• Journal of Society of Preventive Korean Medicine
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• v.21 no.3
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• pp.29-42
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• 2017

Background : Efforts towards increasing insurance coverage for traditional Korean medicine (TKM) are being continued. However, various difficulties are faced in generating evidence for TKM due to limited financial support and the low quality of research methodology. Objectives : The objectives of this study were to review the Swiss evaluation program for complementary and alternative medicine (CAM) and assess the expansion in public health insurance coverage of complementary medicine as approved by referendum in Switzerland. Methods : The regulations of CAM in the European Union were assessed. Research articles, reports, government publications and websites which deal with the 'Programm Evaluation $Komplement{\ddot{a}}rmedizin$ (PEK)' and the referendum in Switzerland were searched for and analyzed. Results : The PEK was conducted from 1998 to 2005. The PEK evaluated the efficacy, utilization and cost-effectiveness of anthroposophical medicine, homeopathy, neural therapy, phytotherapy and traditional Chinese medicine. However, clear conclusions could not be drawn from the evaluation according to the PEK Report. Later, a referendum was implemented in which 5 therapies would be added to the Switzerland Constitution with the support of the public. The coverage of CAM was approved by Swiss a plebiscite with an approval rate of 67.0%. Conclusions : The reason for the successful referendum is suggested to be public support and the solidarity with CAM experts and politicians. It may be surmised that recognition of the political efforts and scientific aspects required to expand insurance coverage of TKM, and towards obtaining public support, is necessary.

• Journal of Pharmacopuncture
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• v.18 no.2
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• pp.42-50
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• 2015

Objectives: The aims of the study were to test the single- dose intravenous toxicity of Daebohwalryeok pharmacopuncture (DHRP) in Sprague-Dawley (SD) rats and to estimate the crude lethal dose. Methods: The experiments were conducted at Biotoxtech Co., a Good Laboratory Practice (GLP) laboratory, according to the GLP regulation and were approved by the Institutional Animal Care and Use Committee of Biotoxtech Co. (Approval no: 110156). The rats were divided into three groups: DHRP was injected into the rats in the two test groups at doses of 10 mL/kg and 20 mL/kg, respectively, and normal saline solution was injected into the rats in the control group. Single doses of DHRP were injected intravenously into 6 week old SD rats (5 male and 5 female rats per group). General symptoms were observed and weights were measured during the 14 day observation period after the injection. After the observation period, necropsies were done. Then, histopathological tests were performed. Weight data were analyzed with a one-way analysis of variance (ANOVA) by using statistical analysis system (SAS, version 9.2). Results: No deaths and no statistical significant weight changes were observed for either male or female SD rats in either the control or the test groups during the observation period. In addition, no treatment related general symptoms or necropsy abnormalities were observed. Histopathological results showed no DHRP related effects in the 20 mL/kg DHRP group for either male or female rats. Conclusion: Under the conditions of this study, the results from single-dose intravenous injections of DHRP showed that estimated lethal doses for both male and female rats were above 20 mL/kg.

• Journal of Korean Medicine Rehabilitation
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• v.21 no.4
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• pp.145-156
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• 2011

Objectives: This study was resigned to observe change of body temperature for patients with low back muscular pain after NUGA MRT-II(pulsed electromagnetic therapy) treatment. Methods: This study was a randomized, patient-assessor blind, placebo-controlled, pilot trial study. After the approval of institutional review board(IRB), we have recruited 38 patients suffering from low back muscular pain and divided them into two groups randomly: the treatment group and control group. To the treatment group, NUGA MRT-II was practiced and to the control group sham device was practiced and their low back muscles and acupuncture points three times a week for 2 weeks from February 2011 to May 2011. After 1 week of last treatment, We compared body temperature of two groups. Results: 1. There was significant decrease of body temperature on both Shinsu(BL23), Chishil(BL52), Kwanwonsu(BL26) acupunture points for the treatment group. 2. There was no difference in the decrease of body temperature between treatment group and control group except. Left Kwanwonsu(BL26). Conclusions: We found out that treatment of NUGA MRT-II on low back muscular pain can reduce the temperature of low back.

