• 제목/요약/키워드: Clinical Trials

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적외선 체열영상을 이용한 최신 해외 임상연구 동향 (Review of Clinical Trials on Infrared Thermography Using Search of Papers in Medline within 5 Years)

  • 황덕상;박경선;김은경;이창훈;장준복;이경섭
    • 대한한방체열의학회지
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    • 제8권1호
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    • pp.13-17
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    • 2010
  • Purpose : This study is to the recent trends of clinical trial using infrared thermography and to review its application in medicine. Methods : We searched for papers which had used infrared thermography in Medicine within 5 years, using English. Results : A total of 23 papers were but 8 were found, but 8 were not related to non-invasive infrared thermography. The other 15 papers were clinical trials about the effect of acupuncture and therapeutic massage, evaluation of post-hepatic neuralgia, sleep disorder, and regional circulation. Conclusion : These results suggest that infrared thermography can be used as a reliable and helpful method in many clinical trials.

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건성안 증후군의 피내침 치료에 대한 임상연구 동향 (Trend of Clinical Trials for Intradermal Acupuncture Treatment on Dry Eye Syndrome)

  • 송지훈;박수연
    • 한방안이비인후피부과학회지
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    • 제33권2호
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    • pp.12-22
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    • 2020
  • Objectives : The aim of this study is to review the trend of clinical trials conducted with the intradermal acupuncture treatment on dry eye syndrome. Methods : Through 4 foreign online databases(PubMed, Cochrane Library, EMBASE, and CNKI) and 3 domestic online databases(NDSL, RISS, and OASIS), we searched for clinical studies performed acupuncture treatment for dry eye syndrome from 2000 to 2020. Only randomized controlled trials(RCT) were selected and analyzed with the research method. Results : A total of 4 studies were reviewed. Cuanzu(攢竹, BL2), Taiyang(太陽, EX-HN5), and Sibai(四白, ST2) were the most frequently used acupoints in the studies. Among the evaluation indexes, Schirmer I test(SIT), tear film break-up time(BUT) were the most frequently used outcomes. In the most of the 4 studies, intradermal acupuncture treatment showed significant therapeutic effects for dry eye syndrome. Conclusions : These results suggest that it is necessary to develop more detailed standards for intradermal acupuncture treatment method as the method of intradermal acupuncture is getting more diverse, and objective tools are needed to evaluating dry eye syndrome.

태아 둔위의 침구치료에 대한 효용성 고찰 (Consideration of the Effectiveness of Moxibustion and Acupuncture for the Treatment of Fetal Breech Presentation)

  • 강기완;이은;이승호;장인수
    • Korean Journal of Acupuncture
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    • 제30권1호
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    • pp.16-20
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    • 2013
  • Objectives : The objective of this study is to report the efficacy of acupuncture and moxibustion for the treatment of fetal breech presentation. Methods : We searched papers in PubMed, using the keywords "breech and moxibustion" and "breech and acupuncture". Search range includes randomized clinical trials(RCTs), controlled clinical trials(CCTs), case reports, and case series. Each original article must have an abstract in English. Finally, 7 RCTs from 102 were included in this review. Results : As a result of analyzing the 7 RCTs, five trials hold that moxibustion or acupuncture at BL67 has been shown to produce a positive effect for the correction of breech presentation and the other two trials indicated no beneficial effect. However, one of the latter could not come to a conclusion owing to the unsatisfactory compliance record of the participants. Conclusions : Acupuncture and moxibustion may be effective to correct fetal breech presentation. In this regard, the related clinical researches are worth to be conducted.

Recent Research Trends in Moxibustion Treatment in Korea

  • Lee, Ju-Hyeon;Hwang, Doo-ree;Hong, Seung-Hyo
    • Journal of Acupuncture Research
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    • 제37권1호
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    • pp.1-12
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    • 2020
  • A total of 1,235 studies were retrieved on June 23, 2019, from 3 databases. Selected 59 studies were evaluated by year of publication, study type, subject condition/disease, acupoint, standards for reporting interventions in clinical trials of moxibustion (STRICTOM), Cochrane risk of bias (RoB), and risk of bias assessment tool for non-randomized study (RoBANS). Most studies were conducted in 2011, after which the number of studies decreased. The most common study type was 25 case reports (CR), 16 uncontrolled clinical trials (UCT), 11 randomized controlled trials (RCT), and 7 controlled clinical trials (CCT). Moxibustion treatment was mainly used for musculoskeletal and circulatory diseases/conditions. A total of 83 acupoints were used, A-shi points being the most used. As for STRICTOM, an average of 7.4 items were satisfactory for UCT and CR without a control group, and an average of 9.4 items were satisfactory for RCT and CCT. RCT was assessed using the RoB, and many items were rated as uncertain. In this study, the need for RCT of moxibustion treatment in Korea was identified. The detailed description of study methods and results will provide evidence for the efficacy of moxibustion treatment in preventive and therapeutic aspects of Korean traditional medicine.

