RESEARCH ARTICLE Shumian capsule 舒眠胶囊 improves symptoms of sleep mood dis-order in convalescent patients of Corona Virus Disease 2019 LI Li, AN Xuedong, ZHANG Qing, TAO Junxiu, HE Jing,
Trang 1© 2021 JTCM All rights reserved.
RESEARCH ARTICLE Shumian capsule (舒眠胶囊) improves symptoms of sleep mood dis-order 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
Ke-jian, LIU Ru, GUO Juan, ZHANG Hao, BA Yuanming,
De-partment of Psychiatry, Hubei Provincial Hospital of
Tradi-tional Chinese Medicine, Wuhan 430061, China;
Depart-ment of Psychiatry, Hubei Province Academy of Traditional
Chinese Medicine, Wuhan 430074, China; Department of
Psychiatry, the Affiliated Hospital of Hubei University of
Chi-nese Medicine, Wuhan 430065, China
AN Xuedong, TONG Xiaolin, Department of
Endocrinolo-gy, 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
Emergen-cy Project (the fifth batch): Study on TCM Screening for
Re-covery 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
tongx-iaolin@vip.163.com; Prof BA Yuanming, Hubei Provincial
Hospital of Traditional Chinese Medicine, Wuhan 430061,
China; Hubei Province Academy of Traditional Chinese
Medi-cine, 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
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
COV-ID-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 cap-sule 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 differ-ence in the scores of insomnia and depression be-tween 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 be-tween the experiment group and the control group (P > 0.05) After 2 weeks of treatment, the scores of insomnia, anxiety, depression and the total effec-tive 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 pres-sure between the experiment group and the con-trol 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
© 2021 JTCM All rights reserved
Trang 2Keywords: COVID-19; convalescence; sleep wake
disorders; mood disorders; Shumian capsule
INTRODUCTION
Most patients with Corona Virus Disease 2019
(COV-ID-19), mainly in Hubei, have entered the
convales-cent period after treatment Although all the
dis-charged patients have met the discharge criteria of
im-provement 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
symp-toms of sleep disorders
To utilize the advantage of Traditional Chinese
Medi-cine (TCM) in "healing and prevention of recurrence,"
appropriate TCM treatment modalities can be selected
and recommended to patients recovering from
COV-ID-19 to help them recover as soon as possible and
re-duce 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
convales-cence period, a randomized, double-blind,
placebo-con-trolled, 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
insom-nia, anxiety, depression, and other clinical symptoms
of sleep disorders
MATERIALS AND METHODS
Clinical characteristics
Between April and May 2020, 200 patients with
conva-lescent COVID-19 with symptoms of insomnia,
anxi-ety, depression, and other sleep disorders were collected
from three sites, and were divided into group A
(experi-ment group, 100 cases) and group B (control group,
100 cases) using a random number table Two hundred
patients were enrolled in the three sites, 6 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-rolled patients completed 2 weeks of treatment and fol-low-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 ad-mission, length of stay, length of discharge, condition classification, CT (Pulmonary Computed Tomogra-phy), blood routine, comorbidity, and concomitant medication Obvious differences were observed be-tween the two groups in terms of length of
interven-tion 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)
Diagnostic criteria
The diagnostic criteria adopted were the criteria for re-lease from isolation and discharge in the "COVID-19 Diagnostic and Treatment Protocol (Trial Version 6)":
1body temperature returns to normal for more than
3 d; respiratory symptoms improve significantly; lung imaging shows significant absorption of inflammation; and two consecutive negative nucleic acid tests for re-spiratory pathogens (with a sampling interval of at least 1 d), then the patient can be released from isola-tion 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 > 2 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; pa-tients who have two of these symptoms at the same time; patients who have a score of ≥ 4 on the Visual Analogue Scale (VAS) for a single symptom; and pa-tients who have signed the informed consent form
Exclusion criteria
Patients who have difficulty taking oral medications due to underlying diseases; patients with serious under-lying diseases that affect survival, including uncon-trolled, clinically significant cardiac, pulmonary, renal, digestive, hematologic, neuropsychiatric,
immunolog-ic, metabolic diseases, malignant tumors, and severe malnutrition; patients with allergies to medications
in-Table 1 Enrollment status (n)
Site
1
2
3
Total
Enrollment A
50
20
30
100
B 50 20 30 100
Total 100 40 60 200
FAS A
48 20 30 98
B 50 20 29 99
Total 98 40 59 197
PPS A
48 19 29 96
B 46 14 26 86
Total 94 33 55 182
SS
48 20 30 98
50 20 29 99
Total 98 40 59 197 Notes: A: experimental group (Shumian capsule), B: control group (Shumian capsule Simulator) The course of intervention was 2 weeks,
1 capsule = 0.4 g, take 3 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.
