Shugan Jieyu capsule(舒肝解郁胶囊) improve sleep and emotional disorder in coronavirus disease 2019 convalescence patients: a randomized, double-blind, placebo-controlled trial  

作　　者：AN Xuedong ZHANG Qing TAO Junxiu LI Li CHEN Yun LI Kejian HE Jing LIU Ru GUO Juan ZHANG Jia ZHU Hui LIAN Fengmei LI Xiaodong 

机构地区：[1]Endocrinology,Guang'anmen Hospital of China Academy of Chinese Medical Sciences,Beijing 100053,China [2]Orthopedics,Hubei Provincial Hospital of Traditional Chinese Medicine,Affiliated Hospital of Hubei University of Chinese Medicine,Hubei Institute of Traditional Chinese Medicine,Wuhan 430000,China [3]Liver Disease branch,Hubei Provincial Hospital of Traditional Chinese Medicine,Affiliated Hospital of Hubei University of Chinese Medicine,Hubei Institute of Traditional Chinese Medicine,Wuhan 430000,China [4]Psychology Department,Hubei Provincial Hospital of TCM,Affiliated Hospital of Hubei University of Chinese Medicine,Hubei Institute of Traditional Chinese Medicine,Wuhan 430000,China [5]Clinical College of Traditional Chinese Medicine,Hubei University of Traditional Chinese Medicine,Wuhan 430061,China

出　　处：《Journal of Traditional Chinese Medicine》2022年第5期803-809,共7页中医杂志（英文版）

基　　金：Supported by Mechanism and Countermeasure of COVID-19 asymptomatic infection and re-detectable positive in SARS-Co V-2 nucleic acid test (No. 2020YFC0861100)。

摘　　要：OBJECTIVE: To evaluate the efficacy of the Shugan Jieyu capsule(舒肝解郁胶囊) on improving sleep and emotional disorder during Coronavirus disease 2019(COVID-19) convalescence. METHODS: We conducted a randomized, double-blind, placebo-controlled trial, and recruit 200 COVID-19 convalescence patients and then divide the subjects into two groups respectively: the experimental group(n = 100) and the control group(n = 100). Patients in the control group were given doses as a placebo, while those in the experimental group were given Shugan Jieyu capsule.The investigators mainly observed the differences between the two groups before and after treatment in terms of the rate of reduction and the rate of efficiency in Hamilton Depression Scale(HAMD-17) total scores from baseline, and recorded the scores of Hamilton Anxiety Scale(HAMA), Patient Health Questionnaire-15(PHQ-15), Insomnia Severity Index(ISI) and Treatment Emergent Symptom Scale at 2 week, the 4 week and the 6 week respectively after treatment, and compared the differences between the groups. And the occurrence of adverse events was recorded. RESULTS: After 6-week treatment, there were statistically significant differences in the rate of reduction as well as efficiency in HAMD-17 scores, HAMA Total Scores, PHQ-15 Score, ISI Score from baseline in the experimental group and control group(P < 0.05). There were 4 adverse events in the experimental group and 1 in the control group. CONCLUSION: Shugan Jieyu capsule could significantly improve sleep and emotional disorder in patients during COVID-19 convalescence.

关 键 词：COVID-19 CONVALESCENCE sleep quality emotional disorder Shugan Jieyu capsule 

分 类 号：R259[医药卫生—中西医结合]