간담도 질환에서의 고빌리루빈혈증에 대한 인진호탕의 임상 효과 : 체계적 고찰 (Clinical Effect of Injinho-tang on Hyperbilirubinemia in Hepatobiliary Disorders: A Systematic Review)

  • 박근준;강희경;한창우
    • 대한한방내과학회지
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    • 제43권6호
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    • pp.1149-1161
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    • 2022
  • Purpose: This systematic review was conducted to evaluate the clinical effects of Injinho-tang on hyperbilirubinemia in hepatobiliary disorders. Methods: We searched for randomized controlled clinical trials that had administered Injinho-tang as an intervention in the following medical databases: Public/Publisher MEDLINE (PubMed), Excerpta Medica dataBASE (EMBASE), Cochrane library, Research Information Sharing Service (RISS), ScienceON, Oriental Medicine Advanced Searching Integrated System (OASIS), and China National Knowledge Infrastructure (CNKI). Among the retrieved studies, only trials that met the inclusion criteria were selected, and serum total bilirubin values were extracted and analyzed from the finally selected trials. Results: The serum total bilirubin values of 1,302 patients with various hepatobiliary diseases were synthesized through a meta-analysis, which confirmed a decrease in serum total bilirubin of 21.03 𝜇mol/L (95% CI -29.58~-12.49, p<0.01) in the group administered with Injinho-tang compared with the control group. Conclusions: Injinho-tang is effective in alleviating hyperbilirubinemia in hepatobiliary diseases when administered with conventional treatment. However, the potential risk of bias, high heterogeneity among the included trials, and differences in herbal composition are limitations of the results of this meta-analysis.

비만 치료 한약의 무작위 대조임상시험에 대한 체계적 분석 (Systematic Review of Randomized Controlled Trials on Herbal Medicine for Treatment of Human Obesity)

  • 박정현;남종경;권동현;김호준;이명종
    • 한방재활의학과학회지
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    • 제19권3호
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    • pp.33-46
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    • 2009
  • Objectives : The objective of the study was to summarize randomized clinical trials(RCTs) that have assessed the effectiveness of herbal medicine on treatment of obesity and to propose better process of study. Methods : NLM Medline(pubmed), EMBASE, the Cochrane library, Science Direct, EBSCO, 4 Korean medical databases were systematically searched and 4 Korean medical journals were manually searched for clinical trials investigating the efficacy of herbal medicines on treatment of overweight or obese people from 1998 to 2008. The methodological quality was assessed using a Jadad score and validity was assessed using Oxford Pain Validity Scale(OPVS). Results : 14 RCTs met all the inclusion criteria. The methodological and ethical quality of the trials was generally low. The mean score by Jadad was 2.6 and the mean score of validity was 11.2. Complex herbal medicine was used in 8 RCTs and single herbal medicine was used in 6 RCTs. Except 1 RCT, the other RCTs reported positive effects of herbal medicine on treatment of obesity. Herbal medicines didn't seem to affect toxicity. In general adverse events relevant with the therapy were minor, but more than half of RCTs did not report about the safety or adverse events of herbal medicine, questioning their reliability. Conclusions : Although most RCTs concluded the efficacy and safety of herbal medicines on treatment of obesity, the quality of trials was low in general. Further rigorous clinical trials using complex herbal medicine should be performed.

효율성 측정지표를 활용한 전자적 임상시험프로세스 효과분석 (Effect Analysis of Electronic Clinical Trial Systems)

  • 이현주;최인영
    • 한국콘텐츠학회논문지
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    • 제11권1호
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    • pp.350-356
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    • 2011
  • 본 연구의 목적은 전자적 임상시험 데이터 관리를 위한 설계 시 시간적 요인에 주목하여 시스템의 효율성을 검증해 보고자 함이다. 임상시험 데이터 관리에 대한 관심이 커지고 있고 시스템 도입이 활발한 데 반해, 실제 효율성 측정에 관한 실증연구는 많지 않다. 특히 국내의 경우 임상시험 데이터 관리를 위한 전산화 도입률 조차 낮은 실정이다. 본 연구는 전자적 임상시험 데이터 관리에 대한 중요성 인식 확산을 위하여 전자적 시스템의 효과에 대한 실증연구를 시도하였으며, 시간효율성 측정지표를 활용하여 다기관 임상시험 사례의 자료를 분석하였다. 연구결과로서 전자적 시스템으로의 전환이 임상시험 전체 프로세스에 제공할 수 있는 시간 측면에서의 효율성을 검증하였으며 전자적 임상시험 데이터 관리 시스템의 활용 효과를 분석하기 위한 국내 첫 실증연구의 시도라는 의미가 있다. 나아가 전략적 데이터 관리 수립 및 임상단계 별 비교연구 등 향후 다양한 비교 연구들의 초석이 될 것이다.

