• 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.

• 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 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.

• 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.

• 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.

• 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 Korean Medicine for Obesity Research
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• v.19 no.1
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• pp.56-67
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• 2019

Objectives: The purpose of this study is to review clinical studies of herb medicine and acupuncture treatment on obesity in menopausal women. Methods: Key words "Obesity", "Menopause", "Herb medicine", "Acupuncture", "Moxibustion", "Catgut embedding" were searched on 9 database systems (PubMed Central, Cochrane Controlled Register of Trials, Embase, China Academic Journals, Korean Traditional Knowledge Portal, Oriental Medicine Advanced Searching Integrated System, Korean Studies Information Service System, National Digital Science Library, DBpia) on April 30th 2019. Results: 1 case report and 17 clinical trials were collected in accordance with the selection and exclusion criteria. Among the 17 trials, 6 were randomized controlled trials, 1 was controlled clinical trial, and 10 were single-arm trials. The types of intervention were herb medicine, electroacupuncture, acupuncture, auricular acupuncture, warm needle acupuncture, moxibustion, laser acupuncture, and catgut embedding. The study design, study results and method of intervention were analyzed. Conclusions: 1 case report described the effectiveness of pharmacopuncture, 4 trials described the effectiveness of herbal medicine, 2 of electroacupuncture, 1 of laser acupuncture, and 2 of catgut embedding. Among the 17 trials, 2 studies showed that herbal medicine treatment was more effective than no treatment or selective serotonin reuptake inhibitors, and 1 study showed that electroacupuncture was more effective than hormone therapy. All of 18 selected studies reported the effectiveness of weight reduction and abdominal obesity reduction after the traditional Korean medicine treatment for obesity in menopausal women.

• Korean Journal of Acupuncture
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• v.28 no.3
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• pp.177-186
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• 2011

Objectives : The aim of this study is to review clinical trials using Qigong exercise on patients with hypertension and to assess their methodology and results. Methods : Electronic literature searches for clinical trials (randomized trial, non-randomized trial, before-after study) of Qigong exercise were performed in 21 electronic databases (5 international databases and 16 Korean databases). English, Korean or Chinese articles were included. Laboratory or animal studies were excluded. Results : A total of 11 studies met the inclusion criteria. Five randomized controlled trials, Four non-randomized trials and two before-after studies were included. Seven studies used self-developed Qigong exercise. Two studies used Guolin Qigong exercise and two studies used Qigong exercise with an anti-hypertension drug. Of the nine randomized trials or non-randomized trials, four studies used an anti-hypertension drug control and three studies used waiting list controls. Compared to baseline, a change in blood pressure after the Qigong exercise treatment was significant in all studies. However, the results effect of blood pressure between Qigong exercise and controlled trials were not consistent. Conclusions : There are low-quality clinical trials of Qigong exercise for hypertension. To evaluate the effects of Qigong exercise, more rigorous trials are warranted.

• Korean Journal of Acupuncture
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• v.25 no.2
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• pp.57-69
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• 2008

Objectives : To review the controlling methods used in RCTs (randomized controlled trials) of auricular acupuncture. Methods : To investigate the controlling methods used in clinical trials of auricular acupuncture, 46 articles were retrieved from PUBMED (from August 1976 to August 2007, with limits: english, clinical trial) using the key words of "ear acupuncture", "auricular acupuncture", "auriculo-medicine", and sorted out according to the types of control treatments. Among them, 10 articles were selected based on STRICTA (Standards for Reporting Intervention in Controlled Trials of Acupuncture), and the controlling methods used in those articles were reviewed. Results : In clinical trials of auricular acupuncture, 'sham acupoints (non-acupoints and non-treatment acupoints included)', 'minimal acupuncture', 'pseudo-intervention', and 'placebo devices' have been used as controlling methods, but their 'inactivity' have been in question. To compensate the disadvantages of 'minimal acupuncture', and 'pseudo-intervention' control, placebo auricular acupuncture needles have been developed, although these needles didn't satisfy the conditions of 'blinding' and 'physical inactivity' simultaneously. Conclusions : Further researches on 'sham acupoints' and new development of 'placebo auricular acupuncture needles' are needed.

• 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.