• 제목/요약/키워드: Randomized Clinical Trials

검색결과 940건 처리시간 0.023초

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

  • 박봉기;조정효;손창규
    • 대한한의학회지
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    • 제30권5호
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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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건성안 증후군의 피내침 치료에 대한 임상연구 동향 (Trend of Clinical Trials for Intradermal Acupuncture Treatment on Dry Eye Syndrome)

  • 송지훈;박수연
    • 한방안이비인후피부과학회지
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    • 제33권2호
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    • pp.12-22
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    • 2020
  • Objectives : The aim of this study is to review the trend of clinical trials conducted with the intradermal acupuncture treatment on dry eye syndrome. Methods : Through 4 foreign online databases(PubMed, Cochrane Library, EMBASE, and CNKI) and 3 domestic online databases(NDSL, RISS, and OASIS), we searched for clinical studies performed acupuncture treatment for dry eye syndrome from 2000 to 2020. Only randomized controlled trials(RCT) were selected and analyzed with the research method. Results : A total of 4 studies were reviewed. Cuanzu(攢竹, BL2), Taiyang(太陽, EX-HN5), and Sibai(四白, ST2) were the most frequently used acupoints in the studies. Among the evaluation indexes, Schirmer I test(SIT), tear film break-up time(BUT) were the most frequently used outcomes. In the most of the 4 studies, intradermal acupuncture treatment showed significant therapeutic effects for dry eye syndrome. Conclusions : These results suggest that it is necessary to develop more detailed standards for intradermal acupuncture treatment method as the method of intradermal acupuncture is getting more diverse, and objective tools are needed to evaluating dry eye syndrome.

Recent Research Trends in Moxibustion Treatment in Korea

  • Lee, Ju-Hyeon;Hwang, Doo-ree;Hong, Seung-Hyo
    • Journal of Acupuncture Research
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    • 제37권1호
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    • pp.1-12
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    • 2020
  • A total of 1,235 studies were retrieved on June 23, 2019, from 3 databases. Selected 59 studies were evaluated by year of publication, study type, subject condition/disease, acupoint, standards for reporting interventions in clinical trials of moxibustion (STRICTOM), Cochrane risk of bias (RoB), and risk of bias assessment tool for non-randomized study (RoBANS). Most studies were conducted in 2011, after which the number of studies decreased. The most common study type was 25 case reports (CR), 16 uncontrolled clinical trials (UCT), 11 randomized controlled trials (RCT), and 7 controlled clinical trials (CCT). Moxibustion treatment was mainly used for musculoskeletal and circulatory diseases/conditions. A total of 83 acupoints were used, A-shi points being the most used. As for STRICTOM, an average of 7.4 items were satisfactory for UCT and CR without a control group, and an average of 9.4 items were satisfactory for RCT and CCT. RCT was assessed using the RoB, and many items were rated as uncertain. In this study, the need for RCT of moxibustion treatment in Korea was identified. The detailed description of study methods and results will provide evidence for the efficacy of moxibustion treatment in preventive and therapeutic aspects of Korean traditional medicine.

임상연구의 고혈압 침치료법에 대한 고찰 (Review of Acupuncture Treatment for Hypertension in Clinical Trials)

  • 정소영;박지은;김정은;김애란;최선미
    • 대한한의학회지
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    • 제33권1호
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    • pp.12-23
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    • 2012
  • Objectives: This study evaluated clinical trials of acupuncture treatment for hypertension and to assess their methodology and results. Methods: Eight Korean databases and four international databases were searched for clinical trials of acupuncture treatment for hypertension up to June 2011. Study quality was assessed using the risk of bias (ROB) tool. Results: Twenty-four trials of acupuncture for hypertension were included. There were 14 randomized and 1 non-randomized controlled trials and 9 before-after studies. The most frequently used acupuncture points were zsnli (ST36), qch (LI11), fngch (GB20), snynjio (SP06), snjin (LI03) and hgu (LI04). In more than half of the studies, needle retention time was 20~30 minutes. Compared to baseline, change of blood pressure after treatment was significant in all studies. However, the results of effect on blood pressure between acupuncture and control were not consistent. Conclusions: There is insufficient evidence to suggest that acupuncture is an effective treatment for hypertension. Further well-designed clinical trials will be required to evaluate the effects and safety of acupuncture treatment for hypertension.

