• 제목/요약/키워드: Randomized clinical trials

검색결과 984건 처리시간 0.021초

Neuroimaging in Randomized, Multi-Center Clinical Trials of Endovascular Treatment for Acute Ischemic Stroke: A Systematic Review

  • Chong Hyun Suh;Seung Chai Jung;Byungjun Kim;Se Jin Cho;Dong-Cheol Woo;Woo Yong Oh;Jong Gu Lee;Kyung Won Kim
    • Korean Journal of Radiology
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    • 제21권1호
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    • pp.42-57
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    • 2020
  • Appropriate use and analysis of neuroimaging techniques is an inevitable aspect of clinical trials for patients with acute ischemic stroke. Neuroimaging examinations were recently used to define the core eligibility criteria and outcomes in acute ischemic stroke research. Recent clinical trials for endovascular treatment in acute ischemic stroke have also demonstrated the efficacy or safety of endovascular treatment using various imaging modalities as well as clinical indices. Furthermore, independent imaging reviews and imaging core laboratory assessments are essential to manage and analyze imaging data in order to enhance the reliability of the outcomes. Therefore, we systematically reviewed the use of neuroimaging in recent randomized clinical trials for endovascular treatment of acute ischemic stroke in order to provide a thorough summary, which would serve as a resource guiding the use of appropriate imaging protocols and analyses in future clinical trials for acute ischemic stroke. This review will help researchers select appropriate imaging biomarkers among the various imaging protocols available and apply the selected type of imaging examination for each study in accordance with the academic purpose.

자궁선근증에 대한 한약의 효과 : 체계적 문헌 고찰 (The Effect of Herbal Medicine for Adenomyosis patients: A Systematic Review)

  • 정재웅;윤영진
    • 대한한방부인과학회지
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    • 제32권4호
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    • pp.87-101
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    • 2019
  • Objectives: The purpose of this study is to investigate the effect of herbal medicine during the Western medicine therapy in adenomyosis. Methods: The author searched 5 electronic databases and search keywords were 'Adenomyosis' and 'Herbal Medicine'. We included randomized controlled clinical trials (RCTs) using herbal medicine therapy combined Western medicine for adenomyosis patients. Results: The author selected 12 studies. The systematic review of the 12 trials indicated that herbal medicine therapy integrated Western medicine therapy was more effective than Western medicine therapy alone. Conclusions: The herbal medicine therapy combined Western medicine for adenomyosis patients seems to improve pain relief and improvement of illness from this research. However, this result should be taken cautiously by unclear risk of bias. More clinical research will be needed to standardize the results of this study through herbal medicine.

A NEW DESIGN FOR RANDOMIZED CLINICAL TRIALS

  • Zelen Marvin
    • 대한예방의학회:학술대회논문집
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    • 대한예방의학회 1994년도 교수 연수회(역학)
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    • pp.261-264
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    • 1994
  • This paper proposes a new method for planning randomized clinical trials. This method is especially suited to comparison of a best standard or control treatment with an experimental treatment. Patients are allocated into two groups by a random or chance mechanism. Patients In the first group receive standard treatment; those in the second group are asked if they will accept the experimental therapy; if they decline. they receive the best standard treatment. In the analyses of results. all those in the second group. regardless of treatment. are compared with those in the first group. Any loss of statistical efficiency can be overcome by Increased numbers. This experimental plan is indeed a randomized clinical trial and has the advantage' that, before providing consent, a patient will know whether an experimental treatment is to be used.

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Traditional Korean Medicine Therapy for Treating Carpal Tunnel Syndrome in Patients with Wrist Pain: A Systematic Review

  • Kim, Jung Hyun;Song, Ho Sueb
    • Journal of Acupuncture Research
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    • 제32권2호
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    • pp.59-64
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    • 2015
  • Objectives : This study aims to evaluate current clinical evidence of traditional Korean medicine treatment on wrist pain with carpal tunnel syndrome. Methods : Ten Korean databases were searched for prospective clinical trials of traditional Korean medicine therapy on wrist pain with carpal tunnel syndrome from the time of their inception to February, 2015. Studies conducted in Korean, Chinese and English were searched. Risk of bias in included non-randomized controlled trials was assessed by the Cochrane handbook procedure. Results : Four non-randomized controlled trials were included. A high risk of bias was observed in all trials. All of the included studies reported favorable effects being experienced by an intervention group compared to a baseline or control group. Included studies never described any occurrence of adverse events. Conclusions : There is no evidence that traditional Korean medicine treatments are effective for treating wrist pain associated with carpal tunnel syndrome. All of the included studies lacked appropriate methodological qualities and internal validity. Future well-designed clinical trials that evaluate the effects and safety of traditional Korean medicine treatment for patients with carpal tunnel syndrome are needed.

