• 대한한방내과학회지
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• 제38권2호
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• pp.201-216
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• 2017

Objective: This research aimed to understand patients' perceptions of Korean medicine treatment for osteoporosis in a clinical trial setting. Methods: Ten patients participating in a clinical trial of a herbal medicine drug for osteoporosis were invited to an interview. Data were collected by in-depth interviews and patient observations. This qualitative study adopted the case study research method, and within-case and cross-case analyses were conducted. Results: A model of the patients' osteoporosis management planning was derived from the study. The results showed that the patients' perceptions of osteoporosis were derived from their knowledge and experience during diagnosis and treatment of the condition. Two groups of patients were recognized: those who overlooked the importance of osteoporosis and those who recognized the importance of osteoporosis. Before making treatment decisions about osteoporosis, the patients evaluated the treatment options and weighed the advantages and disadvantages of each option. When evaluating their treatment, the patients combined their knowledge and experience of Korean and western medicine treatments. Their experience of participating in the clinical trial influenced the management planning of osteoporosis. Two major reasons for low compliance with osteoporosis treatment were ignorance of the disease and insufficient information provided by doctors. Conclusion: The results of this qualitative study pointed to four strategies that could be employed to improve accessibility to Korean medicine treatment for osteoporosis: the dissemination of comprehensive information on osteoporosis in the clinic and mass media, promotion of Korean medicine therapies for osteoporosis, management of clinical trial participants, and insurance coverage for Korean medicine.

• 한방안이비인후피부과학회지
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• 제31권2호
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• pp.40-59
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• 2018

Objectives : We report on the contents and reviews of the guidelines for clinical trials of herbal medicine for psoriasis. Methods : After reviewing the existing reports, the guidelines were drafted by the writing committee on guidelines for Korean medicine clinical trial center in Kyung Hee university Korean medicine hospital. Since then, the guidelines have been consulted by the experts in diseases, clinical trials and pharmaceuticals. In addition, the guidelines have been certified by the Korean medicine clinical trial center association and Korean Medicine Ophthalmology & Otolaryngology & Dermatology Society. Results : The guidelines for clinical trials are divided into 8 categories: (1) general contents, (2) evaluation standards of effectiveness, (3) outcome valuables, (4) selection of study participants, (5) designs of clinical trials, (6) safety evaluations, (7) combination therapies in psoriasis treatment and (8) Korean medical considerations. Conclusions : There are 3 major contents for discussion: (1) obscurity of Korean medical considerations to differentiate from existing guidelines, (2) the absence of Korean version of PASI and DLQI, which are validity parameters and (3) realistic institutional problem using the herbal medicine.

• 한국식품위생안전성학회지
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• 제26권3호
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• pp.266-272
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• 2011

The safety of liquid-type herbal preparations (47 samples) and beverages containing herbal medicines (18 samples), which are distributed in Gyeonggi province was studied by analyzing heavy metals, benzo(a)pyrene, preservatives and sugar content and to explain the differences between medicine and food based on the labeling standards. The herbal preparation is regarded as medicine and can be differentiated from the beverages containing herbal medicine, which is food, based on the fact that the herbal preparation should be labeled with usage, dosage, efficiency and effect. The mean concentrations of Pb, As, Cd, Hg were found to be 0.014 mg/kg, 0.113 mg/kg, 0.004 mg/kg and 0.003 mg/kg in herbal preparation and 0.009 mg/kg, 0.122 mg/kg, 0.003 mg/kg and 0.002 mg/kg in beverages containing herbal medicines, respectively. In 10 cases of herbal preparations and 6 cases of beverages containing Rehmanniae Radix Preparata (Sukjihwang), benzo(a)pyrene was not found. According to preservative test on herbal medicine, dehydroacetic acid was found less than the indicated content in 6 cases out of 37 cases, which labeled with preservatives, and benzoic acid, dehydroacetic acid and methylparaben were contained with 164.0~198.0 mg/kg, 149.8~272.5 mg/kg and 88.4 mg/kg, respectively, in 3 cases out of 10 cases, which was not labeled with preservatives. Among 16 cases of beverages containing herbal medicines, 3 cases of preservative-labeled beverages had the preservatives, and the rest of all, which was not labeled with preservatives, did not show that they contain any preservative, therefore, it was suitable for the labeling standards. As a result of sugar content test, preservative-labeled products were not appreciably different from the others.

