ABSTRACT
Healthy sleep is vital to maintaining the body's homeostasis. With the development of modern society, sleep disorder has gradually become one of the most epidemic health problems worldwide. Shumian capsule (SMC), a kind of traditional Chinese medicine (TCM) commonly used for insomnia, exhibits antidepressant and sedative effects in clinical practice. However, the underlying mechanisms have not been fully clarified. With the aid of a network pharmacology approach and function enrichment analysis, we identified the involvement of melatonin receptors in the antidepressant and sedative effects of SMC. In sleep-deprived mice, SMC treatment significantly alleviated insomnia and relevant mental alterations by improving both sleep latency and sleep duration. However, ramelteon, a selective melatonin receptor agonist that has been approved for the treatment of insomnia, only improved sleep latency. Additionally, SMC exhibited comparable effects on mental alterations with ramelteon as determined by an open-field test (OFT) and forced swimming test (FST). Mechanistically, we revealed that the melatonin receptor MT1 and MT2 signaling pathways involved the therapeutic effects of SMC. In addition to the single effect of traditional melatonin receptor agonists on treating sleep onset insomnia, SMC had therapeutic potential for various sleep disorders, such as sleep onset insomnia and sleep maintenance insomnia. Convergingly, our findings provide theoretical support for the clinical application of SMC.
ABSTRACT
Purpose: Shumian capsule (SMC) is a patent Chinese herbal medicine that can soothe the liver and relieves depression, quiet the spirit. Here, we aimed to investigate the efficacy of SMC for treating insomnia using both scales and polysomnography (PSG). Patients and Methods: A randomized, double-blind, placebo-controlled trial was performed. Twenty-six insomnia patients randomly received SMC (n = 11) or placebo (n = 15) for four weeks. Pittsburgh Sleep Quality Inventory (PSQI), Insomnia Severity Index (ISI), 9-items Patient Health Questionnaire (PHQ-9), 7-items Generalized Anxiety Disorder (GAD-7), 17-item Hamilton Depression Rating Scale (HAMD-17), and Hamilton Anxiety Rating Scale (HAMA) were applied at the baseline and the 2nd, 4th week after treatment. Treatment Emergent Symptom Scale was used to assess adverse reactions. We used PSG to record and analyze sleep features at baseline and after four weeks. Results: PSQI, ISI, PHQ-9, HAMD-17, and HAMA scores decreased significantly after SMC treatment. Also, the total sleep time, rapid-eye-movement (REM) sleep latency, stage 2 sleep, deep sleep, REM sleep, and sleep efficiency improved significantly after SMC treatment. In the placebo group, the only significant change was the decrease of PHQ-9 at week-2. Furthermore, both SMC and placebo reported no adverse events. Conclusion: SMC could safely improve sleep quality with depression and anxiety remission in insomnia patients.
ABSTRACT
OBJECTIVE: To evaluate the clinical effectiveness of Shumian capsule in improving the symptoms of insomnia, anxiety, depression, and other symptoms of convalescent patients of COVID-19. METHODS: Totally 200 patients were collected and randomly divided into experiment group (n = 100) and control group (n = 100). The control group was treated with Shumian capsule simulator, and the experiment group was treated with Shumian capsule. The improvement of TCM symptom score, the total effective rate and symptom disappearance rate of TCM symptoms in the two groups before and after treatment were observed, and the clinical effect was evaluated. RESULTS: One week after treatment, the scores of anxiety symptoms in the experiment group were significantly different from those in the control group (P < 0.05), but there was no significant difference in the scores of insomnia and depression between the experiment group and the control group (P > 0.05). There was no significant difference in the total effective rate and disappearance rate of TCM symptoms of insomnia, anxiety and depression between the experiment group and the control group (P > 0.05). After 2 weeks of treatment, the scores of insomnia, anxiety, depression and the total effective rate of TCM symptoms in the experiment group were significantly different from those in the control group (P < 0.05). There was no significant difference in the disappearance rate of insomnia, anxiety and depression between the experiment group and the control group (P > 0.05). There were no significant differences in heart rate, respiration, systolic blood pressure and diastolic blood pressure between the experiment group and the control group (P > 0.05). CONCLUSION: Shumian capsule can significantly improve the symptoms of insomnia, anxiety and depression in COVID-19's convalescent patients with sleep and mood disorders.
