Korean Journal of Acupuncture

Society for Meridian and Acupoint (경락경혈학회)
권호 표지

The Analysis of Incidence and Type of Adverse Events in Acupuncture & Moxibustion Clinical Trials

침구임상시험에서 나타난 이상반응 발생률 및 유형 분석

  • Jung, Hee-Jung (Acupuncture, Moxibustion & Meridian Research Group, Korea Institute of Oriental Medicine) ;
  • Park, Ji-Eun (Acupuncture, Moxibustion & Meridian Research Group, Korea Institute of Oriental Medicine) ;
  • Liu, Yan (Acupuncture, Moxibustion & Meridian Research Group, Korea Institute of Oriental Medicine) ;
  • Kim, Ae-Ran (Acupuncture, Moxibustion & Meridian Research Group, Korea Institute of Oriental Medicine) ;
  • Choi, Sun-Mi (Acupuncture, Moxibustion & Meridian Research Group, Korea Institute of Oriental Medicine)
  • 정희정 (한국한의학연구원 침구경락연구그룹) ;
  • 박지은 (한국한의학연구원 침구경락연구그룹) ;
  • 류연 (한국한의학연구원 침구경락연구그룹) ;
  • 김애란 (한국한의학연구원 침구경락연구그룹) ;
  • 최선미 (한국한의학연구원 침구경락연구그룹)
  • Received : 2012.08.24
  • Accepted : 2012.09.11
  • Published : 2012.09.27
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Abstract

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.

Keywords

References

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