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Yujin Choi,1,* Na-Yeon Ha,2,* Ae-Ran Kim,3 Haein Jeong,2 Ojin Kwon,1 Ki-Sun Park,1 Jieun Kim,1 Jinsung Kim,2 Hyungjun Kim1 1KM Science Research Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea; 2Division of Digestive Diseases, Department of Korean Internal Medicine, Kyung Hee University College of Korean Medicine, Kyung Hee University Korean Medicine Hospital, Seoul, Republic of Korea; 3R&D Strategy Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea*These authors contributed equally to this workCorrespondence: Jinsung Kim, Department of Digestive Diseases, College of Korean Medicine, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea, Tel +82 2 958 8895, Email oridoc@khu.ac.kr Hyungjun Kim, Division of KM Science Research, Korea Institute of Oriental Medicine, Daejeon, 34054, Republic of Korea, Tel +82 42 869 2796, Email heyjoon73@kiom.re.krIntroduction: Irritable bowel syndrome (IBS) is a chronic condition characterized by recurrent abdominal pain associated with bowel movements. Modified Gwakjeongtang (MGT), an herbal prescription rooted in traditional East Asian medicine, consists of thirteen botanical drugs known for their potential to enhance intestinal barrier function, regulate gastrointestinal motility, and exhibit anti-inflammatory and antioxidant properties. Despite a few previous clinical trials highlighting MGT’s potential for IBS symptom management, limited evidence exists with placebo control.Methods and Analysis: In this pilot randomized clinical trial protocol, we aim to exploratively evaluate the efficacy and safety of MGT in patients with diarrhea-predominant IBS (IBS-D) by comparing it with a placebo. A total of 60 IBS-D patients will be enrolled, and eligible participants will be randomly allocated to either the MGT or placebo groups. Over a 4-week period, they will receive MGT or placebo granules three times a day. The primary endpoint will be the overall response rate post-treatment, determined through daily assessments of abdominal pain intensity and stool consistency.Ethics and Dissemination: This clinical trial protocol has received approval from the Korean Ministry of Food and Drug Safety for an investigational new drug application and Institutional Review Board of the Kyung Hee University Korean Medicine Hospital. The research findings will be submitted and published in international peer-reviewed journal.Trial Registration: Clinical research information service (registration number: KCT0008523).Keywords: irritable bowel syndrome, herbal medicine, Gwakhyang-Jeonggi-San, Huoxiang-Zhengqi-San, Kkako-Shoki-San, clinical protocol

Doori Kim,1 Eun-San Kim,1 Yoon Jae Lee,1 Jee Young Lee,2 Kyong Sun Park,3 So Young Jung,4 Changsop Yang,5 Chang-Hyun Han,6,7 In-Hyuk Ha1 1Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, Seoul, 06110, Republic of Korea; 2Department of Korean Internal Medicine, Integrative Cancer Center, Cha Ilsan Medical Center, Goyang-si, Gyeonggi-do, Republic of Korea; 3Jaseng Hospital of Korean Medicine, Seoul, 06110, Republic of Korea; 4Clinical Research Coordinating Team, Korea Institute of Oriental Medicine, Daejeon, 34054, Republic of Korea; 5Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea; 6Korean Convergence Medical Science, University of Science & Technology (UST), School of Korea Institute of Oriental Medicine, Daejeon, 34054, Republic of Korea; 7KM Science Research Division, Korea Institute of Oriental Medicine, Daejeon, 34054, Republic of KoreaCorrespondence: In-Hyuk Ha, Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, 540 Gangnam-daero, Gangnam-gu, Seoul, 06110, Republic of Korea, Tel +82-2-2222-2740, Fax +82-2-2222-2737, Email hanihata@gmail.com Chang-Hyun Han, KM Science Research Division, Korea Institute of Oriental Medicine, 1672 Yuseong-daero, Yuseong-gu, Daejeon, 34054, Republic of Korea, Tel +82-(0)42-868-9498, Fax +82-(0)42-869-2775, Email chhan@kiom.re.krPurpose: We aimed to compare the efficacy, safety, and cost-effectiveness of non-pharmacological- and pharmacological treatment strategies for Lumbar disc herniation (LDH) in pragmatic clinical settings.Patients and Methods: This study was a pilot, two-armed, parallel pragmatic randomized controlled trial. Thirty patients aged 19– 70 years with a numeric rating scale (NRS) score ≥ 5 for sciatica and confirmed LDH on magnetic resonance imaging (MRI) were included. Participants were assigned in a 1:1 ratio to non-pharmacological (non-Phm) or pharmacological (Phm) treatment group. They were treated for 8 weeks and a total follow-up period was 26 weeks after randomization. Non-Phm treatment included acupuncture, spinal manual therapy, etc., Phm included medication, injection, nerve block, etc., The primary outcome was a numeric rating scale (NRS) of radiating leg pain. NRS for low back pain, Oswestry disability index, visual analog scale, Fear-Avoidance Beliefs Questionnaire, patient global impression of change, Short Form-12 Health Survey, version 2, 5-level European Quality of Life-5 dimensions (EQ-5D) were also measured. Linear mixed model was used to evaluated the difference in change of outcomes from baseline between two groups. An economic evaluation was conducted using incremental cost-effectiveness ratios.Results: There was no significant difference between the two groups in the intervention period, but non-Phm group showed significantly greater degree of improvement in follow-up of Week 14. Difference in the NRS for sciatica and ODI were 1.65 (95% CI 0.59 to 2.71, p=0.003) and 8.67 (95% CI 1.37 to 15.98, p=0.21), respectively in Week 14. The quality-adjusted life year (QALY) value calculated by EQ-5D and Short Form-6 Dimension were 0.006 (95% CI − 0.012 to 0.024, p=0.472) and 0.015 (95% CI − 0.008 to 0.038, p=0.195) higher in non-Phm group than in Phm group. The cost was lower in non-Phm group than in Phm group (Difference: − 682, 95% CI − 3349 to 1699, p=0.563).Conclusion: We confirmed that the non-Phm treatment could be more cost-effective treatments than Phm treatments and feasibility of a large-scale of main study in future.Keywords: conservative treatment, intervertebral disc displacement, low back pain, sciatica

