• 한방재활의학과학회지
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• 제20권2호
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• pp.63-77
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• 2010

Objectives : It is known that abdominal obesity increases the possibility of cardiovascular diseases, early death, and metabolic syndrome including dyslipidemia and insulin resistance. Clinical trials have been under way to verify the effectiveness of treatment for abdominal obesity. The objective of this study is to set criteria about how effective oriental medicine and acupuncture are in abdominal obesity. Methods : I manually search "www.clinicaltrial.gov", 4 Korean medical databases and 4 Korean medical journals of abdominal obesity. Search terms used were "abdominal obesity" or "visceral obesity". In order to see detail review, searching was performed from 01, 01, 2005 to 11, 31, 2009. And I classified all the searched studies into design, intervention, purpose, end point, diseases, condition and etc. Results : 1. I could search total 67 trials in "www.clinicaltrial.gov". I found 9, 10, 13, 8, 6 clinical trial from 2005 to 2009 every year. 2. Test on both gender and adult or adult and senior have been most frequent. 3. Randomization clinical trial is 51 cases that occupied 96.2%. 38 cases use control group. 4. Body mass index(BMI) and waist circunference(WC) are major criteria of abdominal obesity clincal trial. WC, BMI, abdominal fat mass, body weight are measured at end point of abdominal obesity clincal trial. 5. I could search total 86 cases in domestic study. I found 15, 23, 23, 20, 5 cases from 2005 to 2009 every year. 6. Test on female and adult have been most frequent in domestic study. 7. Randomization clincal trial is only 2 cases that occupied 2.3%. 62 cases use control group in domestic study. 8. BMI, body fat percent, WC, visceral-subcutaneous fat ratio(VSR), waist-hip ratio(WHR) are criteria of abdominal obesity clincal trial in domestic study. WC, BMI, abdominal fat mass, body weight are measured at end point of abdominal obesity clincal trial in domestic study. Conclusions : To improve abdominal obesity study in traditional korean medicine, it is need to activate clinical trial, meta analysis, develope of clinical practice guidelines, co-works with conventional medicine and etc.

• 대한예방한의학회지
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• 제16권2호
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• pp.17-30
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• 2012

Objectives : This study was to analyse the reasons for the early termination of our clinical trials that were to know the influences of Tai-chi on non-motor symptoms of Parkinson's disease. Methods : We stopped the primary study of Tai-chi to observe the changes of non-motor symptoms of Parkinson's disease. So we carried out the survey to our participants of clinical trials. We conducted the survey about the patient's characteristics of usual exercise, experience of Tai-chi, appropriate time allocation, difficulties of proceeding the program and patient's opinion for the improvement of education. And the 4 questions about the contributiveness of Tai-chi for the Parkinson's disease, usability of supplied references, difficulties and time allocation of education were using the questionaries form of 5-point scale(Likert scale). Results : The results of survey showed that the benefits of Tai-chi program for the improvement of symptoms was $3.15{\pm}0.89$ and difficulty of lecture was $3.76{\pm}1.09$. 41% of participants answered that the motions of the Tai-chi is difficult to follow and 17% of participants felt the imbalance during the motion of Tai-chi. Conclusions : Participants replied that the Tai-chi is hard for the patients of Parkinson's disease and the time for the education was too short to keep doing exercise. Thus we have plan to educate the patients of Parkinson's disease with Tai-chi program consists of easier motion by developing ourselves or searching previous studies.

• 대한치과교정학회지
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• 제47권6호
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• pp.401-413
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• 2017

Objective: The aim of this systematic review was to assess the occlusal outcome and duration of fixed orthodontic therapy from clinical trials in humans with the Objective Grading System (OGS) proposed by the American Board of Orthodontics. Methods: Nine databases were searched up to October 2016 for prospective/retrospective clinical trials assessing the outcomes of orthodontic therapy with fixed appliances. After duplicate study selection, data extraction, and risk of bias assessment according to the Cochrane guidelines, random-effects meta-analyses of the mean OGS score and treatment duration were performed and 95% confidence intervals (CIs) were calculated. Results: A total of 34 relevant clinical trials including 6,207 patients (40% male, 60% female; average age, 18.4 years) were identified. The average OGS score after treatment was 27.9 points (95% CI, 25.3-30.6 points), while the average treatment duration was 24.9 months (95% CI, 24.6-25.1 months). There was no significant association between occlusal outcome and treatment duration, while considerable heterogeneity was identified. In addition, orthodontic treatment involving extraction of four premolars appeared to have an important effect on both outcomes and duration of treatment. Finally, only 10 (39%) of the identified studies matched compared groups by initial malocclusion severity, although meta-epidemiological evidence suggested that matching may have significantly influenced their results. Conclusions: The findings from this systematic review suggest that the occlusal outcomes of fixed appliance treatment vary considerably, with no significant association between treatment outcomes and duration. Prospective matched clinical studies that use the OGS tool are needed to compare the effectiveness of orthodontic appliances.

