• Title/Summary/Keyword: RCT(randomized controlled trials)

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Systematic Review of Moxibution Treatment for Dry Eye Syndrome (안구건조증의 뜸 치료에 대한 체계적 문헌 고찰)

  • Lee, Ho-Chan;Lee, Yu-Lim;Ko, Hong-Je;Choi, Jung-Hwa;Jeong, Min-Yeong;Park, Soo-Yeon
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.32 no.1
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    • pp.42-58
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    • 2019
  • Objectives : The aim of this study is to review the methodology of clinical trials conducted with the acupuncture and moxibustion treatment on Dry eye syndrome. Methods : Through four foreign online databases(PubMed, Cochrane library, EMBASE, CNKI) and two domestic online databases(NDSL, OASIS), we searched for clinical studies that performed moxibustion for dry eye syndrome from 2000 to December 2018. Only randomized controlled trials(RCT) were selected and anlyzed according to the research method. Results : A total 12 studies were reviewed and conducted in China. BL1, ST2, BL2 were most frequently used acupoints in moxibustion treatment. Among the evaluation indexes, Schirmer I Test(SIT), Tear break-up time(BUT) were used most. In most of the 12 studies, moxibustion treatment showed significant therapeutic effects. Conclusions : These results suggest that it is necessary to develop more detailed standards about moxibustion treatment method as the method of moxibustion is getting more diverse, and objective tools are needed in evaluating dry eye syndrome.

A Review of Clinical Researches for Herbal Medicine Treatment on Vitiligo (백반증의 한약 치료에 대한 임상 연구 고찰)

  • Park, Sul Gi;Park, So Hyun;Lee, Sun Haeng;Lee, Jin Yong
    • The Journal of Pediatrics of Korean Medicine
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    • v.34 no.2
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    • pp.57-74
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    • 2020
  • Objectives The purpose of this study is to analyze clinical studies on the efficacy and safety of herbal medicine in vitiligo by analyzing randomized controlled trials (RCTs). Methods Three electronic databases including the PubMed, EMBASE, and Cochrane library were used to search for randomized controlled trials, by using specific key words and criteria up to January 4th, 2020. Data in regards to years of publication, nation, demographic information, disease characteristics, duration of diseases, treatment methods, treatment period, outcome measures, results and adverse events were collected for this study. Results A total of 11 randomized controlled trials were selected and analyzed. The total effective rate of the treatment group treated with herbal medicine was significantly higher than that of the control group. In the other outcome measures, the treatment group also showed statistically significant differences in improving the outcome measures compared to the control group, or showed similar treatment effects to the control group. The most commonly used herbal medicines were Carthami Flos (紅花), Angelicae Gigantis Radix (當歸), Angelica dahurica Bentham et Hooker f. (白芷), Astragali Radix (黃芪), Glycyrrhizae Radix et Rhizoma (甘草), Salviae Miltiorrhizae Radix (丹參), Persicae Semen (桃仁), Araliae Continentalis Radix (獨活), Tribuli Fructus (白蒺藜), Psoraleae Semen (補骨脂) etc. Hardly any severe adverse events were reported from the trials selected. Conclusions Based on the results of the clinical studies, herbal medicine treatment could be an effective and safe option for vitiligo treatment and symptom improvement.

A comprehensive quality analysis of randomized controlled clinical trials of Asian ginseng and American ginseng based on the CONSORT guideline

