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

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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. ; Prof. BA Yuanming, Hubei Provincial
Hospital of Traditional Chinese Medicine, Wuhan 430061,
China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan 430074, China.
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 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).

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
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LI L et al. / Research Article

Keywords: COVID-19; convalescence; sleep wake
disorders; mood disorders; Shumian capsule

rolled patients completed 2 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)":
1
body 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 respiratory pathogens (with a sampling interval of at
least 1 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 > 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; patients 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 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, 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-

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 1 Enrollment status (n)
Site

Enrollment

FAS

PPS

SS

A

B

Total

A

B

Total

A

B

Total

A

B

Total

1

50

50

100

48

50

98

48

46

94

48

50

98

2

20

20

40

20

20

40

19

14

33

20

20

40

3

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 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.
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Table 2 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 (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)

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)

－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

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)

－0.556

－1.394

0.578
0.163

＜60

0 (0.00)

0 (0.00)

0 (0.00)

－1.394

0.163

60-89
90-99
100-109
≥110

181 (91.88)
12 (6.09)
4 (2.03)
0 (0.00)
19 (19-20)
78 (75-84)

91 (92.86)

5 (5.10)
2 (2.04)
0 (0.00)
19 (19-20)
78 (75-83)

90 (90.91)
7 (7.07)
2 (2.02)
0 (0.00)
19 (19-20)
78 (74-84)

－0.143
－1.803

0.887
0.071

8 (4-17)

8 (4-16)

8 (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 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
(%)]

Statistic
(χ2/Z/t value)
<0.001

Total

≤18.5
18.5-23.99
24-27.99
≥28
Yes
No
Yes
No

P value
1

Mild
96 (48.73)
51 (52.04)
45 (45.45)
－0.201
0.841
Ordinary
66 (33.50)
34 (34.69)
32 (32.32)
Severe
30 (15.23)
10 (10.20)
20 (20.20)
Critical
5 (2.54)
3 (3.06)
2 (2.02)
CT [n (%)]
Normal
44 (22.34)
27 (27.55)
17 (17.17)
3.059
0.08
Abnormal
153 (77.66)
71 (72.45)
82 (82.83)

Blood routine [n (%)]
Normal
180 (91.37)
90 (91.84)
90 (90.91)
0.054
0.817
Abnormal
17 (8.63)
8 (8.16)
9 (9.09)
History of allergies [n (%)]
Yes
19 (9.64)
5 (5.10)
14 (14.14)
4.618
0.032
No
178 (90.36)
93 (94.90)
85 (85.86)
Comorbidity [n (%)]
Yes
98 (49.75)
43 (43.88)
55 (55.56)
2.687
0.101
No

99 (50.25)
55 (56.12)
44 (44.44)
Yes
72 (36.55)
31 (31.63)
41 (41.41)
2.032
0.154
Concomitant medication [n
(%)]
No
125 (63.45)
67 (68.37)
58 (58.59)
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.

volved in the treatment regimen; women who are pregnant 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 participatJTCM | www. journaltcm. com

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.
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tive: symptoms and signs improved, and the symptom
score decreased by ≥ 30% ; (d) ineffective: symptoms
and signs did not improve significantly, or even worsened, and the symptom score decreased by < 30%. The
calculation formula (nimodipine method) was: [(pretreatment points-posttreatment points) ữ pretreatment
points] ì 100%. Safety measures were general physical
examination items: temperature, blood pressure, respiration, 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).

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 2 weeks; approval 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 intervention 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.

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 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 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 3 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

7

Min-Max

2-10

3-10

Median

8

7

mean±SD

7.0±1.6

7.0±1.7

Mean

4

5

Min-Max

0-9

0-10

Median

4

5

mean±SD

4.0±2.5

5.0±2.2

Mean

3

3

Min-Max

0-8

0-9

Median

3

4

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 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: minimum; SD: standard deviation.
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compared. 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 difference 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).

anxiety, and depression were compared. After 1 week
of treatment, there was no significant difference between the two groups (P > 0.05); after 2 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 1 and
2 weeks of treatment (Table 8).

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).

