Viên nang shumian (舒 眠 胶囊) cải thiện các triệu chứng của rối loạn tâm trạng giấc ngủ ở bệnh nhân điều trị của bệnh do vi rút corona 2019

Online Submissions: http://www.journaltcm.com info@journaltcm.com J Tradit Chin Med 2021 December 15; 41(6): 974-981 ISSN 0255-2922 © 2021 JTCM All rights reserved RESEARCH ARTICLE TOPIC Shumian capsule (舒眠胶囊) improves symptoms of sleep mood disorder in convalescent patients of Corona Virus Disease 2019 LI Li, AN Xuedong, ZHANG Qing, TAO Junxiu, HE Jing, CHEN Yun, LI Kejian, LIU Ru, GUO Juan, ZHANG Hao, TONG Xiaolin, BA Yuanming aa LI Li, ZHANG Qing, TAO Junxiu, HE Jing, CHEN Yun, LI Kejian, LIU Ru, GUO Juan, ZHANG Hao, BA Yuanming, Department of Psychiatry, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan 430061, China; Department of Psychiatry, Hubei Province Academy of Traditional Chinese Medicine, Wuhan 430074, China; Department of Psychiatry, the Affiliated Hospital of Hubei University of Chinese Medicine, Wuhan 430065, China AN Xuedong, TONG Xiaolin, Department of Endocrinology, Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing 100053, China Supported by State Administration of Traditional Chinese Medicine COVID-19 Traditional Chinese Medicine Emergency Project (the fifth batch): Study on TCM Screening for Recovery from COVID-19 (No 2020ZYLCYJ08) Correspondence to: Prof TONG Xiaolin, Department of Endocrinology, Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing 100053, China tongxiaolin@vip.163.com; Prof BA Yuanming, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan 430074, China 1723426138@qq.com Telephone: +86-27-87748195; +86-13986179621 DOI: 10.19852/j.cnki.jtcm.2021.06.015 Accepted: March 15, 2021 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 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) Abstract OBJECTIVE: To evaluate the clinical effectiveness of Shumian capsule ( 舒 眠 胶 囊) in improving the symptoms of insomnia, anxiety, depression, and other symptoms of convalescent patients of COVID-19 CONCLUSION: Shumian capsule can significantly improve the symptoms of insomnia, anxiety and depression in COVID-19's convalescent patients with sleep and mood disorders METHODS: Totally 200 patients were collected and randomly divided into experiment group (n = 100) and control group (n = 100) The control group was JTCM | www journaltcm com © 2021 JTCM All rights reserved 974 December 15, 2021 | Volume 41 | Issue | LI L et al / Research Article Keywords: COVID-19; convalescence; sleep wake disorders; mood disorders; Shumian capsule rolled patients completed weeks of treatment and follow-up (Table 1) There were no significant differences between the two groups in terms of sex, age, body mass index, smoking, drinking, temperature, systolic blood pressure, diastolic blood pressure, respiration, pulse, waiting time for admission, length of stay, length of discharge, condition classification, CT (Pulmonary Computed Tomography), blood routine, comorbidity, and concomitant medication Obvious differences were observed between the two groups in terms of length of intervention and history of allergies (P = 0.023; P = 0.032) The average length of intervention was longer in group A than in group B, and more patients in group B had a history of allergies than those in group A (Table 2) INTRODUCTION Most patients with Corona Virus Disease 2019 (COVID-19), mainly in Hubei, have entered the convalescent period after treatment Although all the discharged patients have met the discharge criteria of improvement in lung inflammation and negative nucleic acid tests, a considerable number of patients still suffer from