中医辨证治疗原发性失眠的疗效评价：一项随机、三盲、安慰剂对照试验

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

doi:10.1007/s11655-024-3661-4

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中医辨证治疗原发性失眠的疗效评价：一项随机、三盲、安慰剂对照试验

Original Article | Updated：2024-09-23

- 中医辨证治疗原发性失眠的疗效评价：一项随机、三盲、安慰剂对照试验
- Efficacy of Chinese Medicine Treatment Based on Syndrome Differentiation for Primary Insomnia: A Randomized Placebo Controlled Triple-Blinded Trial
- 中国结合医学杂志（英文版） 2024年30卷第10期页码：867-876
- Affiliations：
  
  1.International Acupuncture and Moxibustion Innovation Institute,School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing (100029), China
  2.Department of Biomedical Data Science, Stanford University School of Medicine, CA 94305, USA
  3.Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing(100700), China
  4.Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing (100053), China
  5.Beijing Jiaotong University, School of Computer and Information Technology, Beijing (100044), China
  6.Beijing Xicheng District Community Healthcare Center, Beijing (100120), China
  7.China Academy of Chinese Medical Sciences, Beijing (100700), China
- Author bio：
  
  Prof. YAN Shi-yan, E-mail: yanshiyan@bucm.edu.cn;
  Prof. LIU Bao-yan, E-mail: liuby5505@139.com
- Funds：
  
  the National Natural Science Foundation of China(81973713;81303149)
- DOI：10.1007/s11655-024-3661-4
  中图分类号：
- 纸质出版日期：2024-10，
  
  网络出版日期：2024-05-16，
  
  录用日期：2023-09-08
- Accepted：
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中医辨证治疗原发性失眠的疗效评价：一项随机、三盲、安慰剂对照试验[J]. 中国结合医学杂志（英文版）, 2024,30(10):867-876.

XIONG Zhi-yi, LU Ying, HE Li-yun, et al. Efficacy of Chinese Medicine Treatment Based on Syndrome Differentiation for Primary Insomnia: A Randomized Placebo Controlled Triple-Blinded Trial[J]. Chinese Journal of Integrative Medicine, 2024,30(10):867-876.
中医辨证治疗原发性失眠的疗效评价：一项随机、三盲、安慰剂对照试验[J]. 中国结合医学杂志（英文版）, 2024,30(10):867-876. DOI： 10.1007/s11655-024-3661-4.

XIONG Zhi-yi, LU Ying, HE Li-yun, et al. Efficacy of Chinese Medicine Treatment Based on Syndrome Differentiation for Primary Insomnia: A Randomized Placebo Controlled Triple-Blinded Trial[J]. Chinese Journal of Integrative Medicine, 2024,30(10):867-876. DOI： 10.1007/s11655-024-3661-4.

摘要

目的

结合辨证论治的特点

评价中医治疗原发性失眠的疗效.

方法

将116名年龄在18-65岁之间的中重度原发性失眠患者随机分配到安慰剂组 (

=20) 或中医治疗组 (

=96)

进行为期4周的治疗和4周的随访. 由3位中医临床医师分别独立对每位患者进行辨证治疗

并随机接受其中任一位医师的处方或安慰剂. 主要结局指标是总睡眠时间 (TST) 较基线的变化. 次要指标包括入睡潜伏期(SOL)、入睡后觉醒时间(WASO)、睡眠效率、匹兹堡睡眠质量指数(PSQI)和中医症状.

结果

与安慰剂组相比

中医治疗组的TST平均多增加0.6h (95%CI: 0.3-0.9

0.001)

34.1%的患者TST增加超过0.5h (95%CI: 10.3%-58.0%

=0.005) . 中医治疗组的PSQI变化为-3.3 (-3.8~-2.7)

与安慰剂组的差异为-2.0 (-3.2~-0.8

0.001). 中医治疗组的中医证候评分比安慰剂组多降低-2.0 (-3.3~-0.7

=0.005) . SOL和WASO变化的组间差异无统计学意义. 对临床医生的处方进行分析发现

血虚和肝郁是最常见的证候类型. 临床医生的处方相对稳定

但用药有所不同. 所有的不良事件均为轻度

且与研究治疗无关.

结论

中医辨证论治可以增加原发性失眠患者的TST

改善睡眠质量

对原发性失眠是一种有效且安全的治疗方法. 未来的研究中

应重视对远期疗效的验证和对治疗医师固定中草药处方的探索. (注册号NO.NCT01613183)

Abstract

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 (

=20) or the CM group (

=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

0.001) TST and 34.1% (10.3%–58.0%

=0.005) more patients beyond 0.5 h TST increment than that of the placebo gr

oup. PSQI was changed –3.3 (–3.8 to –2.7) in the CM group

a –2.0 (–3.2 to –0.8

0.001) difference from the placebo group. The CM symptom score in the CM group decreased –2.0 (–3.3 to –0.7

=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)

关键词

原发性失眠中医辨证随机对照试验

Keywords

primary insomniaChinese medicinesyndrome differentiationrandomized controlled trial

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