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KMID : 1129720120290030421
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Korean Journal of Acupuncture
2012 Volume.29 No. 3 p.421 ~ p.430
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The Analysis of Incidence and Type of Adverse Events in Acupuncture & Moxibustion Clinical Trials
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Jung Hee-Jung
Park Ji-Eun
Liu Yan
Kim Ae-Ran
Choi Sun-Mi
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Abstract
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Objectives: We investigated the incidence rate and type of adverse events associated with RCTs(Randomized Controlled Trials) of acupuncture and moxibustion.
Methods: This study included 949 patients who received acupuncture or moxibustion or usual care from 8 RCTs. We collected data including gender and age of patients, intervention, treatment frequency and type of adverse events in clinical trials from their case report forms.
Results: Among the 949 patients, 83 patients(8.7%) suffered at least one adverse event throughout the clinical trials. Types of adverse event in acupuncture & moxibustion clinical trials are common cold, skin changes, pain, dizziness, bruise, gastrointestinal diseases, changes of blood chemistry, burn. Adverse events were significantly correlated to patients’ age, intervention, body mass index and treatment group.
Conclusions: A Guide-line for collecting and managing adverse events of acupuncture & moxibustion clinical trials are needed.
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KEYWORD
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adverse event, acupuncture, moxibustion, clinical trial
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