• Journal of Society of Preventive Korean Medicine
• /
• v.28 no.1
• /
• pp.31-42
• /
• 2024

Objective : In order to understand the changes in domestic approval regulations applicable to traditional Korean medical device companies, this article will explain the major amendments 「Regulation on Medical Device Approval Report Review, etc.」 from 2005 to the present on a year-by-year basis, and provide a counter plan to the recent changes in approval regulations. Methods : We analysed the changes in approval regulatory amendments related to the traditional Korean medical devices from 2005 to the present. Results : The Ministry of Food and Drug Safety is continuously improving medical device approval regulations to ensure the global competitiveness of domestic medical devices and contribute to the improvement of public health. Recent major approval regulatory amendments include the establishment of a review system for software medical devices and digital therapeutics, the recognition of real world evidence materials, the introduction of a biological evaluation of medical devices within a risk management process and a medical device approval licence renewal system. Conclusions : It is expected that the range of medical devices available to Korean medicine doctors will continue to expand in the future through the provision of non-face-to-face medical services and the development of advanced and new medical devices, as well as wearable medical devices and digital therapeutics. In order to increase the market entry potential of traditional Korean medical devices that incorporate advanced technologies such as digital technology and AI-based diagnosis and prediction technology, it is urgent that the government provide significant support to traditional Korean medical device companies to improve approval regulatory compliance.

• Journal of Physiology & Pathology in Korean Medicine
• /
• v.27 no.5
• /
• pp.530-539
• /
• 2013

This study reviews the latest articles about oriental and traditional medicine treatment of male sexual dysfunction. We searched the article from 2000 to 2012 using 5 data bases. There were no restrictions on the type of publication, but articles not available in full text were excluded. The methological quality of RCT study was assessed according to Jadad scores and Cochrane's assessment of risk of bias. 18 articles were included in this study. 5 articles published in Korea, the rest were foreign articles. 9 articles were randomized controlled trial(RCT), Case-control studies were 3, case reports were 3, One group pre-post test were 3. In RCT studies, Jadad scores were generally low, and risk of selection bias and performance bias were generally high, risk of detection bias was unclear. Oriental and traditional medicine treatment is as effective as western medicine treatment for male sexual dysfunction, more rigorous oriental medicine treatment studies should be warranted.

• The Journal of Churna Manual Medicine for Spine and Nerves
• /
• v.7 no.1
• /
• pp.15-20
• /
• 2012

Objectives : The aims of this study were to introduce the theory of traditional Chinese orthopedic theory(整脊理論) and to analyze the guideline of diagnosis and treatment of common spinal disorders by treating Chinese spinal manipulation technique(常見病中醫整脊指南). Methods : We have searched the web sites of traditional Chinese orthopedics association (整脊學會), a branch of the China academy of traditional Chinese medicine (TCM), and related articles. Additionally, we analyzed the guideline of diagnosis and treatment of common spinal disorders by treating Chinese spinal manipulation technique which was introduced by that association at 7th academic conference in China in 2011. Results : The guideline was prepared by 2 year project leaded by professor Yi-zhong Wei who was a person in charge of the spinal manipulation guideline of national standardization committee of TCM in China. It was a summary of the whole theory of China spinal manipulation therapy in TCM and contained 22 common spinal disorders by the treatment of traditional Chinese Tuina methods. Spinal manipulation theory was summarized by one doctrine, two theories, and two important view points. The treatment method was abstracted as 8 major Tuina techniques. Conclusions : The guideline will be a way of advance of Chinese spinal manipulation technique. This will be a good reference to Korea Chuna manipulation for improving their techniques.

• Journal of Society of Preventive Korean Medicine
• /
• v.20 no.2
• /
• pp.27-38
• /
• 2016

Backgrounds : Taiwan has similar national health insurance (NHI) system for traditional medicine with South Korea. Recently, new quality improvement policies for traditional medicine is being attempted in Taiwan. Objectives : This study aimed to review the Taiwanese NHI system for Chinese Medicine (CM) and introduce quality improvement policies. Methods : Research articles, reports, government publications and year books which handled traditional medicine system and NHI system in Taiwan were searched and collected. The authors analyzed and summarized the contents in a qualitative manner. Results : In Taiwanese NHI system, CM procedures and medication for outpatients are reimbursed through a mix of fee-for-service and global budget payment system. CM shares 4% of total expenditure of NHI in Taiwan. Mostly, the expenses for procedures are reimbursed regardless of disease type, however, in the specialized program for quality improvement, CM doctors have to comply with standard operating procedures (SOPs). Conclusions : Taiwanese NHI system implemented SOP-based new reimbursement system for CM. Yet, the scientific evidences for SOPs are not sufficient, it can be useful references when we develope disease related reimbursement system for Korean Medicine in South Korea.

