Shexian Bupleurum Alleviates Insomnia and Improves Symptoms of Anxiety and Depression:A Randomized Double-Blind Placebo-Controlled Clinical Trial

摘要

Objective:To observe the clinical efficacy of Shexian bupleurum on insomnia based on evaluation scales and polysomnogram(PSG).Methods:A total of 260 patients suffering from insomnia admitted to the outpatient department of Handan Central Hospital were included in a randomized,double blind,placebo-controlled trial.The patients were randomly divided into two groups:a control group(receiving placebo,n=150),and an intervention group(receiving Shexian bupleurum treatment,n=110).The clinical trial lasted for 4 weeks.The Pittsburgh Sleep Quality Index(PSQI),Insomnia Severity Index(ISI),Patient Health Questionnaire(PHQ)-9,Generalized Anxiety Disorder(GAD)-7,17 items of Hamilton Depression Scale(HAMD-17),and Hamilton Anxiety Scale(HAMA)were used to evaluate the patients at baseline as well as two weeks and four weeks after treatment;the Treatment Emergent Symptom Scale(TESS)was used to evaluate adverse reactions;polysomnography(PSG)was used to monitor and analyze their sleep characteristics at baseline and four weeks after treatment.Results:The PSQI,ISI,PHQ-9,HAMD-17,and HAMA scores of the intervention group significantly decreased compared to the control group,while the total sleep time,rapid eye movement sleep latency,stage 2 sleep,deep sleep,rapid eye movement sleep,and sleep efficiency of the intervention group significantly increased compared to the control group.The PHQ-9 score of the control group only decreased two weeks after treatment(p<0.05)compared to the intervention group.In addition,there were no obvious adverse events in both the intervention group and the control group.Conclusion:Shexian bupleurum not only improves sleep quality,but also relieves depression and anxiety in patients who suffer from insomnia.