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Journal of Traditional Chinese Medicine >

2024 , Vol. 44 >Issue 1: 163 - 171

DOI: https://doi.org/10.19852/j.cnki.jtcm.2024.01.002

Original articles

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

  • Yichen WANG ,
  • Shiyi WU ,
  • Zhengyan WANG ,
  • Wenling CHANG ,
  • Zhihao XIE ,
  • Xing TANG ,
  • Songmei ZHAO ,
  • Jing ZHOU ,
  • Zehong CHEN ,
  • Chao WANG ,
  • Chunxia YANG
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  • 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 date: 2023-08-21

  Accepted date: 2023-11-27

  Online published: 2023-12-30

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

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

Cite this article

Yichen WANG , Shiyi WU , Zhengyan WANG , Wenling CHANG , Zhihao XIE , Xing TANG , Songmei ZHAO , Jing ZHOU , Zehong CHEN , Chao WANG , Chunxia YANG . 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 . DOI: 10.19852/j.cnki.jtcm.2024.01.002

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