• 대한한의학원전학회지
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• 제23권4호
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• pp.63-102
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• 2010

Purpose : To propose various types of clinical research which is feasible for botanical new drug (IND) development processes, and suggest essential steps to development of study protocol for IND. Methods : Literature-based discussions and one research group's experience is given regarding domestic act, regulation, and system. Results : In order to get an approval of IND for botanical drug in Korea there are several types of clinical research to conduct. In quality control steps for standardized medicinal herbs, case reports or case series can be conducted, and for good manufacturing practice(GMP) steps, we can conduct case reports, case series, and retrospective cohort studies. In addition, as long as we gathered good laboratory practice(GLP) data we can conduct up to quasi-experimental studies and clinical trials including investigator initiated trials. In order to conduct these studies development of study protocol is essential. First, we obtain historical evidence including target disease and indication, efficacy, safety, and endpoints by reviewing medical classics. Second, we obtain clinically and statistically important data by conducting non-clinical studies, observation studies, and quasi-experimental studies. Third, we generate research hypotheses and purposes and explore methodologies, endpoints, clinical practice guidelines, cost-effectiveness, and commercial potential. Finally, we develop study protocol with aid of biostatistician or expert in contract research organization. Discussions and conclusions : This study have obvious limitations in that most thoughts, suggestions, and proposes are from one research group's experience. Therefore, we hope to see various types of research in this topic and process from other research group as well.

• 대한본초학회지
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• 제24권4호
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• pp.205-213
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• 2009

Objectives : Cancer incidence is increasing in all countries and chemotherapy-induced peripheral neuropathy (CIPN) in patients undergoing chemotherapeutic agents have been a clinically serious problems. So far therapeutic options for CIPN patients are limited and no confirmed methods have yet been established for dealing with peripheral neuropathy. Therefore this review is to provide an evidence-based summary of oriental medicine and CAM (complementary and alternative medicine) neuroprotective and treatment therapies which have gone through clinical trials. Methods : An overview of the domestic and international papers of adult clinical trials relating management of only CIPN symptoms through 1990 to present were searched by electronic databases. Search key words were chemotherapy-induced neurotoxicity, chemotherapy-induced peripheral neuropathy, chemotherapy toxicity & herb, chemotherapy toxicity & acupuncture, chemotherapy toxicity & CAM. Only English and Korean written papers were reviewed. Total 25 papers were reviewed in this study, 18 papers were retrieved by electronic search. Results : Clinical studies of managing CIPN were rare, two acupuncture clinical studies and four herb medicinal studies were found. Rest of 19 papers were about other CAM clinical studies. Total 25 papers were analyzed, and all interventions were focused on their pain control efficacy. Other 24 trials of potential therapies except one proved to be effective for CIPN, however some described to be inadequate positive or sufficient negative. Conclusions : As most of the studies were pilot studies, interventions for the prevention and treatment of CIPN have to go through prospective confirmatory studies, such as larger scale randomized, double-blinded, placebo controlled clinical trials must be done for the safe and effective use of proposed therapies. Also standard measurement scales have to be developed for the better clinical study of CIPN.

• 동의신경정신과학회지
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• 제24권spc1호
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• pp.3-14
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• 2013

Objectives : Hwabyung Research Center of The Korean Society Of Oriental Neuropsychiatry has attempted to develop 'Clinical Guidelines for the Treatment of Hwabyung' based on the clinical study on the theory of oriental medicine and phenomenological approach. The purpose of this guideline is to establish the basic clinical principles and improve the clinical convenience. Methods : Hwabyung Research Center constructed a committee of experts and advisory group. We extracted the core questions, collected the existing data and evaluated them. Simultaneously, we conducted studies on the major topics. Results : We selected and made suitable tools for the assessment and evaluation. We discovered evidences from clinical studies and developed the standard clinical principles. Conclusions : 'Clinical Guidelines for the Treatment of Hwabyung' is expected to be useful at the primary medical clinics of oriental medicine.

• 생물정신의학
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• 제19권4호
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• pp.159-163
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• 2012

An appropriate research design for hypotheses and purposes leads to a good quality of research results. In this review article, we summarized the types of research methods and described the characteristics of clinical trials. Research designs are categorized into observational studies and experimental ones, depending on data collecting methods. In an observational study, there are cross-sectional, cohort and case-control studies. Parallel groups design and crossover trial studies are representative designs in a randomized controlled trial study, a kind of experimental study. Clinical researchers should understand the characteristics of clinical research designs including advantages and disadvantages and choose the suitable design according to their study purposes and the nature of collected data or subjects.

• Journal of Periodontal and Implant Science
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• 제43권6호
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• pp.262-268
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• 2013

The use of dental implants has become a mainstay of rehabilitative and restorative dentistry. With an impressive clinical success rate, there remain a few minor clinical issues with the use of implants such as peri-implant mucositis and peri-implantitis. The use of laser technology with implants has a fascinating breadth of applications, beginning from their precision manufacturing to clinical uses for surgical site preparation, reducing pain and inflammation, and promoting osseointegration and tissue regeneration. This latter aspect is the focus of this review, which outlines various studies of implants and laser therapy in animal models. The use of low level light therapy or photobiomodulation has demonstrated its efficacy in these studies. Besides more research studies to understand its molecular mechanisms, significant efforts are needed to standardize the clinical dosing and delivery protocols for laser therapy to ensure the maximal efficacy and safety of this potent clinical tool for photobiomodulation.