Kyoung Sun Park,1 Changnyun Kim,2 Joo Won Kim,3 Sang‐Don Kim,4 Jee Young Lee,5 Yoon Jae Lee,5 Jinho Lee,1 Min Ji Kim,6 Young Eun Choi,6 Changsop Yang,7 Chang-Hyun Han,7,8,&ast; In-Hyuk Ha5,&ast; 1Jaseng Hospital of Korean Medicine, Seoul, Republic of Korea; 2Daejeon Jaseng Hospital of Korean Medicine, Daejeon, Republic of Korea; 3Bucheon Jaseng Hospital of Korean Medicine, Bucheon, Republic of Korea; 4Haeundae Jaseng Hospital of Korean Medicine, Busan, Republic of Korea; 5Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, Seoul, Republic of Korea; 6Clinical Research Coordinating Team, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea; 7Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea; 8Korean Convergence Medical Science, Korea Institute of Oriental Medicine School, University of Science & Technology, Daejeon, Republic of Korea&ast;These authors contributed equally to this workCorrespondence: Chang-Hyun Han, Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea, Tel +82 42 868 9498, Email chhan@kiom.re.kr In-Hyuk Ha, Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, Seoul, Republic of Korea, Tel +82 2 2222 2740, Email hanihata@gmail.comPurpose: Chronic lower back pain (LBP) is a major global health concern. Pharmacopuncture has been widely used to treat LBP in Korea; however, randomized clinical trials (RCT) or active control have not been conducted to evaluate its effectiveness. Therefore, this RCT aimed to compare the effectiveness of pharmacopuncture and physical therapy (PT) for the treatment of chronic LBP.Patients and Methods: A two-arm, parallel, and multicenter RCT was conducted at four hospitals of Korean medicine. Participants with chronic LBP were randomly assigned at a 1:1 ratio using block randomization to undergo 10 sessions of pharmacopuncture or PT over 5 weeks and followed up for 25 weeks. The numerical rating scale (NRS) and visual analog scale scores of LBP and radiating leg pain and the Oswestry disability index (ODI), 5-level EuroQol-5 dimension (EQ-5D-5L), and the patient global impression of change were recorded at baseline and at 6, 13, and 25 weeks. An intention-to-treat analysis was conducted as the primary analysis using a linear mixed model.Results: One-hundred patients (mean age, 49.27 years; 58 women) were recruited. At 6 weeks after randomization, pharmacopuncture showed statistically superior results compared with PT in LBP (difference in NRS, 1.54; 95% CI, 0.94– 2.13), function (difference in ODI, 4.52%; 95% CI, 0.93– 8.11%), and quality of life (difference in EQ-5D-5L) scores (− 0.05; 95% CI, − 0.08 to − 0.01). This effect persisted for 25 weeks. In the survival analysis for participants with at least a 50% reduction in the NRS scores of LBP during the 182-day follow-up, the pharmacopuncture group showed significantly faster recovery than the PT group (P< 0.001, Log rank test).Conclusion: Pharmacopuncture significantly reduced pain and improved functional outcomes and quality of life in patients with low back pain compared with physical therapy. Based on the findings of this study, pharmacopuncture could be recommended as a treatment for patients with chronic low back pain.Keywords: low back pain, pharmacopuncture, physiotherapy, Oswestry disability index, Roland–Morris disability questionnaire, pragmatic randomized controlled trial

