Insomnia is a common post-stroke complication, which may greatly influence patients' recovery progress, and even induce the recurrence of cerebrovascular diseases. It has been reported that the traditional Wuyintiaoshen therapy has good efficacy in post-stroke insomnia, and can decrease the harm of adverse reactions often produced by western medicine treatment via reducing the intake of such medicines.

To explore the clinical effect and possible mechanism of action of Wuyintiaoshen therapy on post-stroke insomnia.

Post-stroke insomnia inpatients (n=90) were selected from Rehabilitation Department, the Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine from January 2019 to June 2020, and equally randomized into an experimental group and a control group. Besides usual rehabilitation training and basic medical treatment, experimental group received Wuyintiaoshen therapy〔listening to the music symbolizing the five elements (metal, wood, water, fire, and earth) in Chinese philosophy〕 plus acupuncture treatment with Baihui, Shenting, and Yintang acupoints, and the control group received oral alprazolam before sleeping. The treatment for all patients was 4 weeks. Clinical efficacy was evaluated by comparing pre- and post-treatment changes in sleep quality assessed using Pittsburgh Sleep Quality Index (PSQI) , quality of life assessed using Stroke-specific Quality of Life Scale (SS-QOL) , and sensorimotor impairment using Fugl-Meyer Assessment Scale (FMA) , as well as levels of serum 5-HT, melatonin and norepinephrine. Adverse reactions were observed during treatment.

There was no significant difference in overall clinical efficacy between the two groups (P>0.05) . The incidence of adverse reactions was higher in the control group (P<0.05) . The PSQI, SS-QOL and FMA scores as well as serum levels of 5-HT, melatonin and norepinephrine were similar in both groups before and after treatment (P>0.05) . After treatment, the PSQI score and norepinephrine level decreased, and SS-QOL and FMA scores as well as serum levels of 5-HT and melatonin increased in both groups (P<0.05) , but were still similar in both groups (P>0.05) . Correlation analysis results showed that PSQI score was negatively correlated with SS-QOL or FMA score (r=-0.340, P=0.010; r=-0.350, P=0.008) .

Wuyintiaoshen therapy may produce good effects on post-stroke insomnia as an adjuvant therapy, which were similar to those of oral alprazolam, the mechanism may be related to the regulation of serum 5-HT, melatonin and norepinephrine, and sleep quality improvement had a direct linear relationship with motor function and life quality improvement.