薰衣草精油对绝经后失眠妇女的影响:双盲随机试验。
Lavender essential oil on postmenopausal women with insomnia: Double-blind randomized trial.
机构信息
Department of Psychobiology, Universidade Federal de Sao Paulo, Brazil.
Department of Physiological Sciences, Faculdade de Ciências Médicas da Santa Casa de Sao Paulo, Brazil.
出版信息
Complement Ther Med. 2021 Jun;59:102726. doi: 10.1016/j.ctim.2021.102726. Epub 2021 Apr 24.
BACKGROUND
To evaluate the effect of Lavandula angustifolia essential oil inhalation on sleep and menopausal symptoms in postmenopausal women with insomnia.
PARTICIPANTS
35 postmenopausal women with a clinical diagnosis of insomnia were included, 17 in Aroma Group (AG) and 18 in Placebo Group (PG).
METHODS
In this double-blind, randomized controlled trial, PG participants inhaled sunflower oil and AG participants inhaledLavandula angustifolia essential oil, for 29 days. Both groups received sleep hygiene guidelines before the intervention and weekly follow-up during it. Evaluations were performed before and after intervention. All statistical analyses and intention-to-treat test were performed in SPSS 22. Sleep quality (Primary outcome) was measured by Pittsburgh Sleep Quality Index. Secondary outcomes were polysomnography data, severity of insomnia, anxiety and depression symptoms, and postmenopausal symptoms.
RESULTS
There were no significant differences between groups after intervention in the primary outcome (P = 0.22; effect size=0.69); however, a tendency of improvement in wake after sleep onset (WASO) was observed (P = 0.07; effect size=0.81; B = 42.2). Both groups presented better sleep quality over time (AG P < 0.001; PG P = 0.011). AG participants showed a significant decrease in sleep onset latency (P = 0.001), depression levels (P = 0.025), hot flashes (P < 0.001), postmenopausal symptoms (P < 0.001) and, in polysomnography data, increased sleep efficiency (P = 0.002) compared to baseline.
CONCLUSION
Although no significant differences were observed between groups, our data presented a tendency of improvement in WASO. Moreover, AG participants had enhanced overall sleep pattern, quality and sleep efficiency. Weekly follow-up and sleep hygiene instructions were essential for both groups to show improvement in almost all outcomes.
CLINICAL TRIAL REGISTRATION
Brazilian Registry of Clinical Trials, www.ensaiosclinicos.gov.br, RBR-5q5t5z.
背景
评估薰衣草精油吸入对绝经后失眠妇女睡眠和更年期症状的影响。
参与者
35 名临床诊断为失眠的绝经后妇女,其中 17 名在芳香组(AG),18 名在安慰剂组(PG)。
方法
在这项双盲、随机对照试验中,PG 组参与者吸入葵花籽油,AG 组参与者吸入薰衣草精油,共 29 天。两组在干预前均接受睡眠卫生指导,并在干预期间每周随访。在干预前后进行评估。所有统计分析和意向治疗检验均在 SPSS 22 中进行。匹兹堡睡眠质量指数(PSQI)用于测量睡眠质量(主要结局)。次要结局包括多导睡眠图数据、失眠严重程度、焦虑和抑郁症状以及更年期症状。
结果
干预后两组在主要结局上无显著差异(P=0.22;效应量=0.69);然而,观察到入睡后觉醒时间(WASO)有改善趋势(P=0.07;效应量=0.81;B=42.2)。两组的睡眠质量均随时间改善(AG P<0.001;PG P=0.011)。AG 组参与者的入睡潜伏期(P=0.001)、抑郁水平(P=0.025)、热潮(P<0.001)、更年期症状(P<0.001)和多导睡眠图数据中的睡眠效率(P=0.002)均显著降低。
结论
尽管两组间无显著差异,但我们的数据显示 WASO 有改善趋势。此外,AG 组参与者的整体睡眠模式、质量和睡眠效率得到改善。每周随访和睡眠卫生指导对两组几乎所有结局的改善都至关重要。
临床试验注册
巴西临床试验注册处,www.ensaiosclinicos.gov.br,RBR-5q5t5z。