항암화학요법 유발 백혈구감소증에 대한 한약치료의 효과 : 체계적 고찰 및 메타분석(2007-2017) (Clinical Effectiveness of Traditional Herbal Medicine in the Treatment of Chemotherapy-induced Leukopenia: A Systematic Review and Meta-analysis of Randomized Clinical Trials)

  • 김민서;정유진;홍상훈
    • 대한한방내과학회지
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    • 제39권4호
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    • pp.520-549
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    • 2018
  • Objectives: We performed a systematic review and meta-analysis to explore the recent clinical research trends regarding the effects of traditional herbal medicine (THM) on chemotherapy-induced leukopenia. Methods: Randomized controlled trials that verified effects of herbal medicine treating chemotherapy induced leukopenia were included in the study. A literature search was performed in the English, Chinese, and Korean databases for papers published from January 1, 2007, to September 1, 2017. The selected literature was assessed by Cochrane's Risk of Bias (RoB). Results: Forty-two of 232 randomized controlled trials met the inclusion criteria. The most commonly used herbal prescriptions called '升白湯 (shengbai decoction)' which means elevating the numbers of White blood cells (WBCs). And the mostly included herbs such as Astragali Radix, Angelicae Gigantis Radix, Atractylodis Rhizoma Alba, Codonopsis Pilosulae, Glycyrrhizae Radix, Ligustri Lucidi Fructus are commonly used to elevate qi, blood and yin. The count of WBC in peripheral blood, the level of leukopenia presented in WHO (World Health Organization), and clinical symptoms were used to evaluate the treatments. The effective rate was 68.6-98.18% and the effectiveness was significantly higher in the intervention group than in the control group in 38 articles (p<0.05). No serious adverse events were reported. Only five articles (5/42, 11.9%) were rated as having adequate methodological quality with a low level of bias. Conclusion: Some traditional herbal medicines may be effective as therapeutic treatments for chemotherapy-induced leukopenia, but the majority of reviewed studies were of poor quality. The present findings need to be confirmed by rigorously conducted high-quality trials, including pharmacokinetic studies, to confirm the absence of interactions between traditional herbal medicine agents and chemotherapy.

임상에서 흔히 접하는 외상성 손상에 대한 봉독약침요법의 체계적 문헌고찰 (Systematic Review of Bee Venom Therapy for Traumatic Injury)

  • 이재은;이치호;이은정;이정민;오민석
    • 한방재활의학과학회지
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    • 제26권3호
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    • pp.67-77
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    • 2016
  • Objectives To evaluate the evidence supporting the effectiveness of Bee Venom therapy for traumatic injury. Methods We conducted search across 3 electronic databases (Pubmed, CAJ and Oasis) to find clinical trials that used Bee Venom therapy as treatment for traumatic injury. The methodological quality of RCTs (Randomized controlled clinical trials) were assessed using the Cochrane Risk of Bias (RoB) tool, while NRCTs (Non-Randomized controlled clinical trials) were assessed using the Cochrane Risk of Bias Assessment tool for Non-randomized Study (RoBANS) tool. Results Among 87 articles that were searched, 10 RCTs and 19 NRCTs were finally selected. Among 19 selected studies, all studies showed that Bee Venom therapy has significant effect on traumatic injury. Conclusions Our systematic review found encouraging but limited evidence of Bee Venom therapy for traumatic injury. We recommend clinical trials which compare the effectiveness of Bee Venom therapy with other pharmacopuncture therapies to clarify the effectiveness of Bee Venom therapy from other pharmacopuncture therapies.

