Lianbo Li,1,* Mingyue Xia,1,* Xinyu Chen,2,* Fengxiao Wang,1 Jie Li,1 Na Zhao,1 Zhen Liu,1 Yunfei Chen1 

1Department of Acupuncture and Moxibustion, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, People’s Republic of China; 2Macau University of Science and Technology, Macau, People’s Republic of China

*These authors contributed equally to this work

Correspondence: Yunfei Chen, Department of Acupuncture and Moxibustion, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, People’s Republic of China, Tel/Fax +86-21-65162628, Email icyf1968@163.com Zhen Liu, Department of Acupuncture and Moxibustion, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, People’s Republic of China, Tel/Fax +86-21-65162628, Email liuzhen8918@163.com

Background: Chronic Insomnia Disorder (CID) significantly impairs both sleep quality and daytime functioning. However, current treatments have limited efficacy in improving daytime function and are often associated with side effects. This highlights the urgent need for effective and safe therapeutic approaches that can target both nocturnal and daytime symptoms.
Objective: To evaluate the clinical efficacy and safety of acupuncture in improving sleep quality and daytime functioning in patients with chronic insomnia, and to optimize its treatment protocol.
Methods: This study was a single-blind, randomised, controlled trial. The treatment group received acupuncture at HT7, BL15, LR3 and BL18, while the control group was treated at GV20, EX-HN22, BL62 and KI6. Each group underwent 10 sessions administered three times per week. The Insomnia Severity Index (ISI) served as the primary evaluation index for sleep efficacy, while the Pittsburgh Sleep Quality Index (PSQI) and polysomnography (PSG) were secondary indexes for sleep quality. The Beck Anxiety Inventory (BAI), Beck Depression Inventory (BDI), Fatigue Severity Scale (FSS), and Epworth Sleepiness Scale (ESS) were used to evaluate daytime functional impairment.
Results: Totally 76 patients were included in this study and randomly assigned to the treatment group (n=38) and the control group (n=38). Both groups showed significant improvements in sleep quality and daytime functioning. The treatment group exhibited a mean ISI reduction of 7.58 points versus 5.71 points in the control group; however, this difference was not statistically significant. PSG data revealed similar improvements in total sleep time, sleep efficiency, and REM sleep percentage across groups. Notably, the treatment group demonstrated significantly greater reductions in BAI and BDI scores (p< 0.05), while improvements in FSS and ESS scores were comparable.
Conclusion: Acupuncture is an effective and safe treatment to improve sleep as well as daytime functioning for chronic insomnia. The protocol using HT7, BL15, LR3 and BL18 may offer added benefits for reducing anxiety and depressive symptoms.
Clinical Trial Registration: This study was registered with the China Clinical Trial Registry (CCTR), registration ID: ChiCTR2200066102.
Plain Language Summary: Chronic Insomnia Disorder (CID) significantly impairs sleep quality and daytime functioning, leading to fatigue and mood disturbances, and poses a major public health challenge. Current treatments face limitations in accessibility and may cause side effects. This highlights the need for safe, effective, and accessible therapies that address both nocturnal and daytime symptoms.
This study introduces an optimized acupuncture protocol targeting the heart and liver through the Heart-Liver Shu-Yuan acupoint combination. Unlike previous studies that focused primarily on sleep quality, this research evaluates both nocturnal sleep and daytime functioning, addressing emotional and cognitive disturbances often overlooked in CID management.
The findings of this RCT have important clinical implications, offering evidence for a personalized, efficient acupuncture approach that improves both sleep and daytime symptoms. This could inform more comprehensive treatment guidelines for CID and promote the integration of acupuncture into standard care practices.

Keywords: acupuncture, chronic insomnia, daytime function, randomised controlled trial