Efficacy of Zhumian Tang formula granules (助眠汤配方颗粒) combined with eszopiclone for the treatment of poor sleep quality: a multi-center, randomized controlled, superiority trial

doi:10.19852/j.cnki.jtcm.2024.01.002

Journal of Traditional Chinese Medicine ›› 2024, Vol. 44 ›› Issue (1): 163-171.DOI: 10.19852/j.cnki.jtcm.2024.01.002

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Efficacy of Zhumian Tang formula granules (助眠汤配方颗粒) combined with eszopiclone for the treatment of poor sleep quality: a multi-center, randomized controlled, superiority trial

WANG Yichen¹, WU Shiyi², WANG Zhengyan³, CHANG Wenling², XIE Zhihao², TANG Xing⁴, ZHAO Songmei⁵, ZHOU Jing⁶, CHEN Zehong⁷, WANG Chao³(), YANG Chunxia²()

1 Orthopedic geriatrics department, Sichuan Province Orthopedic Hospital, Chengdu 610093, China
2 Department of Epidemiology and Biostatistics, West China School of Public Health and West China Fourth Hospital, Sichuan University, Chengdu 610041, China
3 Sub-health department, Sichuan Integrative Medicine Hospital, Chengdu 610041, China
4 College of Acupuncture and Massage, Chengdu University of Traditional Chinese Medicine, Chengdu 610041, China
5 Internal Medicine Department, Ya'an Hospital of Traditional Chinese Medicine, Ya’an 625000, China
6 Preventive Treatment of Disease Center, Dazhou Integrated TCM and Western Medicine Hospital, Dazhou Second People’s Hospital, Dazhou 635000, China
7 Geriatrics Department, Dayi Wang Country Hospital of Traditional Chinese Medicine, Chengdu 611330, China

Received:2023-08-21 Accepted:2023-11-27 Online:2024-02-15 Published:2023-12-30
Contact: WANG Chao, Sub-health department, Sichuan Integrative Medicine Hospital, Chengdu 610041, China. 563402435@qq.com;YANG Chunxia, Department of Epidemiology and Biostatistics, West China School of Public Health and West China Fourth Hospital, Sichuan University, Chengdu 610041, China. yangchunxia@scu.edu.cn. Telephone: +86-17796417342
Supported by:
Sichuan Province Central Guided Local Science and Technology Development Special Project: a Study of the Chinese and Western Medicine Clinical Consensus Program for People with Poor Sleep Quality(2021ZYD0109);Natural Science Foundation of Sichuan Province: Study on the Efficacy and Mechanism of Acupuncture in Treating Drug-dependent Insomnia from the Liver based on Multi-modal fMRI Technology(2022NSFSC0858)

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Abstract

Abstract:

OBJECTIVE: To evaluate the efficacy and safety of Zhumian Tang formula granules (助眠汤配方颗粒) combined with eszopiclone for treating poor sleep quality.

METHODS: This multi-center, dynamic block-randomized, parallel-group superiority clinical trial included 130 patients. The combined treatment group received Zhumian Tang formula granules combined with eszopiclone treatment, and the control group received eszopiclone treatment only. The group allocation ratio was 1∶1. The duration of treatment was 2 weeks. Participants were asked to complete questionnaires before treatment, after 1 week of the intervention, after 2 weeks of the intervention, and at the follow-up on week 3. The primary outcomes were the Pittsburgh Sleep Quality Index (PSQI) score and the total effective rate of treatment. The secondary outcome was the rate of adverse effects.

RESULTS: Compared with the eszopiclone treatment group, the PSQI score of the combined treatment group was significantly lower after 2 weeks of the intervention (6.98 vs 8.26, P < 0.05). However, there was no significant difference in the mean PSQI score after 1 week of the intervention (9.89 vs 9.15, P = 0.124). After the follow-up on week 3, the PSQI score of the combined treatment group remained significantly lower than that of the eszopiclone treatment group (6.12 vs 8.31, P < 0.001). The total effective rates of treatment of the combined group and the eszopiclone group were 36.92% vs 35.38% (Z = 0.033, P = 0.855) after 1 week of the intervention, 83.08% vs 58.46% (Z = 9.519, P < 0.05) after 2 weeks of the intervention, and 83.08% vs 61.54% (Z = 7.530, P < 0.05) and after the follow-up on week 3, respectively. There was no significant difference in the overall rate of adverse reactions between the combined and eszopiclone treatment groups (21.53% vs 31.8%, P = 0.318).

CONCLUSION: The combination of Zhumian Tang formula granules with eszopiclone was found to be safe and more effective in improving sleep quality than eszopiclone alone. Traditional Chinese medicine can enhance the effectiveness of Western medicine in the treatment of insomnia.

