• Title/Summary/Keyword: Randomized Clinical Trials

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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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    • v.21 no.1
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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.

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

  • Jung, Jae-Woong;Yoon, Young-Jin
    • The Journal of Korean Obstetrics and Gynecology
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    • v.32 no.4
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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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    • 1994.02b
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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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    • v.32 no.2
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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.

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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    • v.16 no.4
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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.

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

  • Son, Chang-Gue
    • Korean Journal of Acupuncture
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    • v.26 no.1
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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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Review of Clinical Trials on Warming Acupuncture for Musculoskeletal Pain Diseases -A Systematic Review- (근골격계 통증성 질환에 대한 온침의 임상 연구 고찰 -계통적 고찰-)

  • Chung, Jie-Youn;Choi, Do-Young;Woo, Hyun-Su;Kang, Sung-Keel
    • Journal of Acupuncture Research
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    • v.26 no.4
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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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A Literature Review of Clinical Trials on Alternative Medicine (대체의학 임상실험 현황에 대한 문헌고찰)

  • Cho, Hyun;Yoo, Jin-Yeong;Park, Soo-Hee
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.11 no.11
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    • pp.4395-4403
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    • 2010
  • The aim of this study is to know about condition of alternative medicine. Methods which An literature search in Pubmed January 2000 to March, 2010 was performed. RCT(Randomized Controlled Trial), CCT(Controled Clinical Trials), and OD(efficacy studies with either a controlled or an Other than controlled Design) were included. PubMed databases were searched using key terms relating to alternative medicine. 19 clinical trials were included among 682 studies searched. RCT was 44%, CCT was 16% and OD was 40% in the review. In the all of included studies, the acupuncture and the massage was the biggest part. The using rate was 20% of pain control about Disease of the Musculoskeletal system and Connective tissue, 15% of Certain infectious and parasitic diseases, and 15% of Neoplasms. There was lack of evidence that alternative medicine was effective for progress. Future well-designed clinical trials is needed.

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

  • Park, Bongki
    • Journal of Korean Traditional Oncology
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    • v.21 no.2
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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.

Review of Recent Clinical Research for Oral Herbal Medicine Treatment on Primary Hyperhidrosis in Children - Focused on Chinese Randomized Controlled Trials - (소아 일차성 다한증의 경구 한약치료에 대한 중의학 임상연구 동향 - 중국 무작위 대조군 임상연구를 중심으로 -)

  • Choil, Il Shin;Kim, Ki Bong;Cheon, Jin Hong
    • The Journal of Pediatrics of Korean Medicine
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    • v.36 no.3
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    • pp.75-86
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    • 2022
  • Objectives The purpose of the study is to review the trend of clinical trials conducted in China with oral herbal medicine treatment on childhood primary hyperhidrosis. Methods We searched the randomized controlled trials (RCTs) with oral herbal medicine treatment on childhood primary hyperhidrosis from the China National Knowledge Infrastructure (CNKI). The demographic data, duration of illness, intervention, treatment period, outcome and composition of herbal medicine were analyzed for this study. Results A total of five RCTs were selected and analyzed. The effectiveness of the oral administration of herbal medicines on childhood primary hyperhidrosis was found to be significant. In one study, there was no statistical difference between the treatment group and the control group when curative effect was evaluated two weeks after the intervention; however, the treatment group showed a statistically higher curative effect than the control group at one and two months after intervention, and also one month after the intervention was terminated. Conclusions Oral herbal medicine has been shown to be an effective treatment for childhood primary hyperhidrosis, and it takes at least one month for the administered oral herbal medicines to take effect. However, further well-designed large-scale randomized controlled trials are needed to confirm the efficacy and safety of oral herbal medicines in childhood primary hyperhidrosis.