• The Korean Journal of Applied Statistics
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• v.7 no.2
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• pp.35-51
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• 1994

For ethical and economic reasons, clinicla trials must be repeatedly monitored for evidence of treatment benefit or harm. Repeated testing at conventional critical values can substantially inflate the overal type I error rate. To maintain acceptable levels, group sequential procedures have been developed for clinical trials. This article gives a brief overview of the group sequential procedures.

• Journal of Acupuncture Research
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• v.30 no.5
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• pp.117-123
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• 2013

Objectives : The purpose is to review large-scale clinical researches, the acupuncture randomized trials(ART) and the acupuncture in routine care(ARC), concerning efficacy and effectiveness of acupuncture performed in Germany. Methods and Results : We have reviewed the studies that were searched by keyword 'acupuncture' as the title and'Witt CM' as one of the main authors in PubMed. Sixteen clinical reports focused on the ART and ARC studies were analyzed among all thirty six were searched. Six studies were related with the ART and eight were focused on the ARC, and other two were on both. Finally, across all researches except osteoarthritis of knee trials in the ART, compared the acupuncture group with the control were significantly improved. On the other hand, ARC showed that additional acupuncture plus routine care was more effective than routine care alone and the response to treatment of the non-randomized group did not differ the one of the randomized acupuncture group. Conclusions : The results may suggest that acupuncture treatment has obvious clinical effectiveness. These results are expected to inspire domestic research and clinical applications in Korea, and more rigorous research on the efficacy of acupuncture should be guaranteed.

• Korean Journal of Acupuncture
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• v.26 no.1
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• pp.27-40
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• 2009

Background : Qigong is an energy-healing intervention used to prevent and cure ailments and to improve health through regular practice. Although qigong-neither itself nor its postulated mechanism of action-are within the paradigm of modern Western medical science, its effects on the human body could be possible. Objectives : This study aims to review the bibliography, biological responses and therapeutic effects of Qigong. In the process, this review will grasp trends in this field of studies and will direct further researches into the right direction. Method : The computerized Korean databases were searched from their respective inceptions up to January 2008. The search terms used were 'qi', 'qigong', 'doin', 'training', 'bioenergy', 'life nurturing' and random or Korean language terms related to qigong. Several specialized journals were also manually searched for relevant articles. Result : Since the 1990s, Qigong papers in the Korean Literature are increased. The articles on Korean traditional medicine had been published more than those on physical education or nursing etc. However, since the majority of the trials determine questionnaire, it was difficult to determine the efficacy of a specific intervention. The methodological quality of the trials was generally low (Jadad score: mean, 1.3; range, 1 to 4), questioning their reliability. Conclusions : More profound studies for Qigong are needed. Further rigorous clinical trials with more objective outcome measures that include sham procedures should be performed. Specifically, we think it should be clinical studies and qualitative research methods for evaluation are needed.

• The Journal of Internal Korean Medicine
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• v.39 no.4
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• pp.520-549
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• 2018

Objectives: We performed a systematic review and meta-analysis to explore the recent clinical research trends regarding the effects of traditional herbal medicine (THM) on chemotherapy-induced leukopenia. Methods: Randomized controlled trials that verified effects of herbal medicine treating chemotherapy induced leukopenia were included in the study. A literature search was performed in the English, Chinese, and Korean databases for papers published from January 1, 2007, to September 1, 2017. The selected literature was assessed by Cochrane's Risk of Bias (RoB). Results: Forty-two of 232 randomized controlled trials met the inclusion criteria. The most commonly used herbal prescriptions called '升白湯 (shengbai decoction)' which means elevating the numbers of White blood cells (WBCs). And the mostly included herbs such as Astragali Radix, Angelicae Gigantis Radix, Atractylodis Rhizoma Alba, Codonopsis Pilosulae, Glycyrrhizae Radix, Ligustri Lucidi Fructus are commonly used to elevate qi, blood and yin. The count of WBC in peripheral blood, the level of leukopenia presented in WHO (World Health Organization), and clinical symptoms were used to evaluate the treatments. The effective rate was 68.6-98.18% and the effectiveness was significantly higher in the intervention group than in the control group in 38 articles (p<0.05). No serious adverse events were reported. Only five articles (5/42, 11.9%) were rated as having adequate methodological quality with a low level of bias. Conclusion: Some traditional herbal medicines may be effective as therapeutic treatments for chemotherapy-induced leukopenia, but the majority of reviewed studies were of poor quality. The present findings need to be confirmed by rigorously conducted high-quality trials, including pharmacokinetic studies, to confirm the absence of interactions between traditional herbal medicine agents and chemotherapy.

• Journal of Korean Medicine Rehabilitation
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• v.26 no.3
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• pp.67-77
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• 2016

Objectives To evaluate the evidence supporting the effectiveness of Bee Venom therapy for traumatic injury. Methods We conducted search across 3 electronic databases (Pubmed, CAJ and Oasis) to find clinical trials that used Bee Venom therapy as treatment for traumatic injury. The methodological quality of RCTs (Randomized controlled clinical trials) were assessed using the Cochrane Risk of Bias (RoB) tool, while NRCTs (Non-Randomized controlled clinical trials) were assessed using the Cochrane Risk of Bias Assessment tool for Non-randomized Study (RoBANS) tool. Results Among 87 articles that were searched, 10 RCTs and 19 NRCTs were finally selected. Among 19 selected studies, all studies showed that Bee Venom therapy has significant effect on traumatic injury. Conclusions Our systematic review found encouraging but limited evidence of Bee Venom therapy for traumatic injury. We recommend clinical trials which compare the effectiveness of Bee Venom therapy with other pharmacopuncture therapies to clarify the effectiveness of Bee Venom therapy from other pharmacopuncture therapies.