• 한국임상약학회지
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• 제22권2호
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• pp.131-136
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• 2012

Objective: This study evaluated and compared the adherence to the CONSORT for quality of reports on the randomized controlled trials (RCT) abstracts by four major Korean Science Citation Index (SCI) journals and The New England Journal of Medicine (NEJM). Methods: A descriptive analysis of published RCT abstracts in Korean SCI journals and NEJM from 2007/01 to 2011/06 was conducted by two reviewers, independently extracting data from a PubMed search. A modification of CONSORT for abstract was used including 16 checklist items. Reporting of checklist items for individual group was conducted to compare adherence patterns between two groups. Results: We identified the potential 57 RCT abstracts from Korean SCI and 50 from NEJM meeting our inclusion criteria; among them, three abstracts from Korean SCI and one from NEJM were excluded. Among total 16 checklist items based on CONSORT statement, Korean SCI journals and NEJM were statistically equivalent in 4 items; Korean journals were better in three items and NEJM were in nine. The methodological quality domains were inadequately reported in both journals: allocation concealment about 1.9% and 4.0%, and blinding 44.4% and 40.8%. In general, The CONSORT adherence of NEJM was better than that of Korean SCI in the method and result domain (p < 0.0001). Conclusions: The quality of NEJM reporting of RCT abstracts was better than that of Korean SCI, in general. This study on adherence of RCT reports from Korean SCI journals and NEJM abstracts to the CONSORT statement reveals that there is a need for improvement, especially Korean SCI. Further investigation on the quality of RCT reports and ways to improve reporting quality is required.

• 대한한방내과학회지
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• 제31권4호
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• pp.722-730
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• 2010

Objectives : While the proportion of clinical trials is increasing in oriental medical research, no studies in recruitment strategies exist. This study was conducted to investigate which recruitment strategy was efficient to increase the number of potential subject and to reduce cost. Methods : Data from 179 callers in a single-center between June 22 and August 12, 2010 were analyzed. Results : We found that daily newspaper and free newspaper advertisement collected maximal participants. Advertisements in the hospital and on the Internet were considered as the most cost-effective methods. Conclusions : Intensive multiple overlapping recruitment strategies might be effective in success of participant registration in a clinical trial.

• Archives of Plastic Surgery
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• 제40권4호
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• pp.312-319
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• 2013

Over the past decade, driven by advances in educational theory and pressures for efficiency in the clinical environment, there has been a shift in surgical education and training towards enhanced simulation training. Microsurgery is a technical skill with a steep competency learning curve on which the clinical outcome greatly depends. This paper investigates the evidence for educational and training interventions of traditional microsurgical skills courses in order to establish the best evidence practice in education and training and curriculum design. A systematic review of MEDLINE, EMBASE, and PubMed databases was performed to identify randomized control trials looking at educational and training interventions that objectively improved microsurgical skill acquisition, and these were critically appraised using the BestBETs group methodology. The databases search yielded 1,148, 1,460, and 2,277 citations respectively. These were then further limited to randomized controlled trials from which abstract reviews reduced the number to 5 relevant randomised controlled clinical trials. The best evidence supported a laboratory based low fidelity model microsurgical skills curriculum. There was strong evidence that technical skills acquired on low fidelity models transfers to improved performance on higher fidelity human cadaver models and that self directed practice leads to improved technical performance. Although there is significant paucity in the literature to support current microsurgical education and training practices, simulated training on low fidelity models in microsurgery is an effective intervention that leads to acquisition of transferable skills and improved technical performance. Further research to identify educational interventions associated with accelerated skill acquisition is required.

• Communications for Statistical Applications and Methods
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• 제16권1호
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• pp.51-65
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• 2009

제 1상 임상시험은 사람을 대상으로 처음 실시되므로 약물 투여의 안전성과 정확성이 신중히 고려되어야 한다. 따라서 제 1상 임상시험에서는 적은 수의 피험자를 통해 최대허용용량(maximum tolerated dose)을 정확하게 찾아야 한다. 제 1상 임상시험에서 최대허용용량을 결정하는 방법에는 표준방법(standard method), 연속재평가방법(continual reassessment method) 그리고 가속적정계획(accelerated titration designs) 방법이 있다. 본 연구에서는 동일한 모형에서 세 방법을 동시에 고려하여 최대허용용량의 안전성과 정확성을 살펴보았다. 또한 세 방법에 대해 최대허용용량에서 기대독성확률을 구하여 비교하였다. 그리고 ATD와 CRM의 단점을 보완한 수정된 ATD와 수정된 CRM을 포함하여 여러 방법들을 동일한 모형에서 동시에 그 성능을 비교하였다.

