• Journal of Oriental Neuropsychiatry
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• v.34 no.3
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• pp.213-234
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• 2023

Objectives: To investigate current status of randomized controlled clinical trial (RCT) registration for suicide attempters. Methods: The World Health Organization International Clinical Trials Registry Platform (WHO-ICTRP) was used to search for data using 'suicide' as a search term. All registration information of RCTs registered up to April 2023 were collected. Results: Among a total of 68 RCTs registered, the United States ranked the highest in terms of quantity in this field (n=30, 46.15%), whereas Asia had only six (8.82%). A total of 62 (91.18%) RCTs involved individual interventions, while nine (13.24%) RCTs involved group interventions. Among individual interventions, 11 (16.18%) and 54 (79.41%) RCTs were on pharmacotherapy and psychotherapy, respectively. Within psychotherapy, there were a total of 17 (25%) studies utilizing digital media, with cognitive behavioral therapy (CBT) via phone being the most common approach. Among non-digital media-based studies, CBT was used the most frequently (n=11, 16.18%), followed by attempted suicide short intervention program (n=6, 8.82%). There were no studies using interventions from East Asian traditional medicine, including Korean medicine (KM). The most frequently used main outcome was the Beck scale for suicidal ideation. Conclusions: Studies on suicide attempts in Asia, especially in South Korea, are very scarce. Despite vigorous psychotherapeutic research in this field, KM psychotherapy has not been used. Thus, KM clinical trial for suicide attempters might be planned in the future based on our findings.

• Journal of Pharmacopuncture
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• v.19 no.3
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• pp.197-206
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• 2016

Introduction: This study aims to investigate the effects of acupuncture stimulation on the radial artery's pressure pulse wave, along with various hemodynamic parameters, and to explore the possible underlying mechanism of pulse diagnosis in healthy participants in their twenties. Methods and analysis: This study is a prospective, single-arm, exploratory clinical study. A total of 25 healthy participants, without regard to gender, in their twenties will be recruited by physicians. Written informed consent will be obtained from all participants. The participants will receive acupuncture once at ST36 on both sides. The radial arterial pulse waves will be measured on the left arm of the subjects by using an applicable pulse tonometric device (KIOM-PAS). On the right arm (appearing twice), electrocardiogram (ECG), photoplethysmogram (PPG), respiration and cardiac output (CO) signals, will be measured using a physiological data acquisition system (Biopac module), while the velocity of blood flow, and the diameter and the depth of the blood vessel will be measured using an ultrasonogram machine on the right arm (appearing twice). All measurements will be conducted before, during, and after acupuncture. The primary outcome will be the spectral energy at high frequencies above 10 Hz ($SE_{10-30Hz}$) calculated from the KIOM-PAS device signal. Secondary outcomes will be various variables obtained from the KIOM-PAS device, ECG, PPG, impedance cardiography modules, and an ultrasonogram machine. Discussion: The results of this trial will provide information regarding the physiological and the hemodynamic mechanisms underlying acupuncture stimulation and clinical evidence for the influence of acupuncture on the pressure pulse wave in the radial artery. Ethics and dissemination: This study was approved by the Institutional Review Board (IRB) of Kyung Hee University's Oriental Medical Center, Seoul, Korea (KOMCIRB-150818-HR-030). The study findings will be published in peer-reviewed journals and presented at national and international conferences. Trial registration number: This trial was registered with the Clinical Research Information Service (CRIS) at the Korea National Institute of Health (NIH), Republic of Korea (KCT0001663), which is a registry in the World Health Organization's (WHO's) Registry Network.

• Journal of Korean Medicine for Obesity Research
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• v.20 no.2
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• pp.138-148
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• 2020

Objectives: The aim of this study is to evaluate the effects of Bangpungtongseong-san (Fangfengtongsheng-san, BTS) and Daesiho-tang (Dachaihu-tang, DST) on weight loss and improvement in lipid metabolism and glucose metabolism. Furthermore, we intend to develop a prediction model for drug effects through the analysis of the single nucleotide polymorphism (SNP), gut-microbiota, and the expression of immune-related biomarkers. Methods: This study is a single-center, randomized, double-blind, parallel-design clinical trial. One hundred twenty-eight participants will be assigned to the BTS group (n=64) and DST group (n=64). Both groups will be administered 4 g medication three times a day for up to 2 weeks. The primary outcomes is weight loss. The secondary outcomes include bioelectrical impedance analysis, waist circumstance, body mass index, total cholesterol, high-density lipoprotein, triglyceride, insulin resistance. The exploratory outcomes include 3-day dietary recall, food frequency questionnaire, quality of life questionnaire, gut microbiota analysis, immune biomarkers analysis, and SNP analysis. Assessment will be made at baseline and at week 4, 8, and 12. Conclusions: This protocol will be implemented by approval of the Institutional Review Board of Dongguk University. The results of this trial will provide a systematic evidence for the treatment of obesity and enable more precise herbal medicine prescriptions.

