首页|Efficacy of Chinese Medicine Treatment Based on Syndrome Differentiation for Primary Insomnia:A Randomized Placebo Controlled Triple-Blinded Trial

Efficacy of Chinese Medicine Treatment Based on Syndrome Differentiation for Primary Insomnia:A Randomized Placebo Controlled Triple-Blinded Trial

扫码查看
原文链接
  • NETL
  • NSTL
  • 万方数据
Objective:To assess efficacy of Chinese medicine(CM)on insomnia considering characteristics of treatment based on syndrome differentiation.Methods:A total of 116 participants aged 18 to 65 years with moderate and severe primary insomnia were randomized to the placebo(n=20)or the CM group(n=96)for a 4-week treatment and a 4-week follow-up.Three CM clinicians independently prescribed treatments for each patient based on syndromes differentiation.The primary outcome was change in total sleep time(TST)from baseline.Secondary endpoints included sleep onset latency(SOL),wake time after sleep onset(WASO),sleep efficiency,Pittsburgh Sleep Quality Index(PSQI)and CM symptoms.Results:The CM group had an average 0.6 h more(95％confidence interval(CI):0.3-0.9,P＜0.001)TST and 34.1％(10.3％-58.0％,P=0.005)more patients beyond 0.5 h TST increment than that of the placebo group.PSQI was changed-3.3(-3.8 to-2.7)in the CM group,a-2.0(-3.2 to-0.8,P＜0.001)difference from the placebo group.The CM symptom score in the CM group decreased-2.0(-3.3 to-0.7,P=0.003)more than the placebo group.SOL and WASO changes were not significantly different between groups.The analysis of prescriptions by these clinicians revealed blood deficiency and Liver stagnation as the most common syndromes.Prescriptions for these clinicians displayed relative stability,while the herbs varied.All adverse events were mild and were not related to study treatment.Conclusions:CM treatment based on syndrome differentiation can increase TST and improve sleep quality of primary insomnia.It is effective and safe for primary insomnia.In future studies,the long-term efficacy validation and the exploratory of eutherapeutic clinicians'fixed herb formulas should be addressed.(Registration No.NCT01613183)

primary insomniaChinese medicinesyndrome differentiationrandomized controlled trial

XIONG Zhi-yi、LU Ying、HE Li-yun、ZHANG Run-shun、ZHOU Xue-zhong、LI Peng、LIU Yan-jiao、ZHU Jian-gui、YAN Shi-yan、LIU Bao-yan

展开 >

International Acupuncture and Moxibustion Innovation Institute,School of Acupuncture-Moxibustion and Tuina,Beijing University of Chinese Medicine,Beijing(100029),China

Department of Biomedical Data Science,Stanford University School of Medicine,CA 94305,USA

Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China

Guang,anmen Hospital,China Academy of Chinese Medical Sciences,Beijing 100053,China

Beijing Jiaotong University,School of Computer and Information Technology,Beijing(100044),China

Beijing Xicheng District Community Healthcare Center,Beijing(100120),China

Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing(100700),China

China Academy of Chinese Medical Sciences,Beijing 100700,China

展开 >

National Natural Science Foundation of ChinaNational Natural Science Foundation of China

8197371381303149

2024

10.1007/s11655-024-3661-4

中国结合医学杂志(英文版)
中国中西医结合学会 中国中医研究院

中国结合医学杂志(英文版)

CSTPCD
影响因子：1.056
ISSN：1672-0415
年,卷(期)：2024.30(10)