Standard Protocol Items for Clinical Trials with Traditional Chinese Medicine 2018: Recommendations, Explanation and Elaboration (SPIRIT-TCM Extension 2018).
10.1007/s11655-018-2999-x
- Author:
Liang DAI
1
;
Chung-Wah CHENG
1
;
Ran TIAN
1
;
Linda Ld ZHONG
1
;
You-Ping LI
2
;
Ai-Ping LYU
1
;
An-Wen CHAN
3
;
Hong-Cai SHANG
4
;
Zhao-Xiang BIAN
5
Author Information
1. Hong Kong Chinese Medicine Clinical Study Centre, School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China.
2. Chinese Evidence-Based Medicine Centre, Sichuan University, Chengdu, 610041, China.
3. Women's College Research Institute, Women's College Hospital, University of Toronto, Toronto, Ontario, M5G 1N8, Canada.
4. Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100007, China.
5. Hong Kong Chinese Medicine Clinical Study Centre, School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China. bzxiang@hkbu.edu.hk.
- Publication Type:Journal Article
- Keywords:
SPIRIT;
clinical trial;
extension;
recommendation;
traditional Chinese medicine
- MeSH:
Clinical Protocols;
Clinical Trials as Topic;
Humans;
Medicine, Chinese Traditional;
Research Design
- From:
Chinese journal of integrative medicine
2019;25(1):71-79
- CountryChina
- Language:English
-
Abstract:
Traditional Chinese Medicine (TCM) is one of the oldest systems of medicine. More and more attention has been paid to TCM application, but the variable quality of clinical trials with TCM impedes its widespread acceptance. The Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 Statement has established guidelines for designing clinical trials to ensure that the trial results are accurate and reliable. However, there are difficulties when applying SPIRIT 2013 Statement to trials with TCM, due to the unique theory and the characteristic of TCM intervention. An Extension to the original SPIRIT was developed to ensure the quality of trial design with TCM. As Chinese herbal formulae, acupuncture and moxibustion are common and representative interventions in TCM practice, the executive working group determined that the SPIRIT-TCM Extension focus on these three interventions. Extension was developed through initiation, 3 rounds of Delphi consensus survey, and finalizing expert meeting. Seven items from the SPIRIT 2013 Statement were modified, namely, "title", "background and rationale", "objectives", "eligibility criteria", "interventions", "outcomes", and "data collection methods". The Extension includes the introduction of the concept of TCM pattern and 3 major TCM interventions, with examples and explanations. The SPIRIT-TCM Extension 2018 provides suggestion for investigators in designing high quality TCM clinical trials. It is expected that wide dissemination and application of this extension ensure continuous improvement of TCM trial quality throughout the world.