• 한방재활의학과학회지
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• 제27권4호
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• pp.33-53
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• 2017

Objectives This study was designed to review animal studies about the efficacy of herbal medicine for Rheumatoid arthritis animal model which was published in Korea after 2008. We also systematically investigated the reporting quality of the animal studies. Methods We systematically searched original articles in 8 databases since 2008. And manual searching was conducted through 10 Korean medicine journals from 2008. Studies were included if they used animal experimental model(s) with orally administered herbal medicine. Data were extracted regarding animal model, rheumatoid arthritis indicator and detail of intervention. Reporting quality of each study was also assessed by the STARA and ARRIVE guidelines. Results Nine hundred two articles were screened. Finally, 35 articles were included. 35 studies all showed that the herbal medicine used in the studies has significant effect on alleviating the macroscopic indicators, hematological indicators, histological indicators, genetic indicators, osteological indicator of Rheumatoid Arthritis and others. Species of animals was reported in 100% while ventilation and noise were reported in 0% in STRASA guidelines. Ethical statement was reported in 42.9%, experimental animals and sample size were reported in 24%, 29% and there was no study reporting funding. Conclusions These results suggest that herbal medicine might be effective treatment for Rheumatoid Arthritis. It should be improved by clinical studies. And there is a need for studying about efficacy and safety of each specific herbal medicine. And we should improve the Reporting quality of the animal studies published in Korea.

• 대한암한의학회지
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• 제16권1호
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• pp.41-53
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• 2011

Background and Objectives: Iodine is an essential constituent of the thyroid hormones associated with the growth and development of humans and animals as an inorganic nutrition. This element may be accumulated in human blood, tissues and body through the intake of foodstuffs, a beverage, a nutritional supplement and a medicine, among others. The aim of the research is to find out a better medicinal stuff for the thyroid cancer patient who required a low level of iodine diet. Methods: Neutron activation analysis (NAA) used for the iodine analysis is one of nuclear analytical techniques using radiation and radioisotopes and very useful as sensitive analytical technique for performing both qualitative and quantitative multi-elemental non-destructive analysis of major, minor and trace components in variety of environmental and biological materials. In this study, iodine contents in ten kinds of oriental herb medicinal products, which is frequently used to cancer patients are determined by using instrumental neutron activation analysis (INAA) at the HANARO research reactor. The samples prescribed are manufactured as powdered form for taking medicine easily. The analytical quality control is performed to assure an uncertainty of the measurement and to compensate the measured data using a biological certified reference material, NIST SRM 1572, Citrus Leaves. The measured value is $1.89{\pm}0.35mg/kg$, and the relative error is 2.88%, and relative standard deviation is 19 % due to high counting error by small counts of gamma ray spectrum. The standard deviations for other elements such as Cl, K, Mn and Na were in the range of 2 to 8%. Result: The level of iodine contents of Biki-huan, Chungryong-huan and Chungcho-huan, samples detected is less than 6 mg/kg except Hangam Plus sample (more than 210 mg/kg) and six samples were not detected. Iodine in the samples of Shoxiho-tang, Shopunghualhyl-tang, Shocungryong-tang, Banhasaxim-tang, Insampaedox-san and Myunyuk Plus were not measured, but possible level of content can be estimated from the detection limits. In addition, the concentrations of some major elements like Cl, K, Mn, Na, in the samples were determined with the detection limits. Conclusions: Most of samples showed low iodine contents of less than 6 mg/kg but it turned out that most of testing samples can be used to classify the level of iodine diet samples considering the recommended low level of iodine diet 50 ${\mu}g$/day, and a better medicinal stuff for the thyroid cancer patient can be found.

• 대한예방한의학회지
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• 제22권3호
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• pp.31-44
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• 2018

Objectives : The aim of this study was to investigate the Korean medicine doctor's perception of the extension and activation of herbal medicine preparations insurance benefits. Methods : The sample of Korean medicine doctors' panel pool which is extracted by examining the square root quota of city location of Korean medicine clinics was used. In case of a vacancy in some participants, the number of Korean medicine doctors were supplemented and placed for investigation. Results : It has 54.0% awareness of the separation of prescribing and dispensing herbal preparations, 87.0% agreed on the need to be insured, but the separation as a necessary condition for being insured was only 60.3% agreed. When a large number of herbal preparations are being insured, it was expected that 30% to 50% of patients(30.3%) will be prescribed herbal preparations and the number of new patients will increase by 5 to 15 for the purpose of prescriptions only(49.3%). Increase amount of medical expense(?3,000) as a result of the separation of prescribing and dispensing herbal preparations are insufficient(54.3%). Conclusions : From the results of this study, extension of national health insurance to cover herbal preparations must be needed to activate herbal medicine preparations and improve Korean medical services.

