• Title/Summary/Keyword: Randomized controlled trial (RCT)

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Overview of RCT for Non-Alcoholic Fatty Liver Disease and Non-Alcoholic Steatohepatitis

  • Son, Chang-Gue
    • The Journal of Korean Medicine
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    • v.32 no.3
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    • pp.44-49
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    • 2011
  • Objective: This study aimed to get information on the current status of therapies to date for non-alcoholic fatty liver disease (NAFLD), including non-alcoholic steatohepatitis (NASH). Methods: All randomized clinical controlled trial (RCT)-derived papers for NAFLD or NASH were reviewed via PubMed Database. Results: 39 RCTs met the review criteria, of which 15 and 24 papers were for NAFLD and NASH, respectively. 83% of the papers were released since 2006, and 30 studies were conducted for western medicines, antioxidants and lifestyle intervention whereas nine trials were done using herbal medicine or acupuncture which showed positive outcome. Conclusions: NAFLD and NASH are new epidemic disorders which can be a target of traditional Oriental medicine. This study will be helpful for the Oriental medicine-based strategies or therapeutic development for them.

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.

Randomized Clinical Controlled Trials of a Herb Remedies in Korea - Systematic Review (한약을 이용한 한국에서의 무작위 임상시험 개괄적 검토)

  • Oh, Rai-Young;Seol, In-Chan;Son, Chang-Gue
    • The Journal of Korean Medicine
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    • v.31 no.4
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    • pp.1-8
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    • 2010
  • Objective: The study aimed to review all randomized controlled clinical trials (RCTs) performed in Korea with herbal medicine, to produce further useful information for herbal-drug development. Methods: All papers reporting RCT with herbal drugs were collected via public database of Korea Science and Technology Integration Services, and various Oriental medicine journals. Then, the clinical question, herbal medicine, result, RCT design, and its conductor were analyzed. Results: A total of 20 RCTs were finally selected, and most of them were performed after 2003. The main subjects of RCT were related to heart and blood circulation, dermatitis, respiration disorder, Sasang constitution, or psychiatric disorders. Eight RCTs were done with a single herb while 12 RCTs were with multiple herbal formulae. In particular, three RCTs for atopic dermatitis with three formulae showed positive results. The quality of RCT was considered as better than average. Conclusions: This study revealed the current status of RCT using herbal drugs. This result would provide helpful information for research and drug development using traditional herbal medicine.

The role of percutaneous neurolysis in lumbar disc herniation: systematic review and meta-analysis

  • Manchikanti, Laxmaiah;Knezevic, Emilija;Knezevic, Nebojsa Nick;Sanapati, Mahendra R.;Kaye, Alan D.;Thota, Srinivasa;Hirsch, Joshua A.
    • The Korean Journal of Pain
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    • v.34 no.3
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    • pp.346-368
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    • 2021
  • Background: Recalcitrant disc herniation may result in chronic lumbar radiculopathy or sciatica. Fluoroscopically directed epidural injections and other conservative modalities may provide inadequate improvement in some patients. In these cases, percutaneous neurolysis with targeted delivery of medications is often the next step in pain management. Methods: An evidence-based system of methodologic assessment, namely, the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) was used. Multiple databases were searched from 1966 to January 2021. Principles of the best evidence synthesis were incorporated into qualitative evidence synthesis. The primary outcome measure was the proportion of patients with significant pain relief and functional improvement (≥ 50%). Duration of relief was categorized as short-term (< 6 months) and long-term (≥ 6 months). Results: This assessment identified one high-quality randomized controlled trial (RCT) and 5 moderate-quality non-randomized studies with an application of percutaneous neurolysis in disc herniation. Overall, the results were positive, with level II evidence. Conclusions: Based on the present systematic review, with one RCT and 5 non-randomized studies, the evidence level is II for percutaneous neurolysis in managing lumbar disc herniation.

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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Recent Clinical Research Trends on Acupuncture Treatment of Meniere's Disease (메니에르 병의 침 치료에 관한 최근 임상 연구 동향)

  • Lee, Kyou-Young;Hong, Chul-Hee
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.31 no.3
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    • pp.26-38
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    • 2018
  • Objectives : The purpose of this study is to investigate the possibility of applying acupuncture to the treatment of meniere's disease, which has no definite treatment methods, by analyzing the latest clinical researches about acupuncture treatment of meniere's disease. Methods : A case study and Randomized Controlled Trial (RCT) related to the acupuncture treatment of meniere's disease were searched using domestic and international thesis search engines including OASIS, CNKI, J-STAGE, PubMed. This study include acupuncture treatment and acupuncture combined with other treatments such as herbal medicine. The search was limitied to the publication date from 2000 to 2018 with free full text. Results : 17 cases were selected. There were 7 case studies in Korea, 5 case studies in China, and 5 RCT papers in China. All 12 cases reported improvement in meniere's disease and all RCT studies showed significantly higher treatment effects in the experimental group than in the control group. Conclusions : Acupuncture treatment showed significant effects for meniere's disease when applied alone or in combination with other treatments. In the future, various systematic studies should be conducted only for acupuncture treatment.

