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

Zhi-Yi Xiong; Ying Lu; Li-Yun He; Run-Shun Zhang; Xue-Zhong Zhou; Peng Li; Yan-Jiao Liu; Jian-Gui Zhu; Shi-Yan Yan; Bao-Yan Liu

doi:10.1007/s11655-024-3661-4

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

Chin J Integr Med. 2024 May 16. doi: 10.1007/s11655-024-3661-4. Online ahead of print.

Authors

Zhi-Yi Xiong¹, Ying Lu², Li-Yun He³, Run-Shun Zhang⁴, Xue-Zhong Zhou⁵, Peng Li⁶, Yan-Jiao Liu⁴, Jian-Gui Zhu⁴, Shi-Yan Yan^{7

8}, Bao-Yan Liu⁹

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, Stanford, 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 School of Computer and Information Technology, Beijing Jiaotong University, Beijing, 100044, China.
⁶ Beijing Xicheng District Community Healthcare Center, Beijing, 100120, China.
⁷ International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, 100029, China. yanshiyan@bucm.edu.cn.
⁸ Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, 100700, China. yanshiyan@bucm.edu.cn.
⁹ China Academy of Chinese Medical Sciences, Beijing, 100700, China. liuby5505@139.com.

PMID: 38753273
DOI: 10.1007/s11655-024-3661-4

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).

Keywords: Chinese medicine; primary insomnia; randomized controlled trial; syndrome differentiation.

Associated data

ClinicalTrials.gov/NCT01613183