Trang 3volved in the treatment regimen; women who are
preg-nant or lactating; patients whose mental status does
not allow them to cooperate and who have psychiatric
disorders, who are unconscious, and who are unable to
express themselves clearly; patients who are
participat-ing in other clinical trials; and patients who, in the judgment of the investigator, may have complications
in enrollment or poor compliance that may affect the evaluation of efficacy and safety
Table 2 Demographic baseline data
Indicator
Sex [n (%)]
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 1 hypertension [n (%)]
Stage 2 hypertension [n (%)]
Stage 3 hypertension [n (%)]
Diastolic blood pressure
[n (%)]
Normal [n (%)]
Stage 1 hypertension [n (%)]
Stage 2 hypertension [n (%)]
Stage 3 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
(%)]
CT [n (%)]
Blood routine [n (%)]
History of allergies [n (%)]
Comorbidity [n (%)]
Concomitant medication [n
(%)]
Male Female Median (IQR)
≤30 31-40 41-50 51-60
≥61
≤18.5 18.5-23.99 24-27.99
≥28 Yes No Yes No 90-139 (140-159) (160-179)
≥180
＜ 60 60-89 90-99 100-109
≥110
Mild Ordinary Severe Critical Normal Abnormal Normal Abnormal Yes No Yes No Yes No
Total
82 (41.62)
115 (58.38)
55 (47-62)
7 (3.55)
24 (12.18)
32 (16.24)
76 (38.58)
58 (29.44) 23.8±2.9
4 (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)
1 (0.51)
0 (0)
0 (0.00)
181 (91.88)
12 (6.09)
4 (2.03)
0 (0.00)
19 (19-20)
78 (75-84)
8 (4-17)
21 (15-30)
57 (53-62) 16.0±2.7
96 (48.73)
66 (33.50)
30 (15.23)
5 (2.54)
44 (22.34)
153 (77.66)
180 (91.37)
17 (8.63)
19 (9.64)
178 (90.36)
98 (49.75)
99 (50.25)
72 (36.55)
125 (63.45)
Group A
48 (48.98)
56 (57.14)
55 (47-62)
5 (5.10)
10 (10.20)
18 (18.37)
32 (32.65)
33 (33.67) 23.7±2.8
2 (2.04)
54 (55.10)
36 (36.73)
6 (6.12)
11 (11.22)
87 (88.78)
7 (7.14)
91 (92.86) 36.4 (36.3, 36.5)
93 (94.90)
4 (4.08)
1 (1.02)
0 (0)
0 (0.00)
91 (92.86)
5 (5.10)
2 (2.04)
0 (0.00)
19 (19-20)
78 (75-83)
8 (4-16)
21 (15-30)
57 (53-62) 14.7±2.1
51 (52.04)
34 (34.69)
10 (10.20)
3 (3.06)
27 (27.55)
71 (72.45)
90 (91.84)
8 (8.16)
5 (5.10)
93 (94.90)
43 (43.88)
55 (56.12)
31 (31.63)
67 (68.37)
Group B
34 (34.34)
65 (65.66)
55 (47-61)
2 (2.02)
13 (13.13)
14 (14.14)
44 (44.44)
25 (25.25) 23.8± 1
2 (2.02)
52 (52.52)
35 (35.35)
10 (10.10)
6 (6.06)
93 (93.94)
8 (8.08)
91 (91.92) 36.4 (36.3, 36.5)
90 (90.91)
9 (9.09)
0 (0)
0 (0)
0 (0.00)
90 (90.91)
7 (7.07)
2 (2.02)
0 (0.00)
19 (19-20)
78 (74-84)
8 (4-18)
22 (15-29)
57 (53-62) 13.7±3.4
45 (45.45)
32 (32.32)
20 (20.20)
2 (2.02)
17 (17.17)
82 (82.83)
90 (90.91)
9 (9.09)
14 (14.14)
85 (85.86)
55 (55.56)
44 (44.44)
41 (41.41)
58 (58.59)
Statistic (χ 2/Z/t value)
<0.001
－ 0.223
－ 1.273
－ 0.327
－ 0.037
1.666 0.06
－0.556
－1.394
－ 1.394
－0.143
－1.803
－ 0.439
－1.338
－ 1.270 2.288
－0.201
3.059 0.054 4.618 2.687 2.032
P value
1
0.824 0.203
0.744 0.971
0.197 0.804 0.578 0.163
0.163
0.887 0.071 0.660 0.181 0.204 0.023 0.841
0.08 0.817 0.032 0.101 0.154 Notes: A: experimental group (Shumian capsule), B: control group (Shumian capsule Simulator) The course of intervention was 2 weeks,
1 capsule = 0.4 g, take 3 capsules at a time, twice a day P value: comparison between group A and group B IQR: interquartile range; SD:
standard deviation; BMI: body mass index; CT: pulmonary computed tomography.
