• Title/Summary/Keyword: Randomized controlled study

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The Assessment of Risk of Bias on Clinical Trials of Korean Medicine for Alopecia (탈모증의 한약제제 임상연구에 대한 비뚤림 위험 평가)

  • Ryu, Deok-hyun;Roh, Seok-sun
    • Journal of Haehwa Medicine
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    • v.24 no.1
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    • pp.25-36
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    • 2015
  • Objective : This study 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 herbs to alopecia and provides the newest reason of effectiveness of herbs to alopecia. Methos : Data were collected through electronic database including NDSL, KISS, KMBASE, Koreantk, OASIS, KoreaMed, KISTI, Pubmd, Cochrane CENTRAL and CINAHL. Two experts in Oriental Medince 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 trials, 13 non-randomized controlled trials and 3 case reports. This study evaluates 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. Conclusion : We must try to specify concretely methods of allocation concealment after planning and practicing it for reducing a selection bias in randomized controlled trials. Also report a reason of missing value and blinding outcome assessments. And we have to agonize and mention methods of blinding of researchers for reducing a detection bias in non-randomized controlled trials.

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Quantity and Quality Assessment of Randomized Controlled Trials in the Atopic Dermatitis (아토피 피부염 무작위배정 임상연구 논문 질 평가)

  • Park, Hye-Joo;Kwon, Ji-Hye;Yoo, Jong-Hyang
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.27 no.4
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    • pp.45-57
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    • 2014
  • Objective : This study aims to provide fundamental data for new directions(the improvement directions) from searching research papers of randomized controlled trials among thesis of Atopic Dermatitis related to oriental medicine in Korea from 2004 to 2014 and identifying the problem and level of a clinical study through an assessment of the quality, CONSORT statement. Methods : Data was collected through the Koreanstudies Information Service System(KISS). Two experts in Oriental Medicine reviewed the title and abstract in thesis, the results of searching the title, "Atopic dermatitis" and topic, "oriental medicine" at KISS, and then they handsearched Randomized Controlled Trials related to oriental medicine in Korea. According to guidelines defined by CONSORT statement, they assessed whether 37 items were followed by guidelines at yes or no answers in order to evaluate the quality as well. They assessed the definition of each item independently. After comparing, they made a decision on the item of different outcomes through an agreement with a third party. Results : Total number of randomized controlled trials in Atopic Dermatitis related to oriental medicine is eleven. A randomized controlled trial was first published in 2007. One or two papers associated it were released every year except 2013. 9 papers of them were approved by Institutional Review Board and were received written consent. The study included between 20 to 40 subjects for 2-arm parallel study design. The effect of treatment was observed for 4 to 8 weeks. On average, the number followed guidelines was 18.64 among those of 37 CONSORT statement and 50.38% of them was followed overall. Conclusion : As an interest about randomized controlled trials was increased, it was needed to care the standard providing information of CONSORT statement on randomized controlled trials related to oriental medicine in Korea. It is suggested to provide more clear information about it, so that it can be a motive for improving quality of the journal in oriental medicine.

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.

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.

Domestic Clinical Studies Related to the Exercise Program Targeting Farmers : a Systematic Review (농업인을 대상으로 한 운동프로그램 관련 국내 임상연구에 대한 체계적 문헌고찰)

  • Kook, Kil-Ho;Lee, Eun-Jung;Oh, Min-Seok
    • Journal of Korean Medicine Rehabilitation
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    • v.21 no.4
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    • pp.77-86
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    • 2011
  • Objectives: This study aims to evaluate domestic clinical studies related to the exercise program targeting farmers. Methods: Five Korean databases were seamed for prospective clinical trials of exercise program targeting farmers from 2001 to August, 2011. Only studies conducted in Korean language were searched. Results: Thirteen clinical studies were included among 3374 studies searched. Six were observational studies, four were non-randomized controlled trials, and three were randomized controlled trials. All of included studies reported favorable effects of exercise group compared to baseline of controlled group. Conclusions: We found various mistake in the applications of statistical methodologies in the studies of exercise program targeting farmers. It is necessary for more randomized controlled trials to evaluate effect of exercise program target farmers.

Systematic Review of Acupuncture Treatment for Tic Disorder (틱장애 침치료에 대한 체계적 문헌고찰)

  • Lee, Kyungjin;Jeong, Minjeong
    • The Journal of Pediatrics of Korean Medicine
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    • v.31 no.2
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    • pp.14-24
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    • 2017
  • Objectives The study was conducted to evaluate the recent treatment and study trends of tic disorder by reviewing domestic and international randomized controlled studies. Methods The acupuncture treatment on tic disorder randomized control study articles (published by June 10th, 2016) were selected from seven academic literature archives; NDSL, OASIS, KTKP, Pubmed, J-STAGE, CNKI, and CINAHL. Results Ten articles were identified after searching. These studies were analyzed by year, diagnostic criteria, intervention, evaluation criteria, treatment points, treatment effect, treatment duration, and 'Risk of Bias' assessment. Conclusions According to the articles, acupuncture was effective in treating tic disorder. However, additional well-designed randomized controlled studies will be required to justify the effectiveness of acupuncture treatment on tic disorder.

