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KMID : 1129720080250020095
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Korean Journal of Acupuncture
2008 Volume.25 No. 2 p.95 ~ p.105
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Causality Assessment of Adverse Events on Acupuncture
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Jung Hee-Jung
Choi Jun-Yong
Park Ji-Eun
Kim Kun-Hyung
Choi Sun-Mi
Oh Dal-Seok
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Abstract
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Objectives: This study is to establish the appropriate assessment of causalities from adverse events (AEs) which are related to acupuncture treatment.
Methods: We assessed thirty AEs which were caused in the early phase trial on concomitant use of acupuncture and herbal medicines. We scored each AE on the questionnaire in Naranjo and SNU algorithm scale which are for drug causality assessment in pharmacoepidemiology.
Results: In Naranjo scale, there were consistencies among the evaluators qualitatively with "Probable", "Possible" degree. In reliability test, parameters, such as, gamma and kendall’s tau-b revealed the degrees of 73%, and 32%, respectively. There were disaccordant tendency in SNU algorithm scale.
Conclusion: A new algorithm which reflects acupuncture properties should be developed and elucidated.
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KEYWORD
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CausalityAssessment, AdverseEvents, Acupuncture, NaranjoAlgorithmScale, SNUAlgorithmScale, ClinicalTrial
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