뜸을 이용한 RCT임상연구의 경향에 대한 개괄 (Overview for pattern and results of moxibustion-derived clinical trials)

  • 손창규
    • Korean Journal of Acupuncture
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    • 제26권1호
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    • pp.41-49
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    • 2009
  • Objective : To make comprehensive picture of clinical trials using moxibustion and their results by today, then help a strategy for moxibustion-derived clinical studies in the future. Methods : Surveyed literatures containing randomized controled clinical trial (RCT) from PubMed and Korean journals. Analysis was performed according to distribution mainly by study subject, target diseases, study design, and its efficacy. Results : Fifty two literatures were selected according to inclusion criteria of randomized controled clinical study. Moxibustion-derived RCT have been rapidly increased from 2003 since the first was published in China in 1992. The main subjects of RCT are associated with immunity, cancer, arthritis, chronic colitis and urogenital disorders, which are connected to cold-elated pathogenesis. The average number of subjects was 94, and direct-moxibustion was mainly applied. The control groups were set up by giving conventional therapy, herbal medicine, acupuncture or only observation. The most of RCTs showed positive results. Conclusions : This study would be helpful for designing or conducting RCTs to develop the scientific development of moxibustion.

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지적장애의 침 치료에 대한 최신 임상연구 동향 - 중국 무작위 배정 임상연구를 중심으로 - (Recent Trends in Clinical Research of Acupuncture Treatment for Intellectual Disability - Focused on Chinese Randomized Controlled Trials -)

  • 김재현;박용석;이지홍;장규태
    • 대한한방소아과학회지
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    • 제35권4호
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    • pp.34-47
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    • 2021
  • Objectives The purpose of this study is to analyze the trend of recent randomized controlled trials (RCTs) which used acupuncture for the treatment of intellectual disability in China, and to evaluate the efficacy of the treatment. Methods The RCTs published from January 2017 to July 2021 were searched using China National Knowledge Infrastructure (CNKI). Then, those were analyzed by acupuncture treatment methods used and their results. Results A total of 18 randomized controlled trials were selected and analyzed. Most studies showed significantly higher Intelligence Quotient, Development Quotient, and a total effective rate in an acupuncture treatment group than those of the control group. The most used acupoints were EX-HN1 followed by Niesanzhen, Naosanzhen, Zhisanzhen, Shouzhizhen, GV20. Conclusions Based on the results of the analyzed randomized controlled trials, an acupuncture treatment has shown to be effective in the treatment of intellectual disability. However, additional well designed clinical trials are needed to solidify these findings.

임상시험 전자자료 관리를 위한 평가 프레임웍 (A Performance Evaluation Framework for e-Clinical Data Management)

  • 이현주
    • 인터넷정보학회논문지
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    • 제13권1호
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    • pp.45-55
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    • 2012
  • 임상시험 전체 소요시간 및 비용의 절감, 임상 데이터 질의 향상을 위해 임상시험 전자자료의 관리가 점차 중요해지고 있다. 또한 임상시험 전자자료 관리는 전자 임상시험의 안정성 및 질을 위해 규정 가이드라인을 준수하는 것이 결정적으로 필요하다. 본 연구는 전자적 시스템을 활용한 임상시험에 있어 데이터 관리의 성과를 평가하기 위한 프레임웍을 개발하고자 한다. 연구의 목적을 위해 임상시험 프로세스에 근거하여 기반능력, 연구설계, 연구진행 및 연구완료 등 네 개의 주요 메트릭을 구성함으로써 데이터 관리의 수준을 측정할 수 있는 성과척도를 도출한다. 이때 각 성과척도의 도출 기준은 임상시험 자체가 지향하는 데이터의 질 향상, 전자자료 관리 프로세스의 비용과 효율성 및 규정 준수 수준 등 네 가지의 관리적 관심을 기준으로 하며, 각 성과척도 별로 전자자료 관리 프로세스 상 실질적으로 측정 가능한 측정지표를 제시한다. 평가 프레임웍은 네 가지의 주요 측정 메트릭에 근거하여, 세 개의 데이터 영역(연구기관, 모니터링, 데이터관리센터) 별로 구성된다. 본 평가 프레임웍의 개발은 전문가 의견 수렴을 통한 델파이 방법론으로 접근한 탐색적 연구로서 향후 실증적 후속 연구를 과제로 남기고 있다.