• Korea Journal of Hospital Management
• /
• v.9 no.2
• /
• pp.76-101
• /
• 2004

The primary purpose of this study was to provide the basic information for improving collaborating care of Korean traditional medicine and western medicine by surveying utilization and attitude on it among cerebral apoplexy(CA) patients hospitalized at a general hospital with both the western and Korean traditional medical department in Busan metropolitan city, Korea. The survey was conducted on 170 patients, 80 from Korean traditional medical department, and 90 from western medical department. The major results of this study were as below: First, CA patient's medical utilization patterns including selecting medical institution, term of treatment and type of medical institution at first-aid were significantly variated by their socio-demographic characteristics such as religion and job. Second, the perceptions of collaborating care, such as effectiveness and reduction of treatment period, were better at respondents who were hospitalized at oriental medical department and had been experienced with collaborating care. Third, the major contents of collaborating care which utilized by respondents in side of western medicine were physical therapy, x-ray, pathologic diagnosis, and medication, and in side of Korean traditional medicine were acupuncture, herbal medication, moxa cautery, cupping a boil therapy. Fourth, overall satisfaction on collaborating care was good(3.5 of 5.0) and was significantly variated by age and religion. Fifth, respondents perceived that collaborating care was most helpful for rehabilitation and the major problem of current duplicate medical system was increasement of medical expenditures, and the major obstacle of collaborating care was prejudice against each other medicine. The results of this study imply that effective marketing for collaborative care suitable for age and religion of customers and patient satisfaction strategy is needed to activate collaborating care.

• Korean Journal of Oriental Medicine
• /
• v.15 no.2
• /
• pp.63-78
• /
• 2009

Choosing an auspicious day originated from cosmobiological concepts which were prevalent in traditional society. This method was devised to minimize the damage and maximize the effect of acupuncture and moxibustion. It is found in most of Asian traditional medicine and still regarded as important in Tibet. In Korea, historical records show that various rules were applied to make certain pills, enhance physical condition, avoid illness and to get medical care. Strict rules were also applied to avoid inauspicious days when using acupuncture and moxibustion. But this tradition lost chance of proper evaluation due to involuntary and rapid westernization. Chimgutaekilpyonjip was published in early Chosun dynasty collecting almost all existing methods from the Huangdineijing to Sung-Chin-Yuan medicine. DonguiBogam Yirimchalyo and Chimgukyunghumbang succeeded these methods in separate ways. But they are similar at particular points. In many clinical cases of Seungjeongwonilgi, most methods written in DonguiBogam were used to choose auspicious days, In this study, the characteristic of Chimgutaekilpyonjip and other medical texts of Chosun are compared by analyzing the contents regarding choosing an auspicious day. Secondly, clinical records of Seungjeongwonilgi are examined to assess their practical use. Studying and evaluating the past theories could help accelerate the procedure of setting a proper standard in our times.

• Korean Journal of Oriental Medicine
• /
• v.2 no.1
• /
• pp.506-513
• /
• 1996

The odor theory(氣味論) has been defined as the Nature(氣) and the Taste(味) of traditional herbal medicine to find the logic in treatment of various diseases by them. There is a strong possibility these Natures of the drug can be categorized according to yin(陰) and yang(陽). To understand the Hot and the Cold Natures of traditional herbal drugs in scientific approaches, changes in skin, rectal temperature of rats have been measured at 0, 30, 60, 90 min after a 5, 10, 20g/Kg oral administration each of Coptidis Rizoma(Ranunculaceae, Coptis chinesis, $F_{RANCH}$), Aconiti Lateralis Preparata Radix(Ranunculaceae, Aconitum carmichaeli $D_{EBX}$). From this study, we obtained as follows. 1. We can categorize the four Natures of drug according to yin(陰) - Cool and Cold Natures and yang(陽) - Warm and Hot Natures. 2. The relation between the four Natures of drug and the changes of body temperature can be studied as the considertion of the dosage and the preparation of crude medicines. 3. Herbs containing toxicant should be studied carefully without the side effects.