뇌졸중 후 중추성 통증 및 시상증후군에 대한 한약치료의 효과 : 체계적 고찰 및 메타분석 - 중의학 저널을 중심으로 (Clinical Effectiveness of Traditional Herbal Medicine in the Treatment of Central Post-Stroke Pain and Thalamic Syndrome: a Systemic Review and Meta-analysis of Randomized Clinical Trials Based on Traditional Chinese Medicine Journals)

  • 정유진;강은진;홍상훈
    • 대한한방내과학회지
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    • 제40권3호
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    • pp.295-311
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    • 2019
  • Objectives: This research aimed to investigate Chinese clinical studies on the treatment of central post-stroke pain (CPSP) and thalamic syndrome after stroke with traditional herbal medicine (THM). Methods: Randomized controlled trials verifying the effects of herbal medicine on treating CPSP and thalamic syndrome after stroke were included in the study. Electrical and hand search were conducted in the China National Knowledge Infrastructure (CNKI), National Discovery for Science Leaders (NDSL), Research Information Sharing Service (RISS), Oriental Medicine Advanced Searching Integrated System (Oasis) for CPSP and thalamic syndrome after stroke. A literature search was performed in the Chinese and Korean databases for papers published from January 1, 2010 to October 1, 2018. The selected literature was assessed by Cochrane's risk of bias. Results: Twelve reports on randomized controlled trials met the inclusion criteria from the 227 identified reports. Effective rate, comparison of visual analogy scale, present pain intensity, pain grading index, recurrence rate, follow-up, and a 36-item short form survey instrument were used to evaluate the treatments. The effective rate of the treatment group was significantly higher than that of the control group in all papers. Side effects occurred less frequently in the treatment group than in the western medicine control group. Conclusions: The treatment of CPSP and thalamic syndrome after stroke with THM was shown to be highly effective. Additional well-designed clinical trials are needed. This study can be used as a basis for further research on the treatment of CPSP and thalamic syndrome after stroke.

CONSORT statement를 기반으로 한 국내 Science Citation Index 저널과 NEJM의 Randomized Controlled Trial의 abstracts 질적 비교 평가 연구 (The quality of Reports on Randomized Controlled Trials abstracts from Korean Science Citation Index journal and NEJM; Evaluation and Comparison of adherence to the CONSORT Statement)

  • 경은정;김효선;김은영
    • 한국임상약학회지
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    • 제22권2호
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    • pp.131-136
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    • 2012
  • Objective: This study evaluated and compared the adherence to the CONSORT for quality of reports on the randomized controlled trials (RCT) abstracts by four major Korean Science Citation Index (SCI) journals and The New England Journal of Medicine (NEJM). Methods: A descriptive analysis of published RCT abstracts in Korean SCI journals and NEJM from 2007/01 to 2011/06 was conducted by two reviewers, independently extracting data from a PubMed search. A modification of CONSORT for abstract was used including 16 checklist items. Reporting of checklist items for individual group was conducted to compare adherence patterns between two groups. Results: We identified the potential 57 RCT abstracts from Korean SCI and 50 from NEJM meeting our inclusion criteria; among them, three abstracts from Korean SCI and one from NEJM were excluded. Among total 16 checklist items based on CONSORT statement, Korean SCI journals and NEJM were statistically equivalent in 4 items; Korean journals were better in three items and NEJM were in nine. The methodological quality domains were inadequately reported in both journals: allocation concealment about 1.9% and 4.0%, and blinding 44.4% and 40.8%. In general, The CONSORT adherence of NEJM was better than that of Korean SCI in the method and result domain (p < 0.0001). Conclusions: The quality of NEJM reporting of RCT abstracts was better than that of Korean SCI, in general. This study on adherence of RCT reports from Korean SCI journals and NEJM abstracts to the CONSORT statement reveals that there is a need for improvement, especially Korean SCI. Further investigation on the quality of RCT reports and ways to improve reporting quality is required.

A Comparative Study of Restricted Randomization Methods in Clinicla Trials

  • Huh, Myung-Hoe
    • Journal of the Korean Statistical Society
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    • 제14권1호
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    • pp.48-55
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    • 1985
  • In clinical trials subjects are avalible sequentially and must be assigned to treatments immediately. Completely randomized procedure for the allocation of treatments to each subject may result in severe imbalance among the number of subjects in treatment groups, especially for small experiments or interim analyses of large experiments. In this study, restricted randomization methods such as biased coin designs (Efron, 1971), permuted block design, and truncated binomial design are compared to teh completely randomized design in the presence of selection and/or accidential bias by Monte Carlo simulations.

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