• Title/Summary/Keyword: Randomized Controlled Trials(RCTs)

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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.

Acupotomy for Superior Cluneal Nerve Entrapment Syndrome: A Review of Randomized Controlled Trials

  • Hye Min Kim;Jae Soo Kim;Hyun Jong Lee;Jung Hee Lee;Sung Chul Lim;Yun Kyu Lee
    • Journal of Acupuncture Research
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    • v.41 no.2
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    • pp.87-95
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    • 2024
  • This review aims to analyze the efficacy of acupotomy in treating superior cluneal nerve entrapment syndrome (SCNES) by summarizing the findings of randomized controlled trials (RCTs). The RCTs were retrieved from seven databases (i.e., the Cochrane Library, PubMed, Embase, China National Knowledge Infrastructure, Korean Studies Information Service System, Research Information Service System, and Oriental Medicine Advanced Searching Integrated System). Seven RCTs were selected for this review. The results indicate that acupotomy is promising for providing significant pain relief and improving function in patients with SCNES. However, more high-quality RCTs are required to establish the long-term effectiveness and safety of acupotomy. This review provides valuable insights for clinicians and researchers in the management of SCNES.

Application of Traditional East Asian Herbal Medicine for Atrophic Vaginitis: A Systematic Review of Randomized Controlled Trials (위축성 질염에 대한 한약 투약의 효과 : 체계적 문헌 고찰)

  • Park, Eo-Jin;Jo, Hee-Geun
    • The Journal of Korean Obstetrics and Gynecology
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    • v.32 no.3
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    • pp.227-244
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    • 2019
  • Objectives: To evaluate the effectiveness and safety of application of Traditional East Asian Herbal Medicine (TEAM) in the treatment of Atrophic Vaginitis (AV). Methods: Randomized Controlled Trials (RCTs) were obtained from PubMed, Cochrane Library, Embase, CNKI, RISS, NDSL, and KISS. The risk of bias was assessed by using Cochrane's risk of bias tool, and RevMan 5.3 software was used. Results: 26 RCTs with 3,162 patients were identified and reviewed. Among them, 21 RCTs observe the effect of integrated traditional Chinese and Western medicine. 23 RCTs reported treatment groups was statistically effective than control groups in the study. Also, the recurrence rate was estimated in 10 RCTs and was lower than control groups. 12 studies observed adverse events (AEs) and severe AEs were not reported. Conclusions: This review suggested that TEAM was safe and effective in the treatment of AV. TEAM may also decrease the recurrence rate. However, this could not be proven conclusively. To ensure evidence-based clinical practice, well-designed trials with larger sample sizes are needed.

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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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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Traditional Herbal Medicine for Dysfunctional Uterine Bleeding versus Western Medicine: A Systematic Review of Randomized Controlled Trials (기능성 자궁출혈에 대한 한약치료 : 체계적 문헌 고찰)

  • Park, Eo-Jin;Jo, Hee-Geun;Choi, Ji-Hyun
    • The Journal of Korean Obstetrics and Gynecology
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    • v.31 no.4
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    • pp.110-127
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    • 2018
  • Objectives: To evaluate the effectiveness and safety of traditional herbal medicine (THM) in the treatment of dysfunctional uterine bleeding (DUB) versus conventional western medicine. Methods: Randomized Controlled Trials (RCTs) comparing THM vs. conventional western medicine for DUB, were obtained from PubMed, Cochrane Library, Embase, CNKI, RISS, NDSL, KISS and OASIS. The risk of bias was assessed by using Cochrane's risk of bias tool. Results: 16 RCTs with 1,659 patients were identified and reviewed. 10 RCTs reported THM was statistically effective than control group in effective rate. Also recurrent rate was estimated in 6 RCTs and was lower than control group. 7 studies observed adverse events (AEs) and severe AEs were not reported. Conclusions: Despite several limitations, this review suggested that THM was safe and effective in the treatment of DUB. THM may also decrease the recurrence rate. However, this could not be proven conclusively. To ensure evidence-based clinical practice, more sternly designed trials are warranted.

