불면증 무작위배정 임상시험에 대한 문헌 고찰

박혜주 ( Hye Joo Park ),유종향 ( Jong Hyang Yoo ),권지혜 ( Ji Hye Kwon ),이시우 ( Si Woo Lee ) 대한한방신경정신과학회 2013 동의신경정신과학회지 Vol.24 No.3

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.

Types of Control in Acupuncture Clinical Trials Might Affect the Conclusion of the Trials: A Review of Acupuncture on Pain Management

Haiyong Chen,Zhipeng Ning,Wing Lok Lam,Wai-Yee Lam,Ying Ke Zhao,Jerry Wing Fai Yeung,Bacon Fung-Leung Ng,Eric Tat-Chi Ziea,Lixing Lao 사단법인약침학회 2016 Journal of Acupuncture & Meridian Studies Vol.9 No.5

Analgesic effects of acupuncture have been extensively studied in various clinical trials. However, the conclusion remains controversial, even among large scale randomized controlled trials. This study aimed to evaluate the association between the conclusion of the trials and the types of control used in those trials via systematic review. Published randomized controlled trials of acupuncture for pain were retrieved from electronic databases (Medline, AMED, Cochrane libraries, EMBASE, PsycINFO, Clinicaltrials.gov, and CAB Abstracts) using a prespecified search strategy. One hundred and thirty-nine studies leading to 166 pairs of acupuncture-control treatment effect comparisons (26 studies comprised of 53 intervention-control pairs) were analyzed based on the proportion of positive conclusions in different control designs. We found that treatment effects of acupuncture compared with nontreatment controls had the highest tendency to yield a positive conclusion (84.3%), compared with nonneedle-insertion controls (53.3%). Whereas with needle-insertion controls, the lowest tendency of positive conclusions was observed (37.8%). Consistently, in studies reporting successful blinding, a higher tendency of positive findings on the treatment effect of acupuncture was found in the noninsertion sham controls compared with that in the insertion sham controls. We conclude that the type of control is likely to affect the conclusion in acupuncture analgesic trials. Appropriate control should be chosen according to the aims of studies. Analgesic effects of acupuncture have been extensively studied in various clinical trials. However, the conclusion remains controversial, even among large scale randomized controlled trials. This study aimed to evaluate the association between the conclusion of the trials and the types of control used in those trials via systematic review. Published randomized controlled trials of acupuncture for pain were retrieved from electronic databases (Medline, AMED, Cochrane libraries, EMBASE, PsycINFO, Clinicaltrials.gov, and CAB Abstracts) using a prespecified search strategy. One hundred and thirty-nine studies leading to 166 pairs of acupuncture-control treatment effect comparisons (26 studies comprised of 53 intervention-control pairs) were analyzed based on the proportion of positive conclusions in different control designs. We found that treatment effects of acupuncture compared with nontreatment controls had the highest tendency to yield a positive conclusion (84.3%), compared with nonneedle-insertion controls (53.3%). Whereas with needle-insertion controls, the lowest tendency of positive conclusions was observed (37.8%). Consistently, in studies reporting successful blinding, a higher tendency of positive findings on the treatment effect of acupuncture was found in the noninsertion sham controls compared with that in the insertion sham controls. We conclude that the type of control is likely to affect the conclusion in acupuncture analgesic trials. Appropriate control should be chosen according to the aims of studies.

세균성 질증의 한방외치요법에 대한 무작위 대조군 비교 임상시험 중심의 고찰

황영식,이진욱,김규태,박승혁,이진무,이창훈,장준복,황덕상 대한한방부인과학회 2019 大韓韓方婦人科學會誌 Vol.32 No.2

Objectives: The purpose of this study was to show effectiveness of Korean medicine external treatment on bacterial vaginosis by analyzing randomized controlled clinical trials. Methods: We searched randomized controlled clinical trials related with Korean external treatment on bacterial vaginosis through national and overseas database and analyzed them in detail. Results: 15 articles were included according to our selection criteria and 2,176 women were involved. 1. All treatment groups were treated with intervention including Korean medicine external treatment and their results were statistically more effective than control groups. 2. External washing was the most frequently used method followed by vaginal tablet, fumigation and powder. 3. The most frequently used herbal medicine was Sophorae Radix followed by Phellodendri Cortex, Cindi Fructus, Dictamni Radicix Cortex and Kochiae Fructusa. 4. There were 4 studies reporting side effects of treatment and no significant side effects were observed. Conclusions: There was significant difference in the effectiveness of the intervention including Korean external therapy. Based on the analysis, it could be an effective way for the treatment of bacterial vaginosis in clinical practice. Objectives: The purpose of this study was to show effectiveness of Korean medicine external treatment on bacterial vaginosis by analyzing randomized controlled clinical trials. Methods: We searched randomized controlled clinical trials related with Korean external treatment on bacterial vaginosis through national and overseas database and analyzed them in detail. Results: 15 articles were included according to our selection criteria and 2,176 women were involved. 1. All treatment groups were treated with intervention including Korean medicine external treatment and their results were statistically more effective than control groups. 2. External washing was the most frequently used method followed by vaginal tablet, fumigation and powder. 3. The most frequently used herbal medicine was Sophorae Radix followed by Phellodendri Cortex, Cindi Fructus, Dictamni Radicix Cortex and Kochiae Fructusa. 4. There were 4 studies reporting side effects of treatment and no significant side effects were observed. Conclusions: There was significant difference in the effectiveness of the intervention including Korean external therapy. Based on the analysis, it could be an effective way for the treatment of bacterial vaginosis in clinical practice.

