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Wonnam Kim,1,* Yeon-Cheol Park,2,3,* Bonhyuk Goo,2 Jung-Hyun Kim,2 Dongwoo Nam,3,4 Eunseok Kim,5,6 Hyun-Jong Lee,7 Dong-Hyun Pyun,8,9 Hae Sun Suh,8– 10 Yoonsung Lee,11 Man S Kim,11 Byung-Kwan Seo,2,3 Yong-Hyeon Baek2,3 1Division of Pharmacology, School of Korean Medicine, Pusan National University, Yangsan, Republic of Korea; 2Department of Acupuncture & Moxibustion, Kyung Hee University College of Korean Medicine, Kyung Hee University Hospital at Gangdong, Seoul, Republic of Korea; 3Department of Acupuncture & Moxibustion, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea; 4Department of Acupuncture & Moxibustion, Kyung Hee University College of Korean Medicine, Kyung Hee University Medical Center, Seoul, Republic of Korea; 5Division of Clinical Medicine, School of Korean Medicine, Pusan National University, Yangsan, Republic of Korea; 6Department of Acupuncture and Moxibustion Medicine, Pusan National University Korean Medicine Hospital, Yangsan, Republic of Korea; 7Department of Acupuncture & Moxibustion, College of Korean Medicine, Daegu Haany University, Daegu, Republic of Korea; 8Department of Regulatory Science, Graduate School, Kyung Hee University, Seoul, Republic of Korea; 9Institute of Regulatory Innovation Through Science (IRIS), Kyung Hee University, Seoul, Republic of Korea; 10College of Pharmacy, Kyung Hee University, Seoul, Republic of Korea; 11Clinical Research Institute, Kyung Hee University Hospital at Gangdong, School of Medicine, Kyung Hee University, Seoul, Republic of Korea*These authors contributed equally to this workCorrespondence: Yong-Hyeon Baek, Department of Acupuncture & Moxibustion, College of Korean Medicine, Kyung Hee University, Seoul, 02447, Republic of Korea, Tel +82 2 440 6099, Fax +82 2 440 714, Email byhacu@khu.ac.krPurpose: Knee osteoarthritis (KOA) is one of the most prevalent degenerative joint diseases worldwide. The herbal decoction, Dokhwalgisaeng-tang (DHGST), has been commonly used in East Asia to treat osteoarthritis. However, there is insufficient evidence to draw clear conclusions concerning its effectiveness and safety for patients with KOA. We aim to determine the efficacy, safety, and economic feasibility of DHGST compared with Celecoxib, an oral COX-2 inhibitor, for patients with degenerative KOA.Trial Design and Methods: This multicenter, randomized, noninferiority trial, involving 160 participants who will be randomized using block randomization with 1:1 allocation, will compare DHGST and Celecoxib. The total trial period is 24 weeks after random allocation, comprising 12 weeks of treatment and 12 weeks of follow-up. Participants with KOA will be administered 200 mg of DHGST (treatment group) or Celecoxib capsules (control group) for 12 weeks. Efficacy and safety evaluations will be conducted at weeks 0, 4, 8, and 12, and 24. The primary outcome measurement is the Korean Western Ontario McMaster score at week 12. Changes in pain intensity using a 100 mm visual analog scale, changes in quality of life using a EuroQol 5-dimension 5-level self-report survey, and patient satisfaction will also be measured to evaluate effectiveness between the two groups. A trial-based economic feasibility evaluation will be conducted to analyze treatment cost-effectiveness from societal and healthcare system perspectives. Drug safety will be assessed through adverse reactions and laboratory test findings.Discussion: This trial protocol has the following limitations. Applying a double-dummy design is not possible, as the tablet and granule forms can easily be distinguished visually, and achieving participant blinding is challenging. The trial findings are intended to inform participants, physicians, and other stakeholders in determining whether DHGST could be used as an alternative therapeutic option for KOA.Trial Registration Number: KCT0008424 (Clinical Research Information Service of the Republic of Korea), registered on 12 May 2023.Keywords: degenerative joint disease, Dokhwalgisaeng-tang, noninferiority trial, randomized controlled trial

