Maternal, Fetal & Neonatal Research Centre, Tehran University of Medical Sciences, Tehran, Iran.
Department of Obstetrics and Gynecology, Yas Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Rev Bras Ginecol Obstet. 2021 Feb;43(2):126-130. doi: 10.1055/s-0040-1721857. Epub 2021 Jan 19.
The present study aimed to assess the effect of (a combination of lemon balm with fennel fruit extract) compared with citalopram and placebo on the quality of life of postmenopausal women with sleep disturbance.
The present study is a randomized, double-blind, placebo clinical trial among 60 postmenopausal women with sleep disturbance who were referred to a university hospital from 2017 to 2019. The participants were randomized to receive (500 mg daily), citalopram (30 mg) or placebo once daily for 8 weeks. The Menopause-Specific Quality of Life (MENQOL) questionnaire was self-completed by each participant at baseline and after 8 weeks of the intervention and was compared between groups.
The mean for all MENQOL domain scores were significantly improved in the group compared with citalopram and placebo ( < 0.001). The mean ± standard deviation (SD) after 8 weeks in the citalopram and placebo groups was 2.2 ± 0.84 versus 0.56 ± 0.58 versus 0.36 ± 0.55 in the vasomotor ( < 0.001), 1.02 ± 0.6 versus 0.28 ± 0.2 versus 0.17 ± 0.1 in the psychomotor-social ( < 0.001), 0.76 ± 0.4 versus 0.25 ± 0.1 versus 0.11 ± 0.1 in the physical and 2.3 ± 1.0 versus 0.35 ± 0.5 versus 0.41 ± 0.5 in the sexual domain, respectively.
The results revealed that may be recommended for improving the quality of life of menopausal women with sleep disturbance.
The present study was registered by the name "Comparison of the efficacy of citalopram and compound of and in treatment of menopausal disorders" with the code IRCT2013072714174N1 in the Iranian Registry of Clinical Trials (IRCT).
本研究旨在评估 (柠檬香蜂草与茴香果提取物的组合)与西酞普兰和安慰剂相比,对睡眠障碍的绝经后妇女生活质量的影响。
本研究是一项随机、双盲、安慰剂对照临床试验,纳入了 2017 年至 2019 年期间来自一所大学医院的 60 名睡眠障碍的绝经后妇女。参与者被随机分为三组,分别每日服用 (500mg)、西酞普兰(30mg)或安慰剂,干预 8 周。每位参与者在基线和干预 8 周后使用绝经特异性生活质量问卷(MENQOL)进行自我评分,并对组间进行比较。
与西酞普兰和安慰剂相比,组的所有 MENQOL 域评分均值均显著改善( < 0.001)。干预 8 周后,组、西酞普兰组和安慰剂组的平均( ± 标准差[SD])值分别为血管舒缩( < 0.001)2.2 ± 0.84 与 0.56 ± 0.58 与 0.36 ± 0.55、精神运动社会( < 0.001)1.02 ± 0.6 与 0.28 ± 0.2 与 0.17 ± 0.1、躯体( < 0.001)0.76 ± 0.4 与 0.25 ± 0.1 与 0.11 ± 0.1 和性( < 0.001)2.3 ± 1.0 与 0.35 ± 0.5 与 0.41 ± 0.5。
结果表明, 可能有助于改善睡眠障碍的绝经后妇女的生活质量。
本研究在伊朗临床试验注册中心(IRCT)以“西酞普兰与复方柠檬香蜂草和茴香果提取物治疗更年期障碍的疗效比较”的名称进行注册,注册号为 IRCT2013072714174N1。