• The Journal of Internal Korean Medicine
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• v.28 no.2
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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.

• The Journal of Korean Medicine
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• v.26 no.2 s.62
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• pp.85-94
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• 2005

Objectives: This study was carried out to estimate the demand for clinical trials and contribute to the consolidation of function and role in the clinical trial centers of oriental medicine. Methods: A survey of the demand was made of 379 faculties of oriental medicine in 11 oriental medical colleges throughout the country using two?part investigations by e-mail questionnaire over 1 month. The final data from 56 faculties were analyzed. Results: Clinical trials of oriental medicine have been continuously increasing. Furthermore, the demand and necessity for clinical trials of oriental medicine have also been continuously enhanced. Although there were arguments for and against the establishment of a clinical trial center for oriental medicine, the demand and necessity for the establishment was the overall consensus. Concerning objections, a high intention of use was observed. Conclusions: These results imply that the demand for clinical trials will increase remarkably through the establishment of a clinical trial center for oriental medicine. Further study is needed about the demand for such a center.

• Journal of Acupuncture Research
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• v.26 no.5
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• pp.105-116
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• 2009

The use of acupuncutre has been increased worldwide, and large number of researches on acupuncture with improved quality has been conducted. Nevertheless, results of acupuncture treatment in those research tend to show mixed results, while many patients continuously seek acupuncture treatment as an adjuvant or alternatives for their health. Researchers and clinicians relevant to acupuncture are faced at this problematic discrepancy between the results of acupuncture in clinical trial including an randomized controlled trial and those of day-to-day clinical practice. The methodology of pragmatic clinical trial seems to be one of the promising research tools administering this problem especially in the area of complementary alternative medicine and traditional Korean medicine. In this study we first reviewed articles on the pragmatic clinical trial, summarized the essential concepts of 'explanatory' clinical trial 'pragmatic' clinical trial and then presented recent recommendations and arguments on this issue. We also analyzed and compared two similar pragmatic clinical trial protocols to show the readers the complexity of research designing. We hope more researchers in traditional Korean medicine will be interested in the methodology of pragmatic clinical trials and this study will serve to produce various high-quality clinical trials.

• Korean Journal of Oriental Medicine
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• v.13 no.2 s.20
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• pp.127-133
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• 2007

Objectives : This study were aimed to estimate the needs for clinical research educational program development focused on oriental medicine. Methods : Department Medical Research of Korea Institute of Oriental Medicine surveyed 204 certified subjects in total by using web-based questionnaires through e-mail from Jan. 17th to Jan. 31th, 2007. Reply from 62 on-line correspondents were collected and statistically analyzed. Results : The number of clinical trial involving oriental medicine continues to increase. According to the survey, many Issues were raised as problems such as difficulty of recruitment, lack of fund and lack of stepped program. Emphasized issues were clinical research methodologies, development of protocols and case report form (CRF), and Regulations including Institutional Review Boards (IRBs) in these three consecutive education training program. Conclusion : The results of this study may contribute to the development of an educational program for oriental medicine, a program that should be taken into consideration for developing practical items, such as, problem-based learnings which reflects participants' actual needs in their works. Also this report be used for future strategy plans and execution of training program for oriental medical clinical trial.

• Korean Journal of Oriental Medicine
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• v.12 no.1
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• pp.13-22
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• 2006

Background and Aims: Herbal drugs and traditional medicines have lately attracted considerable attention by global pharmaceutical corporations because the conventional chemical drugs didn't work well for many chronic diseases or intractable diseases. The government of Korea is also supporting to develop the new drug which is high value added product, and the natural medicine including herbal medicine(or Traditional Korean Medicine) have a significant presence in this field. non-clinical pharmacology/toxicology study and clinical trial are the two major criteria which estimate efficacy and safety for registration of new drugs. All of the pharmaceutical companies producing herbal medicine and the academic and the academic world of Tradition Korean Medicine have the will to develop new herbal drugs, but there are obstacles that they have neither experience nor guideline about clinical trial. Therefore for developing new herbal drugs, it is necessary to research the present conditions and comprehensive systems about clinical trial in Northeast Asian countries China, Taiwan and Japan because they have the common background with Korea in traditional medicine fields. Methods : The present state of clinical trial for herbal medicine in Korea was investigated. And then, those in China, Taiwan, Japan was also investigated. Results and conclusions : There are significant differences among 4 Southeast Asian countries Korea, China, Taiwan and Japan each in present condition, purpose, involved comprehensive system including legislation, and actual operation of clinical trial for traditional medicine.

• Journal of Acupuncture Research
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• v.23 no.6
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• pp.1-8
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• 2006

Introduction : Even though Acupuncture has been know for its effect for a long time, recently it is required to verifiy its effect. To solve this, clinical trial, based on EBM, has been the way to explain acupuncture's treatment effect. Methods: Last year we had a clinical trial based on acupuncture. From this experience we came to a conclusion mentioned below. Results : 1. To find out acupuncture's effect more certainly, it is needed that Korean medical method or treatment should be connected to diagnosis. 2. We had found out that sham and minimal acupuncture are the most appropriate way in single blinding. 3. It is required for the acupuncturist to practice the right real acupuncture point and sham's point in clinical trial. 4. The most important thing to maintain the subjects from dropping out is to always be concerned to the subjects and management them. Conclusion : The best way to advance clinical trial on acupuncture is to use single blinding system with sham acupuncture together in controlled groups and most of all also needs a standardized acupuncture point and depth.

