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

Abstract

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.