Hyo-Rim Jo,1 Yong-Gyun Kim,2 Won-Suk Sung,1 Kyoung Sun Park,3 Yoon Jae Lee,4 Sun Young Cho,5 Byung-Kwan Seo,6 Young-Ee Kwon,2 Eun-Jung Kim1 1Department of Acupuncture & Moxibustion, Dongguk University Bundang Oriental Hospital, Seongnam-si, Gyeonggi-do, Republic of Korea; 2Central Research Institute, Samik Pharmaceutical Company LTD., Incheon, Republic of Korea; 3Jaseng Hospital of Korean Medicine, Seoul, Republic of Korea; 4Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, Seoul, Korea; 5IntegroMedLab Company Ltd., Seoul, Republic of Korea; 6Department of Acupuncture & Moxibustion, Kyung Hee University Hospital at Gangdong, Seoul, Republic of KoreaCorrespondence: Eun-Jung Kim, Department of Acupuncture & Moxibustion, Dongguk University Bundang Oriental Hospital, 268, Buljeong-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea, Tel +82-31-710-3719, Fax +82-31-710-3780, Email hanijjung@naver.comPurpose: Postherpetic neuralgia (PHN) is the most common chronic complication of herpes zoster, associated with poor quality of life and increased patient and healthcare resource expenditure. This randomized controlled trial aims to evaluate the efficacy and safety of SIKD1977 (Sogeonjungtang) in combination with standard treatment and estimate an effective dose for treating PHN.Patients and Methods: This is a protocol for a randomized, placebo-controlled, double-blind, multicenter trial. A total of 90 eligible participants with PHN will be recruited from three hospitals and randomly allocated to high-dose group, low-dose group, or placebo group in a 1:1:1 ratio. The trial will involve a 6-week oral administration of SIKD1977/placebo, and a 1-week follow-up period. The primary outcome will be the weekly average change in average daily pain score (ADPS) from baseline to the end of treatment. The secondary outcomes will include the weekly average changes in ADPS from baseline to week 2, 4, and 7, differences in Short-Form McGill Pain Questionnaire, Visual analogue scale, 5-level EuroQol-5 dimensions, Patient Global Impression of Change, and consumption of rescue drugs. All adverse events will be assessed during the trial.Conclusion: This study will provide evidence for the efficacy and safety of SIKD1977, and an effective dose for PHN.Trial Registration: This protocol has been registered in the Clinical Research Information Service with the identification code KCT0007939.Keywords: postherpetic neuralgia, herbal medicine, SIKD1977, Sogeonjungtang, randomized controlled trial, protocol

Bonhyuk Goo,1,* Yeon-Cheol Park,2,* Eunseok Kim,3,4 Won-Suk Sung,5 Eun-Jung Kim,6 Jung-Hyun Kim,1 Byung-Kwan Seo,2 Yong-Hyeon Baek2 1Department of Acupuncture & Moxibustion, Kyung Hee University Hospital at Gangdong, Seoul, Republic of Korea; 2Department of Acupuncture & Moxibustion, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea; 3Division of Clinical Medicine, School of Korean Medicine, Pusan National University, Yangsan, Republic of Korea; 4Department of Acupuncture and Moxibustion Medicine, Pusan National University Korean Medicine Hospital, Yangsan-si, Republic of Korea; 5Department of Acupuncture & Moxibustion, Dongguk University Bundang Oriental Hospital, Seongnam, Republic of Korea; 6Department of Acupuncture & Moxibustion Medicine, College of Oriental Medicine, Dongguk University, Gyeongju, Republic of Korea*These authors contributed equally to this workCorrespondence: Yong-Hyeon Baek, Department of Acupuncture & Moxibustion, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea, Tel +82 2 440 6099, Fax +82 2 440 7143, Email byhacu@khu.ac.krBackground: The aim of the present study is to confirm the efficacy, safety, and cost-effectiveness of thread-embedding acupuncture (TEA) in the treatment of adhesive capsulitis (AC).Methods: This is a