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

doi:10.19852/j.cnki.jtcm.20220719.003

Journal of Traditional Chinese Medicine ›› 2022, Vol. 42 ›› Issue (5): 803-809.DOI: 10.19852/j.cnki.jtcm.20220719.003

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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

AN Xuedong¹, ZHANG Qing², TAO Junxiu³, LI Li⁴, CHEN Yun⁴, LI Kejian⁴, HE Jing⁴, LIU Ru⁴, GUO Juan⁴, ZHANG Jia⁵, ZHU Hui⁵, LIAN Fengmei¹(), LI Xiaodong³()

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

Received:2022-03-12 Accepted:2022-06-17 Online:2022-10-15 Published:2022-07-19
Contact: LIAN Fengmei,LI Xiaodong
About author:LI Xiaodong, Liver Disease branch, Hubei Hospital of Traditional Chinese Medicine, Hubei University of Chinese Medicine, Affiliated Hospital of Hubei University of Chinese Medicine, Hubei Institute of Traditional Chinese Medicine, Wuhan 430000, Lixiaodong555@126.com Telephone: +86-13651249262; +86-13908658127
LIAN Fengmei, Endocrinology, Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing 100054, China, lfm565@sohu.com;
Supported by:
Mechanism and Countermeasure of COVID-19 asymptomatic infection and re-detectable positive in SARS-CoV-2 nucleic acid test(2020YFC0861100)

Abstract

Abstract:

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.

Key words: COVID-19, convalescence, sleep quality, emotional disorder, Shugan Jieyu capsule

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. 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[J]. Journal of Traditional Chinese Medicine, 2022, 42(5): 803-809.

Figures/Tables 8

References 13.

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Item			Experimental group (n = 99)		Control group (n = 97)	P value
Age (years)^a			54.5±10.8		55.0±9.4	0.7484
Height (cm)			162.9±7.1		164.1±7.4	0.2577
Weight (kg)			63.1±8.9		63.7±9.0	0.6588
BMI (kg/m²)			23.8±2.8		23.6±2.7	0.7221
Gender [n (%)]		Male	26 (26.3)		32 (33.0)	0.3023
		Female	73 (73.7)		65 (67.0)	0.3023
History of allergy [n (%)]		Yes	11 (11.1)		8 (8.2)	0.498
		No	88 (88.9)		89 (91.8)	0.498
PMH [n (%)]		Yes	50 (50.5)		44 (45.4)	0.471
		No	49 (49.5)		53 (54.6)	0.471
Accompanied somatization symptoms [n (%)]		Yes	45 (45.5)		53 (54.6)	0.199
Accompanied somatization symptoms [n (%)]		No	54 (54.5)		44 (45.4)	0.199
Time from Onset to Intervention [n (%)]^b			6.33 (0.7)		6.39 (0.7)	0.592
Drug exposure and compliance	Treatment days with the drug^c			41.2 (2.1)	41.1 (2.0)
Drug exposure and compliance	The drug compliance (%)^d			98.3 (1.2)	98.2 (1.7)

Item			Experimental group (n = 99)		Control group (n = 97)	P value
Age (years)^a			54.5±10.8		55.0±9.4	0.7484
Height (cm)			162.9±7.1		164.1±7.4	0.2577
Weight (kg)			63.1±8.9		63.7±9.0	0.6588
BMI (kg/m²)			23.8±2.8		23.6±2.7	0.7221
Gender [n (%)]		Male	26 (26.3)		32 (33.0)	0.3023
		Female	73 (73.7)		65 (67.0)	0.3023
History of allergy [n (%)]		Yes	11 (11.1)		8 (8.2)	0.498
		No	88 (88.9)		89 (91.8)	0.498
PMH [n (%)]		Yes	50 (50.5)		44 (45.4)	0.471
		No	49 (49.5)		53 (54.6)	0.471
Accompanied somatization symptoms [n (%)]		Yes	45 (45.5)		53 (54.6)	0.199
Accompanied somatization symptoms [n (%)]		No	54 (54.5)		44 (45.4)	0.199
Time from Onset to Intervention [n (%)]^b			6.33 (0.7)		6.39 (0.7)	0.592
Drug exposure and compliance	Treatment days with the drug^c			41.2 (2.1)	41.1 (2.0)
Drug exposure and compliance	The drug compliance (%)^d			98.3 (1.2)	98.2 (1.7)

