Effectiveness of Xiaoyao capsule (逍遥丸) on sleep disorders and mood disturbance in patients in recovery from coronavirus disease 2019: a randomized controlled trial

doi:10.19852/j.cnki.jtcm.2023.02.005

Journal of Traditional Chinese Medicine ›› 2023, Vol. 43 ›› Issue (2): 343-351.DOI: 10.19852/j.cnki.jtcm.2023.02.005

• Original articles • Previous Articles Next Articles

Effectiveness of Xiaoyao capsule (逍遥丸) on sleep disorders and mood disturbance in patients in recovery from coronavirus disease 2019: a randomized controlled trial

YANG Cunqing¹, LIAN Fengmei¹, YANG Guiping², HUANG Yufeng³, ZHANG Shuangbin⁶, WANG Jianghua⁷, ZHOU Jing⁸, GUO Dongqing⁹, SHEN Chuanyun⁶, YE Tiansong⁴, FU Aojie¹⁰, LI Xiaoli⁹, CHEN Le¹¹, ZHANG Huifeng⁵, TU Qiyin¹⁰, WANG Ying¹², YANG Wenzhe⁵, TONG Xiaolin¹³(), BA Yuanming¹⁴()

1 Department of Endocrinology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China
2 Department of Gastroenterology, Xiaogan Hospital of Traditional Chinese Medicine, Xiaogan 432100, China
3 Party Committee Office of Xiaogan Hospital of Traditional Chinese Medicine, Xiaogan 432100, China
4 Department of Nephrology, Xiaogan Hospital of Traditional Chinese Medicine, Xiaogan 432100, China
5 Department of internal Medicine, Xiaogan Hospital of Traditional Chinese Medicine, Xiaogan 432100, China
6 Liver Disease Branch, Xiaogan Hospital of Traditional Chinese Medicine, Xiaogan 432100, China
7 Department of massage, Xiaogan Hospital of Traditional Chinese Medicine, Xiaogan 432100, China
8 Department of Medicine, Xiaogan Hospital of Traditional Chinese Medicine, Xiaogan 432100, China
9 Department of internal Medicine, Dawu County Hospital of Traditional Chinese Medicine, Xiaogan 432800, China
10 Department of Pulmonary Diseases, Xiaogan Hospital of Traditional Chinese Medicine, Xiaogan 432100, China
11 Pharmaceutical Preparation Section, Xiaogan Hospital of Traditional Chinese Medicine, Xiaogan 432100, China
12 Acupuncture and Moxibustion Deparment, Xiaogan Hospital of Traditional Chinese Medicine, Xiaogan 432100, China
13 Institute of Metabolic Diseases, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China
14 Department of nephropathy, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan 430061, China

Received:2021-06-22 Accepted:2022-03-26 Online:2023-04-15 Published:2023-03-14
Contact: Prof. TONG Xiaolin, Institute of Metabolic Diseases, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China. tongxiaolin@vip.163.com; Prof. BA Yuanming, Department of nephropathy, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan 430061, China. 1107799265@qq.com. Telephone: +86-10-88001402

Abstract

Abstract:

OBJECTIVE: To study the efficacy of Xiaoyao capsule (逍遥丸) in improving the clinical symptoms of sleep and mood disorders during recovery from coronavirus disease 2019 (COVID-19).

METHODS: The study cohort comprised 200 patients with sleep and mood disorders during recovery from COVID-19. Patients were randomized into the control group and the experimental group in a 1:1 ratio by blocked randomization. The patients received either Xiaoyao capsule (experimental group) or a placebo Xiaoyao capsule (control group) for 2 weeks. The improvements in the Traditional Chinese Medicine (TCM) syndrome scales, total effective rates, and disappearance rates of irritability, anxiety, and poor sleep were compared between the two groups.

RESULTS: The TCM syndrome pattern scales, total effective rates, and disappearance rates of irritability, anxiety, and poor sleep did not significantly differ between the experimental group versus the control group in the full analysis set and the per protocol set after 1 and 2 weeks of treatment (P > 0.05).

CONCLUSIONS: Xiaoyao capsule do not significantly improve the clinical symptoms of sleep and mood disorders in patients in recovery from COVID-19.

Key words: COVID-19, sleep wake disorders, mood disorders, Xiaoyao capsule

YANG Cunqing, LIAN Fengmei, YANG Guiping, HUANG Yufeng, ZHANG Shuangbin, WANG Jianghua, ZHOU Jing, GUO Dongqing, SHEN Chuanyun, YE Tiansong, FU Aojie, LI Xiaoli, CHEN Le, ZHANG Huifeng, TU Qiyin, WANG Ying, YANG Wenzhe, TONG Xiaolin, BA Yuanming. Effectiveness of Xiaoyao capsule (逍遥丸) on sleep disorders and mood disturbance in patients in recovery from coronavirus disease 2019: a randomized controlled trial[J]. Journal of Traditional Chinese Medicine, 2023, 43(2): 343-351.