• 동의생리병리학회지
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• 제33권4호
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• pp.207-218
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• 2019

It is necessary to investigate the efficacy of commercial Korean herbal medicine for cognitive disorder. The purpose of this study is to select candidates among licensed herbal medicines that are expected to be effective in the treatment of cognitive disorders and can be used in future clinical trial. From laboratory experiments, we first found individual single herbal drugs that could be effective for cognitive disorder, and then through experts recommendation, selected five priorities of single herbal drug and obtained the information of the best herb as a combination of each herbal drug. To derive the final herbal prescriptions, we searched the KFDA drug information system for licensed herbal medicines containing each drug and its combination. As a result of laboratory experiments and experts recommendation, we found that the five effective single herbal drugs for cognitive disorders. They are Ginseng Radix, Acori Graminei Rhizoma, Cyperi Rhizoma, Coptidis Rhizoma, Pinelliae Rhizoma, Hoelen cum Pini Radix, and Rehmanniae Radix Preparata(Pinelliae Rhizoma, Hoelen cum Pini Radix, and Rehmanniae Radix Preparata were tied for $5^{th}$). And licensed herbal prescriptions derived from the planned search are Palbohoichoon-tang, Taehwa-hwan, Bosim-hwan, and so on. Among these, in consideration of the feasibility of research and possibility of success in development, Yukgunja-tang, Samhwangjichul-hwan can be selected as future study subjects. Through experimental studies and expert recommendations, we have derived herbal prescriptions that can be effective in treating cognitive disorders from licensed herbal medicines.

• 한국의사학회지
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• 제27권2호
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• pp.11-37
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• 2014

Objectives : The purpose of this study was to analyze and identify the problems of the changes in regulations that are relevant to approval, notification, and review of herbal medicinal preparations and crude drug preparations. Methods : I collected the regulations of approval, notification, and review of medicinal products mostly from official gazettes, analyzed enactment and amendments regarding herbal medicinal preparations and crude drug preparations, and studied it from the view point of Korean medicine field. Results : Regulations in regards to approval, notification, and review of herbal medicinal preparations and crude drug preparations were first established in 1978. Herbal drugs started to be categorized as crude drug preparations in 1981 and the regulatory outlines were completed in 1999. From 2008 to 2012, the regulatory standards that let crude drug preparations be new drugs from natural products were established. Through those procedures, the followings became crude drug preparations: 1) wholly new prescriptions that are not recorded in Korean Medical Classics, 2) prescriptions that are recorded in Korean Medical classics but prepared with new standard, composition and efficacy, 3) prescriptions that are recorded in Korean Medical classics but prepared with new formulation, and 4) herbal drugs. In case of herbal medicinal preparations, however, only regulations that are related to 1) drugs prepared with new compositions that are not recorded in Korean Medical Classics, 2) drugs with same prescription and same formulation, and 3) drugs with new formulation were arranged. Conclusions : Actual circumstances on crude drug-oriented regulations regarding approval, notification and review and future forms of prescription and drug administration in Korean Medical Institutions can be expected due to expansion in range of herbal medicinal preparations and shrink in that of on-site preparations. Reasonable improvement in efficient usage of modernized herbal medicinal preparations in Korean medical institutions and prospective cooperation from related pharmaceutical industry are needed.

• 대한한방내과학회지
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• 제28권2호
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• pp.363-376
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• 2007

Objectives : This study was undertaken to learn what should be considered in a good clinical trial investigating a herbal medicine as an antidepressant. Methods : Five well-designed clinical trials published from 2000 to 2006 investigating SJWE in depressive disorder were selected. The trials were reviewed and compared in terms of methodology such as trial design, patient selection, efficacy & safety evaluation, and so on. On the basis of this review of the trials and the regulations and guidelines of KFDA, we suggest some points to be considered for a good clinical trial of a herb for depression. Results : Although every trial had its own unique design, procedure, objectives and so on, all trials used randomizing and double blinding methods. If there is no ethical problem, a placebo-controlled design should be considered in a herbal antidepressant clinical trial for depression. Conclusions : Some points to be considered in an optimal & good clinical trial for an antidepressive herbal medicine were suggested as follows: 1) randomizing and double blinding manner is essential, 2) if there is no ethical problem, placebo control design should be considered, 3) the trial period should be 6 weeks, 4) out-patients will be recruited as subjects, 5) investigators will be well-trained psychiatrists or medical doctors, 6) the number of subjects should be calculated by statistical methods, 7) subjects should be diagnosed by DSM-IV criteria, 8) subjects who have current risk of committing suicide should be excluded, etc.

• 동의신경정신과학회지
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• 제21권4호
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• pp.207-218
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• 2010

1. 본 증례보고에서는 세의 남성 광장공포증을 동반한 공황장애 환자에게 약 개월 동안 계지가용골모려탕(桂枝加龍骨牡蠣湯)Ex제를 주 치료 약물로 작약감초탕(芍藥甘草湯)Ex제를 보조 치료 약물로써 투여한 결과 환자의 주소증인 흉통 및 불안을 포함하여 관련 제반 증상들의 완화되는 효과를 관찰할 수 있었다. 2. Ex제는 탕제(湯劑)와 달리 휴대와 복용이 간편하므로 예기치 못한 공황발작 및 불안 발생 시 투여하기에 적합하다. 따라서 경도-중등도의 불안장애 혹은 공황장애 환자에게 계지가용골모려탕(桂枝加龍骨牡蠣湯)Ex제를 적용하여 그 효과를 검증하는 임상연구가 필요하다.