• Journal of Haehwa Medicine
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• v.24 no.1
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• pp.25-36
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• 2015

Objective : This study aims to evaluate a risk of bias by Risk of Bias tool and RoBANS(Risk of Bias Assessment tool for Non-randomized Study) tool for clinical trial papers proving treatment effect of herbs to alopecia and provides the newest reason of effectiveness of herbs to alopecia. Methos : Data were collected through electronic database including NDSL, KISS, KMBASE, Koreantk, OASIS, KoreaMed, KISTI, Pubmd, Cochrane CENTRAL and CINAHL. Two experts in Oriental Medince assessed risk of bias of randomized controlled trials by Cochrane group's Risk of Bias tool and non-randomized controlled trials by RoBANS tool after searching, reviewing and selecting papers. Results : Total number of selected trials is 20 including 4 randomized controlled trials, 13 non-randomized controlled trials and 3 case reports. This study evaluates the risk of bias of 17 papers including 4 randomized controlled trials and 13 non-randomized controlled trials except 3 case reports by risk of bias tool and RoBANS tool. All papers of randomized controlled trials are evaluated unclear for random sequence generation and allocation concealment as there are no word on them. And all papers of non-randomized controlled trials are evaluated unclear for blinding of outcome assessments and relatively low for others. Conclusion : We must try to specify concretely methods of allocation concealment after planning and practicing it for reducing a selection bias in randomized controlled trials. Also report a reason of missing value and blinding outcome assessments. And we have to agonize and mention methods of blinding of researchers for reducing a detection bias in non-randomized controlled trials.

• Journal of Oriental Neuropsychiatry
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• v.24 no.3
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• pp.201-210
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• 2013

Objectives : To review the recent trend of randomized controlled clinical trials on insomnia and to provide information for future clinical trials. Methods : A total of 667 pieces of literature were searched using the key words 'insomnia' and 'randomized controlled trial' and using the title 'insomnia' with the topic 'trial or trials', published from 2008 to 2012 through Web of Science. Studies including randomized controlled clinical trials were sorted from the search result and finally 104 pieces of the literature were selected and examined. Results : Besides 104 clinical trials, 14 trials related to CAM (Complementary and Alternative Medicine) were also reviewed. On average, 20 trials were annually conducted and they showed a growing trend. Participants were between 31 and 90 (34.6%), and were observed for less than 30 days (28.8%) in most trials. As intervention methods for clinical trials, non-pharmaceutical methods were used in 59 studies (56.7%), pharmaceutical drug in 43 studies (41.3%) and combinations in 2 studies (1.9%). In 60 studies, only insomnia without any underlying diseases was examined and other 44 studies involved other diseases. As diagnosis assessment tools, Sleep diary and Polysomnography were used. Conclusions : Randomized controlled trials relevant to insomnia were on the increase, but only a small number of clinical trials on Oriental Medicine have been performed. Larger scientific and well-founded randomized controlled trials are required for developing Oriental Medicine and establishing high-quality guideline going forward.

• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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• v.30 no.2
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• pp.1-18
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• 2017

Objectives : This review aims to evaluate a risk of bias by risk of bias tool and RoBANS(Risk of Bias Assessment tool for Non-randomized Study) tool for clinical trial papers proving treatment effect of Korean medicines to alopecia and provides the newest reason of effectiveness of herbs to alopecia. Methods : Data were collected through electronic database including NDSL, KISS, KMBASE, Koreantk, OASIS, KoreaMed, KISTI, Pubmed, Cochrane CENTRAL and CINAHL. Two experts in Oriental Medicine assessed risk of bias of randomized controlled trials by Cochrane group's Risk of Bias tool and non-randomized controlled trials by RoBANS tool after searching, reviewing and selecting papers. Results : Total number of selected trials is 20 including 4 randomized controlled trial, 13 non-randomized controlled trials and 3 case reports. This study evaluate the risk of bias of 17 papers including 4 randomized controlled trials and 13 non-randomized controlled trials except 3 case reports by risk of bias tool and RoBANS tool. All papers of randomized controlled trials are evaluated unclear for random sequence generation and allocation concealment as there are no word on them. And all papers of non-randomized controlled trials are evaluated unclear for blinding of outcome assessments and relatively low for others. Conclusions : Korean medicine intervention can be an effective for treatment in alopecia. It was evaluated by hair density, thickness and expert panel assessment of photographs and all results are statistically significant. But enhancing levels of evidence, we must try to reduce bias in researches and report a safety, protocol and IRB.

• Journal of Korean Medicine Rehabilitation
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• v.21 no.4
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• pp.77-86
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• 2011

Objectives: This study aims to evaluate domestic clinical studies related to the exercise program targeting farmers. Methods: Five Korean databases were seamed for prospective clinical trials of exercise program targeting farmers from 2001 to August, 2011. Only studies conducted in Korean language were searched. Results: Thirteen clinical studies were included among 3374 studies searched. Six were observational studies, four were non-randomized controlled trials, and three were randomized controlled trials. All of included studies reported favorable effects of exercise group compared to baseline of controlled group. Conclusions: We found various mistake in the applications of statistical methodologies in the studies of exercise program targeting farmers. It is necessary for more randomized controlled trials to evaluate effect of exercise program target farmers.