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 1 week of treatment, the differences in insomnia, anxiety, and depression symptoms were not statistically significant (P >
0.05); after 2 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 4 TCM symptom scores (VAS) of the two groups
Time

Indicator

Week 1

Insomnia

Anxiety

Depression

Week 2

Insomnia

Anxiety

Depression

Group A

Group B

Mean

5

6

Min-Max

1-9

2-9

Median

6

6

mean±SD

5.0±1.8

6.0±1.9

Mean

3

4

Min-Max

0-8

0-8

Median

4

4

mean±SD

3.0±2.2

4.0±2.1

Mean

2

3

Min-Max

0-7

0-7

Median

2

3

mean±SD

2.0±2.0

3.0±2.2

Mean

4

5

Min-Max

0-9

1-10

Median

4

5

mean±SD

4.0±2.1

5.0±2.4

Mean

3

4

Min-Max

0-8

0-8

Median

2

4

mean±SD

3.0±2.1

4.0±2.2

Mean

2

3

Min-Max

0-7

0-8

Median

2

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 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.
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Table 5 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 1

A

90

1.8±1.4

3.136

0.078

B

92

1.4±1.0

Week 2

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 1
Week 2

Depression

Week 1
Week 2

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

Indicator
Insomnia [n (%)]

Anxiety [n (%)]

Depression [n (%)]

Week 2

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 (4.17)

0 (0.00)

Symptom disappeared

0 (0.00)

0 (0.00)

Ineffective

59 (71.95)

65 (82.28)

Effective

20 (24.39)

13 (16.46)

Markedly effective

1 (1.22)

1 (1.27)

Symptom disappeared

2 (2.44)

0 (0.00)

Ineffective

47 (71.21)

52 (80.00)

Effective

18 (27.27)

13 (20.00)

Markedly effective

0 (0.00)

0 (0.00)

Symptom disappeared

1 (1.49)

0 (0.00)

Ineffective

29 (30.21)

41 (47.67)

Effective

52 (54.17)

41 (47.67)

Markedly effective

14 (14.58)

4 (4.65)

Symptom disappeared

1 (1.04)

0 (0.00)

Ineffective

29 (35.37)

44 (55.70)

Effective

38 (46.34)

29 (36.71)

Markedly effective

11 (13.41)

2 (2.53)

Symptom disappeared

4 (4.88)

4 (5.06)

Ineffective

23 (34.85)

39 (60.00)

Effective

33 (30.00)

23 (35.39)

Markedly effective

8 (12.12)

3 (4.62)

Symptom disappeared
2 (3.03)
0 (0.00)
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.

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
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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

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LI L et al. / Research Article
Table 7 Comparison of the overall effective rate across the two groups
Time
Week 1

Indicator
Insomnia [n (%)]
Anxiety [n (%)]
Depression [n (%)]

Week 2

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 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

Indicator
Insomnia [n (%)]
Anxiety [n (%)]
Depression [n (%)]

Week 2

Insomnia [n (%)]
Anxiety [n (%)]
Depression [n (%)]

Group A

Group B

Symptom disappeared

0 (0.00)

0 (0.00)

Symptom did not disappear

96 (100.00)

86 (100.00)

Symptom disappeared

2 (2.44)

0 (0.00)

Symptom did not disappear

80 (97.56)

79 (100)

Symptom disappeared

1 (1.49)

0 (0.00)

Symptom did not disappear

66 (98.51)

65 (100)

Symptom disappeared

1 (1.04)

0 (0.00)

Symptom did not disappear

95 (98.96)

86 (100)

Symptom disappeared

4 (4.88)

4 (5.06)

Symptom did not disappear

78 (95.12)

75 (94.94)

Symptom disappeared

2 (3.03)

0 (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 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.

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 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
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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 7 and Liang et al 8 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

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LI L et al. / Research Article

REFERENCES
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2

3
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5

Office of the National Health Commission, & National
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2020-12-12. Available from URL: />zhengcewenjian/2020-02-19/13221.html

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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

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Chen HQ, Hu LY, Chen HQ. A Clinical study on the
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Liang FF, Zhang X, Jiang QQ, Zhang KN. Sedative and
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367-371.
Liang Y, Wang WD, Zhang HY et al. A randomized study
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