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KMID : 0363320090300010181
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Journal of Korean Oriental Internal Medicine
2009 Volume.30 No. 1 p.181 ~ p.190
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Suggestion of Herbal Medicine-Induced Liver Injury Investigation Forms for Improving the Research Quality of Herbal Safety
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Yun Young-Ju
Shin Byung-Cheul
Shin Woo-Jin
Jang In-Soo
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Abstract
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It is important to establish the safety of herbal medicine because of its frequent and widespread use in Korea. Several studies on the safety of herbal medicine have been performed and there have been rare serious adverse drug reactions from those reports in Korea. However, the results are not strongly supported because of not adopting appropriate enough research methodology as to make the safety issue clear. For improving the quality of the safety research on herbal medicine. including investigations of drug induced liver injury (DILl). the aim of this study was to suggest herbal medicine-induced liver injury investigation forms for performing reasonable safety research. After a systematic review of the preceding studies regarding herbal safety in Korea was performed in 2008, we assessed the quality and the limitations of the primary studies. Two investigation forms for herbal safety research were made as a following step. one a basic investigation form for herbal safety research and the other an advanced investigation form for suspected DILl cases, Those forms include the essential informations and data needed to make an appropriate assessment of whether DILl occurred during or after the use of herbal medicine. Guidelines for using those forms and other recommendations were also suggested. More rigorous studies are required for answering the safety issue of herbal medicine as well as the efficacy issue. We hope for wide use and improvement of those investigation forms in the study of herbal safety by many researchers for establishing better evidences in Korea.
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KEYWORD
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herbal medicine, drug induced liver injury, investigation form, causality assessment, safety, adverse drug reaction
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