Protocol for the Practice guideline for Traditional Chinese Medicine Preventive Treatment on Insomnia disorder

Yuting Duan ^1,2,3,4,5 Yu Wang ⁶ Haichun Yang ^2,3,5,7 Yuejuan Cai ⁴ Shengwei Wu ^8,9 Pinge Zhao ^8,9 Sande Gao ⁷ Enyi Liu ^3,7 Peijing Rong ^10* Lin Yu ^2,3,4,5,7*

• ¹ The Affiliated Traditional Chinese Medicine Hospital, Guangzhou Medical University, Guangzhou, P.R. China, Guangzhou, China
• ² Evidence-based Medicine Center, The Affiliated Traditional Chinese Medicine Hospital, Guangzhou Medical University, Guangzhou, China
• ³ Sleep Research Institute of Traditional Chinese Medicine, Guangzhou Medical University, Guangzhou, China
• ⁴ The Affiliated Guangzhou Hospital of TCM of Guangzhou University of Chinese Medicine, Guangzhou, China
• ⁵ Clinical School of Integrated Traditional Chinese and Western Medicine, Guangzhou Medical University, Guangzhou, China
• ⁶ Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing, China
• ⁷ The Affiliated Traditional Chinese Medicine Hospital, Guangzhou Medical University, Guangzhou, China
• ⁸ The Affiliated Brain Hospital of Guangzhou Medical University, Guangzhou Medical University, Guangzhou, China
• ⁹ Key Laboratory of Neurogenetics and Channelopathies of Guangdong Province and the Ministry of Education of China, Guangzhou Medical University, Guangzhou, China
• ¹⁰ Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China

Background: Most guidelines on insomnia focus more on the treatment of patients after the onset of the illness, with little elaboration on prevention before the onset of the illness. In particular, treatment of insomnia disorder using TCM preventive treatment is rarely mentioned. Therefore, to improve the rehabilitation and quality of life of patients with insomnia disorder and its high-risk groups, the Affiliated TCM Hospital of Guangzhou Medical University and the Institute of Acupuncture and Moxibustion, CACMS have jointly initiated the compilation of the "Practice guideline for TCM preventive treatment of Insomnia disorder".: The guideline will adhere to the principles outlined in WHO Handbook for Guidelines Development, 2nd Edition by the World Health Organization and the Guidelines for the Development of Traditional Chinese Medicine by the Chinese Society of Traditional Chinese Medicine. The quality of evidence and strength of recommendations will be based on the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system. The key steps in developing the guideline include: (1) Establishing Guideline Project Group; (2) Conflict of interest management; (3) Research, Selection and Identification of Clinical Questions; (4) Evidence search and evaluation; (5) Quality and grading of evidence; (6) Decision Table for Forming Recommendations; (7) Recommendation Consensus and Determination; (8) Writing the first draft of the guideline; (9) Peer review. Discussion: Based on the theoretical system of "TCM preventive treatment" of Chinese medicine this guideline is to construct a three-tier preventive framework. The development of this guideline can systematically integrate the characteristic techniques of TCM, such as physical identification, emotional regulation, acupuncture and massage, with the evidence-based evidence of modern sleep medicine, and build a new management model. Conclusion: This guideline will serve as an evidence-based reference for standardized TCM preventive treatment methods, promoting the standardization and normative application of TCM preventive treatment in insomnia disorder. Ultimately, this guideline aims to improve the rehabilitation level and life quality of individuals with insomnia disorder and those at high risk of the disease. Trial Registration: The guideline has been registered in English and Chinese at the Practice guideline REgistration for transPAREncy platform (PREPARE). The registration number is PREPARE-2023CN517.