Key words: sleep quality, eszopiclone, randomized controlled trial, superiority, Zhumian Tang formula granules

WANG Yichen, WU Shiyi, WANG Zhengyan, CHANG Wenling, XIE Zhihao, TANG Xing, ZHAO Songmei, ZHOU Jing, CHEN Zehong, WANG Chao, YANG Chunxia. Efficacy of Zhumian Tang formula granules (助眠汤配方颗粒) combined with eszopiclone for the treatment of poor sleep quality: a multi-center, randomized controlled, superiority trial[J]. Journal of Traditional Chinese Medicine, 2024, 44(1): 163-171.

Figures/Tables 4

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Characteristic	Combined group (n = 65)	Eszopiclone alone group (n = 65)	P value
Male [n (%)]	17 (26.20)	17 (26.20)	-
Age (years)	44.35±12.71	39.98±13.90	0.064
BMI (kg/m²)	21.74±4.83	21.63±3.08	0.873
Systolic blood pressure (mm Hg)	112.51±11.81	112.11±12.74	0.853
Diastolic blood pressure (mm Hg)	72.77±8.65	70.68±7.73	0.148
Breathing (breaths/min)	17.69±1.56	17.52±1.61	0.544
Body temperature (℃)	36.36±0.17	36.42±0.18	0.087
Heart rate (beats/min)	71.78±9.08	69.12±9.38	0.103
Sleep quality assessment (score)
PSQI, total score	12.09±2.08	11.48±2.27	0.110
Sleep quality	2.20±0.64	2.17±0.57	0.774
Sleep latency	2.46±0.69	2.40±0.70	0.614
Sleep duration	2.12±0.74	1.80±0.73	0.014
Sleep efficiency	1.89±0.91	1.58±0.93	0.062
Sleep disturbances	1.23±0.52	1.30±0.61	0.442
Use of sleeping medication	0.23±0.63	0.17±0.57	0.562
Daytime dysfunction	1.94±0.88	2.21±0.67	0.046

Characteristic	Combined group (n = 65)	Eszopiclone alone group (n = 65)	P value
Male [n (%)]	17 (26.20)	17 (26.20)	-
Age (years)	44.35±12.71	39.98±13.90	0.064
BMI (kg/m²)	21.74±4.83	21.63±3.08	0.873
Systolic blood pressure (mm Hg)	112.51±11.81	112.11±12.74	0.853
Diastolic blood pressure (mm Hg)	72.77±8.65	70.68±7.73	0.148
Breathing (breaths/min)	17.69±1.56	17.52±1.61	0.544
Body temperature (℃)	36.36±0.17	36.42±0.18	0.087
Heart rate (beats/min)	71.78±9.08	69.12±9.38	0.103
Sleep quality assessment (score)
PSQI, total score	12.09±2.08	11.48±2.27	0.110
Sleep quality	2.20±0.64	2.17±0.57	0.774
Sleep latency	2.46±0.69	2.40±0.70	0.614
Sleep duration	2.12±0.74	1.80±0.73	0.014
Sleep efficiency	1.89±0.91	1.58±0.93	0.062
Sleep disturbances	1.23±0.52	1.30±0.61	0.442
Use of sleeping medication	0.23±0.63	0.17±0.57	0.562
Daytime dysfunction	1.94±0.88	2.21±0.67	0.046

Group	n	PSQI (scores)				PSQI score reduction rate (%) (after 2 weeks of the intervention)
Group	n	Pre-treatment	After 1 week of the intervention	After 2 weeks of the intervention	After follow-up at week 3
Combined group	65	12.1±2.1	9.9± 2.7	7.0± 3.0	6.1± 3.2	42.6± 22.0
Eszopiclone alone group	65	11.5± 2.3	9.1± 2.7	8.3± 2.5	8.3± 3.6	27.3± 19.3
P value		0.110	0.124	0.010^a	<0.001^a	<0.001^a

Group	n	PSQI (scores)				PSQI score reduction rate (%) (after 2 weeks of the intervention)
Group	n	Pre-treatment	After 1 week of the intervention	After 2 weeks of the intervention	After follow-up at week 3
Combined group	65	12.1±2.1	9.9± 2.7	7.0± 3.0	6.1± 3.2	42.6± 22.0
Eszopiclone alone group	65	11.5± 2.3	9.1± 2.7	8.3± 2.5	8.3± 3.6	27.3± 19.3
P value		0.110	0.124	0.010^a	<0.001^a	<0.001^a

Group	Ineffective participants (n)	Total effective participants (n)	Total effective rate (%) and 95% CI	Z value	P value
After 1 week of the intervention				0.033	0.855
Combined group	41	24	36.92 (25.55, 49.85)
Eszopiclone alone group	42	23	35.38 (24.20, 48.30)
After 2 weeks of the intervention				9.519	0.002^a
Combined group	11	54	83.08 (71.31, 90.85)
Eszopiclone alone group	27	38	58.46 (45.58, 70.34)
After follow-up at week 3				7.530	0.006^a
Combined group	11	54	83.08 (71.31, 90.85)
Eszopiclone alone group	25	40	61.54 (48.62, 73.09)

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Efficacy of Zhumian Tang formula granules (助眠汤配方颗粒) combined with eszopiclone for the treatment of poor sleep quality: a multi-center, randomized controlled, superiority trial

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