• Title/Summary/Keyword: randomized clinical

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Review of the Acupuncture Randomized Trials(ART) and the Acupuncture in Routine Care(ARC): the Acupuncture Trials in Germany (독일에서 수행된 대규모의 침 치료 임상연구 Acupuncture Randomized Trials와 the Acupuncture in Routine Care에 대한 고찰)

  • Han, Kuk In;Yoon, Ju Yeon;Jeong, Jin Su;Lee, Seung Ho;Jang, In Soo
    • Journal of Acupuncture Research
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    • v.30 no.5
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    • pp.117-123
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    • 2013
  • Objectives : The purpose is to review large-scale clinical researches, the acupuncture randomized trials(ART) and the acupuncture in routine care(ARC), concerning efficacy and effectiveness of acupuncture performed in Germany. Methods and Results : We have reviewed the studies that were searched by keyword 'acupuncture' as the title and'Witt CM' as one of the main authors in PubMed. Sixteen clinical reports focused on the ART and ARC studies were analyzed among all thirty six were searched. Six studies were related with the ART and eight were focused on the ARC, and other two were on both. Finally, across all researches except osteoarthritis of knee trials in the ART, compared the acupuncture group with the control were significantly improved. On the other hand, ARC showed that additional acupuncture plus routine care was more effective than routine care alone and the response to treatment of the non-randomized group did not differ the one of the randomized acupuncture group. Conclusions : The results may suggest that acupuncture treatment has obvious clinical effectiveness. These results are expected to inspire domestic research and clinical applications in Korea, and more rigorous research on the efficacy of acupuncture should be guaranteed.

Emotional Freedom Techniques (EFT) for Students' Mental Health: A Systematic Review (학생들의 정신건강을 위한 감정자유기법(EFT): 체계적 문헌고찰)

  • Lee, Seung Hwan;Jeong, Bo Eun;Chae, Han;Lim, Jung Hwa
    • Journal of Oriental Neuropsychiatry
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    • v.28 no.3
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    • pp.165-182
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    • 2017
  • Objectives: The purpose of this systematic review was to understand clinical usefulness of Emotional Freedom Techniques (EFT) on students' mental health. Methods: Ten databases were included to extract clinical studies on effects of EFT intervention with students. Characteristics of selected studies were described, and biases were assessed with Risk of Bias (RoB) or Risk of Bias Assessment for Non-Randomized Studies (RoBANS). Results: A total of 14 clinical trials were extracted for analysis. There were 8 randomized-controlled trials (RCTs), 2 non-randomized-controlled trials (nRCTs), and 4 before-after studies. EFT have significant clinical usefulness in public speaking anxiety, test anxiety, stress, depression, learning related emotions, adolescent anxiety, and eating issues. The risk of selection bias in most studies was high or uncertain. Conclusions: EFT is an effective clinical technique for managing students' mental health issues. However, the included studies have been conducted with relatively poor quality and small sample size. Clinical trials with high quality study design and well-designed EFT education programs are needed to generalize clinical usefulness.

Analysis for Randomized Controlled Clinical Trials of Korean Medicine External Treatment on Bacterial Vaginosis (세균성 질증의 한방외치요법에 대한 무작위 대조군 비교 임상시험 중심의 고찰)

  • Hwang, Young-Sik;Lee, Jin-Wook;Kim, Gyu-Tae;Park, Seung-Hyeok;Lee, Jin-Moo;Lee, Chang-Hoon;Jang, Jun-Bock;Hwang, Deok-Sang
    • The Journal of Korean Obstetrics and Gynecology
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    • v.32 no.2
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    • pp.50-70
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    • 2019
  • Objectives: The purpose of this study was to show effectiveness of Korean medicine external treatment on bacterial vaginosis by analyzing randomized controlled clinical trials. Methods: We searched randomized controlled clinical trials related with Korean external treatment on bacterial vaginosis through national and overseas database and analyzed them in detail. Results: 15 articles were included according to our selection criteria and 2,176 women were involved. 1. All treatment groups were treated with intervention including Korean medicine external treatment and their results were statistically more effective than control groups. 2. External washing was the most frequently used method followed by vaginal tablet, fumigation and powder. 3. The most frequently used herbal medicine was Sophorae Radix followed by Phellodendri Cortex, Cindi Fructus, Dictamni Radicix Cortex and Kochiae Fructusa. 4. There were 4 studies reporting side effects of treatment and no significant side effects were observed. Conclusions: There was significant difference in the effectiveness of the intervention including Korean external therapy. Based on the analysis, it could be an effective way for the treatment of bacterial vaginosis in clinical practice.

Outcomes of epidural steroids following percutaneous transforaminal endoscopic discectomy: a meta-analysis and systematic review

  • Song, Yinghao;Li, Changxi;Guan, Jingjing;Li, Cheng;Wu, Haisheng;Cheng, Xinzhi;Ling, Bingyu;Zhang, Jinglang
    • The Korean Journal of Pain
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    • v.35 no.1
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    • pp.97-105
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    • 2022
  • Background: Percutaneous transforaminal endoscopic discectomy (PTED) has been widely used in the treatment of lumbar degenerative diseases. Epidural injection of steroids can reduce the incidence and duration of postoperative pain in a short period of time. Although steroids are widely believed to reduce the effect of surgical trauma, the observation indicators are not uniform, especially the long-term effects, so the problem remains controversial. Therefore, the purpose of this paper was to evaluate the efficacy of epidural steroids following PTED. Methods: We searched PubMed, Embase, and the Cochrane Database from 1980 to June 2021 to identify randomized and non-randomized controlled trials comparing epidural steroids and saline alone following PTED. The primary outcomes included postoperative pain at least 6 months as assessed using a visual analogue scale (VAS) and the Oswestry Disability Index (ODI). The secondary outcomes included length of hospital stay and the time of return to work. Results: A total of 451 patients were included in three randomized and two non-randomized controlled trials. The primary outcomes, including VAS and ODI scores, did not differ significantly between epidural steroids following PTED and saline alone. There were no significant intergroup differences in length of hospital stay. Epidural steroids were shown to be superior in terms of the time to return to work (P < 0.001). Conclusions: Intraoperative epidural steroids did not provide significant benefits, leg pain control, improvement in ODI scores, and length of stay in the hospital, but it can enable the patient to return to work faster.