  • Chen, Weijie;Li, Xiuzhu;Chen, Zhejie;Hao, Wei;Yao, Peifen;Li, Meng;Liu, Kunmeng;Hu, Hao;Wang, Shengpeng;Wang, Yitao
    • Journal of Ginseng Research
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    • v.46 no.1
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    • pp.71-78
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    • 2022
  • Ginseng is an international herb that has been used for thousands of years. Two species most commonly applied and investigated in the ginseng family are Asian ginseng and American ginseng. The number of randomized controlled clinical trials (RCTs) has conspicuously increased, driven by the rapid development of ginseng. However, the reporting of RCT items of ginseng is deficient because of different trial designs and reporting formats, which is a challenge for researchers who are looking for the data with high quality and reliability. Thus, this study focused on providing an extensive analysis of these two species and examined the quality of the RCTs, based on the Consolidated Standards of Reporting Trials (CONSORT) guideline. Ninety-one RCTs conducted from 1980 to 2019 that were related to Asian ginseng and American ginseng used singly met our inclusion criteria. We found that the reporting quality of the two species has improved during the past 40 years. Publication date and sample size were significantly associated with the reporting quality. Rigorous RCTs designed for the species of ginseng are warranted, which can shed light on product research and development of ginseng in the future.

A Systematic Review of Randomized Controlled Trials on Acupuncture Treatment for Shoulder Pain (견비통에 침치료를 시행한 무작위대조군연구(RCT)들에 대한 계통적 연구)

  • Kim, Hyun-Wook;Kim, Sung-Soo;Park, Se-Woon;Kim, Eon-Kuk;Lee, Geon-Hui;Lee, Geon-Mok
    • Journal of Acupuncture Research
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    • v.27 no.4
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    • pp.67-84
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    • 2010
  • Objectives : To review RCTs on acupuncture treatment for shoulder pain in order to establish a standard acupuncture treatment model in treating shoulder pain. Methods : RCT articles on traditional acupuncture treatment for shoulder pain were searched through online database. Quality of studies were assessed using the FEAS and the modified Jadad score. Results : Eighteen trials of acupuncture for shoulder pain were analyzed. Based on the results of these reviews the following factors might contribute to optimal results from acupuncture treatment. 1) Usage of LI, SI, TE meridians, usage of $LI_{15}$, $TE_{14}$, $GB_{21}$, $LI_{11}$, $LI_4$, $SI_{14}$, $LI_{14}$, $TE_{15}$ acupuncture points. 2) More than four acupuncture points should be used. 3) More than 15 minutes of needle retention time. 4) Needle length-40mm and diameter-0.30mm. 5) More than 9 times treatment 6) More than 5 weeks treatment duration. Conclusions : There was no relation between quality of article and effectiveness of acupuncture. To improve the remedial value, it is necessary to mention De-qi, stimulation of acupuncture and correct variation in diagnosis with the above-mentioned. It is better that clinical trials of acupuncture treatment is designed that type of RCT and double blind. Also when it is set that sham nonpenetrating acupuncture, no treatment group as a control group, and participants don't distinguish wheather acupuncture treatment or not, it will be more meaningful.

The Assessment of Appropriateness of Acupuncture Methodology Based on STRICTA Recommendations;The Discussion of 5 Systematic Reviews and Their Objects 58 Randomized Controlled Trials Using the New Tool (STRICTA 권장안에 기초한 침 연구방법론의 적절성 평가;새로운 평가지수를 이용한 5편 Systematic Review와 그 대상인 58편 무작위대조시험의 고찰)

  • Kim, Woo-Young;Lee, Seung-Deok;Lim, Byung-Mook;Kim, Kap-Sung
    • Journal of Acupuncture Research
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    • v.24 no.5
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    • pp.151-170
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    • 2007
  • Backgraounds : Recent studies provide the evidences that the efficacy of acupuncture may be no better than placebo or inconclusive. These results are very different from those of the actual clinical situations in many acupuncture medical institutions. Objectives : The present study was designed to evaluate the influencing factors which affect the efficacy of acupuncture scale(FEAS) as the methodological assessment tool of acupuncture for examining acupuncture interventions and to demonstrate the importance of it in randomized controlled trials of acupuncture. Data sources : Electronic data were retrieved from NDSL, Pubmed, sciencedirect, LWW, OVID, Black-Well Synergy, Wiley Interscience, EBSCO HOST, springer, PML, and Kluwer. No electronic data were collected from MEDLIS and MEDLAS. Study selection : The inclusion criteria were five systematic reviews included in Alberta study and all randomized controlled trials obtained from their references. Study analysis : The acupuncture rationale, methods of stimulation, treatment regimen, and the practitioner's background were rated by FEAS, and the scores were compared with those by other methodological assessment tools. Results : The number of positive conclusions of high-rank RCTs by FEAS was the same as or higher than that of high-rank RCTs by other methodological assessment tools. Conclusions : We have analysed 5 systematic reviews and their objectives 58 RCTs using FEAS. Practitioner's background has been described slightly in some reviews and studies. It may directly influence the effectiveness of acupuncture negatively in the systematic reviews.