randomized, sham-controlled, patient-assessor blinded trial with two parallel arms in a 1:1 ratio. A total of 160 participants with AC, also known as frozen shoulder, will be recruited and screened according to the eligibility criteria. Those who meet the eligibility criteria will be randomly allocated to a TEA group or a sham TEA (STEA) group. Both groups will receive either real TEA or thread-removed STEA treatment on nine acupoints once a week for 8 weeks while being blinded to the intervention. The shoulder pain and disability index will be evaluated as a primary outcome measure. In addition, a 100-mm pain visual analogue scale, rotator cuff quality of life scale, European Quality of Life 5-dimension 5-level scale, treatment satisfaction, safety assessment, and economic evaluation will be assessed as secondary outcome measures. Outcome assessments will be conducted for a total of 24 weeks, including a treatment period of 8 weeks and follow-up of 16 weeks, according to the schedule.Discussion: The results of this trial will provide a clinical basis for the efficacy, safety and cost-effectiveness of TEA in the treatment of patients with AC.Trial Registration Number: KCT0005920 (Clinical Research Information Service of the Republic of Korea). Registered on 22 February 2021.Keywords: thread-embedding acupuncture, adhesive capsulitis, frozen shoulder, randomized controlled trial, protocol

Jung-Hyun Kim,1 Sung-Min Kim,2 Yong-Chan Kim,2,* Byung-Kwan Seo3,* 1Department of Acupuncture & Moxibustion, Kyung Hee University Hospital at Gangdong, Gangdong-gu, Seoul, 05278, Republic of Korea; 2Department of Orthopaedic Surgery, Kyung Hee University Hospital at Gangdong, Gangdong-gu, Seoul, 05278, Republic of Korea; 3Department of Acupuncture & Moxibustion Medicine, College of Korean Medicine, Kyung Hee University, Dongdaemun-gu, Seoul, 02447, Republic of Korea*These authors contributed equally to this workCorrespondence: Byung-Kwan Seo, Department of Acupuncture & Moxibustion Medicine, College of Korean Medicine, Kyung Hee University, 26, Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea, Tel +82-2-440-6239, Fax +82-2-440-7143, Email seohbk@hanmail.netIntroduction: Efforts are necessary to promote postoperative patient management to reduce complications or side effects, particularly those adapted to spinal surgery. Considering compatible medical system in Korea, the study objective is to report the opinions of Korean medical doctors regarding integrative enhanced recovery after spine surgery.Methods: From December 2020 to January 2021, members of the Korean Medical Association were asked to complete an online questionnaire regarding an integrative enhanced recovery program after spine surgery. A total of 726 participants responded to the survey.Results: Approximately half of the respondents had more than 10 years of medical experience in the Korean health-care system, and 58.29% were affiliated with primary Korean medical clinics. The majority of respondents were not aware of the ERAS program (N = 412, 79.08%) but said that patient management would be advanced from the establishment of a postoperative medical program that reflected an integrated medical perspective (N = 505, 96.92%). Furthermore, Korean medical professionals believe that Korean medical interventions should play a major role in the pain management and digestive improvement sections of the upcoming postoperative program. Moreover, respondents claimed that Korean traditional medical modalities such as acupuncture, moxibustion, cupping, and herbal decoction should be included in the program.Discussion/Conclusion: Responses collected from the present study can be used as a spadework for future studies. A study on the development of a comprehensive postoperative program that reflects the perspectives of patients and conventional medical doctors is needed.Keywords: enhanced recovery after surgery, web-based survey, Korean medical doctors, spinal surgery