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

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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 (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.

Conclusion

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).

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Acknowledement

We appreciate and acknowledge the clinicians Xu BY, Li QY, and Zhang BL from Xiyuan Hospital, China Academy of Chinese Medical Sciences.

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Authors and Affiliations

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

    Zhi-yi Xiong &  Shi-yan Yan

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

    Ying Lu

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

    Li-yun He &  Shi-yan Yan

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

    Run-shun Zhang, Yan-jiao Liu & Jian-gui Zhu

  5. School of Computer and Information Technology, Beijing Jiaotong University, Beijing, 100044, China

    Xue-zhong Zhou

  6. Beijing Xicheng District Community Healthcare Center, Beijing, 100120, China

    Peng Li

  7. China Academy of Chinese Medical Sciences, Beijing, 100700, China

    Bao-yan Liu

Authors
  1. Zhi-yi Xiong
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  2. Ying Lu
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  3. Li-yun He
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  4. Run-shun Zhang
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  5. Xue-zhong Zhou
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  6. Peng Li
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  7. Yan-jiao Liu
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  8. Jian-gui Zhu
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  9. Shi-yan Yan
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  10. Bao-yan Liu
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Contributions

Yan SY, He LY, and Liu BY led the design of the trial. Liu YJ and Zhu JG treated patients with CM. Zhang RS charged of the randomization through a central randomization system. Li P recruited the participants and collected data. Yan SY, Lu Y, Xiong ZY, and Zhou XZ developed the statistical analysis plan and undertook the analyses. Yan SY and Xiong ZY drafted the paper, with critical input from all other authors. Lu Y acted as guarantors. All authors have read and approved the final draft. The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted.

Corresponding authors

Correspondence to Shi-yan Yan or Bao-yan Liu.

Ethics declarations

The authors declare that there is no conflict of interest. The funder of the study had no role in the study design, data collection, data analysis, data interpretation, or writing of the report.

Additional information

Supported by the National Natural Science Foundation of China (No. 81973713 and No. 81303149)

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Xiong, Zy., Lu, Y., He, Ly. et al. Efficacy of Chinese Medicine Treatment Based on Syndrome Differentiation for Primary Insomnia: A Randomized Placebo Controlled Triple-Blinded Trial. Chin. J. Integr. Med. (2024). https://doi.org/10.1007/s11655-024-3661-4

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  • DOI: https://doi.org/10.1007/s11655-024-3661-4

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