• Title/Summary/Keyword: RCTs

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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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A Systematic Review of Chuna Manual Therapy for Adolescent Idiopathic Scoliosis

  • Jung, Ga Hyeon;Lee, Hyun;Kong, Hae Jin;Ryu, Hwa Yeon;Ku, Yong Ho;Kang, Jae Hui
    • Journal of Acupuncture Research
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    • v.36 no.3
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    • pp.119-130
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    • 2019
  • This study analyzed randomized controlled trials (RCTs) and case studies investigating Chuna manual therapy and variations of this term, for adolescent idiopathic scoliosis. On June $15^{th}$, 2019, 6 online databases were used to retrieve studies. A total of 527 articles were retrieved, and 14 RCTs and 20 case studies were selected for review. Typically, the frequency of Chuna therapy was 1-2 times/week. The most common period of treatment was 12 months in RCTs and 3-6 months in case studies. Cobb's angle was the most frequent evaluation index used (11 RCTs and 20 case studies). In control groups, brace treatment was used in 8 RCTs. In 6 RCTs and 20 case studies, Cobb's angle significantly decreased after Chuna therapy, and in 4 RCTs, Chuna therapy was as effective as brace treatment, with no significant difference between groups. Adverse events were not reported except for minor reactions in only 3 case studies. This review suggested that Chuna therapy for adolescent idiopathic scoliosis was more advantageous than and as effective as brace treatment in most cases, although the risk of bias in 13 RCTs was unclear.

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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Systematic Review of Randomized Controlled Trials on Herbal Medicine for Treatment of Human Obesity (비만 치료 한약의 무작위 대조임상시험에 대한 체계적 분석)

  • Park, Jung-Hyun;Nam, Jong-Kyung;Kwon, Dong-Hyun;Kim, Ho-Jun;Lee, Myeong-Jong
    • Journal of Korean Medicine Rehabilitation
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    • v.19 no.3
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    • pp.33-46
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    • 2009
  • Objectives : The objective of the study was to summarize randomized clinical trials(RCTs) that have assessed the effectiveness of herbal medicine on treatment of obesity and to propose better process of study. Methods : NLM Medline(pubmed), EMBASE, the Cochrane library, Science Direct, EBSCO, 4 Korean medical databases were systematically searched and 4 Korean medical journals were manually searched for clinical trials investigating the efficacy of herbal medicines on treatment of overweight or obese people from 1998 to 2008. The methodological quality was assessed using a Jadad score and validity was assessed using Oxford Pain Validity Scale(OPVS). Results : 14 RCTs met all the inclusion criteria. The methodological and ethical quality of the trials was generally low. The mean score by Jadad was 2.6 and the mean score of validity was 11.2. Complex herbal medicine was used in 8 RCTs and single herbal medicine was used in 6 RCTs. Except 1 RCT, the other RCTs reported positive effects of herbal medicine on treatment of obesity. Herbal medicines didn't seem to affect toxicity. In general adverse events relevant with the therapy were minor, but more than half of RCTs did not report about the safety or adverse events of herbal medicine, questioning their reliability. Conclusions : Although most RCTs concluded the efficacy and safety of herbal medicines on treatment of obesity, the quality of trials was low in general. Further rigorous clinical trials using complex herbal medicine should be performed.

Review of Randomized Controlled Trials using Herbal Remedies on Cancer Patients (한약물을 이용한 암 치료 관련 무작위 배정 임상시험에 대한 고찰)

  • Park, Bong-Ky;Wang, Jing-Hua;Cho, Jung-Hyo;Son, Chang-Gue
    • The Journal of Korean Medicine
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    • v.31 no.5
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    • pp.12-32
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    • 2010
  • Objective: This study aimed to review herbal remedy-based RCTs on cancer patients in order to produce helpful information for clinical study of herbal medicine in the future. Methods: We collected all RCTs using herbal remedies on cancer patients from Pubmed and Cochrane databases until November 1st, 2009. Elementary information such as nation where performed, clinical question, design, randomization, double-blinding and allocation concealment were analyzed. Results: 153 RCTs were finally selected. 119 RCTs were conduced in China while only 2 were done in Korea. The most frequent targeted cancer was lung cancer as 29 RCTs. The main clinical questions included improvement of quality of life, elongation of survival rate and regression of tumor being 83, 62 and 55 respectively. 112 RCTs used herbal remedies with western therapy. Adequate methods for randomization and allocation concealment were found in 37% and 10% of trials respectively. Conclusions: We found that herbal remedies are used on cancer patients in aspects of both caring for the human body and tumor treatment itself. The study might provide us useful data for cancer-related clinical study using herbal remedies in the future.