Effect of Acupuncture and Moxibustion for Vitiligo: A Scoping Review of Randomized Controlled Trials (백반증의 침구(鍼灸) 치료 효과: 무작위 대조 시험에 대한 주제 범위 문헌 고찰)

  • Do Kyung Han;Jeewon Shon;Won Gun An
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.36 no.4
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    • pp.145-155
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    • 2023
  • Objectives : The aim of this study is to review the effect of acupuncture/moxibustion on vitiligo. Methods : Using 5 databases(Pubmed, EMBASE, Cochrane Library, RISS, OASIS) clinical studies about effect of acupuncture/moxibustion on vitiligo were searched. Only randomized controlled trials(RCTs) were selected to analyze. Results : Total 235 studies were searched. After screening those studies 5 studies were selected from china and Iran. 3 studies used effective rate to measure the effect of acupuncture for vitiligo. 1 study used Vitiligo Area Scoring Index(VASI) and 1 study assessed 4 grade of repigmentation to prove acupuncture's effect on vitiligo. All studies showed repigmentation in acupuncture/moxibustion group. Adverse effects reported in the five studies were temporary erythema, itching, and dryness. Conclusions : These findings suggest that acupuncture and moxibustion can be considered a safe treatment for vitiligo. However, due to the small number of RCTs conducted on acupuncture and moxibustion for vitiligo, more RCTs should be conducted to confirm the effectiveness of acupuncture and moxibustion for vitiligo.

Recent Trends in Clinical Research of Acupuncture Treatment for Intellectual Disability - Focused on Chinese Randomized Controlled Trials - (지적장애의 침 치료에 대한 최신 임상연구 동향 - 중국 무작위 배정 임상연구를 중심으로 -)

  • Kim, Jae Hyun;Park, Yong Seok;Lee, Jihong;Chang, Gyu Tae
    • The Journal of Pediatrics of Korean Medicine
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    • v.35 no.4
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    • pp.34-47
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    • 2021
  • Objectives The purpose of this study is to analyze the trend of recent randomized controlled trials (RCTs) which used acupuncture for the treatment of intellectual disability in China, and to evaluate the efficacy of the treatment. Methods The RCTs published from January 2017 to July 2021 were searched using China National Knowledge Infrastructure (CNKI). Then, those were analyzed by acupuncture treatment methods used and their results. Results A total of 18 randomized controlled trials were selected and analyzed. Most studies showed significantly higher Intelligence Quotient, Development Quotient, and a total effective rate in an acupuncture treatment group than those of the control group. The most used acupoints were EX-HN1 followed by Niesanzhen, Naosanzhen, Zhisanzhen, Shouzhizhen, GV20. Conclusions Based on the results of the analyzed randomized controlled trials, an acupuncture treatment has shown to be effective in the treatment of intellectual disability. However, additional well designed clinical trials are needed to solidify these findings.

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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Reporting of Adverse Events in Randomized Controlled Trials of Bee Venom Acupuncture: A Systematic Review (봉침을 이용한 무작위배정 비교임상시험연구에서의 유해사례 보고에 대한 체계적 문헌고찰)

  • Yi, Woon-Sup;Kim, Sung-Soo
    • Journal of Korean Medicine Rehabilitation
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    • v.24 no.4
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    • pp.97-109
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    • 2014
  • Objectives Bee venom acupuncture (BVA) is emerging as a potential therapeutic option for several conditions. However, evidence regarding accurate estimates of its adverse events are not available. Therefore, by combining occurrence rates of adverse events in relevant randomized controlled trials (RCTs), we have aimed to give an overall estimated rate of each adverse event following BVA intervention. Methods A systematic search for adverse events of BVA in Pubmed, Cochrane Central Register of Controlled Trials, Embase, NDSL, KoreaMed, KISS, RISS, KISTI, and KMbase was performed. For the quality assessment of the trials, we applied the CONSORT harms reporting recommendations. The overall occurrence rate of each adverse event was assessed as the primary outcome. The overall drop-out rate due to adverse events was assessed as the secondary outcome. Results Ten RCTs reported adverse events following BVA. Two RCTs were eligible of further synthesis. Adverse events of pruritus, localized edema, and erythema occurred significantly more frequently in the BVA group compared to the control group. Data of drop-outs were available in seven RCTs. However, no comparisons showed a significant difference. Conclusions Currently evidence of adverse events is far from sufficient for assessing a reliable, precise occurrence rate. Still, limited evidence shows a tendency that adverse events occur more frequently after the appliance of BVA compared to the control. Thus, we await well designed future studies of BVA with more proper and strict harms reporting methods.