Bryan Vincent Mballa Yene,1 Sang-Yeob Lee,2 Ki-Soo Park,3 Yang Jae Kang,4 Sung Hyo Seo,2 Jun-Il Yoo5 1Department of Bio & Medical Big Data, Gyeongsang National University Hospital, Jinju, South Korea; 2Department of Biomedical Research Institute, Gyeongsang National University Hospital, Jinju, South Korea; 3Department of Preventive Medicine, School of Medicine, Gyeongsang National University, Jinju, South Korea; 4Division of Life Science Department, Gyeongsang National University, Jinju, South Korea; 5Department of Orthopaedic Surgery, Inha University Hospital, Incheon, South KoreaCorrespondence: Jun-Il Yoo, Department of Orthopaedic Surgery, Inha University Hospital, 27 Inhang-ro, Jung-gu, Incheon, 22332, South Korea, Tel +82-32-890-3663, Email furim@hanmail.netObjective: The world population gradually getting older, age-related sarcopenia is becoming more frequent. Known to be highly prevalent in high income countries, relative data in Africa are still scarce. This review aims to estimate the prevalence of sarcopenia in Africa and its characteristics.Study Design and Setting: A literature search in PubMed, Web of Science, Google Scholar, and Scopus was conducted in October 2022. All studies reporting the prevalence of sarcopenia in Africa within 15 years were included, and we did an assessment of bias with Hoy et al’s risk bias assessment tool. The estimated prevalence of sarcopenia was the outcome and we performed secondary analyses by age, gender, and diagnostic criteria. The random effect model was used for the prevalence estimation. The prevalence of sarcopenia and 95% confidence interval (95% CI) were calculated using the inverse-variance method.Results: A total of 17 studies met our eligibility criteria, for a study population of 12,690 participants with 44.3% males and 55.7% females. The overall prevalence of sarcopenia was 25% (95% CI: 19– 30%). The prevalence of sarcopenia among 50 years old and older was 23% (95% CI: 17– 29%). We had a higher prevalence of sarcopenia among males (30%, %95 IC: 20– 39%) than females (29%, %95 IC: 21– 36%). The prevalence of sarcopenia was different depending on the diagnosis criteria used.Conclusion: The prevalence of sarcopenia in Africa was relatively high. However, the fact that the majority of included studies were hospital-based studies shows the necessity of further community-based studies in order to have a more accurate representation of the situation in the general population.Keywords: sarcopenia, prevalence, Africa, meta-analysis

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

Jee Young Lee,1 Kyoung Sun Park,2 Suna Kim,3 Ji Yeon Seo,4 Hyun-Woo Cho,5 Dongwoo Nam,6 Yeoncheol Park,6 Eun-Jung Kim,7 Yoon Jae Lee,1 In-Hyuk Ha1 1Jaseng Spine & Joint Research Institute, Jaseng Medical Foundation, Seoul, Republic of Korea; 2Jaseng Clinical Research Center, Jaseng Hospital of Korean Medicine, Seoul, Republic of Korea; 3Jaseng Clinical Research Center, Daejeon Jaseng Hospital of Korean Medicine, Daejeon, Republic of Korea; 4Jaseng Clinical Research Center, Bucheon Jaseng Hospital of Korean Medicine, Bucheon, Republic of Korea; 5Jaseng Clinical Research Center, Haeundae Jaseng Hospital of Korean Medicine, Busan, Republic of Korea; 6Department of Acupuncture & Moxibustion, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea; 7Department of Acupuncture & Moxibustion, College of Korean Medicine, Dongguk University Bundang Oriental Hospital, Seongnam, Republic of KoreaCorrespondence: In-Hyuk Ha, Jaseng Spine & Joint Research Institute, Jaseng Medical Foundation, 540, Gangnamdae-ro, Gangnam-gu, Seoul, 06110, Republic of Korea, Tel +82-2-2222-2740, Email hanihata@gmail.comPurpose: Lumbar spinal stenosis (LSS) is a chronic degenerative disease. Non-surgical intervention is recommended, considering the risks and benefits for the affected age group, as well as the characteristics of the disease. However, to date, no studies have compared various non-surgical interventions to ascertain the appropriate first-line non-surgical treatment for LSS. Therefore, the objective of this study will be to assess the efficacy of pharmacopuncture as a non-surgical, conservative treatment for LSS.Patients and Methods: A multi-centered, pragmatic, parallel-group study will be conducted. In total, 98 patients will be recruited at seven institutes; recruitment began in May 2022. After two treatment sessions per week over a period of 12 weeks, follow-up assessments will be held at weeks 13, 25, and 53.Results: The efficacy of pharmacopuncture and conservative care will be pragmatically compared in patients radiologically diagnosed with LSS. Pain severity will be measured using the numeric rating scale and visual analog scale. Walking distance will also be evaluated. Patient-centered evaluations will include the Zurich Claudication Questionnaire, Short-Form 12 for Health-Related Quality of Life, EuroQoL 5 Dimension 5 Levels, and Patient Global Impression of Change.Conclusion: The results of this study will confirm the efficacy of pharmacopuncture in comparison to conventional non-surgical treatment and will thus facilitate the prioritization of patient-centered interventions for LSS.Trial registration: This study was registered at Clinicaltrials.gov (registration identifier: NCT05242497) and CRiS (registration identifier: KCT0007145).Keywords: LSS, constriction, non-surgical intervention, acupuncture, pragmatic clinical trial, protocol

