Reporting of Adverse Events in Randomized Controlled Trials of Bee Venom Acupuncture: A Systematic Review

봉침을 이용한 무작위배정 비교임상시험연구에서의 유해사례 보고에 대한 체계적 문헌고찰

  • Received : 2014.09.25
  • Accepted : 2014.10.15
  • Published : 2014.10.31

Abstract

Objectives Bee venom acupuncture (BVA) is emerging as a potential therapeutic option for several conditions. However, evidence regarding accurate estimates of its adverse events are not available. Therefore, by combining occurrence rates of adverse events in relevant randomized controlled trials (RCTs), we have aimed to give an overall estimated rate of each adverse event following BVA intervention. Methods A systematic search for adverse events of BVA in Pubmed, Cochrane Central Register of Controlled Trials, Embase, NDSL, KoreaMed, KISS, RISS, KISTI, and KMbase was performed. For the quality assessment of the trials, we applied the CONSORT harms reporting recommendations. The overall occurrence rate of each adverse event was assessed as the primary outcome. The overall drop-out rate due to adverse events was assessed as the secondary outcome. Results Ten RCTs reported adverse events following BVA. Two RCTs were eligible of further synthesis. Adverse events of pruritus, localized edema, and erythema occurred significantly more frequently in the BVA group compared to the control group. Data of drop-outs were available in seven RCTs. However, no comparisons showed a significant difference. Conclusions Currently evidence of adverse events is far from sufficient for assessing a reliable, precise occurrence rate. Still, limited evidence shows a tendency that adverse events occur more frequently after the appliance of BVA compared to the control. Thus, we await well designed future studies of BVA with more proper and strict harms reporting methods.

Keywords

Bee venom acupuncture;Adverse events;Systematic review;Randomized controlled trials

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