• The Journal of Korean Medicine
• /
• v.44 no.3
• /
• pp.189-200
• /
• 2023

Objectives: The purpose of this study is to analyze the current state of quantitative literature evidence for the prescription of 56 herbal medicines covered by health insurance that have been studied in Korea for the past 30 years, to evaluate the reliability of the evidence, and to find out the research direction of herbal medicine prescription in the future. Methods: 56 kinds of herbal medicine prescriptions were searched in domestic literature search databases OASIS, DBpia, and overseas PubMed, classified into chemistry, toxicity, cells, animals, clinical cases, and clinical trial studies, and built into an EBM pyramid structure. Results: When classified according to research contents, there were 61 cases (7.5%) of physicochemical analysis to identify constituent substances, 80 cases (9.8%) of toxicity evaluation, and 672 cases (82.7%) of efficacy evaluation. The efficacy evidence was classified according to the evidence-based medical pyramid structure: 196 cell trials (29.1%), 372 animal trials (55.4%), 89 case and case reporting series (13.3%), 7 comparative case studies (1.1%), and 8 randomized control clinical trials (1.2%). In the pyramid composition, the basis for the validity of 56 kinds of herbal medicines prescribed was 568 cases (84.5%) in cell and animal units, which could not be said to be highly reliable. There was no relationship between the ranking of quantitative literature evidence for herbal medicine prescriptions and the ranking of salary administration. Conclusions: In an era that continues to require scientific evidence for herbal medicine, traditional herbal medicine should secure the basis for safety validity even for the 10th most frequent prescription among 56 herbal medicine prescriptions for consumers. In particular, traditional herbal medicine should increase the quantitative and qualitative level of case reports on related herbal medicine prescriptions, focusing on each clinical society, and move toward comparative case studies and randomized clinical trial so that traditional herbal medicine is positioned as Evidence-based medicine.

• The Journal of Korean Medical History
• /
• v.29 no.2
• /
• pp.83-105
• /
• 2016

Traditional medical knowledge and its biological resources, including Korean Medicine, has regarded as an important object of intellectual property rights. International organizations have been discussed and implemented various treaties on how to exercise and protect the property rights of traditional medicines. In Korea, the governmental policies and the academic societies have endeavored to establish the protection method and academic foundations of Korean Medicine's intellectual properties. This study will examine the current situation of discussions in major international organizations and Korean governmental policies related to the protection of traditional medical intellectual properties. Furthermore, this paper will contemplate the possible arguments and countermeasures to protect the traditional knowledge of Korean Medicine. We hope that this study will contribute to find the reasonable and effective ways of protection of Korean Medicine's intellectual property rights.

• Journal of Society of Preventive Korean Medicine
• /
• v.14 no.2
• /
• pp.67-75
• /
• 2010

Objectives : Recently, the number of elderly people has been rapidly increasing in Korea, and it led to increase demands of Korean traditional medical services. However, there is a lack of information on Korean traditional service utilization. Thus, this study was intended to identify Korean traditional service utilization patterns such as acupuncture, moxibustion and cupping, since Korean traditional services were specially used in treating chronic diseases for elderly people. It is important to understand health services utilization for quality improvement of healthcare systems. Methods:We used data of 'Survey in Daegu' in 2008 and analyzed characteristics of disease structure and utilization patterns of health care service of 1,097 cases of participated citizens. Results : The proportion of the elderly people (>50 age) in total participators is 52.4%. Male to female ratio is 1:1.65 and most common age group was between 50 and 59 years old. 84.2% of participators were admitted at oriental health care facilities. In addition, the results showed that female were more used the service than man. The most common treated disease is musculoskeletal disorders in both male and female. Conclusions : Acupuncture, moxa and cupping are widely used to treat chronic degenerative diseases such as musculoskeletal disorders at oriental health care facilities. Elders and female prefer to be admitted at oriental health care facilities.