Adverse events from pharmacopuncture treatment in Korea: A protocol for systematic review and meta analysis

Pharmacopuncture is a combination of acupuncture and herbal medicine, which involves the injection of herbal extracts into acupuncture points (acupoints). Pharmacopuncture has become one of the major therapeutic tools used in Korea; however, safety is one of the major concerns associated with it. We...

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Bibliographic Details
Published in:Medicine (Baltimore) 2021-03, Vol.100 (11), p.e25107
Main Authors: Park, Jae Eun, Kang, Sohyeon, Jang, Bo-Hyoung, Shin, Yong-Cheol, Ko, Seong-Gyu
Format: Article
Language:English
Subjects:
Acupuncture Points
Acupuncture Therapy - adverse effects
Acupuncture Therapy - methods
Humans
Medicine, East Asian Traditional - adverse effects
Medicine, East Asian Traditional - methods
Meta-Analysis as Topic
Phytotherapy - adverse effects
Phytotherapy - methods
Plant Preparations - administration & dosage
Plant Preparations - adverse effects
Republic of Korea
Research Design
Study Protocol Systematic Review
Systematic Reviews as Topic
Treatment Outcome
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Summary:Pharmacopuncture is a combination of acupuncture and herbal medicine, which involves the injection of herbal extracts into acupuncture points (acupoints). Pharmacopuncture has become one of the major therapeutic tools used in Korea; however, safety is one of the major concerns associated with it. We aim to systematically review clinical studies on the adverse events of pharmacopuncture in Korea. To collect data on the incidence and characteristics of adverse events (AEs) and to evaluate pharmacopuncture safety, 2 or more researchers will conduct a comprehensive search of pertinent English and Korean databases using the keywords "pharmacopuncture" and "adverse events." Regardless of the participants' conditions or treatment types, we will include clinical studies on the AEs of pharmacopuncture. Studies that were not conducted in Korea, and acupoint injections containing Western medications, vitamins, or autologous serum will be excluded from this study. The severity of AEs will be classified using the common terminology criteria for adverse events, and the causality between pharmacopuncture and AEs will be assessed using the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) causality scale. The quality of identifying and reporting the AEs will be assessed using the McHarm scale. The risk of selection bias will be assessed using the Cochrane risk of bias and the risk of bias for non-randomized studies tools. Studies will be assessed for heterogeneity utilizing Higgins's I2 statistics, and the risk of publication bias will be assessed and expressed in the form of a contour-enhanced funnel plot. Comprehensive investigation of all types of clinical studies in Korea will provide clearer evidence of the safety of pharmacopuncture. The results of this study will be useful for traditional medical doctors and patients who use such treatments and interventions.Systematic Review Registration: Open Science Foundation (osf.io/umhyz).
ISSN:0025-7974
1536-5964
DOI:10.1097/MD.0000000000025107