• 척추신경추나의학회지
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• 제12권1호
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• pp.1-12
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• 2017

Objective : The purpose of this study is to review the randomized clinical trials of Chuna manual therapy for cervicogenic headache and provide a evidence for the efficacy of Chuna manual therapy. Methods : We searched randomized clinical trials that performed Chuna manual therapy for cervical headache up to Feb. 2017 in 6 databases. Randomized clinical trials were selected according to the inclusion criteria and the data were extracted and analyzed. The risk of bias was assessed using the Cochrane Risk of Bias Criteria. Results : 16 RCTs met the inclusion criteria. The meta-analysis of 13 RCTs showed favorable results for the use of chuna manual therapy compared to drug, physical treatment. Conclusions : In 16 RCTs, we found that Chuna manual therapy was effective in cervicogenic headache. However, all RCTs are exposed to a number of bias risks. Therefore, well designed clinical trial would be needed to raise the evidence level of Chuna manual therapy.

• 동의생리병리학회지
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• 제34권3호
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• pp.117-125
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• 2020

The purpose of this review is to confirm whether Soyo-san (Xiaoyao-san) and its modifications is effective on alleviating clinical symptoms in chronic fatigue syndrome (CFS) patients. We collected clinical trials (randomized controlled trial, quasi-randomized controlled trial, controlled clinical trial) to investigate the effects of Soyo-san and its modifications on general symptoms, fatigue, depression and anxiety in CFS patients. The databases used for data retrieval were Pubmed, Central Cochrane, Embase, CNKI, CQVIP, Wanfang, CiNii, OASIS, RISS, and Koreamed. We performed selection/exclusion process from the found studies to conform with prespecified criteria, and assessed the final included trials according to the Cochrane risk of bias tool. The included studies were classified based on the interventions in experimental and control group. Eight randomized controlled trials and one controlled clinical trial (total 921 participants) were eligible and their results were synthesized in the meta analysis. The synthesis showed a considerable effect of Soyo-san and its modifications on improvement of general symptoms (relative risk 0.27 [95% CI 0.19 to 0.39], Z=7.03, P<0.00001; I2=0%) and fatigue severity (SMD -1.20 [95% CI -1.46 to -0.93], Z=8.78, P<0.00001; I2=52%) in CFS patients, while Effect on depression and anxiety were inconclusive. We found that Soyo-san and its modifications were effective for improvement of general symptoms and fatigue severity in CFS post-treatment.

• The Korean journal of internal medicine
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• 제33권6호
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• pp.1119-1128
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• 2018

Background/Aims: In multicenter clinical trials, laboratory tests are performed in the laboratory of each center, mostly using different measuring methodologies. The purpose of this study was to evaluate coefficients of variation (CVs) of laboratory results produced by various measuring methods and to determine whether mathematical data adjustment could achieve harmonization between the methods. Methods: We chose 10 clinical laboratories, including Green Cross Laboratories (GC Labs), the central laboratory, for the measurement of total cholesterol, high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), serum triglycerides, creatinine, and glucose. The serum panels made with patient samples referred to GC Labs were sent to the other laboratories. Twenty serum samples for each analyte were prepared, sent frozen, and analyzed by each participating laboratory. Results: All methods used by participating laboratories for the six analytes had traceability by reference materials and methods. When the results from the nine laboratories were compared with those from GC Labs, the mean CVs for total cholesterol, HDL-C, LDL-C, and glucose analyzed using the same method were 1.7%, 3.7%, 4.3%, and 1.7%, respectively; and those for triglycerides and creatinine analyzed using two different methods were 4.5% and 4.48%, respectively. After adjusting data using Deming regression, the mean CV were 0.7%, 1.4%, 1.8%, 1.4%, 1.6%, and 0.8% for total cholesterol, HDL-C, LDL-C, triglyceride, creatinine, and glucose, respectively. Conclusions: We found that more comparable results can be produced by laboratory data harmonization using commutable samples. Therefore, harmonization efforts should be undertaken in multicenter trials for accurate data analysis (CRIS number; KCT0001235).