Insomnia is a common type of sleep disorder, which usually refers to a disorder of sleep rhythm due to insufficient sleep time or quality. According to the diagnostic criteria of ICD-11, non organic insomnia refers to persistent symptoms of falling asleep, maintaining sleep, or poor sleep quality without any significant physical disease or drug impact, and these symptoms have an impact on daily functions.According to relevant surveys, about 35% to 50% of people worldwide experience insomnia, which is closely related to the occurrence and progression of cardiovascular diseases, obesity, Parkinson's disease, anxiety, depression, and other neurological diseases. Currently, sedative and hypnotic drugs are the first choice in the treatment of insomnia in Western medicine. However, long-term use of these drugs is prone to drug resistance, addiction, and many adverse reactions. Traditional Chinese medicine has some advantages in treating insomnia. However, the heterogeneity of these trial outcome reports hinders their comprehensive clinical results in meta-analysis, thereby reducing the value of clinical trials. At the same time, there may be a risk of selective outcome reporting bias in clinical trials. Therefore, it is necessary and urgent to establish a core outcome set (COS) for the treatment of non organic insomnia with traditional Chinese medicine.
The relevant studies include "Pharmacologic management of insomnia in children and adolescents: consensus statement" and "Developing patient-reported core outcome sets for 10 predominant diseases of heat-sensitive moxibustion in community study". However, the interventions mentioned in these studies mainly involve heat-sensitive moxibustion, while the interventions in this study mainly include Chinese patent medicines, decoctions, and Chinese medicine injections. The age range in this study is broader compared to the other studies which are limited to children and adolescents. Therefore, this study differs from other approaches in terms of study population, interventions, research objectives, etc.
To develop a core outcome set for Traditional Chinese Medicine in non organic insomnia
ContributorsPrincipal investigator:
Wenke Zheng,Evidence-Based Medicine Center,Tianjin University of Traditional Chinese Medicine,Tianjin,China
Other contributors:Ming Zhuang,Evidence-Based Medicine Center,Tianjin University of Traditional Chinese Medicine,Tianjin,China
Disease Category: Neurology
Disease Name: Insomnia
Age Range: 0 - 100
Sex: Either
Nature of Intervention: Traditional Chinese Medicine
- Clinical experts
- Conference participants
- Consumers (patients)
- Researchers
- COS for practice
- Consensus conference
- Delphi process
- Interview
- Systematic review
(1) Systematic literature review
(2) Qualitative semi-structured interview
(3)Two rounds Delphi Survey
(4) Consensus conference