PMID- 33725988
OWN - NLM
STAT- MEDLINE
DCOM- 20210329
LR  - 20230103
IS  - 1536-5964 (Electronic)
IS  - 0025-7974 (Print)
IS  - 0025-7974 (Linking)
VI  - 100
IP  - 11
DP  - 2021 Mar 19
TI  - Adverse events from pharmacopuncture treatment in Korea: A protocol for 
      systematic review and meta analysis.
PG  - e25107
LID - 10.1097/MD.0000000000025107 [doi]
LID - e25107
AB  - BACKGROUND: 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. METHODS: 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. RESULTS AND CONCLUSION: 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).
CI  - Copyright (c) 2021 the Author(s). Published by Wolters Kluwer Health, Inc.
FAU - Park, Jae Eun
AU  - Park JE
AUID- ORCID: 0000-0003-2661-5428
AD  - Department of Global Public Health and Korean Medicine Management, Graduate 
      School.
FAU - Kang, Sohyeon
AU  - Kang S
AD  - Department of Global Public Health and Korean Medicine Management, Graduate 
      School.
FAU - Jang, Bo-Hyoung
AU  - Jang BH
AUID- ORCID: 0000-0002-2141-3483
AD  - Department of Global Public Health and Korean Medicine Management, Graduate 
      School.
AD  - Department of Preventive Medicine, College of Korean Medicine, Kyung Hee 
      University, Seoul, Republic of Korea.
FAU - Shin, Yong-Cheol
AU  - Shin YC
AUID- ORCID: 0000-0001-7614-9336
AD  - Department of Global Public Health and Korean Medicine Management, Graduate 
      School.
AD  - Department of Preventive Medicine, College of Korean Medicine, Kyung Hee 
      University, Seoul, Republic of Korea.
FAU - Ko, Seong-Gyu
AU  - Ko SG
AD  - Department of Global Public Health and Korean Medicine Management, Graduate 
      School.
AD  - Department of Preventive Medicine, College of Korean Medicine, Kyung Hee 
      University, Seoul, Republic of Korea.
LA  - eng
GR  - grant number KHU-20181054/Kyung Hee University/
PT  - Journal Article
PL  - United States
TA  - Medicine (Baltimore)
JT  - Medicine
JID - 2985248R
RN  - 0 (Plant Preparations)
SB  - IM
MH  - Acupuncture Points
MH  - Acupuncture Therapy/*adverse effects/methods
MH  - Humans
MH  - Medicine, East Asian Traditional/*adverse effects/methods
MH  - Meta-Analysis as Topic
MH  - Phytotherapy/*adverse effects/methods
MH  - Plant Preparations/administration & dosage/adverse effects
MH  - Republic of Korea
MH  - Research Design
MH  - Systematic Reviews as Topic
MH  - Treatment Outcome
PMC - PMC7982247
COIS- The authors have no conflicts of interests to disclose.
EDAT- 2021/03/18 06:00
MHDA- 2021/03/30 06:00
PMCR- 2021/03/19
CRDT- 2021/03/17 01:10
PHST- 2021/02/18 00:00 [received]
PHST- 2021/02/19 00:00 [accepted]
PHST- 2021/03/17 01:10 [entrez]
PHST- 2021/03/18 06:00 [pubmed]
PHST- 2021/03/30 06:00 [medline]
PHST- 2021/03/19 00:00 [pmc-release]
AID - 00005792-202103190-00069 [pii]
AID - MD-D-20-11652 [pii]
AID - 10.1097/MD.0000000000025107 [doi]
PST - ppublish
SO  - Medicine (Baltimore). 2021 Mar 19;100(11):e25107. doi: 
      10.1097/MD.0000000000025107.