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Randomized Controlled Clinical Trials in the Journal of Oriental Rehabilitation Medicine : A Quantitative and Qualitative Analysis(1) (한방재활의학과학회지에 수록된 무작위대조임상연구의 양적, 질적 분석(1))

  • Lee, Hyeon-Yeop;Heo, Kwang-Ho;Cho, Hyun-Woo;Hwang, Eui-Hyoung;Shin, Mi-Suk;Shin, Byung-Cheul
    • Journal of Korean Medicine Rehabilitation
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    • v.23 no.1
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    • pp.87-100
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    • 2013
  • Objectives : The aim of this study is to assess the quantity and quality of randomized controlled clinical trials(RCTs) published in the journal of oriental rehabilitation medicine(JORM). Methods : After searching RCTs from all the articles published in the JORM from the inception(1991) to Oct, 2012, quantity assessment were made on the study design, sample size, main intervention, intervention versus control design and medical condition. Quality assessment were made on the cochrane risk of bias(RoB) check list. Assessment was performed by 2 independent reviewers and disagreement was discussed based on concensus of all authors. Results : Among the 1013 articles, total 59 RCTs were published. First RCT was published in 1994. 49 RCTs were parallel 2-arm designed. Average sample size was 35.1 per study and 16.3 per arm. The most common medical condition is musculoskeletal disease(30.5%). Quality from cochrane RoB was generally low. Conclusions : Though RCTs published in JORM were increasing, the quality remains low. Researchers should make a effort to follow the RoB checklists and improve the quantity and quality of studies.

Complementary and Alternative Medicine for Oral Health : a Literature Review of Randomized Controlled Clinical Trials (구강건강에 이용되는 보완대체의학 치료: 무작위대조임상연구를 통한 문헌적 고찰)

  • Kim, Da-Hee;Choi, Gwang-Ho;Hwang, Eui-Hyoung;Heo, Kwang-Ho;Kim, Yong-Deok;Shin, Byung-Cheul
    • Journal of Society of Preventive Korean Medicine
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    • v.18 no.3
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    • pp.23-39
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    • 2014
  • Objective : This review aims at analyzing Complementary and Alternative Medicine (CAM) therapies, using for oral health to know current use of CAM in dental area by analyzing randomized controlled clinical trials (RCTs). Method : We searched the following 6 electronic databases until 1 July 2014. : Pubmed, Medline, Embase, Allied and Complementary Medicine Database(AMED), Cumulative Index to Nursing and Allied Health Literature(CINAHL), the Cochrane Library. We included parallel RCTs and cross-over RCTs that assessed the efficacy of CAM regardless of blinding and language. Results : A total of 154 RCT articles were included. There were 2-arm parallel study design(69.5%), 3-arm parallel study design(20.8%), 4-arm parallel study design(4.5%) and Cross-over design(5.2%). Complementary and alternative medicine RCTs in oral health tend to increase in the early-2000s and in the mid-2010s. In addition, 154 citations were classified according to diseases and interventions that categorized Natural Products studies(68.2%), Mind and Body Practices studies(31.8%). We classified in detail that vitamin and mineral therapies(29.9%), dietary supplements(24.7%), acupuncture(23.3%), Herbal medicine(13.6%), homeopathy (2.6%), energy therapies(2.6%), Massage(1.9%), biofeedback(0.6%), traditional medicine(0.6%). Conclusion : Increasing publications and diverse interventions regarding CAM for oral health is observed by analyzing RCTs from the literature review. Further studies are needed to be performed as systematic reviews to verify their effectiveness and the research to inquire into side effect.