무작위대조군연구(RCT)를 중심으로 한 근골격계 질환의 약침 치료에 관한 고찰

장민기,윤은혜,정찬영,김은정,이승덕,황민섭,김갑성 대한침구의학회 2009 대한침구의학회지 Vol.26 No.3

Objectives : The purpose of this study is to review RCTs on pharmacopuncture treatment for musculoskeletal diseases and to establish standards of pharmacopuncture treatment model. Methods : We searched articles up to date of March 2009 via computerized databases of Pubmed, The Journal of Korean Acupuncture & Moxibustion, Journal of Korean Institute of Herbal Acupuncture, Journal of Oriental Rehabilitation and Journal of Korean Oriental Medicine. Only Randomized Controlled Trials(RCT) concerning the effects of pharmacopuncture on musculoskeletal diseases. The pharmaco- puncture treatment methods were assessed based on STRICTA and items considering the feature of pharmacopuncture. And the methodological quality of the trials was assessed by FEAS and modified Jadad score. Results : Eighteen trials of pharmacopuncture on musculoskeletal diseases were analyzed. Except for 4 trials comparing the effect of SBV and BV, positive outcome was reported in ten trials. Among eighteen trials, most of the trials were about Bee Venom acupuncture, and most of the trials used about five acupuncture points, mainly local acupuncture points. But, the amount of injection to each point and total injection were various. And most of trials were lack in the information about method of stimulation. The adjusted FEAS score ranged from 0 to 12, and modified Jadad scoreranged from 1 to 5. Conclusions : To standardize pharmacopuncture treatment, we need more well-designed, high quality clinical trials. And methodological assessment tools designed for pharmacopuncture treatment are also needed.

무작위 임상시험의 윤리적,법적 문제

최경석 ( Kyung Suk Choi ) 한국의료윤리학회 2008 한국의료윤리학회지 Vol.11 No.1

Human experimentation can be ethically justified when subjects participate on a voluntary basis. Informed consent is required for clinical trials, including randomized clinical trials. Nevertheless, ethical issues arise when subjects are randomly distributed to experimental and control groups in randomized clinical trials. I argue that equipoise as well as informed consent is a condition of randomized clinical trials. Benjamin Freedman distinguishes theoretical equipoise from clinical equipoise. I call the former the "individual physician equipoise" and the latter the "clinical community equipoise". Under clinical community equipoise, randomized clinical trials are ethically justified because physicians may still provide the best treatment to their patients. The above ethical principle should be applied to placebo-controlled randomized clinical trials. When experimental drugs and placebos are in clinical community equipoise, a trial may be ethically justified. In addition, placebo-controlled randomized clinical trials should be designed with double-blinding. The reason for this requirement is that physicians would cheat their patients without doubleblinding. Current FDA regulations in Korea and the US do not sufficiently reflect the above ethical points. Institutional review boards should review their protocols in light of these ethical points. In particular, IRB regulations should reflect the basic ideas of equipoise in randomized clinical trials and double-blinding in placebo-controlled randomized clinical trials.

A Quality Analysis of Randomized Controlled Trials about Erectile Dysfunction

정재훈,이정우,조정기,김규식,이승욱 대한남성과학회 2013 The World Journal of Men's Health Vol.31 No.2

Purpose: A low quality clinical trial could produce errors, and these errors could, in turn, distort the results of the clinical trial. To avoid applying distorted results of trials clinically, a quality analysis of clinical trials is needed. Materials and Methods: We selected randomized controlled trials (RCTs) about erectile dysfunction (ED) conducted in Korea using Medline and KoreaMed. Quality assessment of selected RCTs was performed using three assessment tools (Jadad scales, van Tulder scale, Cochrane Collaboration Risk of Bias Tool [CCRBT]).Results: The first RCT about ED conducted in Korea was published in 2002. Since 2002, a total of 20 RCTs have been published in medical journals. Among the 20 articles, only 1 article was found to have a low risk of bias according to the CCRBT. On the Jadad scale, there were 17 high quality articles, while 19 articles were assessed as high quality by the VTS. Only 2 RCTs described the randomization method adequately. Only 1 RCT presented allocation concealment.Conclusions: A low quality clinical trial could produce errors, and these errors could, in turn, distort the results of the clinical trial. To avoid applying distorted results of trials clinically, a quality analysis of clinical trials is needed. The quality of RCTs was found to be high because almost all of the selected RCTs were double blinded studies. However, the quality of RCTs was inadequate with regard to the lack of randomization and absence of allocation concealment. Therefore, performing adequate randomization and adding a description of the appropriate concealment of allocation may improve the quality of RCTs.

