• Journal of Acupuncture Research
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• v.27 no.1
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• pp.21-29
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• 2010

Objectives : This study aims to evaluate current clinical evidence of acupuncture treatment for rehabilitation in patients with traffic accident in South Korea. Methods : Seven Korean databases were searched for prospective clinical trials for acupuncture on rehabilitation in patients with traffic accident from their inception to June, 2009. Only studies conducted in Korean language were searched. Risk of bias in included randomized controlled trials were assessed by Cochrane Handbook procedure. Results : Fifteen clinical trials were included among 31 studies searched. Eight were observational studies, five were non-randomizedcontrolled trials, and two were randomized controlled trials. In all of included studies, acupuncture were conducted with other concomitant treatment. Included studies dealt with such conditions as neck pain, low back pain tinnitus after traffic accident, post-traumatic stress, oculomotor nerve palsy, diplopia and insomnia. All of included studies reported favorable effects of acupuncture group compared to baseline or control group. All of included studies lacked the occurrence of adverse events. High risk of bias were observed in two randomized controlled trials. Conclusions : There is no evidence that acupuncture is effective for rehabilitation of traffic accident. All of included studies lacked appropriate methodological qualities and internal validity. Future welldesigned clinical trials that evaluate the effects and safety of acupuncture treatment for rehabilitation in patients with traffic accident is needed.

• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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• v.21 no.2
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• pp.94-101
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• 2008

Objectives : To discuss the types of control groups in randomized controlled trials (RCTs) of herbal medicine, and to provide suggestions for improving the design of control group in future clinical trials. Methods : We reviewed the 8 articles about clinical trial design of Chinese herbal preparation which were published from 2005 through 2008. We selected those articles from CNKI(中國知識基礎施設工程(http://www.cnki.net)). Results : It is necessary to have control group in randomized controlled trials(RCTs) of Korean herbal preparation. But there are problems in the selection of appropriate control group drug. This paper lists several problems about the choice of control drug and puts forward some proposals and countermeasures. There are problems such as ethics and manufacturing matching placebo and positive control herbal drug. Conclusion : To improve the quality of control group design, we introduce standard drug plus placebo drug method and add-on research for placebo control group design, double dummy technique, using negative control drug or composite control drug for active control group design.

• Journal of Dental Anesthesia and Pain Medicine
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• v.21 no.4
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• pp.269-282
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• 2021

This review aimed to assess and compare the outcomes of the anesthetic efficacy of inferior alveolar nerve block (IANB) and Gow-Gates mandibular nerve block (GGMNB) in patients with symptomatic irreversible pulpitis. A descriptive systematic review of quantitative research was conducted wherein the "Preferred Reporting Items for Systematic Reviews (PRISMA)" was adopted, and the Problem/Patient/Population, Intervention/Indicator, Comparison, Outcome (PICO) criteria were used to structure the research question. A literature search was performed using PubMed/Medline, Cochrane Library, Google Scholar, and Ovid. Selection criteria were applied for populations over nine years of age, of either sex, with irreversible pulpitis, and articles published in English regarding conventional IANB or IANB and Gow-Gates techniques between 2009 and 2019. Prospective randomized clinical trials or randomized controlled trials were included in the review, in which anesthetic efficacy or success was measured. After screening, four articles were included. Three studies were randomized clinical trials, and two were randomized controlled trials. The validity and reliability of the individual studies were examined. There was evidence of the higher efficacy of the GGMNB technique than that of the IANB technique. However, both techniques can be mastered through training.

• 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.

• 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.

• Journal of Korean Medicine Rehabilitation
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• v.27 no.3
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• pp.95-105
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• 2017

Objectives To evaluate the evidence supporting the effectiveness of Soyeom pharmacopuncture therapy for Pain. Methods We conducted search across 6 electronic databases (Pubmed, CAJ, Oasis, RISS, DBPIA and KoreanTK) and 2 journals to find clinical trials that used Soyeom pharmacopuncture therapy as treatment for pain. The methodological quality of Randomized controlled clinical trials (RCTs) was assessed using the Cochrane Risk of Bias (RoB) tool, while NRCTs (Non-Randomized controlled clinical trials) were assessed using the Risk of Bias Assessment tool for Non-randomized Study (RoBANS) tool. Results Among 75 articles that were searched, 5 RCTs and 2 NRCTs were finally selected. Among 7 selected studies, all studies showed that Soyeom pharmacopuncture therapy has significant effect on Pain. Conclusions Our systematic review found encouraging but limited evidence of Soyeom pharmacopuncture therapy for Pain. We recommend clinical trials which compare the effectiveness of Soyeom pharmacopuncture therapy with other pharmacopuncture therapies to clarify the effectiveness of Soyeom pharmacopuncture therapy from other pharmacopuncture therapies.

