INSERM, Lyon, France.
BMC Complement Altern Med. 2010 Jun 22;10:29. doi: 10.1186/1472-6882-10-29.
To evaluate the effect of a dietary supplement containing polyunsaturated fatty acids, in association with Humulus lupulus extract, on the quality of sleep using the Leeds sleep evaluation questionnaire (LSEQ) in subjects with moderate to severe sleep disorders.
Randomized placebo-controlled trial, in a Population-based setting. Participants were adult patients 25 to 65 years old with a chronic primary insomnia who volunteered for the study. The tested intervention consisted of two soft gelatine capsules per day, containing either the dietary supplement (active group) or olive oil (placebo group) for a month. Subjects could also volunteer for two ancillary studies on melatonin and actigraphy. Evaluation criteria included i) perception of the quality of sleep at the end of treatment using the LSEQ questionnaire, ii) sleep efficiency measured by one-week actigraphic movement measurement performed before and during the treatment in a subsample of subjects, iii) night melatonin and 6 sulfatoxymelatonin (aMT6S) urine rates in a subsample of subjects.
The average of Leeds score was similar in both groups (p = 0.95). A marked improvement in the quality of sleep was observed in both placebo (62%) and active (65%) group (p = 0.52). The evolution of urinary melatonin, aMT6S, and of the Mel/aMT6S ratio showed no differences between the two groups. Sleep efficiency, as measured by actigraphy, improved similarly in both groups during the treatment period, from 72% to 76% and 75% in the active and placebo group respectively (p = 0.91).
The dietary supplement had neither effect on the perceived quality of sleep, nor on the melatonin metabolism and sleep-wake cycle.
clinical trials.gov:NCT00484497.
为了评估一种含有多不饱和脂肪酸的膳食补充剂与葎草提取物联合使用对睡眠质量的影响，使用利兹睡眠评估问卷（LSEQ）对患有中重度睡眠障碍的受试者进行评估。
这是一项随机安慰剂对照试验，在基于人群的环境中进行。参与者为 25 至 65 岁的慢性原发性失眠成年患者，自愿参加研究。试验干预包括每天服用两粒软胶囊，其中含有膳食补充剂（实验组）或橄榄油（安慰剂组），持续一个月。受试者还可以自愿参加关于褪黑素和活动记录仪的两项辅助研究。评估标准包括：i）使用 LSEQ 问卷评估治疗结束时的睡眠质量，ii）在实验组和对照组的一部分受试者中进行为期一周的活动记录仪运动测量以评估睡眠效率，iii）测量一部分受试者的夜间褪黑素和 6-硫酸褪黑素（aMT6S）尿液水平。
两组的利兹评分平均值相似（p=0.95）。安慰剂组（62%）和实验组（65%）的睡眠质量均有明显改善（p=0.52）。两组之间的尿液褪黑素、aMT6S 和 Mel/aMT6S 比值的变化没有差异。活动记录仪测量的睡眠效率在治疗期间两组均有类似的改善，实验组和对照组分别从 72%增加到 76%和 75%（p=0.91）。
该膳食补充剂对睡眠质量、褪黑素代谢和睡眠-觉醒周期均无影响。
clinicaltrials.gov:NCT00484497。