clinical discomfort and organ damage, such as cough, chest tightness, shortness of breath, increased heart rate, and fibrotic lesion changes in the lungs, as well as insomnia, anxiety, depression, and other symptoms of sleep disorders To utilize the advantage of Traditional Chinese Medicine (TCM) in "healing and prevention of recurrence," appropriate TCM treatment modalities can be selected and recommended to patients recovering from COVID-19 to help them recover as soon as possible and reduce the risk of recurrent COVID-19 infection In this study, combined with symptoms related to sleep mood disorders in patients with COVID-19 in the convalescence period, a randomized, double-blind, placebo-controlled, multicenter design was used to evaluate the therapeutic effects of using the TCM Shumian capsule (舒眠胶囊) as an intervention drug to improve insomnia, anxiety, depression, and other clinical symptoms of sleep disorders Diagnostic criteria The diagnostic criteria adopted were the criteria for release from isolation and discharge in the "COVID-19 Diagnostic and Treatment Protocol (Trial Version 6)": body temperature returns to normal for more than d; respiratory symptoms improve significantly; lung imaging shows significant absorption of inflammation; and two consecutive negative nucleic acid tests for respiratory pathogens (with a sampling interval of at least d), then the patient can be released from isolation or discharged and enter the convalescence period Inclusion criteria Patients who meet the diagnostic criteria for recovery from COVID-19; patients who have been cured and discharged from the hospital for > weeks; patients who are aged between 18 and 70 years; patients who have irritability, anxiety, poor sleep, and other sleep mood disorders as main clinical manifestations; patients who have two of these symptoms at the same time; patients who have a score of ≥ on the Visual Analogue Scale (VAS) for a single symptom; and patients who have signed the informed consent form MATERIALS AND METHODS Clinical characteristics Between April and May 2020, 200 patients with convalescent COVID-19 with symptoms of insomnia, anxiety, depression, and other sleep disorders were collected from three sites, and were divided into group A (experiment group, 100 cases) and group B (control group, 100 cases) using a random number table Two hundred patients were enrolled in the three sites, cases were eliminated, and 12 cases were dropped As a result, 197 patients were included in the FAS (Full Analysis Set, FAS), and 182 patients were included in the PPS (Per-Protocol Set, PPS) for statistical analysis All en- Exclusion criteria Patients who have difficulty taking oral medications due to underlying diseases; patients with serious underlying diseases that affect survival, including uncontrolled, clinically significant cardiac, pulmonary, renal, digestive, hematologic, neuropsychiatric, immunologic, metabolic diseases, malignant tumors, and severe malnutrition; patients with allergies to medications in- Table Enrollment status (n) Site Enrollment FAS PPS SS A B Total A B Total A B Total A B Total 50 50 100 48 50 98 48 46 94 48 50 98 20 20 40 20 20 40 19 14 33 20 20 40 30 30 60 30 29 59 29 26 55 30 29 59 Total 100 100 200 98 99 197 96 86 182 98 99 197 Notes: A: experimental group (Shumian capsule), B: control group (Shumian capsule Simulator) The course of intervention was weeks, capsule = 0.4 g, take capsules at a time, twice a day P value: comparison between group A and group B FAS: full analysis set; PPS: per-protocol set; SS: safety set JTCM | www journaltcm com 975 December 15, 2021 | Volume 41 | Issue | LI L et al / Research Article Table Demographic baseline data Indicator Group A Group B 82 (41.62) 115 (58.38) 48 (48.98) 56 (57.14) 34 (34.34) 65 (65.66) 55 (47-62) 55 (47-62) 55 (47-61) －0.223 0.824 (5.10) 10 (10.20) 18 (18.37) 32 (32.65) 33 (33.67) 23.7±2.8 (2.04) 54 (55.10) 36 (36.73) (6.12) 11 (11.22) 87 (88.78) (7.14) 91 (92.86) 36.4 (36.3, 36.5) 93 (94.90) (4.08) (1.02) (0) (2.02) 13 (13.13) 14 (14.14) 44 (44.44) 25 (25.25) 23.8± (2.02) 52 (52.52) 35 (35.35) 10 (10.10) (6.06) 93 (93.94) (8.08) 91 (91.92) 36.4 (36.3, 36.5) 90 (90.91) (9.09) (0) (0) －1.273 0.203 －0.327 －0.037 0.744 0.971 1.666 0.197 0.06 0.804 90-139 (140-159) (160-179) ≥180 (3.55) 24 (12.18) 32 (16.24) 76 (38.58) 58 (29.44) 23.8±2.9 (2.03) 106 (53.81) 71 (36.04) 16 (8.12) 17 (8.63) 180 (91.37) 15 (7.61) 182 (92.39) 36.4 (36.3, 36.5) 183 (92.90) 13 (6.60) (0.51) (0) －0.556 －1.394 0.578 0.163 ＜60 (0.00) (0.00) (0.00) －1.394 0.163 60-89 90-99 100-109 ≥110 181 (91.88) 12 (6.09) (2.03) (0.00) 19 (19-20) 78 (75-84) 91 (92.86) (5.10) (2.04) (0.00) 19 (19-20) 78 (75-83) 90 (90.91) (7.07) (2.02) (0.00) 19 (19-20) 78 (74-84) －0.143 －1.803 0.887 0.071 (4-17) (4-16) (4-18) －0.439 0.660 21 (15-30) 21 (15-30) 22 (15-29) －1.338 0.181 57 (53-62) 57 (53-62) 57 (53-62) －1.270 0.204 16.0±2.7 14.7±2.1 13.7±3.4 2.288 0.023 Sex [n (%)] Male Female Median (IQR) ≤30 31-40 41-50 51-60 ≥61 Age [n (%)] BMI (mean±SD) Low [n (%)] Normal [n (%)] Overweight [n (%)] Obesity [n (%)] Smoking [n (%)] Drinking [n (%)] Temperature [M（P25, P75)] Systolic blood pressure [n (%)] Stage hypertension [n (%)] Stage hypertension [n (%)] Stage hypertension [n (%)] Diastolic blood pressure [n (%)] Normal [n (%)] Stage hypertension [n (%)] Stage hypertension [n (%)] Stage hypertension [n (%)] Respiration [median (IQR)] Pulse [median (IQR)] Waiting time for admission [median (IQR)] Length of stay [median (IQR)] Length of discharge [median (IQR)] Length of intervention (mean ± SD) Condition classification [n (%)] Statistic (χ2/Z/t value) 0.05) between the two groups regarding insomnia, anxiety, and depression before treatment (Table 3) Treatment methods Subjects were randomized in a 1∶1 ratio into two groups, with 100 patients in each group The study drug was dispensed according to the drug number obtained from the central randomization system The drug number remained unchanged throughout the trial Experiment group (group A): The intervention drug for all subjects in the observation group was Shumian capsule The duration of intervention was weeks; approval number: NMPA20050543; drug specification: capsule = 0.4 g; and the route of administration: oral, capsules at a time, times a day Control group (group B): The intervention drug was a mock-up of Shumian capsule The duration of intervention was weeks; drug specification: capsule = 0.4 g; and the route of administration: oral, capsules at a time, times a day Statistical analysis SPSS 25.0 (IBM Corp Released 2017 IBM SPSS Statistics for Windows, Version 25.0 Armonk, NY, USA) statistical software was used to analyze all the data in this study Missing data were filled using last carryover Quantitative data were expressed as mean, standard deviation, median, upper quartile, and lower quartile A two-sample t-test was used for normally distributed quantitative data, and Mann-Whitney U test was used for non-normally distributed quantitative data The qualitative data described the number of cases and percentages for each category Other qualitative variables were subjected to the χ2 test, and Fisher's exact test was used when the conditions for χ2 test were not met The statistical