• The Journal of Pediatrics of Korean Medicine
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• v.31 no.4
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• pp.19-30
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• 2017

Objectives The study was conducted to evaluate the acupuncture treatment for burns by reviewing international randomized controlled studies and case controlled studies. Methods In the review, ten academic literature archives; NDSL, OASIS, PubMed, Cochrane library, CNKI, WANFANG, CINAHL, J-STAGE, CiNii, and EMBASE were used as the main databases to search for the randomized controlled trials or the case controlled trials about acupuncture treatment of burns using the keywords "burns AND acupuncture", "burn AND acupuncture", and "scald AND acupuncture". Results Initially, a total of 852 studies were founded except duplicate studies. 801 studies were excluded after screening of title and abstract. After reviewing 51 papers, a total of four randomized controlled trials and two case controlled trials were selected. These studies were analyzed by year, subjects, treatment intervention, evaluation criteria, treatment effect, adverse events, and 'Risk of Bias' assessment for randomized studies and non-randomized studies. From the six papers out of 51 papers those were reviewed, patients with burns were divided into two groups. The experimental group received acupuncture treatment, while the control group did not. The results of the completed studies have shown that the experimental group receiving acupuncture treatment demonstrated significant improvement compared to the control group, and there was no serious adverse events. Conclusions According to some of the studies, acupuncture in burn treatment is worth to try. However, additional well-designed randomized controlled studies will be required to justify the effectiveness of acupuncture treatment of burns.

• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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• v.27 no.4
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• pp.45-57
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• 2014

Objective : This study aims to provide fundamental data for new directions(the improvement directions) from searching research papers of randomized controlled trials among thesis of Atopic Dermatitis related to oriental medicine in Korea from 2004 to 2014 and identifying the problem and level of a clinical study through an assessment of the quality, CONSORT statement. Methods : Data was collected through the Koreanstudies Information Service System(KISS). Two experts in Oriental Medicine reviewed the title and abstract in thesis, the results of searching the title, "Atopic dermatitis" and topic, "oriental medicine" at KISS, and then they handsearched Randomized Controlled Trials related to oriental medicine in Korea. According to guidelines defined by CONSORT statement, they assessed whether 37 items were followed by guidelines at yes or no answers in order to evaluate the quality as well. They assessed the definition of each item independently. After comparing, they made a decision on the item of different outcomes through an agreement with a third party. Results : Total number of randomized controlled trials in Atopic Dermatitis related to oriental medicine is eleven. A randomized controlled trial was first published in 2007. One or two papers associated it were released every year except 2013. 9 papers of them were approved by Institutional Review Board and were received written consent. The study included between 20 to 40 subjects for 2-arm parallel study design. The effect of treatment was observed for 4 to 8 weeks. On average, the number followed guidelines was 18.64 among those of 37 CONSORT statement and 50.38% of them was followed overall. Conclusion : As an interest about randomized controlled trials was increased, it was needed to care the standard providing information of CONSORT statement on randomized controlled trials related to oriental medicine in Korea. It is suggested to provide more clear information about it, so that it can be a motive for improving quality of the journal in oriental medicine.

• 대한예방의학회:학술대회논문집
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• 1994.02b
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• pp.336-341
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• 1994

Multicenter controlled clinical trials require It synthesis of the scientific method and the precepts of modern management. The management tasks associated with these studies are akin to those found in other kinds of complex corporate endeavors. It is recommended that clinical investigators become more knowledgeable about management concepts and methods and management specialists be given a major role in the planning and conduct of large-scale clinical trials.

• Journal of Acupuncture Research
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• v.19 no.6
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• pp.134-154
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• 2002

Acupuncture treatment and control group interventions in parallel-group randomised trials of acupuncture are not always precisely reported. In an attempt to improve standards, an international group of experienced acupuncturists and researchers devised a set of recommendations, designating them STRICTA : STandards for Reporting Interventions in Controlled Trials of Acupuncture. In a further consensus-building round, the editors of several journals helped redraft the recommendations. These follow the CONSORT format, acting as an extension of the CONSORT guidelines for the specific requirements of acupuncture studies. Participating journals are publishing the STRICTA recommendations and requesting prospective authors to adhere to them when preparing reports for publication. Other journals are invited to adopt these recommendations. The intended outcome is that interventions in controlled trials of acupuncture will be more adequately reported, thereby facilitating an improvement in critical appraisal, analysis and replication of trials.

• Journal of the Korea Academia-Industrial cooperation Society
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• v.11 no.11
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• pp.4395-4403
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• 2010

The aim of this study is to know about condition of alternative medicine. Methods which An literature search in Pubmed January 2000 to March, 2010 was performed. RCT(Randomized Controlled Trial), CCT(Controled Clinical Trials), and OD(efficacy studies with either a controlled or an Other than controlled Design) were included. PubMed databases were searched using key terms relating to alternative medicine. 19 clinical trials were included among 682 studies searched. RCT was 44%, CCT was 16% and OD was 40% in the review. In the all of included studies, the acupuncture and the massage was the biggest part. The using rate was 20% of pain control about Disease of the Musculoskeletal system and Connective tissue, 15% of Certain infectious and parasitic diseases, and 15% of Neoplasms. There was lack of evidence that alternative medicine was effective for progress. Future well-designed clinical trials is needed.

• Clinical and Experimental Pediatrics
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• v.55 no.11
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• pp.403-407
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• 2012

Noninferiority trials test whether a new experimental treatment is not unacceptably less efficacious than an active control treatment already in use. With continuous improvements in health technologies, standard care, and clinical outcomes, the incremental benefits of newly developed treatments may be only marginal over existing treatments. Sometimes assigning patients to a placebo is unethical. In such circumstances, there has been increasing emphasis on the use of noninferiority trial designs. Noninferiority trials are more complex to design, conduct, and interpret than typical superiority trials. This paper reviews the concept of noninferiority trials and discusses some important issues related to them.