Asadi Mojgan, Molavi Fatemeh, Qorbani Mostafa, Davari Tanha Fatemeh
Osteoporosis Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.
Department of Internal Medicine, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.
J Family Reprod Health. 2020 Sep;14(3):186-191. doi: 10.18502/jfrh.v14i3.4672.
To evaluate the efficacy of Zolpidem and Nigella sativa compared to placebo in treatment of sleep disturbance in healthy postmenopausal women. Menopause is a period that diagnosed after 12 months of amenorrhea and is characterized by a group of symptoms that include irregular menses; vasomotor and urogenital symptoms. The effects of non-hormonal therapies are being widely researched on menopause symptoms. There has been no study to compare Zolpidem and Nigella sativa versus placebo. In this double-blind, placebo controlled trial, we compared the effect of Zolpidem with Nigella sativa and placebo in reducing sleep quality in 60 menopausal women. The prior and the later results were compared. We divided the patients into three groups after history taking and physical examination and filling the Pittsburgh questionnaire. Each group received their medication as the following order: Group A: Zolpidem, Group B: Nigella sativa, Group C: placebo. The first group received Zolpidem with the dose of 5 mg for 8 weeks. The second group received Nigella sativa with the dose of 600 mg for 8 weeks. The third group received placebo for 8 weeks. After two months, the Pittsburg questionnaire was filled again. In the nigella sativa group, we had not significant improvement in sleep quality (p =0.07), hot flashes (p =0.15), palpitation (p =0.56) and night sweets (p =0.08). In zolpidem group, we have seen lack of improvement of hot flashes (p =0.73), and palpitation (p =0.36), which are nonsignificant statistically according to p values, but in zolpidem group, we had significant improvement in sleep quality (p =0.01), and night sweats (p =0.049). It seems that zolpidem has some effect on improving the quality of sleep in postmenopausal women. zolpidem also is good for night sweats. Nigella sativa was not effective in vasomotor symptoms and sleep quality.
评估唑吡坦和黑种草籽与安慰剂相比，在治疗健康绝经后女性睡眠障碍方面的疗效。绝经是指闭经12个月后诊断出的时期，其特征是出现一组症状，包括月经不规律、血管舒缩症状和泌尿生殖系统症状。非激素疗法对绝经症状的影响正在广泛研究中。尚无研究比较唑吡坦和黑种草籽与安慰剂的效果。在这项双盲、安慰剂对照试验中，我们比较了唑吡坦、黑种草籽和安慰剂对60名绝经女性睡眠质量的影响。比较了治疗前后的结果。在进行病史采集、体格检查并填写匹兹堡问卷后，我们将患者分为三组。每组按以下顺序接受药物治疗：A组：唑吡坦，B组：黑种草籽，C组：安慰剂。第一组接受5毫克剂量的唑吡坦，持续8周。第二组接受600毫克剂量的黑种草籽，持续8周。第三组接受8周的安慰剂。两个月后，再次填写匹兹堡问卷。在黑种草籽组中，睡眠质量（p = 0.07）、潮热（p = 0.15）、心悸（p = 0.56）和盗汗（p = 0.08）均无显著改善。在唑吡坦组中，潮热（p = 0.73）和心悸（p = 0.36）无改善，根据p值，在统计学上无显著意义，但在唑吡坦组中，睡眠质量（p = 0.01）和盗汗（p = 0.049）有显著改善。似乎唑吡坦对改善绝经后女性的睡眠质量有一定作用。唑吡坦对盗汗也有效果。黑种草籽对血管舒缩症状和睡眠质量无效。