• The Journal of Internal Korean Medicine
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• v.43 no.3
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• pp.423-435
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• 2022

Purpose: The purpose of this study was to confirm the clinical efficacy of Gyeongok-go. Methods: Public/Publisher MEDLINE (PubMed), Cochrane Central Register of Controlled Trials (CENTRAL), Excerpta Medica dataBASE (EMBASE), Research Information Sharing Service (RISS), ScienceON, Korean Traditional Knowledge Portal (KTKP), and China National Knowledge Infrastructure (CNKI) were searched for randomized controlled clinical trials administering Gyeongok-go as an intervention, published from inception to December 31, 2021. The risk-of-bias of the included trials was assessed with the Cochrane risk-of-bias tool for randomized trials version 2. From the experimental and control groups of the selected trials, the mean value (or rate) of each outcome was extracted and statistically compared. Results: Statistically significant mean differences were in VO₂max (MD 6.82), post-exercise heart rate (MD -8.76 at 5 min, -11.58 at 30 min, -14.6 at 60 min), senescence scale (MD -6.52), Th1 cells and Th2 cells in pulmonary tuberculosis (MD 2.79 and -1.64), yin-deficient and qi-deficient score (MD -9.64 and -9.76), and phlegm-dampness score (MD 5.56). Overall risk-of-bias was 20% low risk, 80% some concerns, and 0% high risk. There were no reports of adverse events. Conclusions: Gyeongok-go is likely to have the effect of improving cardiorespiratory endurance, increasing fatigue recovery ability, reducing senescence, and enhancing immune function in tuberculosis patients. Also, it is more suitable for those who are yin-deficient or qi-deficient, and those with phlegm-dampness probably need caution.

• Journal of Korean Medicine Rehabilitation
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• v.33 no.1
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• pp.13-29
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• 2023

Objectives To evaluate the evidence supporting the effectiveness of acupuncture for facet joint syndrome. Methods We conducted search across 9 electronic databases (PubMed, EMBASE, Cochrane CENTRAL (CENTRAL), KoreaMed, Kmbase, Koreanstudies Information Service System (KISS), ScienceOn, China National Knowledge Infrastructure (CNKI), and Wanfang) to find clinical trials that used acupuncture as treatment for facet joint syndrome. The methodological quality of randomized controlled clinical trials (RCTs) were assessed using the Cochrane Risk of Bias (RoB) tool, while non-randomized controlled clinical trials (nRCTs) were assessed using the Cochrane Risk of Bias Assessment tool for Non-randomized Study (RoBANS) tool. Results Nine RCTs and one nRCT met our inclusion criteria. Fire needle was more effective than medial branch block in terms of visual analogue scale (VAS) after 1 month (p=0.02). Also, Fire needle was more effective than Ibuprofen in terms of VAS and oswestry disability index (ODI) (p<0.05). However, in the rest of the study results, the intervention group did not show a statistically significant difference than the control group. Conclusions Although our review found encouraging but limited evidence of acupuncture for facet joint syndrome, most of the studies included in the analysis were evaluated as methodologically high risk of bias. From now on further well-designed RCTs should be encouraged.

• Journal of Physiology & Pathology in Korean Medicine
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• v.37 no.6
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• pp.185-192
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• 2023

The purpose of this study is to analyze trends in domestic and international clinical research studies on pharmacopuncture treatment for fractures. We searched five online databases (PubMed, CNKI, RISS, KISS, and OASIS), and selected a total of 13 clinical research studies from Korea and China. Selected studies were analyzed according to publication year, subject, intervention, treatment method, evaluation scale, adverse event, risk of bias, etc. A total of 10 case studies and 3 randomized controlled trials were included. The study subjects were more often female, and the most common type of fracture was vertebral compression fracture. In Korea, herbal medicine preparations and bee venom were used for pharmacopuncture solution, whereas in China, both herbal medicine preparations and Western medicine preparations were used. All studies commonly used local acupoint needling, and in most cases, the treatment period for case study was less than 1 month, and the observation period of randomized controlled trials was diverse. The most frequently used evaluation scale was numeric rating scale, adverse events were mentioned in only three studies, and no adverse events were reported. Overall risk of bias of all included randomized controlled trials was judged "some concerns". According to this study, pharmacopuncture treatment for fractures was found to be relatively effective and safe, but research that complements the limitations of this study is needed.

• Journal of Haehwa Medicine
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• v.24 no.1
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• pp.15-24
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• 2015

Objectives : This study was carried out to assess the risk of bias of clinical trials on acne treatment with herbal medicine that have been published in Korea. Methods : 7 electronic databases in Korea were searched for clinical trials on acne treatment. Two independent reviewers selected clinical trials on herbal medicine treatment for acne. Selected studies are categorized according to DAMI(Study Design Algorithm for Medical literature of Intervention). RCTs are assessed according to Cochrane RoB(Risk of Bias), non-randomized studies(Before-after studies) are assessed according to RoBANS(Risk of Bias Assessment tool for Non-randomized Study). Results : After selection process, 25 articles are left. Among 25 articles, 3 RCTs and 4 before-after studies are finally included. In RCTs, the proportion of 'unclear' is high in criteria of 'random sequence generation', 'allocation concealment', and 'blinding'. In before-after studies, 'high' is high in criteria of 'blinding for outcome assessment' and 'incomplete outcome data'. Conclusions : Considering the above results of the assessment, it is necessary to conduct more well designed clinical trials on acne treatment with herbal medicine.