tests were two-tailed, and P ≤ 0.05 was considered statistically significant The study was approved by the Ethics Committee of Hubei Provincial Hospital of TCM (No HBZY2020-C27-01) and registered with the Chinese Clinical Trial Registry under registration number ChiCTR2000032214 Observational indicators Clinical symptoms: VAS was used to observe the changes in clinical symptoms of the two groups at weeks 0, 1, and 2, and the worst symptom score and the mean score were recorded within 24 h Efficacy evaluation indicators and criteria The severity of clinical symptoms such as irritability, anxiety, and poor sleep caused by the decline in pulmonary and cardiac function was evaluated in two groups using VAS Scores "0" and "10" were set on both ends of the vernier caliper, with "0" representing no symptoms and "10" representing the most severe symptoms The patients were asked to move the vernier caliper to mark the severity of their own symptoms from to 10 points, with higher scores indicating more severe symptoms Criteria for determining the efficacy were as follows: (a) Symptoms disappeared: symptoms and signs disappeared, and the symptom score was 0; (b) markedly effective: symptoms and signs improved significantly, and the symptom score decreased by ≥ 70%; (c) effec- RESULTS Comparison of TCM symptom scores The scores for insomnia, anxiety, and depression were Table Scores for insomnia, anxiety, and depression of the subjects before treatment Indicator Insomnia Anxiety Depression Group A Group B t value P value 0.308 0.759 -1.835 0.068 -1.443 0.151 Mean 7 Min-Max 2-10 3-10 Median mean±SD 7.0±1.6 7.0±1.7 Mean Min-Max 0-9 0-10 Median mean±SD 4.0±2.5 5.0±2.2 Mean 3 Min-Max 0-8 0-9 Median mean±SD 3.0±2.4 3.0±2.6 Notes: A: experimental group (Shumian capsule), B: control group (Shumian capsule Simulator) The course of intervention was weeks, capsule = 0.4 g, take capsules at a time, twice a day P value: comparison between group A and group B Max: maximum; Min: minimum; SD: standard deviation JTCM | www journaltcm com 977 December 15, 2021 | Volume 41 | Issue | LI L et al / Research Article compared After week of treatment, no difference was observed between the two groups in insomnia and depression (P > 0.05), but there was a significant difference in anxiety (P = 0.05); after weeks of treatment, there was a significant difference between the two groups in these symptoms (P < 0.01) (Table 4) anxiety, and depression were compared After week of treatment, there was no significant difference between the two groups (P > 0.05); after weeks of treatment, there was a significant difference between the two groups (P < 0.05) (Table 7) Comparison of TCM symptom disappearance rates The disappearance rates of insomnia, anxiety, and depression were compared, which showed no significant difference (P > 0.05) across the two groups after and weeks of treatment (Table 8) Comparison of the efficacy of TCM symptoms Analysis of covariance revealed no significant difference between the two groups after week of treatment (P > 0.05) in insomnia, anxiety, and depression After weeks of treatment, there was a significant difference between the two groups in these symptoms (P < 0.05) (Table 5) DISCUSSION Studies have shown that patients with COVID-19 suffer from the disease and also experience psychological distress such as insomnia, anxiety, and depression due to the threat of the virus, life changes, and isolation restrictions The TCM theory indicates that the onset of COVID-19 is usually caused by "cold and dampness," which invades the body with hostility (COVID-19) and obstructs the body's Qi flow