Chuna Manual Therapy Alone for Cervicogenic Dizziness: A Systematic Review (추나 단독 치료의 경추성 현훈에 대한 효과: 체계적 문헌 고찰)

  • Shin, Seon-Ho;Min, Kyung-Jin;Kim, Eui-Byeol;Ha, Won-Bae;Ko, Youn-Seok
    • Journal of Korean Medicine Rehabilitation
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    • v.29 no.1
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    • pp.1-6
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    • 2019
  • Objectives The purpose of this study is to provide an evidence base for the effectiveness of Chuna manual therapy (CMT) alone for cervicogenic dizziness. Methods We conducted a search up to October 2018 in 7 electronic databases. The randomized controlled trials (RCTs) that performed CMT for cervicogenic dizziness were included. The risk of bias was assessed using the Cochrane risk of bias tool. Results Ten RCTs met the inclusion criteria. The meta-analysis of 4 RCTs showed favorable results for the use of CMT alone compared to medication. Conclusions In 10 RCTs, we found that CMT was effective in cervicogenic dizziness. However, most of the included RCTs were unclear risk of bias. Therefore, well designed RCTs would be needed to obtain the stronger evidence level of CMT for cervicogenic dizziness.

Sanjoin-tang (Suanzaoren decoction) for Insomnia in Menopausal Syndromes: A Systematic Review and Meta-analysis (산조인탕치료가 여성갱년기 수면장애에 미치는 효과 : 체계적 문헌고찰 및 메타분석)

  • Jun, Ji Hee;Choi, Tae-Young;Lee, Myeong Soo;Song, Eunhye;Ang, Lin;Park, Sunju
    • Journal of Society of Preventive Korean Medicine
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    • v.24 no.1
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    • pp.1-14
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    • 2020
  • Objectives : The purpose of this systematic review was to investigate the efficacy and safety of Sanjoin-tang (Suanzaoren decoction, SZRD) for insomnia in menopausal syndromes. Method : We searched the following databases: PubMed, Cochrane Library, EMBASE, China National Knowledge Infrastructure (CNKI), Chinese Science and Technique Journals Database (VIP), Wanfang, Research Information Service System (RISS), OASIS, Korean studies Information Service System (KISS), and National Digital Science Library (NDSL) databases. Randomized controlled trials (RCTs) or quasi-RCTs that used SZRD for women in menopause were included. The methodological quality of each RCT was assessed using the risk of bias tool. Results : In total, nine RCTs were finally included. The included RCTs had a high risk of bias across their domains. Three RCTs examined the effects of SZRD compared with western medicine (WM) in insomnia. Three RCTs showed favorable effects of SZRD with insomnia. Infrastructure also showed that SZRD resulted in better clinical WM (RR 1.19, 95% CI 1.07 to 1.32, P=0.001, I2=0%). Four RCTs showed favorable effects of Modified SZRD with insomnia. Infrastructure also showed that Modified SZRD resulted in better clinical WM (RR 1.13, 95% CI 1.04 to 1.23, P=0.004, I2=0%). Among the 4 RCTs, three RCTs showed an equivalent effect on the total Pittsburh Sleep Quality Index (PSQI). The meta-analysis also showed that Modified SZRD had a superior effect on the total of PSQI (total of PSQI : MD -2.55, 95% CI -3.72 to -1.37, P<0.0001, I2=85%). Only 2 trials reported adverse events and none reported severe adverse events. Conclusion : SZRD appears to be safe, but there is insufficient evidence to make a definitive conclusion because only a few studies reported adverse events. Due to the poor methodological quality of the included studies and the small number of trials included, the evidence cannot be reproduced and assessed. Well-designed RCTs with a larger sample size are needed in the future.

TheAssessment of risk of bias in randomized controlled trials published in the Korean Journal of Physical Therapy: A 2018~2022 review (한국 물리치료 학술지에 무작위대조연구의 비뚤림 위험 평가: 2018~2022년 검토)