Time	Group	n	Scores	Changes in scores	P value
Baseline	Experimental	99	20.0±2.2	-	0.283
Baseline	Control	97	19.6±2.3	-
2nd Week	Experimental	99	16.8±3.8	–3.1±3.0	0.001
2nd Week	Control	97	17.8±3.6	–1.9±2.4	0.001
4th Week	Experimental	98	13.2±4.2	–6.8±3.4	0.001
4th Week	Control	97	16.5±4.9	–3.1±3.6	0.001
6th Week	Experimental	98	9.3±4.5	–10.7±3.6	0.001
6th Week	Control	96	15.3±6.4	–4.3±5.2	0.001

Time	Group	n	Scores	Changes in scores	P value
Baseline	Experimental	99	20.0±2.2	-	0.283
Baseline	Control	97	19.6±2.3	-
2nd Week	Experimental	99	16.8±3.8	–3.1±3.0	0.001
2nd Week	Control	97	17.8±3.6	–1.9±2.4	0.001
4th Week	Experimental	98	13.2±4.2	–6.8±3.4	0.001
4th Week	Control	97	16.5±4.9	–3.1±3.6	0.001
6th Week	Experimental	98	9.3±4.5	–10.7±3.6	0.001
6th Week	Control	96	15.3±6.4	–4.3±5.2	0.001

Follow-up examinations	Experimental group (n = 98)	Control group (n = 97)
Remission after treatment [n (%)]	34 (34.7)	13 (13.5)
Effective treatment [n (%)]	22 (22.4)	3 (3.1)
Ineffective treatment [n (%)]	42 (42.9)	80 (83.3)
Obvious effective treatment (Remission + Response rate) [n (%)]	56 (57.1)	16 (16.7)
95%CI	(46.7, 67.1)	(9.8, 25.6)
Rate Differences (%)	40.5	-
Rate Differences of 95%CI	(26.9, 52.5)	-
P value	< 0.001

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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

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Figures/Tables 8

References 13.

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Time	Group	n	Scores	Changes in scores	P value
Baseline	Experimental	99	15.1±4.4		0.1128
Baseline	Control	97	16.2±5.8		0.1128
2nd Week	Experimental	99	13.6±3.9	–1.4±2.0	0.001
2nd Week	Control	97	15.6±5.4	–0.6±2.0	0.001
4th Week	Experimental	98	10.7±4.2	–4.4±2.6	0.001
4th Week	Control	97	14.3±6.0	–1.9±2.4	0.001
6th Week	Experimental	98	7.7±3.8	–7.4±3.3	0.001
6th Week	Control	96	13.8±6.9	–2.4±3.4	0.001

Time	Group	n	Scores	Changes in scores	P value
Baseline	Experimental	99	10.1±3.3	-	0.1701
Baseline	Control	97	10.8±4.0	-	0.1701
2nd Week	Experimental	99	9.0±3.2	-1.1±1.8	0.003
2nd Week	Control	97	10.4±4.0	-0.4±2.1	0.003
4th Week	Experimental	98	6.7±3.1	-3.4±2.2	< 0.001
4th Week	Control	97	9.5±4.6	-1.3±2.7	< 0.001
6th Week	Experimental	98	4.7±2.4	-5.4±2.6	< 0.001
6th Week	Control	96	9.1±4.8	-1.7±3.2	< 0.001

Time	Group	n	Scores	Changes in scores	P value
Baseline	Experimental	99	17.7±5.3		0.7755
Baseline	Control	97	18.0±5.6		0.7755
2nd Week	Experimental	99	15.2±5.4	-2.5±3.2	< 0.001
2nd Week	Control	97	17.1±5.3	-0.9±2.5	< 0.001
4th Week	Experimental group	98	10.8±5.5	-7.0±4.4	< 0.001
4th Week	Control Group	97	15.8±5.6	-2.1±3.6	< 0.001
6th Week	Experimental group	98	6.6±4.4	-11.2±4.5	< 0.001
6th Week	Control Group	96	15.4±7.6	-2.6±4.6	< 0.001

Group	AE	Start date	End date	Outcome	Exit test
Shugan Jieyu capsule	Abnormal liver function	2020-10-02	2020-10-03	recovery	No
	Diarrhea	2020-08-27	2020-08-29	recovery	No
	Cervical polyp	2020-09-12	-	recovery	No
	Stomach pain	2020-09-01	2020-09-04	recovery	No
Control	Gastrointestinal discomfort	2020-09-03	2020-09-08	recovery	No

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