In the convalescent period, positive Qi is weak, remaining pathogenic factors are still present, liver Qi is not drained, and the mind is restless, resulting in symptoms of sleep mood disorders such as insomnia, anxiety, and depression Efficacy evaluation of TCM symptoms According to the rank-sum test, after week of treatment, the differences in insomnia, anxiety, and depression symptoms were not statistically significant (P > 0.05); after weeks of treatment, the differences in these symptoms between the two groups were statistically significant (P ≤ 0.001), and group A had better improvements in these symptoms than group B (Table 6) Comparison of the overall effective rate of TCM symptom improvement The overall effective rate of improvement in insomnia, Table TCM symptom scores (VAS) of the two groups Time Indicator Week Insomnia Anxiety Depression Week Insomnia Anxiety Depression Group A Group B Mean Min-Max 1-9 2-9 Median 6 mean±SD 5.0±1.8 6.0±1.9 Mean Min-Max 0-8 0-8 Median 4 mean±SD 3.0±2.2 4.0±2.1 Mean Min-Max 0-7 0-7 Median mean±SD 2.0±2.0 3.0±2.2 Mean Min-Max 0-9 1-10 Median mean±SD 4.0±2.1 5.0±2.4 Mean Min-Max 0-8 0-8 Median mean±SD 3.0±2.1 4.0±2.2 Mean Min-Max 0-7 0-8 Median 2 t value P value －0.936 0.351 －1.972 0.05 －1.842 0.067 －2.774 0.006 －2.795 0.006 －3.042 0.003 mean±SD 2.0±1.6 2.0±2.2 Notes: A: experimental group (Shumian capsule), B: control group (Shumian capsule Simulator) The course of intervention was weeks, capsule = 0.4 g, take capsules at a time, twice a day P value: comparison between group A and group B TCM: traditional Chinese Medicine; VAS: visual analog scale; Max: maximum; Min: minimum; SD: standard deviation JTCM | www journaltcm com 978 December 15, 2021 | Volume 41 | Issue | LI L et al / Research Article Table Results of analysis of covariance for the difference in TCM symptom scores (VAS) Indicator Time Group Number Difference (mean±SD) F value P value Insomnia Week A 90 1.8±1.4 3.136 0.078 B 92 1.4±1.0 Week A 90 3.1±2.0 11.918 0.001 B 92 2.1±1.9 A 82 1.1±0.9 0.521 0.472 B 79 1.0±1.0 A 82 2.0±1.6 4.431 0.037 B 79 1.6±1.6 A 66 0.8±1.1 2.885 0.092 B 65 0.7±0.9 A 66 1.7±1.6 11.303 0.001 B 65 1.1±1.4 Anxiety Week Week Depression Week Week Notes: A: experimental group (Shumian capsule), B: control group (Shumian capsule Simulator) The course of intervention was weeks, capsule = 0.4 g, take capsules at a time, twice a day P value: comparison between group A and group B TCM: Traditional Chinese Medicine; VAS: visual analog scale; SD: standard deviation Table Efficacy evaluation of TCM symptoms after treatment in groups A and B Time Week Indicator Insomnia [n (%)] Anxiety [n (%)] Depression [n (%)] Week Insomnia [n (%)] Anxiety [n (%)] Depression [n (%)] Group A Group B Z value P value Ineffective 63 (65.63) 61 (70.93) －0.355 0.723 －1.326 0.185 －1.025 0.305 －2.904 0.004 －2.755 0.006 －3.100 0.002 Effective 29 (30.21) 25 (29.07) Markedly effective (4.17) (0.00) Symptom disappeared (0.00) (0.00) Ineffective 59 (71.95) 65 (82.28) Effective 20 (24.39) 13 (16.46) Markedly effective (1.22) (1.27) Symptom disappeared (2.44) (0.00) Ineffective 47 (71.21) 52 (80.00) Effective 18 (27.27) 13 (20.00) Markedly effective (0.00) (0.00) Symptom disappeared (1.49) (0.00) Ineffective 29 (30.21) 41 (47.67) Effective 52 (54.17) 41 (47.67) Markedly effective 14 (14.58) (4.65) Symptom disappeared (1.04) (0.00) Ineffective 29 (35.37) 44 (55.70) Effective 38 (46.34) 29 (36.71) Markedly effective 11 (13.41) (2.53) Symptom disappeared (4.88) (5.06) Ineffective 23 (34.85) 39 (60.00) Effective 33 (30.00) 23 (35.39) Markedly effective (12.12) (4.62) Symptom disappeared (3.03) (0.00) Notes: A: experimental group (Shumian capsule), B: control group (Shumian capsule Simulator) The course of intervention was weeks, capsule = 0.4 g, take capsules at a time, twice a day P value: comparison between group A and group B TCM: Traditional Chinese Medicine Studies have shown that, compared with western medicine in the treatment of insomnia, TCM treatment of insomnia is economical, simple, effective, no side effects and no addiction, and has a broader development prospect.2 Shumian capsule, as a Traditional Chinese Medicine JTCM | www journaltcm com product that has been on the market for more than 10 years, has been widely used in patients with insomnia.3 The Shumian capsule is composed of the seed of Suanzaoren (Semen Zizyphi Spinosae), Chaihu (Radix Bupleuri), Baishao (Radix Albus Paeoniae Lactiflorae), Hehuanhua (Flos Albiziae), Hehuanpi (Cortex Albizziae Ju979 December 15, 2021 | Volume 41 | Issue | LI L et al / Research Article Table Comparison of the overall effective rate across the two groups Time Week Indicator Insomnia [n (%)] Anxiety [n (%)] Depression [n (%)] Week Insomnia [n (%)] Anxiety [n (%)] Depression [n (%)] Group A Group B Effective 33 (34.38) 25 (29.07) Ineffective 63 (65.63) 61 (70.93) Effective 23 (28.05) 14 (17.72) Ineffective 59 (71.95) 65 (82.28) Effective 19 (28.79) 13 (20.00) Ineffective 47 (71.21) 52 (80.00) Effective 67 (69.79) 45 (52.33) Ineffective 29 (30.21) 41 (47.67) Effective 53 (64.63) 35 (44.30) Ineffective 29 (35.37) 44 (55.70) Effective 43 (65.15) 26 (40.00) χ2 value P value 0.588 0.443 2.424 0.119 1.37 0.242 5.847 0.016 6.71 0.01 8.31 0.004 Ineffective 23 (34.85) 39 (60.00) Notes: A: experimental group (Shumian capsule), B: control group (Shumian capsule Simulator) The course of intervention was weeks, capsule = 0.4 g, take capsules at a time, twice a day P value: comparison between group A and group B Table Comparison of symptom disappearance rates across the two groups Time Week Indicator Insomnia [n (%)] Anxiety [n (%)] Depression [n (%)] Week Insomnia [n (%)] Anxiety [n (%)] Depression [n (%)] Group A Group B Symptom disappeared (0.00) (0.00) Symptom did not disappear 96 (100.00) 86 (100.00) Symptom disappeared (2.44) (0.00) Symptom did not disappear 80 (97.56) 79 (100) Symptom disappeared (1.49) (0.00) Symptom did not disappear 66 (98.51) 65 (100) Symptom disappeared (1.04) (0.00) Symptom did not disappear 95 (98.96) 86 (100) Symptom disappeared (4.88) (5.06) Symptom did not disappear 78 (95.12) 75 (94.94) Symptom disappeared (3.03) (0.00) Symptom did not disappear 64 (96.97) 65 (100.00) χ2 value P value - - 1.951 0.162 0.978 0.323 0.901 0.343 0.003 0.957 2.00 0.157 Notes: A: experimental group (Shumian capsule), B: control group (Shumian capsule Simulator) The course of intervention was weeks, capsule = 0.4 g, take capsules at a time, twice a day P value: comparison between group A and group B librissinis), Jiangcan (Stiff Silkworm), Chantui (Ps Cicadae), Dengxincao (Juncaceae Juss) Suanzaoren (Semen Zizyphi Spinosae) has the effect of tonifying the liver and tranquilizing the heart, astringing sweat, and promoting the secretion of saliva Chaihu (Radix Bupleuri) is responsible for the liver and gallbladder meridians, and has the effect of relieving fever, soothing the liver, and elevating Yang Qi Baishao (Radix Albus Paeoniae Lactiflorae) is combined with Hehuanhua (Flos Albiziae) and Hehuanpi (Cortex Albizziae Julibrissinis) to soothe the liver, relieve depression, and calm the mind The Jiangcan (Stiff Silkworm) and Chantui (Ps Cicadae) sooth the liver and relieve spasms; Dengxincao (Juncaceae