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Standard Protocol Items for Clinical Trials with Traditional Chinese Medicine 2018: Recommendations, Explanation and Elaboration (SPIRIT-TCM Extension 2018).
Dai, Liang; Cheng, Chung-Wah; Tian, Ran; Zhong, Linda Ld; Li, You-Ping; Lyu, Ai-Ping; Chan, An-Wen; Shang, Hong-Cai; Bian, Zhao-Xiang.
Afiliación
  • Dai L; Hong Kong Chinese Medicine Clinical Study Centre, School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China.
  • Cheng CW; Institute of Digestive Diseases, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, China.
  • Tian R; Hong Kong Chinese Medicine Clinical Study Centre, School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China.
  • Zhong LL; Hong Kong Chinese Medicine Clinical Study Centre, School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China.
  • Li YP; Hong Kong Chinese Medicine Clinical Study Centre, School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China.
  • Lyu AP; Chinese Evidence-Based Medicine Centre, Sichuan University, Chengdu, 610041, China.
  • Chan AW; Hong Kong Chinese Medicine Clinical Study Centre, School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China.
  • Shang HC; Women's College Research Institute, Women's College Hospital, University of Toronto, Toronto, Ontario, M5G 1N8, Canada.
  • Bian ZX; Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100007, China.
Chin J Integr Med ; 25(1): 71-79, 2019 Jan.
Article en En | MEDLINE | ID: mdl-30484022
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Protocolos Clínicos / Ensayos Clínicos como Asunto / Medicina Tradicional China Tipo de estudio: Diagnostic_studies / Guideline / Qualitative_research Límite: Humans Idioma: En Revista: Chin J Integr Med Asunto de la revista: TERAPIAS COMPLEMENTARES Año: 2019 Tipo del documento: Article País de afiliación: China Pais de publicación: China
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Protocolos Clínicos / Ensayos Clínicos como Asunto / Medicina Tradicional China Tipo de estudio: Diagnostic_studies / Guideline / Qualitative_research Límite: Humans Idioma: En Revista: Chin J Integr Med Asunto de la revista: TERAPIAS COMPLEMENTARES Año: 2019 Tipo del documento: Article País de afiliación: China Pais de publicación: China