Tansupswatdikul P, Chaikittisilpa S, Jaimchariyatam N, Panyakhamlerd K, Jaisamrarn U, Taechakraichana N
Menopause Research Unit, Division of Reproductive Medicine, Department of Obstetrics-Gynecology, Faculty of Medicine, Chulalongkorn University , Bangkok.
Climacteric. 2015 Apr;18(2):198-204. doi: 10.3109/13697137.2014.964670. Epub 2014 Nov 27.
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).
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.
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.
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.
确定雌激素疗法对无严重血管舒缩症状和/或睡眠期间未出现明显潮热的失眠绝经后女性客观睡眠质量的影响。研究设计：随机、双盲、安慰剂对照试验，平行设计（ClinicalTrials.gov标识符：NCT01501422）。
40名无严重血管舒缩症状和/或睡眠期间未出现明显潮热的失眠绝经后女性被随机分为两组，分别接受为期2个月的50μg经皮雌二醇贴片治疗或安慰剂治疗。通过手腕活动记录仪客观测定睡眠质量。比较治疗前后的睡眠效率、总睡眠时间、睡眠开始后的觉醒次数和觉醒总次数。使用失眠严重程度指数（ISI）和爱泼华嗜睡量表（ESS）问卷对治疗前后的主观睡眠质量进行评估。
研究表明，单独使用雌激素或安慰剂的女性在睡眠效率改善方面无显著差异（中位数分别为85.7%和85.2%，p = 0.71）。同样，ISI和ESS评估的睡眠质量得分也无显著差异。
在本研究期间，未发现雌激素疗法对无严重血管舒缩症状和/或睡眠期间未出现明显潮热的失眠绝经后女性的睡眠效率有改善作用。
