PMID- 36050272
OWN - NLM
STAT- MEDLINE
DCOM- 20221108
LR  - 20230222
IS  - 2095-4964 (Print)
VI  - 20
IP  - 6
DP  - 2022 Nov
TI  - Safety of acupotomy in a real-world setting: A prospective pilot and feasibility 
      study.
PG  - 514-523
LID - S2095-4964(22)00091-7 [pii]
LID - 10.1016/j.joim.2022.08.003 [doi]
AB  - OBJECTIVE: Acupotomy is a modern acupuncture method that includes modern surgical 
      methods. Since acupotomy is relatively more invasive than filiform acupuncture 
      treatment, it is important to establish the safety profile of this practice. To 
      justify further large-scale prospective observational studies, this preliminary 
      study was performed to assess the feasibility of the approach and investigate the 
      safety profile and factors potentially associated with adverse events (AEs). 
      METHODS: This was a prospective pilot study that assessed the feasibility of a 
      large-scale forthcoming safety study on acupotomy treatment in a real-world 
      setting. The feasibility (call response rate, drop-out rate, response rate for 
      each variable and recruitment per month) and safety profile (incidence, type, 
      severity and causality of AEs, and factors potentially associated with AEs) were 
      measured. RESULTS: A total of 28 participants joined the study from January to 
      May 2018. A follow-up assessment was achieved in 258 (1185 treatment points) out 
      of 261 sessions (1214 treatment points). The response rate via telephone on the 
      day after treatment was 87.3%. There were 8 systemic AEs in all the sessions 
      (8/258; 3.11%) and 27 local AEs on the total points treated (27/1185; 2.28%). 
      Severe AEs did not occur. Total AE and local AE occurrence were associated with 
      blade width and the number of needle stimulations per treatment point. 
      CONCLUSION: The findings suggest that it could be feasible to analyze the safety 
      of acupotomy in a real-world setting. Moreover, the primary data on some relevant 
      AEs could be determined. We are planning large-scale prospective studies based on 
      these findings. TRIAL REGISTRATION: Clinical Research Information Service (CRIS) 
      KCT0002849 (https://cris.nih.go.kr/cris/search/detailSearch.do/11487).
CI  - Copyright (c) 2022 Shanghai Changhai Hospital. Published by Elsevier B.V. All 
      rights reserved.
FAU - Yoon, Sang-Hoon
AU  - Yoon SH
AD  - Chung-Yeon Korean Medicine Clinic, Gangnam-gu, Seoul 06224, Republic of Korea.
FAU - Kwon, Chan-Young
AU  - Kwon CY
AD  - Department of Oriental Neuropsychiatry, Dong-eui University College of Korean 
      Medicine, Busanjin-gu, Busan 47340, Republic of Korea.
FAU - Jo, Hee-Geun
AU  - Jo HG
AD  - Department of Herbal Pharmacology, College of Korean Medicine, Gachon University, 
      1342 Seongnamdae-ro, Sujeong-gu, Seongnam 13120, Republic of Korea.
FAU - Sul, Jae-Uk
AU  - Sul JU
AD  - Department of Korean Rehabilitation Medicine, Dongshin University Korean Medicine 
      Hospital, Gwangju 61619, Republic of Korea.
FAU - Lee, Hyangsook
AU  - Lee H
AD  - Acupuncture and Meridian Science Research Center, Kyung Hee University, 
      Dongdaemun-gu, Seoul 02447, Republic of Korea; Department of Science in Korean 
      Medicine, Graduate School, Kyung Hee University, Dongdaemun-gu, Seoul 02447, 
      Republic of Korea.
FAU - Won, Jiyoon
AU  - Won J
AD  - KM Science Research Division, Korea Institute of Oriental Medicine, Daejeon 
      34054, Republic of Korea.
FAU - Jeong, Su Jin
AU  - Jeong SJ
AD  - Department of Statistics Support, Medical Science Research Institute, Kyung Hee 
      University Medical Center, Dongdaemun-gu, Seoul 02447, Republic of Korea.
FAU - Lee, Jun-Hwan
AU  - Lee JH
AD  - Clinical Medicine Division, Korea Institute of Oriental Medicine, Yuseong-gu, 
      Daejeon 34054, Republic of Korea; Korean Medicine Life Science, University of 
      Science & Technology (UST), Campus of Korea Institute of Oriental Medicine, 
      Yuseong-gu, Daejeon 34054, Republic of Korea. Electronic address: 
      omdjun@kiom.re.kr.
FAU - Leem, Jungtae
AU  - Leem J
AD  - College of Korean Medicine, Wonkwang University, Iksan, Jeollabuk-do 54538, 
      Republic of Korea. Electronic address: julcho@naver.com.
LA  - eng
SI  - ClinicalTrials.gov/KCT0002849
PT  - Journal Article
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20220817
PL  - Netherlands
TA  - J Integr Med
JT  - Journal of integrative medicine
JID - 101603118
SB  - IM
MH  - Humans
MH  - Feasibility Studies
MH  - Prospective Studies
MH  - Pilot Projects
MH  - *Acupuncture Therapy/adverse effects/methods
MH  - Research Design
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Acupotomy
OT  - Acupuncture
OT  - Adverse effects
OT  - Observational study
OT  - Safety
OT  - Traditional Chinese medicine
COIS- Declaration of competing interest The authors declare that they have no known 
      competing financial interests or personal relationships that could have appeared 
      to influence the work reported in this paper.
EDAT- 2022/09/02 06:00
MHDA- 2022/11/09 06:00
CRDT- 2022/09/01 22:08
PHST- 2021/07/09 00:00 [received]
PHST- 2022/07/11 00:00 [accepted]
PHST- 2022/09/02 06:00 [pubmed]
PHST- 2022/11/09 06:00 [medline]
PHST- 2022/09/01 22:08 [entrez]
AID - S2095-4964(22)00091-7 [pii]
AID - 10.1016/j.joim.2022.08.003 [doi]
PST - ppublish
SO  - J Integr Med. 2022 Nov;20(6):514-523. doi: 10.1016/j.joim.2022.08.003. Epub 2022 
      Aug 17.