• Annals of Clinical Neurophysiology
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• 제5권1호
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• pp.1-10
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• 2003

Small-fiber neuropathy (SFN) is a common clinical problems. The disorder is a generalized peripheral polyneuropathy that selectively involves small-diameter myelinated and unmyelinated nerve fibers. It is often idiopathic and typically presents with painful feet in patients over the age of 60. And autoimmune mechanisms are often suspected, but rarely identified. The clinical features consisted of painful dysesthesias and postganglionic sympathetic dysfunction, as well as reduced pinprick and temperature sensation. Although affected patients complain of neuropathic pain, this condition is often difficult to diagnose because of the few objective physical signs and normal nerve conduction studies. Diagnosis of SFN is made on the basis of the clinical features, normal nerve conduction studies, and abnormal specialized tests of small fiber function. These specialized studies include assessment of epidermal nerve fiber density as well as sudomotor, quantitative sensory, and cardiovagal testing. Unless an underlying disease is identified, treatment is usually directed toward alleviation of neuropathic pain.

• 한방재활의학과학회지
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• 제25권1호
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• pp.63-70
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• 2015

Objectives The purpose of this study is to understand the research trend of reports on forest therapy so far and analyze the Korean medicine therapy being applied in forest therapy programs. Methods We ran a keyword search on domestic databases with the following keyword 'forest therapy, forest healing, forest treatment, recreational forest, forest bath, forest experience'. The search took place in December 2014 and there was no limit to search time. A total of 334 forest therapy articles have been selected. Results The number of research on forest therapy continued to rise from 1985, with 334 articles being published from 84 journals. When those 188 articles were sorted by their contents and methods, except 146 articles of survey on simple satisfaction, recognition and visting, 94 were clinical studies, 79 were literature studies, 15 were experimental studies. Of the 94 clinical researches, there were 52 CCTs (Controled Clinical Trials), 39 ODs (efficacy studies with either a controlled or an Other than controlled Design) and 3 RCTs (Randomized Clinical Trials). Among the clinical researches, there were a total of 21 studies that used Korean Medicine programs, and meditation was the most popular, being used in 18 studies. Herbal food and tea therapy and Qigong were used in 3 studies each, and Korean medicine music programs were used in 2 studies. Conclusions A systematic and standardized Korean medicine forest therapy program must be developed, and based on the program, more research treating diseases should be conducted.

• Korean Journal of Acupuncture
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• 제35권2호
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• pp.56-69
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• 2018

Objectives : The aim of this study is to review the current research trend on the acupuncture and moxibustion treatment for pancreatitis. Methods : Through nine search engines, articles were collected, which had involved the use of acupuncture and moxibustion treatment for pancreatitis. Data were extracted from the selected articles regarding the year, country, type of pancreatitis, study design, evaluation variable, intervention, point for acupuncture and moxibustion, and effectiveness of treatment. Results : Total 56 articles were reviewed. The number of studies increased gradually every ten years. Fifty-one studies(91%) were conducted in China. Most of clinical studies and animal experimentations reported on acute pancreatitis. Thirty-nine studies were randomized controlled trials(RCTs), but most of them were assessed as uncertain in the risk of bias evaluation. The degree of overall improvement(79%) was used mainly as evaluation variable of clinical studies. In animal experimentations, the examination of pancreatitis tissue(77%) and blood test(77%) were used the most. Most of studies were conducted with the acupuncture, one with moxibustion. Among them, electroacupuncture was the most common intervention of treatment group. ST36 was the most frequently used acupuncture point in the included studies. Effective rate increased and serum amylase, clinical symptoms, recovery time of gastrointestinal function decreased statistically significantly in the treatment group of clinical studies. Conclusions : The result of this study could be used for the future practice and research about the acupuncture and moxibustion treatment for pancreatitis.

• 대한한방소아과학회지
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• 제29권4호
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• pp.77-89
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• 2015

Objectives The purpose of this study is to analyze Korean clinical studies in Korean medicine and complementary and alternative medicine for allergic rhinitis and to propose for better methods of clinical studies and effective treatments on allergic rhinitis. Methods Electronic researches were performed with NDSL, RISS, KISTI, KISS, OASIS by keyword 'Allergic rhinitis'. Results The treatments used in 36 studies were herbal medicines, acupuncture, pharmacopuncture, moxibustion, cupping, inject medicine to nasal cavity, aroma therapy, ointment, nasal cleansing solution, laser treatment, infra-red therapy, oxygen nebulizer, diet treatment, moxa-pellet treatment, mindfulness meditation and space-spine manipulation techniques. The most common acupoints were LI4 and LI20 (Large Intestine Meridian). The most common methods of assessment is subjective nasal symptoms. All studies using subjective nasal symptoms and quality of life as assessment methods to show valid results on the improvement of allergic rhinitis. Conclusions This study shows that Korean medicine and complementary and alternative medicine on allergic rhinitis are effective. It will be expected to use that various methods for allergic rhinitis and more clinical studies for allergic rhinitis and pediatric patients needed in the future.

• 턱관절균형의학회지
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• 제8권1호
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• pp.1-5
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• 2018

Objectives: The purpose of this review is to analyse the trends of clinical studies using oral appliance in Korean Medicine. Methods: We reviewed Korean Medicine papers by searching Korean web databases 'Korea Traditional Knowledge Portal (KTKP)', 'Korea Medical Information Portal (OASIS)', 'Academic Research Information Service (RISS)', 'Scientific and Technological Information Integration Service (NDSL)'. We classified the papers by the year of publishment, the title of journals, the type of study and contents. Results: 1. Clinical studies using oral appliance have been increasingly published since 2011. 2. Most of the studies were published in the Journal of TMJ Balancing Medicine. 3. 33 research papers were divided in to 6 original articles, 27 case reports. But almost presented a low level of evidence. 4. In the content of the studies, oral appliance were used for various diseases such as nervous system, musculoskeletal system and visceral system. Conclusions: We expect that various studies and clinical application will be actively carried out with the development of technology related to oral appliance.