A Review of Clinical Studies with Herbal Medicine for Depression - Based on Randomized Controlled Clinical Trial - (우울증에 대한 한약물 치료 문헌적 고찰 - 무작위 대조군 임상연구를 중심으로 -)

  • Lee, Jae-Eun;Kwon, Yong-Ju;Cho, Seung-Hun
    • Journal of Oriental Neuropsychiatry
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    • v.22 no.4
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    • pp.31-39
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    • 2011
  • Objectives : This study aimed to investigate frequently used herbal materials among herbal prescription for depression focusing on randomized controlled trial. Methods : Every article relevant to depression was initially obtained from China National Infrastructure(CNKI), Korean database and book hand-searching. Searching keywords were 'depression', 'herbal medicine' and 'randomized controllled trial(RCT)'. Results : Among comorbidity with depression, the most accompanied disease was that of circulatory system. Among sixty-five articles, depression with cerebral vascular disease was twenty-eight. Article about mood disorder was twenty-four. High frequently used herbal materials were Bupleuri Radix(41times), Curcumae Radix(34 times), Acori Graminei Rhizoma and Cnidii Rhizoma(24 times). Conclusions : According to this study, we could know select frequent-used herbal medicine. In a clinical treatment, herbal materials can be added herbal prescription related to depression. As these results, it can be helpful to develop new drugs.

A Randomized Controlled Trial to Verify Effects of Kuesu Point on Low Back Pain and Accompanied Sciatica

  • Lee, Jeong-Won;Kim, Dong-Il
    • The Journal of Korean Medicine
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    • v.28 no.4
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    • pp.86-94
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    • 2007
  • Objective : Kuesu point is a newly discovered point, it is located in 3-cun from the centre of sacrum laterally, paralleled to the 4th foramen on the sacrum. This controlled trial was to evaluate the superior effect of Kuesu point on back pain which radiated to lower extremities. Methods : Randomized Controlled Trial (RCT) and Single Blind in patient was designed. Patients (n=31) were randomized to two groups, Kuesu-point acupuncture group (Group A, n=16) and non Kuesu point acupuncture group (Group B, n=15). Group A was acupunctured on B25 (大腸兪), B26 (關元兪) and B60 (崑崙) with Kuesu point. Group B was acupunctured on the same points without Kuesu point. The clinical subjects were female patients. Beside acupuncture, the other therapies were excluded. Clinical period was three weeks total. Each group was treated 4-5 times per week for 3 weeks. The outcome measurements were The Estimation Index of Backache (quality of life), Pain Rating Scale (pain intensity) and other physical examinations (ROM, SLR, etc.). Results : 31 patients (Group A: n=16, Group B: n=15) were Randomized, 6 of them dropped out. Eventually 25 patients (Group A: n=15, Group B: n=10) were included in the analysis. Group A acupunctured on Kuesu point scored more significant Estimation Index of Backache and lower PRS (Pain Rating Scale) than Group B acupunctured without Kuesu point (p=0.003/2). It turned out that the group acupunctured on Kuesu point show meaningful high improvement index. And other examination's results showed that the treatment effects of Group A are twice as better as Group B. Conclusion : These results suggest that Kuesu point acupuncture was more effective on lower back pain and improved the life quality of patients, being compared with non Kuesu point acupuncture.

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Systemic Review of RCTs focusing on Chronic Fatigue

  • Son, Chang-Gue
    • The Journal of Korean Medicine
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    • v.30 no.6
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    • pp.80-85
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    • 2009
  • Objective: This study aimed to build an overview of randomized clinical controlled trials (RCTs) for chronic fatigue-related symptoms to extract the useful data for management of patients and development of therapeutics using Korean traditional medicine in the future. Methods: All RCT-derived papers for chronic fatigue-related symptoms were collected via PubMed Database. We surveyed elementary information of RCTs such as clinical question, study design, and its quality and results. Results: A total of fifty-three RCTs met these review criteria. Most of the RCTs were performed in Western countries, particularly the UK and USA. The major portion of RCTs focused on chronic fatigue syndrome using immune modulators, psychotherapeutic and anti-depressants. Five RCTs using complementary and alternative medicine, including herbal remedies, showed positive results. Conclusions: Fatigue-related symptoms are a main target of Oriental medicine. This study provides helpful information for planning clinical study of chronic fatigue-related symptoms using traditional Korean medicine.

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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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