Trang 4Treatment 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
ob-tained 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 2 weeks;
ap-proval number: NMPA20050543; drug specification:
1 capsule = 0.4 g; and the route of administration:
oral, 3 capsules at a time, 2 times a day
Control group (group B): The intervention drug was a
mock-up of Shumian capsule The duration of
inter-vention was 2 weeks; drug specification: 1 capsule =
0.4 g; and the route of administration: oral, 3 capsules
at a time, 2 times a day
Observational indicators
Clinical symptoms: VAS was used to observe the
chang-es 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
pulmo-nary 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
symp-toms and "10" representing the most severe sympsymp-toms
The patients were asked to move the vernier caliper to
mark the severity of their own symptoms from 0 to 10
points, with higher scores indicating more severe
symptoms
Criteria for determining the efficacy were as follows:
(a) Symptoms disappeared: symptoms and signs
disap-peared, and the symptom score was 0; (b) markedly
ef-fective: symptoms and signs improved significantly,
and the symptom score decreased by ≥ 70%; (c)
effec-tive: symptoms and signs improved, and the symptom score decreased by ≥ 30% ; (d) ineffective: symptoms and signs did not improve significantly, or even wors-ened, and the symptom score decreased by < 30% The calculation formula (nimodipine method) was: [(pre-treatment points-post[(pre-treatment points) ÷ pre[(pre-treatment points] × 100% Safety measures were general physical examination items: temperature, blood pressure, respi-ration, pulse, and heart rate There was no significant
difference (P > 0.05) between the two groups regarding
insomnia, anxiety, and depression before treatment (Table 3)
Statistical analysis
SPSS 25.0 (IBM Corp Released 2017 IBM SPSS Sta-tistics 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 de-viation, 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 per-centages for each category Other qualitative variables were subjected to theχ2test, and Fisher's exact test was used when the conditions forχ2test were not met The
statistical tests were two-tailed, and P ≤ 0.05 was
con-sidered 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 ChiC-TR2000032214
RESULTS
Comparison of TCM symptom scores
The scores for insomnia, anxiety, and depression were
Table 3 Scores for insomnia, anxiety, and depression of the subjects before treatment
Indicator
Insomnia
Anxiety
Depression
Mean Min-Max Median
mean±SD
Mean Min-Max Median
mean±SD
Mean Min-Max Median
mean±SD
Group A 7 2-10 8 7.0±1.6 4 0-9 4 4.0±2.5 3 0-8 3 3.0±2.4
Group B 7 3-10 7 7.0±1.7 5 0-10 5 5.0±2.2 3 0-9 4 3.0±2.6
t value
0.308
-1.835
-1.443
P value
0.759
0.068
0.151
Notes: A: experimental group (Shumian capsule), B: control group (Shumian capsule Simulator) The course of intervention was 2 weeks,
1 capsule = 0.4 g, take 3 capsules at a time, twice a day P value: comparison between group A and group B Max: maximum; Min: mini-mum; SD: standard deviation.
Trang 5compared After 1 week of treatment, no difference
was observed between the two groups in insomnia and
depression (P > 0.05), but there was a significant
differ-ence in anxiety (P = 0.05); after 2 weeks of treatment,
there was a significant difference between the two
groups in these symptoms (P < 0.01) (Table 4).