Juss) draws all the herbs to the heart to soothe the liver, relieve depression, and calm the mind.3,4 Relevant studies have shown that Shumian capsule combined with psychological intervention can improve the sleep quality and anxiety and depression of patients.5 Liang et al found that the mechanism of the sedative and hypnotic effects of capsules may be related to an increase in brain tissue GABA (γ-aminobutyric JTCM | www journaltcm com acid) levels, a decrease in Glu (glutamic acid) content, and an up-regulation of hippocampal 5-HT1AR (5-hydroxytryptamine 1A receptor) protein expression Xia et al and Liang et al also showed that the treatment of insomnia with Shumian capsules has few adverse effects, is well tolerated, and has a high safety profile This study showed that the scores for TCM symptoms of insomnia, anxiety, and depression, as well as the overall effective rate of TCM symptoms in the test group treated with Shumian capsule were significantly different from those in the control group (P < 0.05), indicating that Shumian capsule had obvious improvement effect on sleep mood disorders in the COVID-19 convalescent period In summary, the impact of COVID-19 on patients' sleep quality and mood is common, and some patients still have symptoms of insomnia, anxiety, and depression in the convalescent period TCM diagnosis and treatment should continue to play an advantageous role in consolidating treatment and improving patients' quality of life 980 December 15, 2021 | Volume 41 | Issue | LI L et al / Research Article REFERENCES Office of the National Health Commission, & National Administration of Traditional Chinese Medicine Notice on the Issuance of the COVID-19 Diagnostic and Treatment Protocol (Trial Version 6), online 2020-02-18, cited 2020-12-12 Available from URL: http://yzs.satcm.gov.cn/ zhengcewenjian/2020-02-19/13221.html Song YY, Yin SM, Yu HM Research progress of Traditional Chinese Medicine treatment of insomnia Sichuan Zhong Yi 2018; 36(6): 205-208 Xie M, Liao ML Shumian capsules Zhong Guo Xin Yao Za Zhi 2001; 10(5): 386 Song HX Analysis of efficacy and safety of Shumian capsule in the treatment of elderly patients with insomnia Hai Xia Yao Xue 2019; 31(3): 86-87 JTCM | www journaltcm com 981 Chen HQ, Hu LY, Chen HQ A Clinical study on the treatment of depression and sleep disorders by combining psychological interventions with Shumian capsules Xin Zhong Yi 2019; 51(12): 268-271 Liang FF, Zhang X, Jiang QQ, Zhang KN Sedative and hypnotic effects of shumian capsules and its mechanism Xi'an Jiao Tong Da Xue Xue Bao (Yi Xue Ban) 2021; 42 (1): 168-174 Xia LF, Li LS, Zhang Q, Wu WW, Chen SC Comparison of the clinical efficacy of insomnia treatment by shumian capsules and estazolam Anhui Yi Yao 2015; 19(2): 367-371 Liang Y, Wang WD, Zhang HY et al A randomized study comparing the efficacy and safety of Shumian capsules and Jieyuanshen capsules in the treatment of insomnia Zhong Guo Xin Yao Za Zhi 2015; 24(10): 1155-1159 December 15, 2021 | Volume 41 | Issue | ... convalescence period, a randomized, double-blind, placebo-controlled, multicenter design was used to evaluate the therapeutic effects of using the TCM Shumian capsule (舒? ? ?胶囊) as an intervention drug... history of allergies than those in group A (Table 2) INTRODUCTION Most patients with Corona Virus Disease 2019 (COVID-19), mainly in Hubei, have entered the convalescent period after treatment Although... with Shumian capsule were significantly different from those in the control group (P < 0.05), indicating that Shumian capsule had obvious improvement effect on sleep mood disorders in the COVID-19