  • Jae Hyun Lim;Chi Bok Park;Byeong Geun Kim
    • Journal of Korean Physical Therapy Science
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    • v.30 no.4
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    • pp.82-91
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    • 2023
  • Background: Randomized controlled trials (RCTs) provide evidence on the effectiveness and safety of interventions and inform systematic reviews and guideline preparation for clinical application. However, methodological flaws can occur in many RCTs, and Cochrane's risk of bias version 2 (RoB2) can be used to evaluate RCTs' risk of bias (RoB). However, physical therapy RCTs in Korea did not confirm RoB. Therefore, the purpose of this study was to evaluate RoB using RoB2 in RCTs published in the Korean Physical Therapy Journal. Design: Review. Methods: The RCTs subject to evaluation were RCTs published in 11 physical therapy journals in Korea from 2018 to 2022. RoB2 evaluated a total of five domains: bias arising from the randomization process, bias due to deviations from intended interventions, bias due to missing outcome data, bias in measurement of the outcome, and bias in selection of the reported result. Results: A total of 616 RCTs were evaluated. As for bias arising from the randomization process, high risk was the highest at 555 (90.1%), followed by low risk at 41 (6.7%) and some concerns at 20 (3.2%). For bias due to deviations from intended interventions, the proportion of some concerns was the highest at 390 (63.3%), followed by high risk at 218 (35.4%) and low risk at 8 (1.3%). As for the bias due to missing outcome data, the rate of low risk was the highest at 399 (64.8%), followed by high risk at 159 (25.8%) and some concerns at 58 (9.4%). As for bias in measurement of the outcome, high risk was the highest at 294 (47.7%), followed by low risk at 224 (36.4%) and some concerns at 98 (15.9%). In the bias due to missing outcome data, the ratio of high risk was the highest at 610 (99%), followed by low risk at 4 (0.7%) and some concerns at 2 (0.3%). Conclusion: Most of the RoB evaluation results of RCTs published in the Korean Physical Therapy Journal were rated as high risk. Methodological quality of RCTs needs to be improved.

Randomized Controlled Clinical Trials in the Journal of Korean Society of Chuna Manual Medicine for Spine and Nerves: A Quantitative and Qualitative Analysis (척추신경추나의학회지에 수록된 무작위대조임상 연구의 양적, 질적 분석)

  • Cho, Hyun-Woo;Lee, Hyeon-Yeop;Heo, Kwang-Ho;Hwang, Eui-Hyoung;Shin, Mi-Suk;Shin, Byung-Cheul
    • The Journal of Churna Manual Medicine for Spine and Nerves
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    • v.7 no.2
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    • pp.15-23
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    • 2012
  • Objectives: The aim of this study is to assess the quantity and quality of randomized controlled clinical trials (RCTs) published in the journal of Korean Society of Chuna Manual Medicine for Spine and Nerves (KSCMSN). Methods: All relevant RCTs were selected and extracted. Data extract of RCTs from all the articles published in the jounal of KSCMSN up to now, quantity assessment was made on the study design, sample size, intervention, control group and medical condition. of the consolidated standards of reporting trials (CONSORT) check list. Assessment was performed by 2 independent reviewers and disagreement was discussed based on concensus. Results: Among the 276 articles, 10 RCTs were published. 1st articles were published in 2003 and half of RCTs were published in 2011. All RCTs were parallel 2-arm designed. Average sample size was 29.2 per study and 14.6 per arm. Main intervention was consisted as acupuncture 40%, pharmacopuncture 30% and Chuna 30%. Average of adequacy of CONSORT check list was 10.3% and overall reports were insufficient. Conclusions: Though RCTs published in jounal of KSCMSN were increasing, the quality remains low. KSCMSN should make a effort to follow the CONSORT statement and improve the quantity and quality of studies.

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Quantity and Quality Assessment of Randomized Controlled Trials in the Journal of Oriental Rehabilitation Medicine (한방재활의학과학회지에 수록된 무작위대조시험 연구의 양적, 질적 평가)

  • Kwon, Dong-Hyun;Nam, Jong-Kyung;Jung, Min-Kyu;Kim, Ho-Jun;Lee, Myeong-Jong
    • Journal of Korean Medicine Rehabilitation
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    • v.20 no.4
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    • pp.91-103
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    • 2010
  • Objectives : The purpose of this study is to perform quantity and quality assessment of randomized controlled trials(RCTs) in the journal of oriental rehabilitation medicine(JORM). Methods : Upon extracting randomized controlled trial from all the articles published in the JORM from 1991 to 2009, assessments were made on the adequacy of the consolidated standards of reporting trials(CONSORT) checklist. The assessment were performed independently by two researchers, and adjustment of the differences were done by discussions. Results : Among the 824 articles from 1981 to 1999, 33 RCTs were selected. 4 RCTs were published from 1991 to 2002, and 29 RCTs were published from 2003 to 2009. Adequacy of the CONSORT checklist was 29.4%(27.3% from 1999 to 2005, 31.6% from 2006 to 2009). Conclusions : RCTs of the JORM consistently increased in quantity and quality. But researchers should make an effort to reporting more accurate.