Dose-Dependent Impacts of Omega-3 Fatty Acids Supplementation on Anthropometric Variables in Patients With Cancer: Results From a Systematic Review and Meta-Analysis of Randomized Clinical Trials

  • Seyed Mojtaba Ghoreishy;Sheida Zeraattalab-Motlagh;Reza Amiri Khosroshahi;Amirhossein Hemmati;Morvarid Noormohammadi;Hamed Mohammadi
    • Clinical Nutrition Research
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    • 제13권3호
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    • pp.186-200
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    • 2024
  • Meta-analyses have been conducted with conflicting results on this topic. Due to missing several eligible studies in previous meta-analysis by Lam et al., we conducted an extensive systematic review and dose-response meta-analysis of randomized controlled trials in this regard. A comprehensive search was conducted across various databases, including MEDLINE/PubMed, ISI Web of Knowledge, Scopus, and Google Scholar, until November 2023. Based on the analysis of 33 studies comprising 2,047 individuals, it was found that there was a significant increase in body weight for each 1 g/day increase in omega-3 lipids (standardized MD [SMD], 0.52 kg; 95% confidence interval [CI], 0.31, 0.73; I2 = 95%; Grading of Recommendations Assessment, Development and Evaluation [GRADE] = low). Supplementation of omega-3 fatty acids did not yield a statistically significant impact on body mass index (BMI) (SMD, 0.12 kg/m2; 95% CI, -0.02, 0.27; I2 = 79%; GRADE = very low), lean body mass (LBM) (SMD, -0.02 kg; 95% CI, -0.43, 0.39; I2 = 97%; GRADE = very low), fat mass (SMD, 0.45 kg; 95% CI, -0.25, 1.15; I2 = 96%; GRADE = low), and body fat (SMD, 0.30%; 95% CI, -0.90, 1.51; I2 = 96%; GRADE = very low). After excluding 2 studies, the findings were significant for BMI. Regarding the results of the dose-response analysis, body weight increased proportionally by increasing the dose of omega-3 supplementation up to 4 g/day. Omega-3 fatty acid supplementation can improve body weight, but not BMI, LBM, fat mass, or body fat in cancer patients; large-scale randomized trials needed for more reliable results.

Pharmacological Treatment of Major Depressive Episodes with Mixed Features: A Systematic Review

  • Shim, In Hee;Bahk, Won-Myong;Woo, Young Sup;Yoon, Bo-Hyun
    • Clinical Psychopharmacology and Neuroscience
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    • 제16권4호
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    • pp.376-382
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    • 2018
  • We reviewed clinical studies investigating the pharmacological treatment of major depressive episodes (MDEs) with mixed features diagnosed according to the dimensional criteria (more than two or three [hypo]manic symptoms+principle depressive symptoms). We systematically reviewed published randomized controlled trials on the pharmacological treatment of MDEs with mixed features associated with mood disorders, including major depressive disorder (MDD) and bipolar disorder (BD). We searched the PubMed, Cochrane Library, and ClinicalTrials.gov databases through December 2017 with the following key word combinations linked with the word OR: (a) mixed or mixed state, mixed features, DMX, mixed depression; (b) depressive, major depressive, MDE, MDD, bipolar, bipolar depression; and (c) antidepressant, antipsychotic, mood stabilizer, anticonvulsant, treatment, medication, algorithm, guideline, pharmacological. We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. We found few randomized trials on pharmacological treatments for MDEs with mixed features. Of the 36 articles assessed for eligibility, 11 investigated MDEs with mixed features in mood disorders: six assessed the efficacy of antipsychotic drugs (lurasidone and ziprasidone) in the acute phase of MDD with mixed features, although four of these were post hoc analyses based on large randomized controlled trials. Four studies compared antipsychotic drugs (olanzapine, lurasidone, and ziprasidone) with placebo, and one study assessed the efficacy of combination therapy (olanzapine+fluoxetine) in the acute phase of BD with mixed features. Pharmacological treatments for MDEs with mixed features have focused on antipsychotics, although evidence of their efficacy is lacking. Additional well-designed clinical trials are needed.

뜸을 이용한 RCT임상연구의 경향에 대한 개괄 (Overview for pattern and results of moxibustion-derived clinical trials)

  • 손창규
    • Korean Journal of Acupuncture
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    • 제26권1호
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    • pp.41-49
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    • 2009
  • Objective : To make comprehensive picture of clinical trials using moxibustion and their results by today, then help a strategy for moxibustion-derived clinical studies in the future. Methods : Surveyed literatures containing randomized controled clinical trial (RCT) from PubMed and Korean journals. Analysis was performed according to distribution mainly by study subject, target diseases, study design, and its efficacy. Results : Fifty two literatures were selected according to inclusion criteria of randomized controled clinical study. Moxibustion-derived RCT have been rapidly increased from 2003 since the first was published in China in 1992. The main subjects of RCT are associated with immunity, cancer, arthritis, chronic colitis and urogenital disorders, which are connected to cold-elated pathogenesis. The average number of subjects was 94, and direct-moxibustion was mainly applied. The control groups were set up by giving conventional therapy, herbal medicine, acupuncture or only observation. The most of RCTs showed positive results. Conclusions : This study would be helpful for designing or conducting RCTs to develop the scientific development of moxibustion.