• Journal of Acupuncture Research
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• v.15 no.2
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• pp.183-198
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• 1998

This study was done in order to present clinical trial method for safety of herb-acupuncture. The results were summerized as follow: In case of western medicine, clinical trial divides into four phase 1. Phase I: Investigate safety and drug movement for health people. 2. The first phase II: Investigate safety, effectiveness for the limited patient. The late phase II: Investigate propriety of an applicable disease, the way to use and dose. 3. Phase III: Through the comparative, public trial, investigate a final, applicable disease and side effect. 4. Phase IV: After NDA, investigate safety and effectiveness for the wide patients. In case of herb-acupuncture, we have to investigate the following for safety and effectiveness 1. Drug dose: Decide with 1/2 or 1/3 of oral dosage or a basis of animal's of maximum dosage or a ratio of man and animal. 2. Toxicity: Examine blood, urine, liver function, EKG, after herb-acupuncture during acertain period of time. 3. Regional response: Estimate response of swelling, redness, pruritus. etc 4. Treatment effectiveness: After exactly diagnosis, estimate effectiveness with a objective guide post.

• The Journal of Pediatrics of Korean Medicine
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• v.26 no.4
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• pp.32-37
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• 2012

Objectives: The purpose of this study was to obtain some understanding about Korean medicine treatment on language disorder in cerebral palsy for future practice and the research, from the clinical studies. Methods: The literature was searched using the database-China Academic Journals (CAJ). Clinical studies of Korean medicine treatment for language disorder in cerebral palsy, including Randomized controlled trial (RCT), case control study, case series, case report were analyzed. Results: Fifteen Clinical studies met our inclusion criteria; One case study and six case series, one non-randomized controlled trial and seven RCTs. Acupuncture treatment, especially Head acupuncture, was the major treatment for language disorder of cerebral palsy in clinical studies, as it was used in fourteen studies. Acupoint massage, tuina, and acupoint injection were employed as treatment methods in the studies. Acupuncture treatment was used for language disorder of cerebral palsy combined with language therapy and other rehabilitation treatment in many studies. The effectiveness in the treatment groups, regardless of treatment methods, was higher than that of control group in all RCT studies. Conclusions: The results of this study could be used in the practice and the future study about language disorder of cerebral palsy.

• Journal of Oriental Neuropsychiatry
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• v.20 no.4
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• pp.137-148
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• 2009

Objectives : The purpose of this study is to review the recent trends in the clinical trial studies that have been published since 2004. Methods : We reviewed the Medline & Pubmedcentral databases by using searching word of "acupuncture". Then 20 articles were selected within total 803 articles. In oriental medicine journals in Korea, we investigated 6 journals represented Korean Oriental medicine and chose 13 articles. Results & Conclusions : 1. We found 33 articles in journals. 2. The patterns of study were as follows: Randomized Controlled Trials(18), Single case series clinical study(9), Case-Control clinical study(4), Randomized crossover Trial(1) and Prospective Clinical analysis(1). 3. The fields of study were as follows: Combined anxiety, depression & other psychiatic symptoms(18), Stress & heart rate variablity(5), The single study of anxiety(5), The single study of depression(3), Stress & pupil variablity(1), Stress and heart rate & pupil variablity(1). 4. The methods of acupuncture were as follows: Acupuncture on points of 14 meridians(24), Auricular acupuncture(3), Electro acupuncture(2) and Both Auricular & Electro acupuncture(1). 5. Stomach meridian(足陽明胃經) and ST36(足三里) were used mostly.