Kyoung Sun Park,1 Suna Kim,2 Ji Yeon Seo,3 HyunWoo Cho,4 Jee Young Lee,5 Yoon Jae Lee,5 Jinho Lee,1 Min Ji Kim,6 Young Eun Choi,6 Chang Sop Yang,7 Chang-Hyun Han,7,8,&ast; In-Hyuk Ha5,&ast; 1Jaseng Hospital of Korean Medicine, Seoul, Republic of Korea; 2Daejeon Jaseng Hospital of Korean Medicine, Daejeon, Republic of Korea; 3Bucheon Jaseng Hospital of Korean Medicine, Bucheon, Republic of Korea; 4Haeundae Jaseng Hospital of Korean Medicine, Busan, Republic of Korea; 5Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, Seoul, Republic of Korea; 6Clinical Research Coordinating Team, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea; 7KM Science Research Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea; 8 Korean Convergence Medicine, University of Science & Technology (UST), Campus of Korea Institute of Oriental Medicine, Daejeon, Republic of Korea&ast;These authors contributed equally to this workCorrespondence: In-Hyuk Ha, Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, 2F Vision Tower, 540 Gangnam-daero, Gangnam-gu, Seoul, 06110, Republic of Korea, Tel +82 2 2222 2740, Email hanihata@gmail.comPurpose: Chronic low back pain (LBP) is a common musculoskeletal disorder that affects everyday life; moreover, it occasionally causes disability and increases medical expenditure. This pragmatic randomized clinical trial aims to investigate the effects of pharmacopuncture on chronic LBP by comparing the effectiveness of pharmacopuncture and physiotherapy strategies.Patients and Methods: In this two-armed, parallel, multi-center randomized controlled study, the participants will randomly undergo 10 sessions of pharmacopuncture therapy or physiotherapy over five weeks based on the randomization outcomes. The primary outcome will be the numeric rating scale (NRS) score of LBP. The secondary outcomes will include the NRS score of radiating leg pain, visual analog scale (VAS) score of LBP and radiating leg pain, Oswestry disability index, the Korean version of the Roland–Morris disability questionnaire, patient global impression of change (PGIC), short Form-12 health survey version 2, and 5-level EuroQol-5 dimension (EQ-5D-5L).Conclusion: This protocol aims to examine the comparative effectiveness of pharmacopuncture, which is a widely used therapy in Korean medicine, with respect to the standard therapy through a pragmatic randomized controlled trial to present useful data to facilitate clinical or policy decision making.Trial Registration: Clinicaltrials.gov (NCT04833309); Clinical Research Information Service (KCT0006088).Keywords: low back pain, pharmacopuncture, physical therapy, pragmatic randomized controlled trial, protocol, musculoskeletal disorder, Korean medicine

Jin Namgoong,1 Yun-Ha Lee,1 Ah Ra Ju,1 Jiwon Chai,1 DongJoo Choi,1 Hyo Jung Choi,1 Ji-Yeon Seo,1 Kyoung Sun Park,2 Yoon Jae Lee,1,3 Jinho Lee,2 In-Hyuk Ha1,3 1Bucheon Jaseng Hospital of Korean Medicine, 414 KR in Sangdong, Bucheon-si, Gyeonggi-do, Republic of Korea; 2Jaseng Hospital of Korean Medicine, Seoul, Republic of Korea; 3Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, Seoul, Republic of KoreaCorrespondence: In-Hyuk Ha, Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, 3F JS Tower, 538 Gangnam-daero, Gangnam-gu, Seoul, 06110, Republic of Korea, Tel +82 2 2222 2740, Fax +82 2 3218 2244, Email hanihata@gmail.comPurpose: Integrative Korean medicine treatment (KMT) is a conservative treatment approach for the ossification of the posterior longitudinal ligament (OPLL) in Korea; nonetheless, relevant studies focusing on KMT for OPLL are lacking. A multicenter retrospective analysis of patient medical records and a questionnaire survey were conducted to investigate the effectiveness of integrative KMT in patients with OPLL treated for neck pain.Patients and Methods: A total of 78 inpatients radiologically diagnosed with OPLL and treated for neck pain at four Korean medicine hospitals from April 1, 2016, to December 31, 2019, were enrolled. The primary index was an improvement in the numeric rating scale (NRS) score for neck pain, whereas the secondary outcome indices were improvements in the NRS score for arm pain, neck disability index (NDI) score, and EuroQol 5-dimension 5-level (EQ-5D-5L) score.Results: At discharge, the NRS score for neck pain, NRS score for arm pain, and NDI score decreased by 2.47 (95% confidence interval [CI], − 2.81 to − 2.14), 1.32 (95% CI, − 1.73 to − 0.91), and 16.02 (95% CI, − 18.89 to − 13.15), respectively, as compared with the scores at admission (p < 0.001). The EQ-5D-5L score increased by 0.12 (95% CI, 0.09 to 0.16) as compared with the score at admission (p < 0.001). This trend was also evident during follow-up. With respect to Patient Global Impression of Change evaluation, 33 (61.1%) patients claimed to have very much improved, whereas 17 (31.5%) patients reported to have much improved.Conclusion: Inpatients with OPLL who received integrative KMT showed improvements in neck pain, arm pain, the NDI, and quality of life, which were retained throughout the follow-up period.Keywords: integrative medicine, Korean medicine, OPLL, neck pain

