Abstract
Polygonatum sibiricum (PS) rhizome, which contains glyceryl-1-monolinoleate as its primary active component, has been shown to improve insomnia in animal models. Based on these findings, we aimed to investigate the safety and efficacy of PS rhizome extract in improving sleep quality in individuals with mild insomnia. Eighty individuals with mild insomnia were enrolled in a four-week, randomized, double-blind, placebo-controlled trial of PS rhizome extract (500 mg/day, n = 40, PS group) or placebo (n = 40, placebo group). The primary outcome measure was change in total score on the Athens Insomnia Scale (AIS) to indicate sleep quality. The secondary outcome measures included change in actigraphy data and perfusion levels in the brain regions within the default mode network (DMN), which is known to play a key role in insomnia. The PS group showed greater improvement in the total AIS score with a significant increase in total sleep time, relative to the placebo group. In addition, significant group-by-visit interactions were observed in the perfusion level of the medial prefrontal cortex within the DMN. Findings of the current study provide first evidence that PS rhizome extract could be an effective natural ingredient for improving sleep in mild insomnia using a human model.
Highlights
Insomnia is highly prevalent in the general population and is associated with several functional impairments such as increased work absenteeism, higher rates of occupational or transportation-related accidents, and lower quality of life [1,2,3]
There was no significant difference in the adherence to the clinical trial product as measured by the number of unused tablets returned by the participants, and the compliance rate was 91.5% for the Polygonatum sibiricum (PS)
Results of this study suggest that a four-week administration of PS rhizome could improve sleep disturbances in the form of sleep quality and sleep duration for mild insomnia
Summary
Insomnia is highly prevalent in the general population and is associated with several functional impairments such as increased work absenteeism, higher rates of occupational or transportation-related accidents, and lower quality of life [1,2,3]. Debilitating health conditions including cognitive impairment, emotional disturbance, and increased risks of cardiovascular disease or psychiatric disorders have been reported to be associated with persistent insomnia [4,5,6]. Individuals with insomnia are reported to prefer self-help strategies over professional consultations [11]. These self-help strategies often entail natural remedies including herbs, vitamins, and dietary supplements [12]
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