Comparison of the efficacy of TCM symptoms
Analysis of covariance revealed no significant difference
between the two groups after 1 week of treatment (P >
0.05) in insomnia, anxiety, and depression After 2
weeks of treatment, there was a significant difference
between the two groups in these symptoms (P < 0.05)
(Table 5)
Efficacy evaluation of TCM symptoms
According to the rank-sum test, after 1 week of
treat-ment, the differences in insomnia, anxiety, and
depres-sion symptoms were not statistically significant (P >
0.05); after 2 weeks of treatment, the differences in
these symptoms between the two groups were
statisti-cally significant (P ≤ 0.001), and group A had better
im-provements 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,
anxiety, and depression were compared After 1 week
of treatment, there was no significant difference
be-tween the two groups (P > 0.05); after 2 weeks of
treat-ment, 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 de-pression were compared, which showed no significant
difference (P > 0.05) across the two groups after 1 and
2 weeks of treatment (Table 8)
DISCUSSION
Studies have shown that patients with COVID-19 suf-fer 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 re-strictions 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 fac-tors 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
Table 4 TCM symptom scores (VAS) of the two groups
Time
Week 1
Week 2
Indicator Insomnia
Anxiety
Depression
Insomnia
Anxiety
Depression
Mean Min-Max Median
mean±SD
Mean Min-Max Median
mean±SD
Mean Min-Max Median
mean±SD
Mean Min-Max Median
mean±SD
Mean Min-Max Median
mean±SD
Mean Min-Max Median
mean±SD
Group A 5 1-9 6 5.0±1.8 3 0-8 4 3.0±2.2 2 0-7 2 2.0±2.0 4 0-9 4 4.0±2.1 3 0-8 2 3.0±2.1 2 0-7 2 2.0±1.6
Group B 6 2-9 6 6.0±1.9 4 0-8 4 4.0±2.1 3 0-7 3 3.0±2.2 5 1-10 5 5.0±2.4 4 0-8 4 4.0±2.2 3 0-8 2 2.0±2.2
t value
－ 0.936
－ 1.972
－ 1.842
－ 2.774
－ 2.795
－ 3.042
P value
0.351
0.05
0.067
0.006
0.006
0.003
Notes: A: experimental group (Shumian capsule), B: control group (Shumian capsule Simulator) The course of intervention was 2 weeks,
1 capsule = 0.4 g, take 3 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.
Trang 6Studies have shown that, compared with western
medi-cine in the treatment of insomnia, TCM treatment of
insomnia is economical, simple, effective, no side
ef-fects and no addiction, and has a broader development
prospect.2
Shumian capsule, as a Traditional Chinese Medicine
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
Suan-zaoren (Semen Zizyphi Spinosae), Chaihu (Radix
Bu-pleuri), Baishao (Radix Albus Paeoniae Lactiflorae),
He-huanhua (Flos Albiziae), Hehuanpi (Cortex Albizziae
Ju-Table 5 Results of analysis of covariance for the difference in TCM symptom scores (VAS)
Indicator
Insomnia
Anxiety
Depression
Time Week 1
Week 2
Week 1
Week 2
Week 1
Week 2
Group A B A B A B A B A B A B
Number 90 92 90 92 82 79 82 79 66 65 66 65
Difference (mean±SD)
1.8±1.4 1.4±1.0 3.1±2.0 2.1±1.9 1.1±0.9 1.0±1.0 2.0±1.6 1.6±1.6 0.8±1.1 0.7±0.9 1.7±1.6 1.1±1.4
F value
3.136
11.918
0.521
4.431
2.885
11.303
P value
0.078
0.001
0.472
0.037
0.092
0.001
Notes: A: experimental group (Shumian capsule), B: control group (Shumian capsule Simulator) The course of intervention was 2 weeks,
1 capsule = 0.4 g, take 3 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 6 Efficacy evaluation of TCM symptoms after treatment in groups A and B
Time
Week 1
Week 2
Indicator
Insomnia [n (%)]
Anxiety [n (%)]
Depression [n (%)]
Insomnia [n (%)]
Anxiety [n (%)]
Depression [n (%)]
Ineffective Effective Markedly effective Symptom disappeared Ineffective Effective Markedly effective Symptom disappeared Ineffective Effective Markedly effective Symptom disappeared Ineffective Effective Markedly effective Symptom disappeared Ineffective Effective Markedly effective Symptom disappeared Ineffective Effective Markedly effective Symptom disappeared
Group A
63 (65.63)
29 (30.21)
4 (4.17)
0 (0.00)
59 (71.95)
20 (24.39)
1 (1.22)
2 (2.44)
47 (71.21)
18 (27.27)
0 (0.00)
1 (1.49)
29 (30.21)
52 (54.17)
14 (14.58)
1 (1.04)
29 (35.37)
38 (46.34)
11 (13.41)
4 (4.88)
23 (34.85)
33 (30.00)
8 (12.12)
2 (3.03)
Group B
61 (70.93)
25 (29.07)
0 (0.00)
0 (0.00)
65 (82.28)
13 (16.46)
1 (1.27)
0 (0.00)
52 (80.00)
13 (20.00)
0 (0.00)
0 (0.00)
41 (47.67)
41 (47.67)
4 (4.65)
0 (0.00)
44 (55.70)
29 (36.71)
2 (2.53)
4 (5.06)
39 (60.00)
23 (35.39)
3 (4.62)
0 (0.00)
Z value
－ 0.355
－ 1.326
－ 1.025
－ 2.904
－ 2.755
－ 3.100
P value
0.723
0.185
0.305
0.004
0.006
0.002
Notes: A: experimental group (Shumian capsule), B: control group (Shumian capsule Simulator) The course of intervention was 2 weeks,
1 capsule = 0.4 g, take 3 capsules at a time, twice a day P value: comparison between group A and group B TCM: Traditional Chinese
Medicine.