Hyun Woo Cho,1 Ju Hun Park,1 Dong Hwi Yoo,1 Dong Wook Hwang,1 Sang Don Kim,1 Eun-San Kim,2 Kyoung Sun Park,3 Yoon Jae Lee,2 Jinho Lee,3 Changsop Yang,4 Chang Hyun Han,4,5 In-Hyuk Ha2 1Haeundae Jaseng Hospital of Korean Medicine, Busan, 48102, Republic of Korea; 2Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, Seoul, 06110, Republic of Korea; 3Jaseng Hospital of Korean Medicine, Seoul, 06110, Republic of Korea; 4KM Science Research Division, Korea Institute of Oriental Medicine, Daejeon, 34054, Republic of Korea; 5Korean Convergence Medical Science, Korea Institute of Oriental Medicine School, University of Science & Technology, Daejeon, 34054, Republic of KoreaCorrespondence: Chang Hyun Han, Clinical Medicine Division, Korea Institute of Oriental Medicine, 1672 Yuseong-daero, Yuseong-gu, Daejeon, 34054, Republic of Korea, Tel +82 42-868-9498, Email chhan@kiom.re.kr In-Hyuk Ha, Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, 3F 538 Gangnam-daero, Gangnam-gu, Seoul, 06110, Republic of Korea, Tel +82 2-2222-2740, Email hanihata@gmail.comPurpose: Cervical myelopathy (CM) is generally considered an indication for surgery in Western medicine. Case reports have indicated that Korean medicine (KM) treatments are effective in improving CM-associated symptoms. We investigated the effectiveness of non-surgical KM treatment of CM patients through a retrospective chart review and follow-up survey.Patients and Methods: We retrospectively analyzed the medical records and surveyed follow-up data of CM patients with neurological symptoms admitted to KM hospitals between January 2011 and January 2018. The admission and discharge assessments included the numeric rating scale (NRS) for neck and arm pain, neck disability index (NDI), and 5-level EuroQol 5-dimension (EQ-5D-5L). A follow-up survey was conducted about whether surgery was subsequently performed or recommended, symptom recurrence, discomfort in daily living, current treatment, as well as NRS, NDI, EQ-5D-5L, and patient global impression of change (PGIC) scores.Results: The NRS for neck pain decreased from 4.88 ± 2.03 (95% CI: 4.23‒5.52) at admission to 3.23 ± 1.64 (95% CI: 2.70‒3.75) at discharge and 2.24 ± 1.84 (95% CI: 1.43‒3.05) at follow-up. The NRS for radiating arm pain decreased from 5.42 ± 1.55 (95% CI: 4.93‒5.92) to 3.77 ± 1.54 (95% CI: 3.28‒4.27) at discharge and 2.43 ± 1.60 (95% CI: 1.72‒3.13) at follow-up. The NDI decreased significantly from 36.24 ± 18.79 (95% CI: 30.24‒42.24) at admission to 30.89 ± 15.54 (95% CI: 25.93‒35.86) at discharge and 13.35 ± 11.95 (95% CI: 8.08‒18.63) at follow-up. The EQ-5D score improved significantly from 0.70 ± 0.21 (95% CI: 0.63‒0.77) to 0.78 ± 0.17 (95% CI: 0.73‒0.84) at discharge and 0.84 ± 0.08 (95% CI: 0.80‒0.88) at follow-up. At the follow-up, four patients experienced persistent pain and were undergoing treatment (19.1%), while 20 patients (95.8%) reported symptom improvement.Conclusion: From a long-term perspective, integrative KM treatment may help to reduce pain and improve function, and improve quality of life of CM patients.Keywords: cervical myelopathy, Korean medicine, acupuncture, musculoskeletal manipulations, pharmacopuncture, Shinbaro

INTRODUCTION: Periprosthetic joint infection (PJI) of the hip due to methicillin-resistant bacteria is difficult to treat and remain a challenge for arthroplasty surgeon. MATERIALS AND METHODS: Retrospective review was done to the patients who received two-stage revisions with an antibiotic loaded cement-spacer for PJI of the hip between January 2010 to May 2015. We found 65 patients (65 hips) with positive culture findings. Eight patients were lost to follow-up and excluded from the study. Among the rest of the 57 patients, methicillin-resistant infection (MR Group) was found in 28 cases. We also evaluate the 29 other cases that caused by the other pathogen as control group. We compared all of the relevant medical records and the treatment outcomes between the two groups. RESULTS: The mean of follow-up period was 33.7 months in the methicillin-resistant group and 28.4 months in the control group (p = 0.27). The causal pathogens in the methicillinresistant group were: Methicillin-resistant Staphylococcus aureus (MRSA) in 10 cases, Methicillin-resistant Staphylococcus epidermidis (MRSE) in 16 cases and Methicillin-resistant coagulase-negative Staphylococcus (MRCNS) in two cases. The reimplantation rate was 92.8% and 89.6% in the methicillin-resistant and control group, respectively (p= 0.66). The rates of recurrent infection after reimplantation were 23.1% (6/26) in the methicillin-resistant group and 7.6% (2/26) in the control group (p= 0.12). The overall infection control rate was 71.4% (20/28) and 89.6% (26/29) in the methicillin-resistant and control group, respectively (p = 0.08). Both groups showed comparable baseline data on mean age, BMI, gender distribution, preoperative ESR/CRP/WBC and comorbidities. CONCLUSION: Two-stage revision procedure resulted in low infection control rate and high infection recurrency rate for the treatment of methicillin-resistant periprosthetic joint infection (PJI) of the hip. Development of the treatment strategy is needed to improve the outcome of methicillinresistant periprosthetic joint infection (PJI) of the hip.

