionnaires were used for subjective sleep quality assessment before and after treatment.

Results The study showed no significant difference in sleep efficiency improvement between women having estrogen alone or placebo (median 85.7% vs. 85.2%, respectively, p = 0.71). Similarly, sleep quality scores assessed by ISI and ESS were not significantly different.

Conclusion Estrogen therapy in insomniac postmenopausal women without severe vasomotor symptoms and/or recognized hot flushes during sleep was not found to improve sleep efficiency during the study period.

Key words::

• POSTMENOPAUSE
• INSOMNIA
• SLEEP DISTURBANCE
• ACTIGRAPHY
• ACTIWATCH
• ESTROGEN

ACKNOWLEDGEMENTS

We would like to give our sincere thanks to the Menopause Research Unit, Division of Reproductive Medicine, Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University for the support of the present study. We really appreciate the kind assistance of Jirayos Chintanadilok, MD and Asst. Tayard Desudchit in procuring the actigraphy devices and Ms Somtawin Pojjanasopanakun, BSc as a research assistant.

Conflict of interest The authors report no conflict of interest. The authors alone are responsible for the content and writing of this paper.

Source of funding Ratchadapiseksompotch Endowment Fund, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; Menopause research unit, Division of Reproductive Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.