Clinique Lyon Lumière, Meyzieu, Lyon, France.
Medical Department, Sanofi Consumer Health Care, Paris, France.
Complement Ther Med. 2019 Aug;45:104-108. doi: 10.1016/j.ctim.2019.05.024. Epub 2019 May 25.
Currently available pharmaceutical therapies for sleep disorders have significant side effects and dependence potential, thus necessitating the need for alternative treatment approaches. This study investigated the effect of a combination of melatonin, vitamin B6 and medicinal plants in patients with mild-to-moderate sleep disorders.
This was a 4-week, single-center, single-arm, open-label study conducted in 40 participants with mild-to-moderate insomnia, in Poland.
Participants received Novanuit Triple Action (melatonin, vitamin B6, California poppy extract, passionflower extract, and lemon balm extract) capsules per day for two weeks.
Using a daily electronic sleep diary, information was collected on sleep quality (assessed on a 0-10 scale), total sleep duration, sleep onset latency, sleep-related daytime impairment, and safety of the study medication.
There was a statistically significant (p < 0.001) improvement in sleep quality by the end of the 2-week treatment period, with mean sleep quality score increasing by 1.9 points from pre-treatment (5.4 points) to post-treatment (7.3 points). Similarly, statistically significant improvements were observed following treatment completion in sleep onset latency, total sleep duration, and sleep-related daytime parameters (p < 0.01 for all outcomes). Administration of the combination of melatonin, vitamin B6, and medicinal plants was associated with high compliance (39/40; 97.5%). No serious adverse events were reported.
This pilot study suggests that the combination of melatonin, vitamin B6, and medicinal plants may be beneficial in mild-to-moderate insomnia.
目前用于睡眠障碍的药物疗法有显著的副作用和潜在的依赖性，因此需要替代治疗方法。本研究旨在探讨褪黑素、维生素 B6 和药用植物联合应用于轻中度睡眠障碍患者的效果。
这是一项为期 4 周、单中心、单臂、开放性研究，在波兰的 40 名轻度至中度失眠患者中进行。
参与者每天服用 Novanuit Triple Action（褪黑素、维生素 B6、加利福尼亚罂粟提取物、西番莲提取物和柠檬香脂提取物）胶囊，为期两周。
使用每日电子睡眠日记，收集睡眠质量（0-10 分评定）、总睡眠时间、入睡潜伏期、与睡眠相关的日间损害以及研究药物的安全性信息。
在 2 周治疗期末，睡眠质量有统计学显著改善（p<0.001），睡眠质量评分从治疗前（5.4 分）增加到治疗后（7.3 分），平均增加 1.9 分。同样，在完成治疗后，入睡潜伏期、总睡眠时间和与睡眠相关的日间参数也观察到统计学显著改善（所有结局均为 p<0.01）。褪黑素、维生素 B6 和药用植物联合使用的依从性很高（39/40；97.5%）。未报告严重不良事件。
这项初步研究表明，褪黑素、维生素 B6 和药用植物的联合应用可能对轻度至中度失眠有益。