국내 의학 잡지에 게재된 무작위대조임상시험 논문들의 보고의 질

황예원,황인홍,김수영,이경우 대한가정의학회 2008 Korean Journal of Family Medicine Vol.29 No.4

Background: The revised Consolidated Standards for Reporting of Trials (CONSORT) were developed to improve the reporting of Randomized Controlled Trials. We studied to survey the extent to which RCTs report items included in the revised CONSORT recommendations. Methods: A descriptive survey of RCTs enrolled in 2005 at KoreaMed, which is a representative database in Korea was done. The main outcome measures were the proportion of RCTs that reported each of 22 checklist items of CONSORT. Results: We identified 125 RCTs from 26 journals. Random sequence implementation (0%), estimated effect size and its precision (0%), sample size determination (8.9%), method of random sequence generation (7.3%), allocation concealment (3.2%), participant flow (4.8%) and any other analysis (7.3%), generalizability of the trial findings (0.8%) were pooly reported. Conclusion: The proportions of following the CONSORT recommendations in Korean medical journals were very low. An effort to improve the reporting of RCTs by application and recommendation of CONSORT statement is required. (J Korean Acad Fam Med 2008;29:276-282) 연구배경: Consolidated Standards for Reporting of Trials (CONSORT) 개정안은 무작위대조임상시험의 보고의 질을 향상시키기 위해 개발되었다. 국내 의학 잡지에 게재된 무작위대조임상시험 논문들이 개정된 CONOSRT 권고안의 항목들을 어느 정도 보고하고 있는지를 확인하였다. 방법: 한국의 대표적인 데이터베이스인 Korea Med에 2005년 색인자료 중 무작위대조임상시험을 검색하였다. 검색된 논문에서 CONSORT 체크리스트의 22가지 항목을 얼마나 보고하고 있는지를 조사하였다. 결과: 26개의 의학 잡지에서 124개의 무작위대조임상시험을 추출하였다. CONSORT 체크 리스트 중 필요한 대상자 수를 결정하는 방법(8.9%), 무작위 배정의 순서를 결정하는 구체적인 방법(7.3%), 배정 은닉(3.2%), 무작위 배정의 실행(0%), 참가자 흐름도(4.8%), 결과의 추정치의 정밀도(0%), 부차적 분석결론(7.3%), 연구결과의 일반화 가능성(0.8%) 등의 보고의 질이 낮았다. 결론: 우리나라 의학 학술지에 실린 무작위 대조 연구들의 CONOSRT 권고안을 따르는 비율은 매우 낮았다. CONSORT 양식의 채택과 권고를 통해 무작위 대조 연구의 보고의 질을 향상시키려는 노력이 필요하다.

한약제제 무작위 대조군 연구에서 대조군 설계의 문제점과 대안

윤영희,최인화,Yun, Young-Hee,Choi, In-Hwa 대한한방안이비인후피부과학회 2008 한방안이비인후피부과학회지 Vol.21 No.2

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.

의학교육연구의 질을 향상시키기 위한 '연구보고의 표준' 의 활용

유지수,Yoo, Ji-Soo 연세대학교 의과대학 2008 의학교육논단 Vol.10 No.2

Objectives: Through using of the strong research method like a Randomized Controlled Trial: RCT, we have to heighten quality of Medical Education study. I'd like to introduce "CONSORT", which stands for Consolidated Standards of Reporting Trials. Contents: Preventive Service Task Force(200l) in USA proposed Levels of evidence for enlarging evidence-based Practice: EBP. And the CONSORT was introduced, which encompasses various initiatives developed by the CONSORT Group to alleviate the problems arising from inadequate reporting of randomized controlled trials (RCTs). the CONSORT has 13 guides like these: 1. How participants were allocated to interventions 2. Scientific background and explanation of rationale 3. Eligibility criteria for participants. The settings and locations where the data were collected. 4. Precise details of the interventions intended for each group and how and when they were actually administered 5. Specific objectives and hypotheses 6. Clearly defined primary and secondary outcome measures, When applicable. any methods to enhance the quality of measurements (e.g., multiple observations, training of assessors) 7. How sample size was determined. When applicable, explanation of any interim analyses and stopping rules 8. Method used to generate the random allocation sequence, Details of any restriction [of randomization] 9. Method used to implement the random allocation sequence 10. Who generated the allocation sequence, who enrolled participants. and who assigned participants to their groups 11. Whether or not participants, those administering the interventions, and those assessing the outcomes were blinded to group assignment. If done, how the success of blinding was evaluated 12. Statistical methods used to compare groups for primary outcome(s), Methods for additional analyses, such as subgroup analyses and adjusted analyses 13. Flow of participants through each stage (a diagram is strongly recommended) Specifically, for each group report the numbers of participants randomly assigned. receiving intended treatment, completing the study protocol. and analyzed for the primary outcome. Results and Conclusion: Randomized Controlled Trial: RCT guided of CONSORT will contribute to do stronger evidence-based medical studies.

Understanding noninferiority trials

Hahn, Seokyung The Korean Pediatric Society 2012 Clinical and Experimental Pediatrics (CEP) Vol.55 No.11

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.