• Title, Summary, Keyword: Randomized controlled clinical trial

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Research Trends of Randomized Clinical Trial for Insomnia Using the Network Analysis (네트워크 분석을 이용한 불면의 무작위임상시험 해외 연구 동향)

  • Baek, Younghwa;Jin, Hee-Jeong
    • The Journal of the Korea Contents Association
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    • v.13 no.12
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    • pp.1036-1047
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    • 2013
  • In this study, we applied the time series analysis to the randomized controlled trial (RCT) researches related to insomnia for finding international trends. The data used in the analysis of 379 of ClinicalTrials, Web of Science was the of 132 by several keyword related with 'Insomnia' and 'Randomized Clinical Trial'. In ClinicalTials, RCT studies for insomnia, drug, cognitive behavioral therapy, depression were the key words make up the main network. In WOS, 'melatonin' key word was added in the main network. In addition to, we found the characteristic that the elderly and female subjects were steady studied.

Literature Review of Randomized Clinical Trials Regarding Insomina (불면증 무작위배정 임상시험에 대한 문헌 고찰)

  • Park, Hye Joo;Yoo, Jong Hyang;Kwon, Ji Hye;Lee, Si Woo
    • 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.

A Review of Clinical Studies with Herbal Medicine for Depression - Based on Randomized Controlled Clinical Trial - (우울증에 대한 한약물 치료 문헌적 고찰 - 무작위 대조군 임상연구를 중심으로 -)

  • Lee, Jae-Eun;Kwon, Yong-Ju;Cho, Seung-Hun
    • Journal of Oriental Neuropsychiatry
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    • v.22 no.4
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    • pp.31-39
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    • 2011
  • Objectives : This study aimed to investigate frequently used herbal materials among herbal prescription for depression focusing on randomized controlled trial. Methods : Every article relevant to depression was initially obtained from China National Infrastructure(CNKI), Korean database and book hand-searching. Searching keywords were 'depression', 'herbal medicine' and 'randomized controllled trial(RCT)'. Results : Among comorbidity with depression, the most accompanied disease was that of circulatory system. Among sixty-five articles, depression with cerebral vascular disease was twenty-eight. Article about mood disorder was twenty-four. High frequently used herbal materials were Bupleuri Radix(41times), Curcumae Radix(34 times), Acori Graminei Rhizoma and Cnidii Rhizoma(24 times). Conclusions : According to this study, we could know select frequent-used herbal medicine. In a clinical treatment, herbal materials can be added herbal prescription related to depression. As these results, it can be helpful to develop new drugs.

Review of Early Intervention for Children with Autism Spectrum Disorder: Focused on Randomized Controlled Trials

  • Yang, Young-Hui
    • Journal of the Korean Academy of Child and Adolescent Psychiatry
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    • v.30 no.4
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    • pp.136-144
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    • 2019
  • Early identification and intervention for autism spectrum disorder (ASD) were reported to be important for outcomes or clinical courses. However, there have been a few robust evidences for effectiveness of early intervention until now. This review aims to identify the effectiveness of early intervention by investigating the randomized controlled trial (RCT) of early intervention for autism. There are some RCT studies using behavioral program. Although there are some significant findings, the outcome measurements and small sample size are the limitations. Further studies are needed.

Review of Moxibustion Treatment for Hypertension in Clinical Trials (임상연구에서 나타난 고혈압 뜸치료법에 대한 고찰)

  • Liu, Yan;Park, Ji-Eun;Kim, Ae-Ran;Jung, Hee-Jung;Choi, Sun-Mi
    • Journal of Acupuncture Research
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    • v.28 no.5
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    • pp.87-96
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    • 2011
  • Objectives : The aim of this study is to review clinical trials using moxibustion on hypertension and to assess their methodology and results. Methods : Electronic literature searches for clinical trials (randomized trial, non-randomized trial, before-after study) of moxibustion were performed in nine electronic databases (four international databases and five Korean databases) and handsearch. English, Korean or Chinese articles were included. Laboratory or animal studies were excluded. Results : A total of twelve studies met the inclusion criteria. Seven randomized controlled trial, three non-randomized trials and two before-after studies were included. Seven studies used direct moxibustion(two are scarring one) and five used indirect one. Five of twelve studies used moxibustion treatment just one time, except for that most frequency was once daily or 2-3 times per week for 1-2 months. Of ten randomized or non-randomized studies, three used antihypertension drug control and another three used waiting list control. Compare to baseline, change of blood pressure after moxibustion treatment was significant in all studies. However, the results of effect in blood pressure between moxibustion and controlled were not consistent. Methodological quality of clinical trials included in this review was low and has risk of bias, especially in blinding of parcitipant. Conclusions : There are little high-quality clinical trials of moxibustion for hypertension. To evaluate the effect of moxibustion, more rigorous trials are warranted. Also, methodology of clinical trials have to be descripted in detail.

