首页|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

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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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.

sleep qualityeszopiclonerandomized controlled trialsuperiorityZhumian 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

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Orthopedic geriatrics department,Sichuan Province Orthopedic Hospital,Chengdu 610093,China

Department of Epidemiology and Biostatistics,West China School of Public Health and West China Fourth Hospital,Sichuan University,Chengdu 610041,China

Sub-health department,Sichuan Integrative Medicine Hospital,Chengdu 610041,China

College of Acupuncture and Massage,Chengdu University of Traditional Chinese Medicine,Chengdu 610041,China

Internal Medicine Department,Ya'an Hospital of Traditional Chinese Medicine,Ya'an 625000,China

Preventive Treatment of Disease Center,Dazhou Integrated TCM and Western Medicine Hospital,Dazhou Second People's Hospital,Dazhou 635000,China

Geriatrics Department,Dayi Wang Country Hospital of Traditional Chinese Medicine,Chengdu 611330,China

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Sichuan Province Central Guided Local Science and Technology Development Special Project四川省自然科学基金

2021ZYD01092022NSFSC0858

2024

10.19852/j.cnki.jtcm.2024.01.002

中医杂志(英文版)
中国中医药学会 中国中医研究院

中医杂志(英文版)

影响因子：0.855
ISSN：0255-2922
年,卷(期)：2024.44(1)
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