Hip geometry abnormalities found in patients with hereditary multiple exostoses (HME) could promote premature hip joint degeneration which needs treatment. We report the case of a 45-year old male with right hip arthrosis who underwent two-incision minimally invasive (MIS-2) total hip arthroplasty (THA), with satisfactory outcome. This technique could be an alternative approach for performing THA in patients with hereditary multiple exostoses.

Mi-Ji Kim,1–3 Ki Soo Park,1–3 Ae-Rim Seo,1,2 Sang-Il Lee,4 Yong-Chan Ha,5 Jun-Il Yoo2,3,6 1Department of Preventive Medicine, Gyeongsang National University College of Medicine, Jinju, Republic of Korea; 2Institute of Health Sciences, Gyeongsang National University College of Medicine, Jinju, Republic of Korea; 3Center for Farmer’s Safety and Health, Gyeongsang National University Hospital, Jinju, Republic of Korea; 4Department of Internal Medicine, Institute of Health Sciences, Gyeongsang National University School of Medicine, Gyeongsang National University Hospital, Jinju, Republic of Korea; 5Department of Orthopedic Surgery, Chung-Ang University Hospital, Seoul, Republic of Korea; 6Department of Orthopedic Surgery, Gyeongsang National University Hospital, Jinju, Republic of Korea Purpose: The purposes of this study were to investigate the effect of hand-grip strength (HGS) on the Disabilities of the Arm, Shoulder, and Hand (DASH) score in women with upper extremity musculoskeletal disorders (UEMDs) living in rural communities and examine whether upper extremity diseases affected upper extremity functional activity in each group (normal/low HGS) and whether grip strength (GS) was an effect modifier in upper extremity functional activity. Methods: A total of 239 women older than 60 years who had completed a medical workup for epicondylitis, rotator cuff tears, and/or hand osteoarthritis were included in the final study. Functional activity was assessed by DASH, and muscle strength was measured by GS. Low HGS was defined according to the Asian Working Group for Sarcopenia (HGS

Madhusmita Dhupal,1,2 Jae-Min Oh,3 Dipti Ranjan Tripathy,4 Soo-Ki Kim,2 Sang Baek Koh,5 Kyu-Sang Park6 1Department of Global Medical Science, Wonju College of Medicine, Yonsei University, Wonju, Republic of Korea; 2Department of Microbiology, Wonju College of Medicine, Yonsei University, Wonju, Republic of Korea; 3Department of Chemistry and Medical Chemistry, College of Science and Technology, Yonsei University, Wonju, Republic of Korea; 4Department of Neurology, Gauhati Medical College and Hospital, Gauhati, India; 5Department of Preventive Medicine, Wonju College of Medicine, Yonsei University, Wonju, Republic of Korea; 6Department of Physiology, Wonju College of Medicine, Yonsei University, Wonju, Republic of Korea Background: Titanium dioxide nanoparticles (TiO2 NPs) represent a scientific breakthrough in the areas of biological and medicinal applications. Interaction of TiO2 NPs with components of innate immune system remains elusive. Aim: This study explored in vitro immunotoxicity of murine macrophage RAW 264.7 to TiO2 NPs (20 nm, negative charge) and its underlying molecular mechanism by way of immunoredox profiling. Materials and methods: In this study, chemically synthesized BSA-functionalized TiO2 NPs (20 nm, negative charge) were characterized and immunotoxicity was investigated on RAW 264.7 cells. Results: We found that reactive oxygen species levels significantly increased with increasing nitric oxide production, whereas depleting endogenous antioxidant super oxide dismutase as well as nuclear factor erythroid 2-related factor 2 (Nrf2) protein levels. Furthermore, NPs exposure increased the expression of apoptotic factors such as BAX, BIM, and PUMA with disruption of mitochondrial membrane potential (ΔΨm) that lead to decrease in immunocytes. Molecular immune profiling revealed the activation of multiple toll-like receptors (TLRs) 4/9/12/13 simultaneously with the phosphorylation of p-p38MAPK and p-SAPK/c-Jun N-terminal kinase (JNK) compared to untreated control. Conclusion: Collectively, this study shows that the molecular nature of TiO2SA20(-) NP-induced immunotoxicity in RAW 264.7 macrophage is simultaneous induction of immunocyte apoptosis and multiple TLRs signaling through oxidative stress-dependent SAPK/JNK and p38 mitogen-associated protein kinase activation. This is the first study to address newer molecular mechanism of TiO2SA20(-) NP-induced immunotoxicity. Keywords: titanium dioxide, toll-like receptors, MAPK pathways, apoptosis, nanoparticles, oxidative stress

