Lopresti Adrian L, Smith Stephen J, Metse Alexandra P, Drummond Peter D
College of Science, Health, Engineering, and Education, Murdoch University, Perth, Western Australia, Australia.
Clinical Research Australia, Perth, Western Australia, Australia.
J Clin Sleep Med. 2020 Jun 15;16(6):937-947. doi: 10.5664/jcsm.8376.
Herbal medicines are frequently used by adults with sleep difficulties. However, evidence of their efficacy is limited. Therefore, the goal of this study was to examine the sleep-enhancing effects of a standardized saffron extract (affron).
This was a 28-day, parallel-group, double-blind, randomized controlled trial. Sixty-three healthy adults aged 18-70 with self-reported sleep problems were recruited and randomized to receive either saffron extract (affron; 14 mg twice daily) or a placebo. Outcome measures included the Insomnia Severity Index (ISI; primary outcome measure) collected at baseline and days 7, 14, 21, and 28 and the Restorative Sleep Questionnaire (RSQ) and the Pittsburgh Sleep Diary (PSD) collected on days -1, 0, 3, 7, 14, 27, and 28.
Based on data collected from 55 participants, saffron was associated with greater improvements in ISI total score (P = .017), RSQ total score (P = .029), and PSD sleep quality ratings (P = .014) than the placebo. Saffron intake was well tolerated with no reported adverse effects.
Saffron intake was associated with improvements in sleep quality in adults with self-reported sleep complaints. Further studies using larger samples sizes, treatment periods, objective outcome measures, and volunteers with varying demographic and psychographic characteristics are required to replicate and extend these findings.
Registry: Australian New Zealand Clinical Trials Registry; Name: Effects of Saffron on Sleep Quality in Healthy Adults with Self-Reported Unsatisfactory Sleep; URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377781; Identifier: ACTRN12619000863134.
有睡眠困难的成年人经常使用草药。然而，其疗效证据有限。因此，本研究的目的是检验标准化藏红花提取物（藏红花）对睡眠的改善作用。
这是一项为期28天的平行组、双盲、随机对照试验。招募了63名年龄在18 - 70岁、自我报告有睡眠问题的健康成年人，随机分为两组，分别接受藏红花提取物（藏红花；每日两次，每次14毫克）或安慰剂。观察指标包括在基线、第7天、第14天、第21天和第28天收集的失眠严重程度指数（ISI；主要观察指标），以及在第 - 1天、第0天、第3天、第7天、第14天、第27天和第28天收集的恢复性睡眠问卷（RSQ）和匹兹堡睡眠日记（PSD）。
根据从55名参与者收集的数据，与安慰剂相比，藏红花在ISI总分（P = 0.017）、RSQ总分（P = 0.029）和PSD睡眠质量评分（P = 0.014）方面有更大改善。服用藏红花耐受性良好，未报告有不良反应。
服用藏红花与自我报告有睡眠问题的成年人睡眠质量改善有关。需要进一步开展样本量更大、治疗周期更长、采用客观观察指标以及纳入不同人口统计学和心理特征志愿者的研究来重复和扩展这些发现。
注册机构：澳大利亚新西兰临床试验注册中心；名称：藏红花对自我报告睡眠不满意的健康成年人睡眠质量的影响；网址：https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377781；标识符：ACTRN12619000863134 。
