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KMID : 0363620140350010114
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Journal of Korean Oriental Medicine
2014 Volume.35 No. 1 p.114 ~ p.123
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Introduction of evidence-based practical medicine through safety classification for herbal medicine(1)
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Park Yeong-Chul
Lee Sun-Dong
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Abstract
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Objectives: Evidence-based medicine(EBM) advocates the use of up-to-date “best” scientific evidence from health care research as the basis for making medical decisions. EBM also has been applied to traditional Korean medicine(TKM), especially in the field of safety. Recently, the standard prescription for TKM by Korea Institute of Oriental Medicine was published based on toxic index from various toxicity tests. However, there are some limitations when the results from the study based on EBM are applied in clinics. To overcome these imitations, the term “evidence-based practical medicine” was developed and defined as clinically applicable results from the study based on EBM. And safety classification for TKM was suggested as an example of evidence-based practical medicine.
Methods: For safety classification for TKM, the data for LD50(50% lethal dose), which was transformed to theoretical LD1(1% lethal dose), was analyzed as one of tools for EMB study and divided by maximum dose used in clinics.
Results and Conclusions: As a result, human equivalent dose(HED)-based MOS(margin of safety) for korean traditional medicine was calculated and used for safety classification with 5 categories. These categories would be helpful for oriental medicine clinicians to decide the increase and decrease of dosage according to various factors such as patient’s sensitivity, potential toxicity of herbal medicines, clinician’s experience for better cure. Thus, this safety classification provides some evidences enough that evidence-based practical medicine should be not the same with EBM and defined differently from EBM.
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KEYWORD
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Herbal medicine, Safety classification, Evidence-based practical medicine
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