Yong Joo Jun,1,* Jung Hyun Park,2,* Prakash G Avaji,1 Kyung Su Park,3 Kyung Eun Lee,3 Hwa Jeong Lee,2 Youn Soo Sohn1 1C & Pharm, Ewha Womans University, Seodaemun-gu, Seoul, Republic of Korea; 2Graduate School of Pharmaceutical Sciences, Ewha Womans University, Seodaemun-gu, Seoul, Republic of Korea; 3Advanced Analysis Center, Korea Institute of Science and Technology, Seongbuk-gu, Seoul, Republic of Korea *These authors contributed equally to this work Abstract: To prepare an efficient theranostic polyphosphazene–docetaxel (DTX) conjugate, a new drug delivery system was designed by grafting a multifunctional lysine ethylester (LysOEt) as a spacer group along with methoxy poly(ethylene glycol) (MPEG) to the polyphosphazene backbone ([NP]n), and then DTX was conjugated to the carrier polymer using acid-cleavable cis-aconitic acid (AA) as a linker. The resultant polyphosphazene–DTX conjugate, formulated as [NP(MPEG550)3(Lys-OEt)(AA)(DTX)]n and named “Polytaxel”, exhibited high water solubility and stability by forming stable polymeric micelles as shown in its transmission electron microscopy image and dynamic light scattering measurements. Another important aspect of Polytaxel is that it can easily be labeled with various imaging agents using the lysine amino group, enabling studies on various aspects, such as its organ distribution, tumor-targeting properties, pharmacokinetics, toxicity, and excretion. The pharmacokinetics of Polytaxel was remarkably improved, with prolonged elimination half-life and enhanced area under the curve. Ex vivo imaging study of cyanine dye-labeled Polytaxel showed that intravenously injected Polytaxel is long circulating in the blood stream and selectively accumulates in tumor tissues. Polytaxel distributed in other organs was cleared from all major organs at ~6 weeks after injection. The in vitro study of DTX release from the carrier polymer showed that >95% of conjugated DTX was released at pH 5.4 over a period of 7 days. Xenograft trials of Polytaxel using nude mice against the human gastric tumor cell line MKN-28 showed complete tumor regression, with low systemic toxicity. Polytaxel is currently in preclinical study. Keywords: docetaxel, polyphosphazene, anticancer drug, nanomedicine, theranostics

Jaewoo Pak,1–3* Jung Hun Lee,1,4* Kwang Seung Park,4 Jeong Ho Jeon,4 Sang Hee Lee4 1Stems Medical Clinic, Gangnamgu, Seoul, Republic of Korea; 2TEDA‑Puhua International Hospital, Tianjin, People’s Republic of China; 3Life Science Institute, Komplek Permata Senayan, Jalan Tentara Pelajar, Jakarta Selatan, Indonesia; 4National Leading Research Laboratory, Department of Biological Sciences, Myongji University, Yongin, Gyeonggido, Republic of Korea *These authors contributed equally to this work Abstract: The menisci of the human knee play an important role in maintaining normal functions to provide stability and nutrition to the articular cartilage, and to absorb shock. Once injured, these important structures have very limited natural healing potential. Unfortunately, the traditional arthroscopic meniscectomy performed on these damaged menisci may predispose the joint toward early development of osteoarthritis. Although a very limited number of studies are available, mesenchymal stem cells (MSCs) have been investigated as an alternative therapeutic modality to repair human knee meniscal tears. This review summarizes the results of published applications of MSCs in human patients, which showed that the patients who received MSCs (autologous adipose tissue-derived stem cells or culture-expanded bone marrow-derived stem cells) presented symptomatic improvements, along with magnetic resonance imaging evidences of the meniscal repair. Keywords: adipose tissue-derived stem cells, bone marrow-derived stem cells, human knee, meniscal tear, articular cartilage, therapeutic modality

Sang Geun Bae,1 Sin Kam,2 Ki Soo Park,3,4 Keon-Yeop Kim,2 Nam-Soo Hong,2 Ki-Su Kim,2 Yu-mi Lee,2 Won Kee Lee,2 Michael Sung Pil Choe5 1Department of Preventive Medicine, Regional Cardiocerebrovascular Disease Center, Kyungpook National University Hospital, 2Department of Preventive Medicine, Kyungpook National University School of Medicine, Daegu, 3Department of Preventive Medicine and Institute of Health Sciences, Gyeongsang National University School of Medicine, 4Department of Preventive Medicine, Regional Cardiocerebrovascular Disease Center, Gyeongsang National University Hospital, Jinju, 5Department of Emergency Medicine, CHA Gumi Medical Center, CHA University, Gumi, Korea Purpose: We assessed medication nonadherence, categorized as intentional or unintentional, and related factors in elderly patients with hypertension, correlating the data with measurement of blood pressure as the final target of medication adherence and other possible influencing factors, such as lifestyle. Patients and methods: Subjects were aged ≥65 years, resided in a rural area, and were taking antihypertensive drugs. The survey was conducted in July 2014. Participants were divided into the following three groups: “Adherence”, “Unintentional nonadherence”, and “Intentional nonadherence”. Individual cognitive components, such as necessity and concern as well as self-efficacy and other related factors, were compared according to adherence groups. The interrelationships between those factors and nonadherence were tested using structural equation modeling analysis. Results: Of the 401 subjects, 182 (45.6%) were in the adherence group, 107 (26.7%) in the unintentional nonadherence group, and 112 (27.9%) in the intentional nonadherence group. Necessity and self-efficacy were found to have a significant direct influence on unintentional nonadherence behaviors (necessity β=–0.171, P=0.019; self-efficacy β=–0.433, P