Review of Randomized Controlled Trials on Korean Traditional Medicine Treatment for Postpartum Pain (산후신통의 한방 치료에 대한 무작위대조군연구에 관한 고찰)

  • Noh, Eun-Ji;Choi, Su-Ji;Kim, Dong-Il
    • The Journal of Korean Obstetrics and Gynecology
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    • v.33 no.2
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    • pp.90-111
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    • 2020
  • Objectives: The purpose of this study was to analyze randomized controlled trials (RCTs) related to the effect and safety of Korean Traditional Medicine treatment for postpartum pain, and to suggest desirable future clinical research trend. Methods: Randomized controlled trials (RCTs) on postpartum pain were searched using domestic and foreign search engines to investigate the effect and safety of Korean Traditional Medicine on postpartum pain, and 12 studies were selected as a result. Results: There were 4 studies using Acupoint Therapy, 3 studies using Herbal Medicine, 3 studies using Using Acupoint Therapy and Herbal Medicine together, and 2 studies using Manipulative Therapy for postpartum pain. As control interventions, non-treatment, other Korean Traditional Medicine treatment, or Western medicine were used. All the studies reported a significant effect in experimental group compared to the control group, with no or minor side effects. Conclusions: Korean Traditional Medicine treatment showed effectiveness and safety for postpartum pain. In the future, it is necessary to eliminate the ambiguity of recruiting subjects and to study the most effective application method of Korean Traditional Medicine treatment for postpartum pain.

Review of Randomized Controlled Trials of Korean Medicine for Chronic Urinary Tract Infections (만성 요로감염의 한약 치료에 관한 무작위 대조군 임상 연구 분석)

  • Lee, Ji-Won;Kim, Dong-Chul
    • The Journal of Korean Obstetrics and Gynecology
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    • v.33 no.4
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    • pp.113-126
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    • 2020
  • Objectives: This study aimed to review randomized controlled trials on the effectiveness of korean medicine for chronic urinary tract infections. Methods: We analyzed the randomized controlled trials that intervented korean medicine treatment on chronic urinary tract infections retrieved using seven databases. Literature search was conducted on August 10, 2020. Results: Of the 188 studies searched, 8 studies were finally selected. In all studies, the treatment group was treated with korean medicine and the control group was treated with western medicine. Although the evaluation index was different for each study, all the indexes in the treatment group were significantly improved compared to the control group. Conclusions: Korean medicine treatment for chronic urinary tract infections had a significant effect compared to the western medicine treatment. Further high quality randomized controlled trials should be carried out to verify the strong evidence and safety of herbal medicine treatment.

Maternal Health Effects of Internet-Based Education Interventions during the Postpartum Period: A Systematic Review (인터넷 기반 교육 중재가 산욕기 어머니 건강에 미치는 영향에 대한 체계적 고찰)

  • Chae, Jung Mi;Kim, Hyun Kyoung
    • Research in Community and Public Health Nursing
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    • v.32 no.1
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    • pp.116-129
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    • 2021
  • Purpose: This study aimed to investigate the maternal health effects of internet-based education interventions on parturients during the postpartum period through a systematic review of randomized controlled trials. Methods: An electronic literature search of the Cochrane Library, CINAHL, EMBASE, Eric, PsycINFO, PubMed, RISS, and KISS databases was performed, using the combination of keywords such as 'parenthood education', '*natal education', '*birth intervention', 'internet-based intervention', 'randomized controlled trial'. The inclusion criteria were peer-reviewed papers in English regarding randomized controlled trials of internet-based postnatal education interventions. Educational interventions were delivered through any web, mobile, eHealth, mHealth, virtual reality, short message service, or social networking service platform. Quality appraisal was performed using the Risk of Bias 2 (RoB 2) for randomized controlled trials. Nine articles were yielded, and the intervention effects were analyzed. Results: Internet-based education interventions during the postpartum period affect maternal self-efficacy, postpartum depression, and successive breastfeeding; however, they do not affect maternal satisfaction and parenting confidence. Conclusion: This study demonstrated that internet-based education interventions affect maternal health status in terms of psychological, emotional, and physical wellness. Therefore, maternal health care professionals can utilize remote education using the internet or mobile-based interventions during the postpartum period.

Quantity and Quality Assessment of Randomized Controlled Trials in the Journal of Oriental Rehabilitation Medicine (한방재활의학과학회지에 수록된 무작위대조시험 연구의 양적, 질적 평가)

  • Kwon, Dong-Hyun;Nam, Jong-Kyung;Jung, Min-Kyu;Kim, Ho-Jun;Lee, Myeong-Jong
    • Journal of Korean Medicine Rehabilitation
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    • v.20 no.4
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    • pp.91-103
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    • 2010
  • Objectives : The purpose of this study is to perform quantity and quality assessment of randomized controlled trials(RCTs) in the journal of oriental rehabilitation medicine(JORM). Methods : Upon extracting randomized controlled trial from all the articles published in the JORM from 1991 to 2009, assessments were made on the adequacy of the consolidated standards of reporting trials(CONSORT) checklist. The assessment were performed independently by two researchers, and adjustment of the differences were done by discussions. Results : Among the 824 articles from 1981 to 1999, 33 RCTs were selected. 4 RCTs were published from 1991 to 2002, and 29 RCTs were published from 2003 to 2009. Adequacy of the CONSORT checklist was 29.4%(27.3% from 1999 to 2005, 31.6% from 2006 to 2009). Conclusions : RCTs of the JORM consistently increased in quantity and quality. But researchers should make an effort to reporting more accurate.