• The Journal of Internal Korean Medicine
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• v.40 no.3
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• pp.295-311
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• 2019

Objectives: This research aimed to investigate Chinese clinical studies on the treatment of central post-stroke pain (CPSP) and thalamic syndrome after stroke with traditional herbal medicine (THM). Methods: Randomized controlled trials verifying the effects of herbal medicine on treating CPSP and thalamic syndrome after stroke were included in the study. Electrical and hand search were conducted in the China National Knowledge Infrastructure (CNKI), National Discovery for Science Leaders (NDSL), Research Information Sharing Service (RISS), Oriental Medicine Advanced Searching Integrated System (Oasis) for CPSP and thalamic syndrome after stroke. A literature search was performed in the Chinese and Korean databases for papers published from January 1, 2010 to October 1, 2018. The selected literature was assessed by Cochrane's risk of bias. Results: Twelve reports on randomized controlled trials met the inclusion criteria from the 227 identified reports. Effective rate, comparison of visual analogy scale, present pain intensity, pain grading index, recurrence rate, follow-up, and a 36-item short form survey instrument were used to evaluate the treatments. The effective rate of the treatment group was significantly higher than that of the control group in all papers. Side effects occurred less frequently in the treatment group than in the western medicine control group. Conclusions: The treatment of CPSP and thalamic syndrome after stroke with THM was shown to be highly effective. Additional well-designed clinical trials are needed. This study can be used as a basis for further research on the treatment of CPSP and thalamic syndrome after stroke.

• Journal of Korean Academy of Nursing
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• v.42 no.7
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• pp.1027-1038
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• 2012

Purpose: This study was done to analyze the job of clinical research coordinators (CRCs). Methods: Through the "developing a curriculum (DACUM)" workshop, the definition of CRCs' role was described and CRCs' duties and tasks were identified. Finally, the developed duties and tasks were validated for importance, difficulty, and frequency. Results: A CRC is defined as the one who coordinates and performs tasks related to clinical research/trials among investigators, participants, and sponsors according to the Good Clinical Practice at institutions conducting clinical trials. Twelve duties and 78 tasks were identified on the DACUM chart which represented the importance, difficulty, and frequency of tasks represented as A, B, and C respectively. Based on determinant coefficient (DC) of the task, the highest ranked task was confirming the eligibility of participants for research (DC=8.03) and the lowest was inventory management for clinical study materials (3.95). Conclusion: In this study, the job of a CRC was analyzed through the DACUM process and it was found that CRCs were doing various duties and tasks. Based on these results, it is suggested that it is necessary to develop CRC education programs considering the career ladder of CRCs.

• Journal of The Korean Society of Integrative Medicine
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• v.10 no.3
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• pp.27-36
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• 2022

Purpose : This study was aimed to analyze the effects of cosmetics containing Persicaria perfoliata water extract (PPWE) on the skin moisturizing and improvement of skin condition in clinical trials. Methods : Clinical trial was conducted for five weeks after IRB approval at Dong-Eui University. Out of a total of 64 people, 15 people each were assigned to four groups as follows; control group A, B, C and the experimental group A that using cosmetic containing PPWE. Skin condition was measured two times, before and after clinical trial, by a professional skin analyzer, SDM (skin diagnosis system). Moisture and oil value of participants was analyzed twice, each morning and evening, using a portable device on their cheeks. In addition, the survey was investigated subjective satisfaction on change in skin condition and the satisfaction on the use of cosmetics. Result : The experimental group exhibited subjectively significant changes before and after clinical trials on skin its dryness (p=.039), blush (p=.017), and redness (p<.001). In addition, subjective evaluation was also the highest satisfaction in aspects of number of application (p=.003), amount of application (p=.002), moisture maintenance, and skin scratching frequency. The satisfaction on the use of cosmetics was the highest in the intention to repurchase (p=.045), recommendation willingness to others (p=.020), and intention to use various products (p=.001). Skin moisture of the clinical trial participants using the SDM, moisture level and elasticity of the experimental group increased by 12.94 and 10.28. Moisture level, which was measured by a portable device, was the most potently increased in the experimental group. Conclusion : Consequently, PPWE containg cosmetics exhibited the effects of moisturization and attenuated skin dryness in clinical trials, which might be utilized as a fundamental data to develop numerous lines of cosmetics.

• The Korean Journal of Applied Statistics
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• v.27 no.1
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• pp.13-20
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• 2014

Phase I Clinical Trials estimate a Maximum Tolerated Dose(MTD). In this paper, an MTD estimation method applied stopping rule is proposed for Phase I Clinical Trials. The suggested MTD estimation method is compared to the Continual Reassessment Method(CRM) method using a Monte Carlo simulation study.

• The Journal of the Korean dental association
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• v.45 no.3 s.454
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• pp.169-181
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• 2007

In this second part of series report on evidence-based dentistry, the level of evidence and the methods for critical appraisal are discussed. The epidemiologic studies, namely clinical studies have some bias per se, and the degree of bias is somewhat predetermined by the study design. The level of evidence can be defined as the reliability of the clinical study and it is dependent on the degree of bias. Thus, it is important to determine the type of the study and to understand its structure before critically appraising them. Systematic reviews of primary studies, randomized controlled trials, nonrandomized clinical trials, cohort studies, case-control studies, and case reports / series constitute the clinical studies and the level of evidence follows the order of the studies listed above. Critical appraisal is the most important procedure in evidence-based dentistry. It is done to determine the credibility of research papers and their usefulness in the clinician s own practice. Critical appraisal is consisted of multiple questions that are helpful for evaluating validity and usefulness of the studies concerning therapy, diagnosis, prognosis, and causation.