Figures/Tables 8

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Index	Group	Before treatment	Course
Index	Group	Before treatment	1 week	2 weeks
Irritability	A B	4.4±2.2	3.6±2.0	2.7±1.9
Irritability	A B	4.4±2.1	3.5±1.9	2.5±1.9
Anxiety	A B	4.9±1.8	4.0±1.6	3.1±1.8
Anxiety	A B	4.6±1.7	3.7±1.6	2.9±1.8
Poor sleep	A B	5.5±1.7^a	4.4±1.6	3.5±1.7
Poor sleep	A B	5.0±1.7^a	4.1±1.6	3.4±1.6

Index	Group	Before treatment	Course
Index	Group	Before treatment	1 week	2 weeks
Irritability	A B	4.4±2.2	3.6±2.0	2.7±1.9
Irritability	A B	4.4±2.1	3.5±1.9	2.5±1.9
Anxiety	A B	4.9±1.8	4.0±1.6	3.1±1.8
Anxiety	A B	4.6±1.7	3.7±1.6	2.9±1.8
Poor sleep	A B	5.5±1.7^a	4.4±1.6	3.5±1.7
Poor sleep	A B	5.0±1.7^a	4.1±1.6	3.4±1.6

Index	Group		Before treatment	Course
Index	Group		Before treatment	1 week	2 weeks
Irritability	A B	4.4±2.2		3.5±2.0	2.6±1.9
Irritability	A B	4.3±2.2		3.4±1.9	2.4±1.9
Anxiety	A B	4.9±1.9		4.0±1.6	3.1±1.8
Anxiety	A B	4.5±1.7		3.7±1.6	2.8±1.8
Poor sleep	A B	5.5±1.7^a		4.4±1.6	3.4±1.6
Poor sleep	A B	5.0±1.7^a		4.1±1.6	3.3±1.5

Index	Group		Before treatment	Course
Index	Group		Before treatment	1 week	2 weeks
Irritability	A B	4.4±2.2		3.5±2.0	2.6±1.9
Irritability	A B	4.3±2.2		3.4±1.9	2.4±1.9
Anxiety	A B	4.9±1.9		4.0±1.6	3.1±1.8
Anxiety	A B	4.5±1.7		3.7±1.6	2.8±1.8
Poor sleep	A B	5.5±1.7^a		4.4±1.6	3.4±1.6
Poor sleep	A B	5.0±1.7^a		4.1±1.6	3.3±1.5

Time	Index	Group	Syndrome pattern
Time	Index	Group	Disappears	Significant	Effective	Ineffective	P value
1 week	Irritability	A	3 (3.26)	1 (1.09)	20 (21.74)	68 (73.91)	0.502
		B	8 (8.70)	0 (0.00)	23 (25.00)	61 (66.30)	0.502
	Anxiety	A	0 (0.00)	3 (3.06)	19 (19.39)	76 (77.55)	0.592
		B	1 (1.05)	0 (0.00)	24 (25.26)	70 (73.68)	0.592
	Poor sleep	A	1 (1.00)	0 (0.00)	23 (23.00)	76 (76.00)	0.971
		B	0 (0.00)	0 (0.00)	23 (24.47)	71 (75.53)	0.971
2 weeks	Irritability	A	14 (15.22)	5 (5.43)	39 (42.39)	34 (36.96)	0.388
		B	24 (26.09)	2 (2.17)	34 (36.96)	32 (34.78)	0.388
	Anxiety	A	8 (8.16)	7 (7.14)	41 (41.84)	42 (42.86)	0.731
		B	10 (10.53)	6 (6.32)	40 (42.11)	39 (41.05)	0.731
	Poor sleep	A	3 (3.00)	4 (4.00)	49 (49.00)	44 (44.00)	0.337
		B	3 (3.19)	1 (1.06)	43 (45.75)	47 (50.00)	0.337

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Effectiveness of Xiaoyao capsule (逍遥丸) on sleep disorders and mood disturbance in patients in recovery from coronavirus disease 2019: a randomized controlled trial

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Figures/Tables 8

References 34.

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Time	Index	Group	Effective	Ineffective	P value
1 week	Irritability	A	22 (27.27)	64 (72.73)	0.497
		B	26 (30.23)	60 (69.77)	0.497
	Anxiety	A	22 (27.40)	72 (76.60)	0.579
		B	24 (26.97)	65 (73.03)	0.579
	Poor sleep	A	24 (25.00)	72 (75.00)	1.000
		B	22 (25.00)	66 (75.00)	1.000
2 weeks	Irritability	A	57 (64.77)	31 (35.23)	0.711
		B	58 (67.44)	28 (32.56)	0.711
	Anxiety	A	56 (59.57)	38 (40.43)	0.759
		B	55 (61.80)	34 (38.20)	0.759
	Poor sleep	A	56 (58.33)	40 (41.67)	0.41
		B	46 (52.27)	42 (47.73)	0.41

Index	Time	Group	Case number	Difference (mean ± SD)	F value	P value
Irritability	1st week	A	92	3.9±1.7	0.004	0.952
		B	92	3.6±1.8	0.004	0.952
	2nd week	A	92	2.9±1.9	0.217	0.642
		B	92	2.6±1.9	0.217	0.642
Anxiety	1st week	A	98	4.1±1.5	0.189	0.664
		B	95	3.7±1.6	0.189	0.664
	2nd week	A	98	3.2±1.8	0.014	0.907
		B	95	2.9±1.8	0.014	0.907
Poor sleep	1st week	A	100	4.4±1.6	0.153	0.696
		B	94	4.2±1.5	0.153	0.696
	2nd week	A	100	3.5±1.7	0.185	0.668
		B	94	3.4±1.6	0.185	0.668

Index	Time	Group	Case number	Difference (mean ± SD)	F value	P value
Irritability	1st week	A	88	3.8±1.7	0.026	0.872
		B	86	3.6±1.8	0.026	0.872
	2nd week	A	88	2.8±1.8	0.340	0.561
		B	86	2.5±1.9	0.340	0.561
Anxiety	1st week	A	94	4.1±1.5	0.128	0.721
		B	89	3.7±1.6	0.128	0.721
	2nd week	A	94	3.1±1.7	0.025	0.873
		B	89	2.8±1.8	0.025	0.873
Poor sleep	1st week	A	96	4.4±1.6	0.212	0.646
		B	88	4.1±1.5	0.212	0.646
	2nd week	A	96	3.4±1.6	0.136	0.713
		B	88	3.3±1.5	0.136	0.713

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