• Journal of Society of Preventive Korean Medicine
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• v.18 no.1
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• pp.23-41
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• 2014

Objective : The purpose of this study was to lay the groundwork for understanding the details and scope of the legal definition of medicinal products, following the changes in the relevant laws and regulations. This will let readers properly understand the origins of the ongoing conflicts on herbal drugs and new drugs from natural products that are present in the medical field and the medical industry. Possible solutions are proposed in the end. Method : I analyzed the changes in definition of medicinal products since 1945 that have been used in relevant laws and regulations(i.e. Pharmaceutical Affairs Act) and drug approval process(i.e. New Drug Application and Investigational New Drug Application). Results : Legal definition of medicinal products has changed in accordance with the changes in the pharmaceutical industry, such as the establishment of dualistic medical and pharmaceutical System and the introduction of the substance patent. Due to those changes, boundaries of Western medicinal products and health food expanded, while those of herbal medicine products relatively downscaled. Conclusion : Legal definition of medicinal products-i.e. Herbal Drugs, Crude Drugs, and New Drugs from Natural Products-should be reestablished according to academic legitimacy and dualistic medical and pharmaceutical System.

• Clinical and Experimental Reproductive Medicine
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• v.42 no.3
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• pp.126-129
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• 2015

Essure (Bayer) received approval from the U.S. Food and Drugs Administration as a permanent non-hormonal contraceptive implant in November 2002. While the use of Essure in the management of hydrosalpinx prior to in vitro fertilization (IVF) remains off-label, it has been used specifically for this purpose since at least 2007. Although most published reports on Essure placement before IVF have been reassuring, clinical experience remains limited, and no randomized studies have demonstrated the safety or efficacy of Essure in this context. In fact, no published guidelines deal with patient selection or counseling regarding the Essure procedure specifically in the context of IVF. Although Essure is an irreversible birth control option, some patients request the surgical removal of the implants for various reasons. While these patients could eventually undergo hysterectomy, at present no standardized technique exists for simple Essure removal with conservation of the uterus. This article emphasizes new aspects of the Essure procedure, as we describe the first known association between the placement of Essure implants and the subsequent development of fluid within the uterine cavity, which resolved after the surgical removal of both devices.

• Dementia and Neurocognitive Disorders
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• v.21 no.2
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• pp.45-58
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• 2022

Recently, aducanumab, a beta amyloid targeted immunotherapy, has been approved by the US Food and Drug Administration for the treatment of Alzheimer's dementia (AD). Although many questions need to be answered, this approval provides a promising hope for the development of AD drugs that could be supported by new biomarkers such as blood-based ones and composite neuropsychological tests that can confirm pathologic changes in early stages of AD. It is important to elucidate the complexity of AD which is known to be associated with other factors such as vascular etiologies and neuro-inflammation. Through the second international conference of the Korean Dementia Association (KDA), researchers from all over the world have participated in the exchange of opinions with KDA members on the most up-to-date topics. The Academic Committee of the KDA summarizes lectures to provide the depth of the conference as well as discussions. This will be an important milestone to widen the latest knowledge in the research of AD's diagnosis, therapeutics, pathogenesis that can lead to the establishment of future directions.

• Archives of Plastic Surgery
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• v.39 no.6
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• pp.585-592
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• 2012

During the past decade, many studies using platelet-rich plasma (PRP) or adipose-derived stem cells (ASCs) have been conducted in various medical fields, from cardiovascular research to applications for corneal diseases. Nonetheless, there are several limitations of practical applications of PRP and ASCs. Most reports of PRP are anecdotal and few include controls to determine the specific role of PRP. There is little consensus regarding PRP production and characterization. Some have reported the development of an antibody to bovine thrombin, which was the initiator of platelet activation. In the case of ASCs, good manufacturing practices are needed for the production of clinical-grade human stem cells, and in vitro expansion of ASCs requires approval of the Korea Food and Drug Administration, such that considerable expense and time are required. Additionally, some have reported that ASCs could have a potential risk of transformation to malignant cells. Therefore, the authors tried to investigate the latest research on the efficacy and safety of PRP and ASCs and report on the current state and regulation of these stem cell-based therapies.

