Safety of acupotomy in a real-world setting: A prospective pilot and feasibility study.
10.1016/j.joim.2022.08.003
- Author:
Sang-Hoon YOON
1
;
Chan-Young KWON
2
;
Hee-Geun JO
3
;
Jae-Uk SUL
4
;
Hyangsook LEE
5
,
6
;
Jiyoon WON
7
;
Su Jin JEONG
8
;
Jun-Hwan LEE
9
,
10
;
Jungtae LEEM
11
Author Information
1. Chung-Yeon Korean Medicine Clinic, Gangnam-gu, Seoul 06224, Republic of Korea.
2. Department of Oriental Neuropsychiatry, Dong-eui University College of Korean Medicine, Busanjin-gu, Busan 47340, Republic of Korea.
3. Department of Herbal Pharmacology, College of Korean Medicine, Gachon University, 1342 Seongnamdae-ro, Sujeong-gu, Seongnam 13120, Republic of Korea.
4. Department of Korean Rehabilitation Medicine, Dongshin University Korean Medicine Hospital, Gwangju 61619, Republic of Korea.
5. Acupuncture and Meridian Science Research Center, Kyung Hee University, Dongdaemun-gu, Seoul 02447, Republic of Korea
6. Department of Science in Korean Medicine, Graduate School, Kyung Hee University, Dongdaemun-gu, Seoul 02447, Republic of Korea.
7. KM Science Research Division, Korea Institute of Oriental Medicine, Daejeon 34054, Republic of Korea.
8. Department of Statistics Support, Medical Science Research Institute, Kyung Hee University Medical Center, Dongdaemun-gu, Seoul 02447, Republic of Korea.
9. Clinical Medicine Division, Korea Institute of Oriental Medicine, Yuseong-gu, Daejeon 34054, Republic of Korea
10. 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.
11. College of Korean Medicine, Wonkwang University, Iksan, Jeollabuk-do 54538, Republic of Korea. Electronic address: julcho@naver.com.
- Publication Type:Journal Article
- Keywords:
Acupotomy;
Acupuncture;
Adverse effects;
Observational study;
Safety;
Traditional Chinese medicine
- MeSH:
Humans;
Feasibility Studies;
Prospective Studies;
Pilot Projects;
Acupuncture Therapy/methods*;
Research Design;
Treatment Outcome
- From:
Journal of Integrative Medicine
2022;20(6):514-523
- CountryChina
- Language:English
-
Abstract:
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).
