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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