FOLLOWUS
Syndrome pattern and its application in parallel randomized controlled trials
- Chinese Journal of Integrative Medicine Vol. 19, Issue 3, Pages: 163-171(2013)
- Affiliations：
1. Division of Clinical Medicine, School of Korean Medicine, Pusan National University, Yangsan, Republic of Korea
2. Department of Korean Medicine, School of Korean Medicine, Pusan National University, Yangsan, Republic of Korea
3. Department of Korean Medical Science, School of Korean Medicine, Pusan National University, Yangsan, Republic of Korea
- Author bio：
- Funds：
DOI：10.1007/s11655-012-1256-y
CLC：Published：2013，
Published Online：3 December 2012，
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Shin, BC., Kim, S. & Cho, YH. Syndrome pattern and its application in parallel randomized controlled trials., Chin. J. Integr. Med. 19, 163–171 (2013). https://doi.org/10.1007/s11655-012-1256-y
Byung-Cheul Shin, Sina Kim, Young-Hun Cho. Syndrome pattern and its application in parallel randomized controlled trials. [J]. Chinese Journal of Integrative Medicine 19(3):163-171(2013)
Shin, BC., Kim, S. & Cho, YH. Syndrome pattern and its application in parallel randomized controlled trials., Chin. J. Integr. Med. 19, 163–171 (2013). https://doi.org/10.1007/s11655-012-1256-y DOI：
Byung-Cheul Shin, Sina Kim, Young-Hun Cho. Syndrome pattern and its application in parallel randomized controlled trials. [J]. Chinese Journal of Integrative Medicine 19(3):163-171(2013) DOI： 10.1007/s11655-012-1256-y.
摘要
Syndrome pattern (SP) is a core concept of Chinese medicine (CM) and is used to diagnose and treat patients based on an overall analysis of symptoms and signs. This study aimed to systematically review randomized controlled trials (RCTs) using the SP concept and to demonstrate how the SP concept could be applied to the study design of parallel RCTs
considering a gold standard of clinical research. After conducting a brief systematic review by way of a PubMed search
we analyzed how the SP concept was applied to the design of RCT in a CM herbal medicine trial. We then formulated possible research questions
applied the SP concept to answer the research questions
and suggested possible RCT designs to be used for conducting future trials. Fourteen RCTs were included in our systematic review
and three key points of the SP concept were formulated for the design of parallel RCTs: the time point of SP diagnosis between before and after randomization; the relationship between the international classification of diseases (ICD) and SP for the inclusion of target population; and the proper diagnostic method of SP. In this study
we formulated three possible research questions and then suggested perspectives for five possible RCT models arrived at using SP concepts. Future trials applying SP concept to RCTs should overcome the shortcomings of past SP trials
moving CM forward from experience-based to evidence-based medicine.
Abstract
Syndrome pattern (SP) is a core concept of Chinese medicine (CM) and is used to diagnose and treat patients based on an overall analysis of symptoms and signs. This study aimed to systematically review randomized controlled trials (RCTs) using the SP concept and to demonstrate how the SP concept could be applied to the study design of parallel RCTs
considering a gold standard of clinical research. After conducting a brief systematic review by way of a PubMed search
we analyzed how the SP concept was applied to the design of RCT in a CM herbal medicine trial. We then formulated possible research questions
applied the SP concept to answer the research questions
and suggested possible RCT designs to be used for conducting future trials. Fourteen RCTs were included in our systematic review
and three key points of the SP concept were formulated for the design of parallel RCTs: the time point of SP diagnosis between before and after randomization; the relationship between the international classification of diseases (ICD) and SP for the inclusion of target population; and the proper diagnostic method of SP. In this study
we formulated three possible research questions and then suggested perspectives for five possible RCT models arrived at using SP concepts. Future trials applying SP concept to RCTs should overcome the shortcomings of past SP trials
moving CM forward from experience-based to evidence-based medicine.
关键词
syndrome patternrandomized controlled trialTraditional Chinese Medicineevidence-based medicineIntegrative Medicine
Keywords
syndrome patternrandomized controlled trialTraditional Chinese Medicineevidence-based medicineIntegrative Medicine
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