Subject(s)
COVID-19/complications , Mood Disorders/drug therapy , Sleep Wake Disorders/drug therapy , Adult , Anxiety , Depression , Female , Humans , Male , Medicine, Chinese Traditional , Middle Aged , Sleep Initiation and Maintenance DisordersABSTRACT
【Objective】 To investigate the central sedative and hypnotic effects and mechanisms of Shumian Capsule. 【Methods】 The blank control group, the positive drug diazepam group, and the low-, medium-, and high-dose groups of Shumian Capsule were designed in the experiments. Male Kunming mice were administered orally by gavage. We conducted the experiment of mouse autonomous activity, and assessed supra- and sub-threshold dose sleep with pentobarbital sodium, respectively. The levels of γ-aminobutyric acid (GABA) and glutamic acid (Glu) in the brain tissue of the mice were measured by enzyme-linked immunosorbent assay (ELISA) or colorimetric method. Male SD rats were injected intraperitoneally with p-chlorophenyl alanine [PCPA, 350 mg/(kg·d)] to establish an insomnia rat model, after which rats were continuously administered intragastrically for 7 days. The general status and body weight of the rats were observed. Total distance and standing times of rats were measured by open field test. Western blotting and immunohistochemistry assays were used to evaluate the protein expression of 5-HT1A receptor (5-HT1AR) in the rat hippocampus. 【Results】 Compared with the blank control group, the three dose groups of Shumian Capsule [1.6, 3.2, 6.4 mg/(kg·d)] for 14 consecutive days had significantly reduced the number of spontaneous activities and standing times in the mice (P<0.01). The high dose significantly prolonged the sleep duration of the mice induced by the supra-threshold dose of pentobarbital sodium (P<0.01). Compared with the blank control group, each dose group of Shumian Capsule had an increased GABA level in the mouse brain tissue in a dose-dependent manner (P<0.05); the medium- and high-dose groups had significantly reduced Glu levels in the hippocampus (P<0.05), while the high-dose group had significantly reduced Glu level in the cortex (P<0.05). In insomnia model rats, their activity was sluggish; their circadian activity rhythm disappeared; the hair became hard, rough and dull, with severe hair loss; and their weight reduced. After 7 consecutive days of the drug administration, the rats’ mental state in each Shumian Capsule dose group was improved. Compared with the blank control group, the rats’ body weight gains were significantly reduced after intraperitoneal injection of PCPA (P<0.01). Compared with the model group, each rat group of Shumian capsule treatment had significantly increased body weight gains (P<0.01). Compared with the blank control group, the distance of the rats in the model group increased in the open field test, and the expression level of 5-HT1AR protein in the hippocampus decreased. However, the distance of rats in diazepam group and each dose group of Shumian Capsule was significantly reduced (P<0.01), and the expression level of 5-HT1AR protein in the hippocampus of the high- and medium-dose groups of Shumian Capsule and diazepam group increased significantly (P<0.01). 【Conclusion】 Shumian Capsule has obvious effects of sedation, hypnosis and insomnia improvement, and its underlying mechanisms may be related to the increased GABA and decreased Glu contents in brain tissues, as well as up-regulated 5-HT1AR protein expression in the hippocampus.
ABSTRACT
OBJECTIVE:To observe the efficacy and safety of sertraline combined with Shumian capsule for depression of dyssomnia.METHODS:86 patients with depression were randomly assigned to receive sertraline alone(single group) or in combination with Shumian capsule(combined group) for 8 weeks.Clinical effectiveness was evaluated using HAMD and PSQI,and TESS was used to assess the adverse effects.RESULTS:After treatment for 8 weeks,the total effective rate was 88.2% for combined group and 85.7% for single group(P