• Journal of Veterinary Clinics
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• v.35 no.4
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• pp.119-125
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• 2018

In vitro diagnostic veterinary medical reagents (IVDVMRs) were diverted the medical devices from medicine by the revision of the pharmaceutical affairs act enforcement regulations in 2015 in Korea. It classified into class I-IV according to risks of individual and public health. However, good manufacturing practices requirements on IVDVMRs were exempted from the current system. The registration of IVDVMRs by the Animal and Plant Quarantine Agency has gradually increased since 2012, and total of 584 products from 68 companies were registered from 1978 to 2017. Most of these items are clinical immunochemistry (infection disease), clinical immunochemistry (non-infection disease), molecular genetics, endocrinology, blood gas analysis, clinical microbiology, toxin, heavy metal and drug of abuse, other etc. The market size of IVDVMRs reported from the Korea Animal Health Products Association was estimated to be approximately 51.9 billion won in 2017. The domestic consumption and the export sales were approximately 31.2 and 20.7 billion won, respectively. They are increasing 23.9% (CAGR) in domestic consumption and 40.4% (CAGR) in export from 2011 to 2017.

• Journal of Korean Foot and Ankle Society
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• v.21 no.2
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• pp.70-74
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• 2017

Fractures and fracture-dislocations of the ankle are caused by a variety of mechanisms. In addition to fractures, injuries of soft tissue, such as ligaments, tendons, nerves, and muscles may also occur. Among these, a tibialis posterior tendon injury is difficult to be identified due to swelling and pain at the fracture site. It is difficult to observe tibialis posterior tendon injury on a simple radiograph; it is usually found during surgery by accident. There are some studies regarding irreducible ankle fracture-dislocations due to interposition of the tibialis posterior tendon; however, to the best of our knowledge, there has not been any report about interposition of injured tibialis posterior tendon. Herein, we report a case of an irreducible fracture-dislocation of the ankle due to injured tibialis posterior tendon interposition that was observed intraoperatively, interrupting the reduction of ankle fracture-dislocation. We obtained satisfactory clinical result after reduction of the trapped tendon, fracture reduction, and internal fixation; therefore, we are willing to report this case with the consent of the patient. This study was conducted with an approval from the local Institutional Ethics Review Board.

• The Journal of Internal Korean Medicine
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• v.33 no.4
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• pp.485-497
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• 2012

Objectives : The aim of this study was to systematically investigate herbal-drug-associated adverse drug reactions (herbal ADRs) reports submitted by a single oriental hospital and to analyze the general characteristics, causative agents, clinical manifestations, severity and types of herbal medicines which caused herbal ADRs. Methods : This study proceeded with IRB approval. The data on herbal ADR were collected prospectively from January 2008 to February 2012 by EMR of Dongguk University Ilsan Oriental Hospital. The World Health Organization (WHO)-Uppsala Monitoring Center (UMC) criteria was used to determinate causality for each herbal ADR. WHO-Adverse Reaction Terminology (WHO-ART) System Organ Class (SOC) code and WHO severity category were also used in this study. Results : A total of twenty eight cases were reported. Twenty two cases were assessed to have over possible relations with herbal medication. The gender ratio of these cases were 64.6 percent female and 36.4 percent male, demonstrating no statistical significance. Patients aged over 60 were 59.1%. Gastro-intestinal system was reported to be the most frequently affected organ (38.8%), and followed by psychiatric system (22.4%), and integumentary system (22.4%). The most common clinical symptom was headache (12.2%), followed by diarrhea (10.2%), and pruritus (10.2%). The severity of most cases was assessed to be mild (89.8%). The percentage of moderate ones was 10.2%, and there were no severe cases. Conclusions : Progressive study and further analysis on herbal ADRs are warranted for safety in the clinical use of herbal medicines.