• Title/Summary/Keyword: Randomized Controlled Trials

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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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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.

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.

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.

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.

Systematic Review on Complementary and Alternative Medicine for Female Sexual Dysfunction (여성 성기능장애의 보완대체의학적 치료에 관한 논문 연구)

  • Jeong, Young-Min;Kim, Song-Baek;Choi, Chang-Min;Seo, Yun-Jung;Cho, Han-Baek
    • The Journal of Korean Obstetrics and Gynecology
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    • v.26 no.2
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    • pp.66-87
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    • 2013
  • Objectives: The aim of this study was to review systemically clinical trials on the trends of studies for Complementary and Alternative Medicine in the treatment of female sexual dysfunction and provide basic resource for future treatment and suggestions for improving research methods. Methods: Through medical website 'Pubmed', foreign clinical literatures about female sexual dysfunction were searched and domestic clinical literatures about female sexual dysfunction were searched using internet websites 'National assembly library', 'KISS', 'RISS', 'Korean traditional knowledge portal'. Results: Total 19 literatures were selected from January 2000 to June 2012. 15 foreign literatures were selected through medical website and 4 domestic literatures were chosen using internet websites or hand-searching. 5 literatures were published in 2008 and 13 literatures mentioned about age group of patients. FSFI is most common tool for female sexual dysfunction. 9 of 19 literatures were using Herbal medicine for treatment. 5 literatures were about CBT, 6 literatures were about Biofeedback and other one literatures are about Perineal massage. There were 14 Randomized controlled trials and 5 Non-randomized controlled trials. And randomized controlled trials were relatively low in risk of bias than non-randomized controlled trials. Conclusions: Upon these results, in similar future more clinical trials should be done and accumulate Evidence-based literatures.

A Review on Randomized Controlled Trials of Herbal Medicine Treatment for Pregnancy-induced Hypertension (임신성 고혈압의 한약 치료에 대한 무작위 대조군 연구의 문헌고찰)

  • Hwang, Su-In;Yoon, Young-Jin;Park, Jang-Kyung
    • The Journal of Korean Obstetrics and Gynecology
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    • v.33 no.3
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    • pp.119-135
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    • 2020
  • Objectives: The purpose of this study is to confirm the effectiveness and safety of herbal medicine treatment for treating pregnancy-induced hypertension. Methods: We searched for randomized controlled trials of pregnancy-induced hypertension treated with herbal medicine, through nine databases. Interventions and results of the selected clinical studies were analyzed. Results: Eleven randomized controlled trials were finally included according to the inclusion and exclusion criteria. Treatment group was treated with herbal medicine alone in two studies, and with herbal medicine and western medicine in nine studies. Control group was treated with western medicine. Taxilli Ramulus (桑寄生) (54.5%) was the most frequently used herb in herbal medicine treatment. In all of eleven studies, treatment group was more effective for pregnancy-induced hypertension than the control group. Conclusions: This study suggested that herbal medicine treatment alone or combined with western medicine treatment could be helpful in improving the therapeutic effect on pregnancy-induced hypertension and reducing side effects as well. However, in order to obtain stronger evidence of herbal medicine treatment for pregnancy-induced hypertension, more high-quality and well-designed randomized controlled trials should be conducted.

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.

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 Effect of Manual Stretching and Positioning and Developmental Treatment in Congenital Muscular Torticollis: randomized Controlled Trials (선천성 근성 사경 환아에서 수기신장과 자세와 발달을 이용한 치료의 효과에 대한 무작위 연구)

  • Lee, In-Hee
    • Physical Therapy Korea
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    • v.16 no.1
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    • pp.34-41
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    • 2009
  • The purpose of this study is to compare the outcomes of manual stretching treatment with those of motor development and positioning physical therapy (MDPPT) for congenital muscular torticollis (CMT). This study was designed to be randomized controlled trials and to evaluate the outcomes of 43 consecutive patients with CMT who were first seen when they were average 26 days old. Before treatments, the patients were unintentionallv classified into two clinical groups along with the treatment methods. Among the 43 patients, 22 were classified to the manual stretching group and 21 to the MDPPT group. By means of independent t-test on the result. the duration of treatment according to methods was not significantly different in two groups (p>.05). The duration of treatment in accordance with head tilt level was not significantly different in two groups (p>.05). There was change of mass diameter, between at the beginning day of treatment and after treatment in manual stretching group with a strong positive linear correlation (p=.000, r=.734), but slightly positive linear correlation in MDPPT group. The result of this study indicates that two therapeutic methods make little difference in effectiveness.

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