• Korean Journal of Oriental Medicine
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• v.8 no.2 s.9
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• pp.37-46
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• 2002

Clinical trials are experimental studies with human subjects in which various limitations and variables exist by their nature. As a preparatory stage for designing clinical trials in Oriental medicine, this study considers a virtual protocol to show guideline regarding tasks necessary when writing a trials protocol. Clinical trials have many difficulties in planning, procedure, and interpretation of results, and these may be influenced by various biases that are difficult to predict and eliminate. To deal with these issues, clinical trials need a collaboration between medical experts and biostatisticians from the beginning, through the entire trial, until the final analysis. Therefore, the first stage of clinical trials is to write out a trial plan among the experts in each field to derive the best design for the trial.

• The Journal of Korean Obstetrics and Gynecology
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• v.24 no.2
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• pp.97-103
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• 2011

Objectives: Recently, high attention has been drawn towards evidence based medicine(EBM). However, there is little follow study after Park's analysis research (2002) in the journal of oriental gynecology. Therefore, there is a need to conduct analyzed research on the topic, due to the increasing interest about EBM. Methods: To analyze the treatises of the journal of oriental gynecology, we examined 56 journals published from 1987 to 2010. we followed the way of Park, classifying treatises into bibliographic, experimental and clinical categories. Results: Analytic research, as a part of clinical treatises, increased rapidly from 2001. As a result, it took 53.3% of whole study in general after 2002 and it reached up to 70.0% in 2004. Most part of clinical treatises until 2002 was about case report of patients, but the amount of clinical trial started to increase since 2003. Case report and case series showed dramatic increase after 2001, and clinical trial started to increase after 2003. As a result, 43.8% of the analyzed research was due to clinical trial by 2009. Conclusions: On the base of this research, quality evaluation of clinical treatises using guality assessment tool is needed for EBM in the part of oriental obstetrics & gynecology.

• The Journal of Korean Medicine
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• v.27 no.1 s.65
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• pp.196-203
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• 2006

Objectives : The aim of this study is to investigate how does the methods of treatment and diagnosis of Traditional Korean Medicine(TKM) get the evidence of efficacy and safety and what type of efficient body and appropriate facility of the coordination center for clinical trial in TKM. Methods : We have got the information of clinical trial center or clinical collaboration center by site invitation, search of paper and reports and internet exploration for the domestic or foreign site. Results : Coordination center for clinical trial usually involves every steps of clinical trials, such as development of Case Report From (CRF), design of study, calculation of sample size, randomization, maintenance of blinding, monitoring and audit of the resource document, data and CRF, data entry, quality control of data, analysis and report. Conclusions : The body needs several aresa of experts, which are epidemiologists, biostatisticians, research nurses for coordination, data manager and programmer, and administrator. This body would be enhance and help he clinical researches including clinical trials in TKM.

• Journal of Sasang Constitutional Medicine
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• v.23 no.1
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• pp.98-107
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• 2011

1. Objectives: In this research, job and stress of the staffs who is working on clinical trial of oriental medicine involved in the project of Korea Institute of Oriental Medicine (KIOM) was identified. And an efficient way to enhance the working ability of clinical trial of oriental medicine was developed by recognizing the relationship of job satisfaction, organizational commitment and job performance with their stress. 2. Methods: A survey was conducted on 18 staffs in 12 hospitals who is working in the project of The construction of constitutional information collecting system for the scientification of Sasang Constitution. The collected data was analyzed with computer software of SPSS 17.0 3. Results: The research results are as follows: 1. The staffs of clinical trial of oriental medicine responded that they want to receive the rewards for their work with a salary, and they felt that through clinical demonstration followed by SOP and front face photograph are the most difficult works in clinical trial of oriental medicine. 2. Permanent workers showed higher organizational commitment than temporary workers in the relationship of job satisfaction, organizational commitment and job performance with general characteristics(p=0.026). 3. In the relationship of job stress with general characteristics, the workers who are higher than college graduates had dissatisfaction in salary with the highest frequency(p=.004), and the workers whose monthly salary is higher than 2 millions won showed the lowest job stress(p=.021). 4. In the relationship of job satisfaction, organizational commitment and job performance with job stress, as job apprehension stress is increased, job performance is dramatically decreased(p=.027). And as improper salary stress is increased, job satisfaction and organizational commitment is dramatically decreased (p=.018, p=.050). 4. Conclusions: It was clearly evidenced that job satisfaction, organizational commitment and job performance is closely related with stress of the staffs who is working on clinical trial of oriental medicine. And it is highly recommended that the improvement of working condition and the decrease of job stress can enhance the working ability of them.