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 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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Analysis for Randomized Controlled Clinical Trials of Acupuncture-type Treatment on Gastrointestinal Dysfunction after Ceasarean Section (제왕절개술 후 발생한 위장관 기능장애에 대한 최신 RCT 연구 동향 분석 - 경혈 자극을 중심으로 -)

  • Jeong, So-Mi;Lee, Jin-Moo;Lee, Chang-Hoon;Hwang, Deok-Sang;Jang, Jun-Bock
    • The Journal of Korean Obstetrics and Gynecology
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    • v.33 no.1
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    • pp.19-35
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    • 2020
  • Objectives: The purpose of this study was to show effectiveness of Acupuncture treatment on gastrointestinal dysfunctions after Cesarean section by analyzing randomized controlled clinical trials. Methods: We searched randomized controlled clinical trials related with acupuncture treatment on gastrointestinal dysfunctions after Cesarean section through national and overseas database and analyzed them in detail. Results: 6 articles were included according to our selection criteria and 1,084 women were involved. 3 studies used TEAS (Transcutaneous Electrical Acupoint Stimulation), 2 studies used Elastic band and 1 study used Acupressure by hand. Their results were statistically more effective than control groups. The most frequently used acupoints were Neiguan (PC6), Zusanli (ST36) followed by Sanyinjiao (SP6), Hegu (IL4). Conclusions: There was significant difference in the effectiveness of the intervention including Acupuncture treatment. Based on analysis, it could be an effective way for the treatment of gastrointestinal dysfunctions after Cesarean section in clinical practice.

Acupuncture Treatment for Rotator Cuff Disorder: A Systematic Review (회전근개 질환에 대한 침술 치료의 효과: 체계적 문헌 고찰)

  • Choi, Hyun-Min;Han, Soo-Yeon;Hwang, Doo-Ree;Kang, Jun-Hyuk
    • Journal of Korean Medicine Rehabilitation
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    • v.28 no.4
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    • pp.11-20
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    • 2018
  • Objectives To systematically explore the effects of acupuncture treatment for rotator cuff disorders and review the clinical trials. Methods We searched 9 electronic databases (PubMed, Cochrane central, Embase, China National Knowledge Infrastructure [CNKI], Korea Institute of Science and Technology Information [KISTI], National Digital Science Library [NDSL], Korean studies Information Service System [KISS], Research Information Sharing Service [RISS], Oriental Medicine Advanced Searching Integrated System [OASIS]) to find randomized controlled trials that used acupunture treatment for rotator cuff disorders. We assessed the designs of the randomized controlled trials and the method of acupuncture treatment according to the Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA). The methodological quality of randomized controlled trials were assessed using the Cochrane Risk of Bias (RoB) tool. Results Total 5 trials were reviewed. 4 out of 5 randomized clinical trials reported meaningful effects of acupuncture treatments compared to control group. However risk of bias seemed high. Conclusions Although the results suggest that acupuncture treatment has favorable effects for rotator cuff disorders, most of the studies included methodologically high risk of bias. Thus, well designed randomized clinical trials which evaluate the effects of acupuncture treatment for rotator cuff disorders should be encouraged.

Randomized Clinical Controlled Trials with Herbal Acupuncture (Pharmacopuncture) in Korea - A Systematic Review (무작위 배정 비교 임상 시험을 통한 국내의 약침 연구에 대한 체계적 고찰)

  • Park, Bong-Ky;Cho, Jung-Hyo;Son, Chang-Gue
    • The Journal of Korean Medicine
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    • v.30 no.5
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    • pp.115-126
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    • 2009
  • Objective: By assessing the quality of methodology and synthesis of results of RCTs (Randomized Controlled Clinical Trials) with herbal acupuncture (pharmacopuncture), we hope to help with administrating herbal acupuncture therapy in clinic and conducting RCT with herbal acupuncture. Methods: Reports of RCT conducted in Korea published in medical journals until February 2009 were collected. We surveyed elementary information of RCTs, evaluated randomization, double-blinding, allocation concealment and put together the results of RCTs by seven clinical topics. Results: 38 RCTs with herbal acupuncture were selected, then adequate methods for randomization and allocation concealment were found in 39% and 5% of studies. Complete double-blinding and a clear accounting of all participants were conducted in 42% and 50% of reports. The synthesis of RCTs revealed that herbal acupuncture was useful and effective on degenerative gonarthritis, omarthralgia on cerebrovascular accident, acute ankle sprain, back sprain, neck sprain, headache, rheumatoid arthritis and tennis elbow, generally. Conclusions: Although further improvement in quality of methodology of RCTs with herbal acupuncture is required, clinical usefulness of herbal acupuncture was shown especially on disorders of musculoskeletal system via RCTs.

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