Chinese Journal of Integrative Medicine

, Volume 25, Issue 1, pp 71–79 | Cite as

Standard Protocol Items for Clinical Trials with Traditional Chinese Medicine 2018: Recommendations, Explanation and Elaboration (SPIRIT-TCM Extension 2018)

  • Liang Dai
  • Chung-wah Cheng
  • Ran Tian
  • Linda LD Zhong
  • You-ping Li
  • Ai-ping Lyu
  • An-wen Chan
  • Hong-cai Shang
  • Zhao-xiang BianEmail author
Regulation and Guideline


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.


SPIRIT traditional Chinese medicine clinical trial extension recommendation 


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We thanks David Moher for his critical comments about this project. Special thanks for Dr. Martha Dahlen for her help in polishing this manuscript.

Supplementary material

11655_2018_2999_MOESM1_ESM.pdf (983 kb)
Standard Protocol Items for Clinical Trials with Traditional Chinese Medicine 2018: Recommendations, Explanation and Elaboration (SPIRIT-TCM Extension 2018)


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Copyright information

© Chinese Association of the Integration of Traditional and Western Medicine 2018

Authors and Affiliations

  • Liang Dai
    • 1
    • 2
  • Chung-wah Cheng
    • 1
  • Ran Tian
    • 1
  • Linda LD Zhong
    • 1
  • You-ping Li
    • 3
  • Ai-ping Lyu
    • 1
  • An-wen Chan
    • 4
  • Hong-cai Shang
    • 5
  • Zhao-xiang Bian
    • 1
    Email author
  1. 1.Hong Kong Chinese Medicine Clinical Study Centre, School of Chinese MedicineHong Kong Baptist UniversityHong Kong SARChina
  2. 2.Institute of Digestive Diseases, Longhua HospitalShanghai University of Traditional Chinese MedicineShanghaiChina
  3. 3.Chinese Evidence-Based Medicine CentreSichuan UniversityChengduChina
  4. 4.Women’s College Research Institute, Women’s College HospitalUniversity of TorontoTorontoCanada
  5. 5.Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen HospitalBeijing University of Chinese MedicineBeijingChina

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