Trang 7librissinis), Jiangcan (Stiff Silkworm), Chantui (Ps
Cica-dae), Dengxincao (Juncaceae Juss) Suanzaoren (Semen
Zizyphi Spinosae) has the effect of tonifying the liver
and tranquilizing the heart, astringing sweat, and
pro-moting 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
Albiz-iae) and Hehuanpi (Cortex Albizziae Julibrissinis) to
soothe the liver, relieve depression, and calm the mind
The Jiangcan (Stiff Silkworm) and Chantui (Ps
Cica-dae) 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
pa-tients.5 Liang et al 6 found that the mechanism of the
sedative and hypnotic effects of capsules may be related
to an increase in brain tissue GABA (γ-aminobutyric
acid) levels, a decrease in Glu (glutamic acid) content, and an up-regulation of hippocampal 5-HT1AR (5-hy-droxytryptamine 1A receptor) protein expression Xia
et al7 and Liang et al8 also showed that the treatment
of insomnia with Shumian capsules has few adverse ef-fects, 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 improve-ment 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 depres-sion in the convalescent period TCM diagnosis and treatment should continue to play an advantageous role in consolidating treatment and improving pa-tients' quality of life
Table 7 Comparison of the overall effective rate across the two groups
Time
Week 1
Week 2
Indicator
Insomnia [n (%)]
Anxiety [n (%)]
Depression [n (%)]
Insomnia [n (%)]
Anxiety [n (%)]
Depression [n (%)]
Effective Ineffective Effective Ineffective Effective Ineffective Effective Ineffective Effective Ineffective Effective Ineffective
Group A
33 (34.38)
63 (65.63)
23 (28.05)
59 (71.95)
19 (28.79)
47 (71.21)
67 (69.79)
29 (30.21)
53 (64.63)
29 (35.37)
43 (65.15)
23 (34.85)
Group B
25 (29.07)
61 (70.93)
14 (17.72)
65 (82.28)
13 (20.00)
52 (80.00)
45 (52.33)
41 (47.67)
35 (44.30)
44 (55.70)
26 (40.00)
39 (60.00)
χ 2 value 0.588
2.424
1.37
5.847
6.71
8.31
P value
0.443
0.119
0.242
0.016
0.01
0.004
Notes: A: experimental group (Shumian capsule), B: control group (Shumian capsule Simulator) The course of intervention was 2 weeks,
1 capsule = 0.4 g, take 3 capsules at a time, twice a day P value: comparison between group A and group B.
Table 8 Comparison of symptom disappearance rates across the two groups
Time
Week 1
Week 2
Indicator
Insomnia [n (%)]
Anxiety [n (%)]
Depression [n (%)]
Insomnia [n (%)]
Anxiety [n (%)]
Depression [n (%)]
Symptom disappeared Symptom did not disappear Symptom disappeared Symptom did not disappear Symptom disappeared Symptom did not disappear Symptom disappeared Symptom did not disappear Symptom disappeared Symptom did not disappear Symptom disappeared Symptom did not disappear
Group A
0 (0.00)
96 (100.00)
2 (2.44)
80 (97.56)
1 (1.49)
66 (98.51)
1 (1.04)
95 (98.96)
4 (4.88)
78 (95.12)
2 (3.03)
64 (96.97)
Group B
0 (0.00)
86 (100.00)
0 (0.00)
79 (100)
0 (0.00)
65 (100)
0 (0.00)
86 (100)
4 (5.06)
75 (94.94)
0 (0.00)
65 (100.00)
χ 2 value
-1.951
0.978
0.901
0.003
2.00
P value
-0.162
0.323
0.343
0.957
0.157 Notes: A: experimental group (Shumian capsule), B: control group (Shumian capsule Simulator) The course of intervention was 2 weeks,
1 capsule = 0.4 g, take 3 capsules at a time, twice a day P value: comparison between group A and group B.
Trang 81 Office of the National Health Commission, & National
Administration of Traditional Chinese Medicine Notice
on the Issuance of the COVID-19 Diagnostic and
Treat-ment 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
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