• Annals of Clinical Neurophysiology
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• v.10 no.1
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• pp.29-32
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• 2008

Although various criteria on the diagnosis of diabetic neuropathy are applied from trial to trial, being tailored in concert with its purpose, the utmost evidences of the diagnosis are subjective symptoms and objective signs of neurologic deficit. The application and interpretation of auxiliary electrophysiological test including nerve conduction study (NCS) should be made on the context of clinical pictures. The evaluation of the functions of small, thinly myelinated or unmyelinated nerve fibers has been increasingly stressed recently with the advent of newer techniques, e.g., measurement of intraepidermal fiber density, quantitative sensory testing, and autonomic function test. And the studies with those techniques have shed light to the nature of the evolution of diabetic neuropathy. The practical application of these techniques to the diagnosis of diabetic neuropathy in the individual patients, however, should be made cautiously due to several shortcomings: limited accessibility, wide overlapping zone between norm and abnormality with resultant unsatisfactory sensitivity and specificity, difficulty in performing subsequent tests, unproven quantitative correlation with clinical deficit, and invasiveness of some technique. NCS, as an extension of clinical examination, is still the most reliable electrophysiological test in evaluating neuropathy and gives the invaluable information about the nature of neuropathy, whereas the newer techniques need more refinement of the procedure and interpretation, and the accumulation of large scaled data of application to be considered as established diagnostic tools of peripheral neuropathy.

• The Journal of Pediatrics of Korean Medicine
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• v.24 no.2
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• pp.59-74
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• 2010

Objectives The purpose of this study is to analyzing clinical trials of the current acupoint sticking treatment on Sambok* to prevent winter diseases through summer prophylactic treatment. Methods 33 Chinese clinical studies published in last fifteen years were selected for analysis. Results Acupoint sticking treatment on Sambok* is used in asthma, rhinitis, bronchitis. Commonly used herbs are Sinapis Semen(白芥子), Asari Herba Cum Radix(細辛), Euphorbiae Kansui Radix(甘遂), Corydalis Tuber(玄胡索), Moschi Moschus(麝香), Ephedrae Herba(麻黃), Cinnamomi Cortex Spissus(肉桂) and Commonly used acupoints are Feishu(肺兪), Kohwang(膏肓), Shinsu(腎兪), Pisu(脾兪). 33 studies showed that the effect of treatment in different age, symptom, acupoints, herbs, methods. However, it shows that acupoint sticking treatment on Sambok* is effective in various diseases, especially in respiratory disease. Conclusions This study shows that acupoint sticking treatment on Sambok* is effective in preventing many diseases. More clinical studies about acupoint sticking treatment and standardizations to evaluate effectiveness are needed to prove its efficacy clearly.

• Korean Journal of Acupuncture
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• v.32 no.1
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• pp.1-12
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• 2015

Objectives : The purpose of this study was to review the acupuncture and moxibustion therapy for gastroesophageal reflux disease(GERD) in China. Methods : The literatures were searched using the database-China Academic Journals(CAJ)(~2015.1.). Clinical studies of acupuncture and moxibustion therapy for GERD such as randomized controlled trial(RCT), non-randomized controlled trial(NRCT), case series, or case report were included. Results : Thirty studies met our inclusion criteria: 24 RCTs, 4 NRCTs, 1 case series, 1 case report. Various kinds of treatment such as body acupuncture, abdominal acupuncture, acupuncture therapy with finger on back-shu point, electroacupuncture, acupoint injection, auricular acupuncture, and moxibustion were used in the clinical studies. The treatment groups take herbal medicines at the same time in 16 studies, and proton pump inhibitor(PPI) and histamine 2 receptor antagonist were used as a comparative treatment in the most of studies. Acupuncture or moxibustion treatments were done daily or 2~3 times a week for 5 days~18 weeks. All of studies reported higher effective rate in the acupuncture or moxibustion treatment group compared to the western medication control group. Conclusions : The results of this study could be used for the future practice and the clinical research about the acupuncture and moxibustion therapy for GERD.

• Korean Journal of Acupuncture
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• v.28 no.4
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• pp.147-158
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• 2011

Objectives : The purpose of this study was to obtain some knowledge about the acupuncture treatments on Parkinson's disease for the future practice and the research from the clinical studies in China. Methods : The literatures were searched using the data base-China Academic Journals (CAJ) (1994-2011). Clinical studies of acupuncture for Parkinson's disease such as randomized controlled trial (RCT), non-randomized controlled trial (NRCT), case series, case report were included. Results : Of 145 articles, 52 Clinical studies met our inclusion criteria: 20 RCTs, 7 NRCTs, 22 case series and 3 case reports. Various kinds of acupuncture treatments such as scalp acupuncture, body acupuncture, abdominal acupuncture, acupoint injection, eye acupuncture and thick needle acupuncture (粗鍼) were used in the clinical studies. The treatment and control groups take Madopa Tablet (Levodopa + Benserazide HCl) in the same time in many studies, and Madopa treatment was used as a comparative treatment in the most of studies. Acupuncture treatment was done daily or 2~3 times a week for 2~20 weeks. All of studies reported high effective rate in the treatment group compared to control group. Conclusions : The results of this study could be used for the future study about the acupuncture therapy for Parkinson's disease.