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Copyright © 2022 Boram Lee et al. This is an open access article distributed under the Creative Commons Attribution License (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. https://creativecommons.org/licenses/by/4.0/

Abstract

Objective. Functional dyspepsia (FD) is a common gastrointestinal disorder that significantly affects sufferers’ quality of life and increases the economic burden on society. Saam acupuncture, a form of traditional Korean acupuncture, is frequently used to treat FD in Korean medicine clinical settings. This study aimed to evaluate the feasibility and preliminary effectiveness and safety of Saam acupuncture for treating FD. Methods. We conducted a pilot, pragmatic, assessor-blinded randomized controlled trial. Patients with FD according to the ROME III criteria were randomly allocated to an acupuncture plus usual care group or a usual care group. Saam acupuncture based on individualized FD and systemic symptoms was conducted in the acupuncture group three times per week for 4 weeks. Study feasibility outcomes, including recruitment, completion, and acupuncture adherence rates, were calculated. In addition, preliminary evaluation of participant responses to the intervention was tested using the gastrointestinal symptom (GIS), FD-related quality of life (FD-QoL), visual analog scale (VAS), patient global assessment (PGA), and EuroQol-5 Dimensions (EQ-5D) scores. Results. Twenty-four participants who met the eligibility criteria were included. The recruitment and completion rates of the clinical trials were 60% and 79.2%, and the acupuncture adherence rate was 83.3%. Although there was no significant difference between the two groups in the dyspepsia symptoms as measured by GIS, VAS, and PGA at Week 4, significant differences were found between the two groups at the follow-up assessments (Weeks 8 and 12). In particular, the early satiety subscore of GIS was significantly improved in the Saam acupuncture group compared with the usual care group at Week 4. The quality of life measured by FD-QoL and EQ-5D improved only in the Saam acupuncture group, although there were no significant differences between the two groups. No adverse events related to Saam acupuncture were reported. Conclusions. Saam acupuncture can be a feasible, preliminarily effective, and safe treatment for FD. Further confirmatory trials with a larger sample size are needed to confirm its effectiveness and safety. The trail is registered with CRIS-KCT0000164, URL: https://cris.nih.go.kr/cris/search/detailSearch.do/2098.

Details

Title
Saam Acupuncture for Treating Functional Dyspepsia: A Feasibility Randomized Controlled Trial
Author
Lee, Boram 1   VIAFID ORCID Logo  ; O-Jin, Kwon 1 ; Joo-Hee, Kim 2 ; Kang, Jung Won 3 ; Kim, Tae-Hun 4   VIAFID ORCID Logo  ; Lee, Seunghoon 3 ; Kim, Jungeun 5 ; Ae-Ran Kim 6 ; So Young Jung 6 ; Park, Hyo-Ju 6 ; Sun-Mi, Choi 7   VIAFID ORCID Logo 

 KM Science Research Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea 
 Department of Acupuncture and Moxibustion Medicine, College of Korean Medicine, Sangji University, Wonju, Gangwon-do, Republic of Korea; Research Institute of Korean Medicine, Sangji University, Gangwon-do, Republic of Korea 
 Department of Acupuncture and Moxibustion, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea 
 Korean Medicine Clinical Trial Center, Korean Medicine Hospital, Kyung Hee University, Seoul, Republic of Korea 
 Acupuncture, Moxibustion & Meridian Research Group, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea 
 Clinical Research Coordinating Team, Korea Institute of Oriental Medicine, Yuseong-daero 1672, Yuseong-gu, Daejeon, Republic of Korea 
 KM Data Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea; Korean Convergence Medical Science, University of Science & Technology (UST), Daejeon, Republic of Korea 
Editor
Jing-Yu (Benjamin) Tan
Publication year
2022
Publication date
2022
Publisher
John Wiley & Sons, Inc.
ISSN
1741427X
e-ISSN
17414288
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
2687532049
Copyright
Copyright © 2022 Boram Lee et al. This is an open access article distributed under the Creative Commons Attribution License (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. https://creativecommons.org/licenses/by/4.0/