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근골격계 통증성 질환에 대한 온침의 임상 연구 고찰 -계통적 고찰- (Review of Clinical Trials on Warming Acupuncture for Musculoskeletal Pain Diseases -A Systematic Review-)

  • 정지윤;최도영;우현수;강성길
    • Journal of Acupuncture Research
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    • 제26권4호
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    • pp.11-18
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    • 2009
  • Objectives : The objective of this review was to evaluate clinical trials of warming acupuncture for musculoskeletal pain diseases, to assess the methodologic quality of the trials and determine whether low-quality trials are associated with positive outcomes, to document adverse effects and to identify the effectiveness of the warming acupuncture. Methods : Seven databases and the Journal ZHONGGUO ZHENJIU(中國鍼灸) published between 2004-2008 were searched. Korean and Chinese randomized trials were evaluated for methodologic quality using the modified Jadad scale. Outcome measurements were pain, function and global improvement. The best-evidence synthesis was performed to determine the strength of evidence by control group. Results : Six clinical trials representing 564 patients with musculoskeletal pain diseases were identified. For pain and function, there was moderate evidence that warming acupuncture is more effective than manual acupuncture. For patient global assesment, there was limited evidence that warming acupuncture is more effective than manual acupuncture. However, for function, there was inconclusive evidence that warming acupuncture is more effective than acupuncture with TDP or western medicine or acupoint-injection treatment. Conclusions : The evidence suggests that warming acupuncture is more effective for musculoskeletal pain diseases than manual acupuncture, acupuncture with TDP, western medicine and acupoint-injection treatment. But the evidence is moderate to inclusive due to the low methodologic quality of the trials. Further clinical trials with high methodologic quality is required to investigate the effectiveness of warming acupuncture.

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대체의학 임상실험 현황에 대한 문헌고찰 (A Literature Review of Clinical Trials on Alternative Medicine)

  • 조현;유진영;박수희
    • 한국산학기술학회논문지
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    • 제11권11호
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    • pp.4395-4403
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    • 2010
  • 본 연구는 2000년 1월부터 2010년 3월까지 Pubmed에 게재된 논문 중, alternative medicine 으로 검색하여 근거중심 대체의학에 대한 연구 현황을 알아보고자 문헌고찰을 하였다. 682편의 연구 중 대체의학에 관한 임상연구는 19개였으며 연구전체 대상자는 2,573명이었다. 논문분석 결과 RCT(Randomized Controlled Trial) 실험 설계연구가 44%였으며 CCT(Controlled Clinical Trials)가 16%, OD(efficacy studies with either a controlled or an Other than controlled Design) 40%였다. 가장 많은 임상실험이 시행된 중재 방법은 Acupuncture과 Massage 였다. 대상 질병군 분포는 근골격계 및 결합조직의 질환과 관련된 '통증 완화'에 대한 임상연구가 20%, 다음으로 특정 감염성 및 기생충성 질환, 신생물이 각각 15% 순이었다. 근거중심 대체의학 현황을 파악하고자 문헌 고찰한 결과 대체의학을 통한 중재가 질병치료에 효과가 있는지에 대한 과학적 근거를 제시한 임상연구가 부족하다. 대체의학의 품질, 안정성, 유효성 확보를 위해 대체의학에 대한 질 높은 연구필요하며 근거중심 대체의학의 활성화가 필요할 것으로 생각된다.

한약을 이용한 chemotherapy-induced peripheral neuropathy (CIPN) 치료 관련 무작위 배정 임상 시험에 대한 고찰 (A review of herbal medicines for chemotherapy induced peripheral neuropathy)

  • 박봉기
    • 대한암한의학회지
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    • 제21권2호
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    • pp.51-61
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    • 2016
  • Background : Chemotherapy-induced peripheral neuropathy (CIPN) is a common adverse effect in cancer patients who were exposed to chemotherapy. CIPN impacts on the quality of life and could delay chemotherapy. The aim of this review was to assess the therapeutic effectiveness of herbal medicine in CIPN patients. Methods : Randomized controlled trials (RCTs) were included in this review. We searched MEDLINE, Cochrane database, EMBASE, CNKI, Wanfang and four Korean databases without restrictions on time or language. The risk of bias was assessed using the Cochrane risk of bias tool. Results : Eleven RCTs involving 706 patients met the inclusion criteria. Eleven different herbal medicines were examined in the included trials. Almost RCTs showed insufficiency in the reporting randomization method and allocation concealment. One trial used allocation concealment and a double-blinding method. Five studies reported that participants dropped out of RCTs and conducted an 'as-treated analysis'. One trials reported adverse effects of herbal medicine. In ten of the eleven trials, the use of herbal medicine had shown significant differences in clinical symptoms or nerve conduction velocity. Conclusions : The use of herbal medicines for CIPN showed significant improvements in the management of CIPN. However, conclusions cannot be drawn because of the generally low quality of methodology and low quantity of data for each single herbal medicine. Further rigorous trials are needed.