Obesity, defined as the excessive accumulation of body fat, increases the risk of hypertension, dyslipidemia, type 2 diabetes (diabetes), coronary heart disease (CHD), stroke, and certain cancers, seriously affecting human health and daily life. According to the WHO, more than one billion people worldwide are obese, and the number is still increasing. Traditional Chinese medicine (TCM), such as Chinese herbal medicines and acupuncture intervention methods, has been shown to be effective in treating obesity in many studies. It also alleviates the manifestations of spleen deficiency, phlegm, and dampness in obese patients. However, in the current clinical trials of TCM for obesity, the reporting of outcomes is mostly limited to weight and body mass index (BMI), and the reporting of outcomes varies greatly between studies. This makes it impossible to provide high-level evidence when conducting systematic reviews and meta-analysis due to high heterogeneity. In addition, most studies failed to report efficiency, TCM symptoms (zheng hou in Chinese), or other outcomes. Therefore, it is necessary and urgent to develop a Core outcome set (COS) for Traditional Chinese Medicine (including Chinese herbal medicines, acupuncture, acupoint catgut embedding, etc.) in the treatment of Obesity. The COS can provide a reference for the selection of outcomes and improve the standardization and consistency of the outcome report of related clinical research. We hope that using this COS will better reflect the efficacy of Traditional Chinese medicine on Obesity. After searching the COMET database, no ongoing or completed COS studies on Traditional Chinese Medicine for adult obesity were found.
AimTo develop a core outcome set for traditional Chinese medicine treatment for obesity
ContributorsWu Tongtong, Yu Yan, and Yu Ruifang from the second clinical college of Guangzhou University of Chinese Medicine, China.
Liu Shaonan, Yang Lihong, Chen Xueyin, Huang Qian, Chen Genghang, Lai Jiaqi, and Guo Xinfeng from the second affiliated hospital of Guangzhou University of Chinese Medicine, China.
Disease Category: Endocrine & metabolic
Disease Name: Obesity
Age Range: 18 - 100
Sex: Either
Nature of Intervention: Traditional Chinese Medicine
- Clinical experts
- Conference participants
- Consumers (caregivers)
- Consumers (patients)
- Journal editors
- Methodologists
- Policy makers
- Researchers
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Interview
- Survey
- Systematic review
Firstly, The list of outcomes will be generated by systematic review and qualitative research with Clinicians and patients. And then we will conduct two rounds of the Delphi process to determine which outcome domains to be included in the core outcome set. Finally, a consensus meeting will be held to confirm the recommended core outcome set.