• Title, Summary, Keyword: randomized controlled trial

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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.

Acupuncture for the Treatment of Burns: A Systematic Review of Randomized Controlled Trials and Case Controlled Trials (화상의 침 치료에 대한 체계적 문헌고찰)

  • Lee, Jieun;Jeong, Seoyoon;Choi, Yoomin;Jeong, Minjeong
    • The Journal of Pediatrics of Korean Medicine
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    • v.31 no.4
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    • pp.19-30
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    • 2017
  • Objectives The study was conducted to evaluate the acupuncture treatment for burns by reviewing international randomized controlled studies and case controlled studies. Methods In the review, ten academic literature archives; NDSL, OASIS, PubMed, Cochrane library, CNKI, WANFANG, CINAHL, J-STAGE, CiNii, and EMBASE were used as the main databases to search for the randomized controlled trials or the case controlled trials about acupuncture treatment of burns using the keywords "burns AND acupuncture", "burn AND acupuncture", and "scald AND acupuncture". Results Initially, a total of 852 studies were founded except duplicate studies. 801 studies were excluded after screening of title and abstract. After reviewing 51 papers, a total of four randomized controlled trials and two case controlled trials were selected. These studies were analyzed by year, subjects, treatment intervention, evaluation criteria, treatment effect, adverse events, and 'Risk of Bias' assessment for randomized studies and non-randomized studies. From the six papers out of 51 papers those were reviewed, patients with burns were divided into two groups. The experimental group received acupuncture treatment, while the control group did not. The results of the completed studies have shown that the experimental group receiving acupuncture treatment demonstrated significant improvement compared to the control group, and there was no serious adverse events. Conclusions According to some of the studies, acupuncture in burn treatment is worth to try. However, additional well-designed randomized controlled studies will be required to justify the effectiveness of acupuncture treatment of burns.

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.

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.

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.

Individualized Traditional Korean Acupuncture for Knee Osteoarthritis : a Protocol for a Randomized Controlled Trial

  • Byun, Hyuk;Baek, Seung-Tae;Park, In-Shik;Kim, Kap-Sung;Kim, Sun-Woong;Choi, Sun-Mi;Lee, Seung-Deok
    • The Journal of Korean Medicine
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    • v.27 no.4
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    • pp.225-232
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    • 2006
  • Objective : To test the hypotheses that individualized traditional Korean acupuncture improves pain and disability in patients with osteoarthritis of the knee and that benefits remain after stopping treatment more so than is the case for standardized minimal acupuncture. Design : Randomized single blind controlled trial with two intervention arms (individualized traditional Korean acupuncture, standardized minimal acupuncture) of six weeks' duration and three months follow-up. Setting : Acupuncture interventions were applied by two training doctors in the Department of Acupuncture and Moxibustion in a 1000-bed hospital. Assessment of the result was performed in a university-based laboratory. Participants : 50 patients with symptoms of knee osteoarthritis as diagnosed by an orthopedist. Intervention : Individualized traditional Korean acupuncture or standardized minimal acupuncture for six weeks. Main outcome measures: Primary outcome measure was pain as measured by the visual analogue scale. Secondary measures of pain and disability included the Western Ontario and McMaster Universities (WOMAC) index, Short Form-36 (SF-36), Lequesne Functional Index (LFI) score and Korean version of Health Assessment Questionnaire (KHAQ). Discussion : This paper presents detail on the rationale, design, methods and operational aspects of the trial.

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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 Randomized Controlled Trial Studies during 5 Years for Treatment of Chondromalacia Patella Using China National Knowledge Infrastructure Database (슬개골 연골연화증의 무작위대조군 연구 최근 5년간의 경향 분석: 중국지식기초설시공정(中國智識基礎設施工程)(CNKI) 검색을 중심으로)

  • Choi, Yun-Young;Yang, Su-Hyeon;Jang, Yeong-Suk;Kim, Hyeon-Jin;Ahn, Jae-Young;Lee, Soo-Jin;Oh, Da-Yoon;Hong, Noo-Ri;Kim, Doo-Hee
    • Journal of Korean Medicine Rehabilitation
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    • v.30 no.2
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    • pp.77-93
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    • 2020
  • Objectives This study was conducted to investigate randomized controlled trial studies about clinical treatment of traditional Chinese medicine for chondromalacia patellae. Methods We searched randomized controlled trial studies about traditional Chinese medicine treatment for chondromalacia patella through China National Knowledge Infrastructure (CNKI). 27 articles published from 2015-2019 were finally chosen and analyzed by published year, number of samples, evaluation criteria, treatment duration, treatment method. Results Various treatments such as acupuncture therapy, herbal medicine, moxibustion therapy, manipulation, external treatment were practiced in China. Most of them were combined with western medicine or injection, rehabilitation therapy. Conclusions There were diverse studies about traditional Chinese medical treatment for chondromalacia patellae in China. In Korea, more clinical research about chondromalacia patellae is still needed. This study will be helpful for future research on Korean medicine for chondromalacia patellae.

Problems and Countermeasures of Control Group Design in Randomized Controlled Trials of Herbal Medicine (한약제제 무작위 대조군 연구에서 대조군 설계의 문제점과 대안)

  • Yun, Young-Hee;Choi, In-Hwa
    • 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.

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The efficacy and safety of a Huanglian-jie-du decoction on Hwa-byung patients: A study protocol for a randomized controlled trial

  • Choi, Yu-Jin;Chung, Sun-Yong;Cho, Seung-Hun
    • Journal of Pharmacopuncture
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    • v.21 no.1
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    • pp.7-13
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    • 2018
  • Objective: Hwa-byung is one of the cultural concept of distress in Korea resulted from chronic accumulated anger. It is characterized by various symptoms like stuffy in the chest, hot or heat sensation, something pushing up in the chest, feeling of mortification, and a flush of anger. This protocol aims to explore the efficacy and safety of Huanglian-jie-du decoction on various somatic symptoms and insomnia in patients with Hwa-byung. Methods: This is study protocol for a randomized, double-blind, placebo-controlled trial. A total of 44 patients will be randomly assigned to the experimental group or the placebo group in a 1:1 ratio. All medications will be taken orally 3 times per day for 7 consecutive days. The primary outcomes are the mean changes in Patient Health Questionnaire of physical symptoms (PHQ-15) and Insomnia Severity Index (ISI) after the 7 days of administration. The secondary outcomes include the scales to assess stress response, symptoms of Hwa-byung, and state anger. Conclusion: The results of this study will provide high quality and explorative evidence to investigate the effect of Huanglian-jie-du decoction on Hwa-byung.