A Systematic Review of Clinical Researches of Korean Medicine for Alopecia (탈모증의 한약제제 치료효과에 대한 체계적 문헌 고찰)

  • Ryu, Deok-Hyun;Roh, Seok-Sun
    • 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.

A Systematic Review of Clinical Studies for Herbal Medicine of Dementia - based on Korean Literature - (치매의 한약물 치료에 대한 체계적 임상논문 고찰 - 국내문헌을 중심으로 -)

  • Kwon, Yong-Ju;Cho, Hye-Young;Whang, Wei-Wan;Cho, Seung-Run
    • Journal of Oriental Neuropsychiatry
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    • v.21 no.4
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    • pp.151-161
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    • 2010
  • Objectives : This study aimed to evaluate any clinical studies regarding the herbal medicine for dementia focusing on Korean literature for future rigorous clinical research. Methods: Every article relevant to dementia was initially obtained from oriental medical related journals by electronic search at journal web sites or manual searches. Journals were limited to those registered with the Korea Research Foundation. From initial findings. two independent reviewers selected clinical articles and these articles were further analyzed separately by predefined criteria according to prospective and retrospective studies. For randomized controlled trial and non randomized controlled trial. quality assessment was also conducted. Results: From ninety seven patients initially obtained articles. twenty three patients were finally analyzed. One article was randomized controlled study. Four articles were prospective whereas eighteen patients were retrospective. In the qualitative evaluation of prospective articles. there was deduction regarding pre-calculated study size and prospective data collecting. Assessment measurement most frequently used was Mini Mental State Examination. The order of frequency of use herbs were identified. Conclusions : According to our study. the herbal medicine for dementia in general showed a positive effect in the cognitive aspects of dementia patients. Further well-designed randomized controlled studies should be conducted.

Effectiveness of Soyo-san (Xiaoyao-san) and its Modifications on Chronic Fatigue Syndrome: a Systematic Review and Meta-analysis (만성피로증후군에 대한 소요산(逍遙散)과 그 변방(變方)의 효과 : 메타분석을 통한 체계적인 문헌고찰)

  • Kim, Junyeol;Song, Jeongyun;Nam, Donghyun
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.34 no.3
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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.

Regulatory innovation for expansion of indications and pediatric drug development

  • Park, Min Soo
    • Translational and Clinical Pharmacology
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    • v.26 no.4
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    • pp.155-159
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    • 2018
  • For regulatory approval of a new drug, the most preferred and reliable source of evidence would be randomized controlled trials (RCT). However, a great number of drugs, being developed as well as already marketed and being used, usually lack proper indications for children. It is imperative to develop properly evaluated drugs for children. And expanding the use of already approved drugs for other indications will benefit patients and the society. Nevertheless, to get an approval for expansion of indications, most often with off-label experiences, for drugs that have been approved or for the development of pediatric indications, either during or after completing the main drug development, conducting RCTs may not be the only, if not right, way to take. Extrapolation strategies and modelling & simulation for pediatric drug development are paving the road to the better approval scheme. Making the use of data sources other than RCT such as EHR and claims data in ways that improve the efficiency and validity of the results (e.g., randomized pragmatic trial and randomized registry trial) has been the topic of great interest all around the world. Regulatory authorities should adopt new methodologies for regulatory approval processes to adapt to the changes brought by increasing availability of big and real world data utilizing new tools of technological advancement.

Development of Acupuncture and Moxibustion Protocol in a Clinical Trial for Irritable Bowel Syndrome

  • Anastasi, Joyce K.;Capili, Bernadette;Chang, Michelle
    • Journal of Acupuncture & Meridian Studies
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    • v.10 no.1
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    • pp.62-66
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    • 2017
  • Traditional Chinese medicine encompasses many different practices, most notably acupuncture and moxibustion. Traditionally, these modalities are used in combination to augment treatment but seldom are they tested together in clinical studies. Numerous acupuncture studies have been conducted in Asia, Europe, and the United States but there have been few randomized controlled trials utilizing moxibustion outside of East Asia. Limited studies have described the use of a moxibustion control or placebo procedure. The methods for developing an acupuncture and moxibustion protocol used in a randomized controlled trial for irritable bowel syndrome, diarrhea predominant in adults are described here. Our approach conformed to the scientific rigor for a clinical trial and was consistent to the foundations of traditional Chinese medicine.