Prakash G Avaji,1,2,* Jung Hyun Park,1,* Hyun Jeong Lee,1 Yong Joo Jun,2 Kyung Su Park,3 Kyung Eun Lee,3 Soo-Jin Choi,4 Hwa Jeong Lee,1 Youn Soo Sohn2 1Graduate School of Pharmaceutical Sciences, Ewha Womans University, Seoul, Republic of Korea; 2C & Pharm, Ewha Womans University, Seoul, Republic of Korea; 3Advanced Analysis Center, Korea Institute of Science and Technology, Seoul, Republic of Korea; 4Department of Food Science and Technology, Seoul Women’s University, Seoul, Republic of Korea *These authors contributed equally to this work Abstract: To develop a theranostic nanomedicine involving the antitumor-active moiety (dach)Pt(II) (dach: trans-(±)-1,2-diaminocyclohexane) of oxaliplatin (OX), a new biocompatible polyphosphazene carrier polymer was designed by grafting with a methoxy poly(ethylene glycol) (MPEG) to increase duration of circulation in the blood and with aminoethanol (AE) as a spacer group. The antitumor (dach)Pt moiety was conjugated to the carrier polymer using cis-aconitic acid (AA) as a linker, resulting in a polymer conjugate formulated as [NP(MPEG550)(AE-AA)Pt(dach)]n, named “Polyplatin” (PP). PP was found to self-assemble into very stable polymeric nanoparticles with a mean diameter of 55.1 nm and a critical aggregation concentration of 18.5 mg/L in saline. PP could easily be labeled with a fluorescence dye such as Cy5.5 for imaging studies. The time-dependent ex vivo image studies on organ distributions and clearance of Cy-labeled PP have shown that PP accumulated in the tumor with high selectivity by the enhanced permeability and retention effect but was cleared out from all the major organs including the liver in about 4 weeks postinjection. Another time-dependent bioimaging study on distribution and clearance of PP in mouse kidney using laser ablation inductively coupled plasma mass spectroscopy has shown that PP accumulates much less in kidney and is more rapidly excreted than monomeric OX, which is in accord with the very low acute toxicity of PP as shown by its high LD50 value of more than 2000 mg/kg. The pharmacokinetic study of PP has shown that it has a much longer half-life (t1/2β) of 13.3 hours compared with the 5.21 hours of OX and about a 20 times higher area under the curve value of 42,850.8 ng h/mL compared with the 2,320.4 ng h/mL of OX. The nude mouse xenograft trials of PP against the gastric MKN-28 tumor cell line exhibited remarkably better tumor efficacy compared with OX at the higher tolerated dose, with lower systemic toxicity. Keywords: polyphosphazene, anticancer agent, theranostics, nanomedicine, oxaliplatin

Migratory bone marrow edema syndrome (BMES) of the hip is a rare entity. We report the case of a 41-year old male with migratory BMES of the hip with eight months interval period between onset of the pain and consultation. This patient was successfully treated non-surgically. It is important to always inform the patient with unilateral BMES of the hip regarding the possibility of future involvement of the contralateral hip.

Bhagwan S Batule,1 Ki Soo Park,1 Moon Il Kim,2 Hyun Gyu Park1 1Department of Chemical and Biomolecular Engineering (BK21+ Program), Korea Advanced Institute of Science and Technology (KAIST), Daejeon, 2Department of BioNano Technology, Gachon University, Seongnam, Republic of Korea Abstract: We developed a simple but efficient method to synthesize protein-inorganic hybrid nanostructures with a flower-like shape (nanoflowers), which relies on sonication to facilitate the synthesis of the nanoflowers. With this technique, we synthesized nanoflowers containing laccase as a model protein and copper phosphate within 5 minutes at room temperature. The resulting laccase nanoflowers yielded greatly enhanced activity, stability, and reusability, and their usefulness was successfully demonstrated by applying them in the colorimetric detection of epinephrine. The strategy developed could be used to rapidly synthesize nanoflowers for various applications in biosensor and enzyme catalysis and would expand the utilization of nanoflowers in diverse fields of biotechnology. Keywords: copper phosphate, laccase, epinephrine, hybrid nanomaterials