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KMID : 1123920110250050927
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Korean Journal of Oriental Physiology and Pathology
2011 Volume.25 No. 5 p.927 ~ p.933
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Quality Assessment of Randomized Controlled Trials using Herbal Remedies in Korea
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Kim Yun-Young
Yoo Jong-Hyang
Lee Su-Kyung
Lee Si-Woo
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Abstract
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This study aimed to evaluate the quality of herbal medicine-related RCT (Randomized controlled clinical trial) papers. 79 papers were searched from the domestic Hakjin paper list, and 16 papers of them were evaluated in terms of the Jadad Quality Assessment Scale and the adequacy of allocation concealment, and ethical validity. The evaluation results from Jadad Quality Assessment Scale showed that 15 papers showed high quality with the Jadad score of 3 points or higher, and none of the papers had a problem with randomization and double-blinding. The evaluation results from adequacy of allocation concealment showed that 3 of the papers were executed proper allocation concealment, and all of them had 5 points of Jadad score. IRB (Institutional Review Board) approval and written consent was investigated for the evaluation of ethical validity, and 12 papers had the IRB approval, and 14 papers had written consent. The papers published before 2005 were absent of IRB approval and written consent, and none of the papers had IRB approval number. From the above results, it is concluded that rigorous clinical research led high quality of research papers, and the ethical aspect of clinical researches are getting more important to protect the rights of research participants.
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KEYWORD
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quality assessment, randomized controlled trials, herbal remedies
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