The Quality Assessment of Reporting of Intervention Studies on Sasang Constitutional Diet (사상체질 식이 중재연구 보고에 대한 질 평가)

  • Kim, Ji Hwan;Lee, Ju Ah
    • Journal of Sasang Constitutional Medicine
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    • v.32 no.4
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    • pp.11-28
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    • 2020
  • Objectives The purpose of this study was to evaluate quality of reporting of intervention studies on Sasang Constitutional diet (SCD) based on the Consolidated Standards for Reporting of Trials (CONSORT) and Transparent Reporting of Evaluations with Nonrandomized Designs (TREND) statements. Methods We searched for Randomized controlled trials (RCT) and Non randomized studies for intervention (NRSI) on SCD in 4 databases and other sources, selected them by the inclusion criteria, and then evaluated quality of reporting of them. Results 1. A total of 10 studies (1 RCT and 9 NRSI) from 1999 to 2006 were selected and evaluated. The detailed items of up to 78%, at least 40%, and median value of 59% in the CONSORT and TREND statements were not reported. 2. One RCT was reporting 4 (11%) sufficiently, and 4 (11%) insufficiently among the 37 detailed items in the CONSORT statement while it was not reporting 29 (78%) items. 3. Nine NRSI were reporting 7 (12%) items sufficiently, and 2 (3%) items insufficiently among the 58 detailed items in the TREND statement while they were not reporting 15 (26%) items. Twenty (34%) items in the TREND statement were reported in some papers but not in more than half. Conclusions The quality of reporting of intervention studies on SCD has been assessed to be generally low. Subsequent researchers are recommended to select an appropriate statement for research design, and use it as a checklist from the time of designing the study to the time of reporting.

Review of Randomized Controlled Trials on Ideal Acupuncture Treatment for Degenerative Knee Osteoarthtritis (RCT논문을 중심으로 한 퇴행성 슬관절염 침구 치료 방법에 대한 고찰)

  • Kim, Eun-Jung;Lee, Seung-Deok;Jung, Chan-Yung;Yoon, Eun-Hye;Jang, Min-Gee;Nam, Dong-Woo;Kim, Hyun-Wook;Lee, Eun-Yong;Kim, Kyung-Ho;Lee, Geon-Mok;Lee, Jae-Dong;Kim, Kap-Sung
    • Journal of Acupuncture Research
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    • v.26 no.2
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    • pp.125-145
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    • 2009
  • Objectives : To analyze the inclusion criteria of participants, control group interventions, and the results of prior studies of acupuncture for OA. Also to identify aspects of the procedure that are associated with positive outcomes in order to establish ideal acupuncture treatment model. And to assess the methodological quality of the trials with modified Jadad score and FEAS in order to evaluate the quality of prior studies and find out whether or not acupuncture has a positive effect in treating OA. Methods : Articles up to the date of November 2008 were searched via computerized databases of PubMed, Journal of Korean Oriental Medicine, The Journal of Korean Acupuncture & Moxibustion Society and Journal of Oriental Rehabilitation Medicine. Bibliographies of reviewed papers were also searched and reviewed. Only randomized controlled trials (RCTs) and systematic reviews concerning the effects of acupuncture or electroacupuncture (EA) on symptoms of osteoarthritis of the human knee, published in English and Korean were included. The acupuncture treatment methods of the reviewed trials were assessed based on STRICTA. And the methodological quality of the trials was assessed by modified Jadad score and FEAS. Results : Twenty one trials of acupuncture for OA were analyzed. Based on the results of this review the following factors might contribute to optimal results from acupuncture treatment. 1) Usage of $ST_{35}$, $GB_{34$, $EX_{32}$, $ST_{36}$ and $SP_9$ acupuncture points. 2) More than four acupuncture points should be used. 3) More than 15 minutes of needle retention time. 4) Needle length-40mm and diameter-0.30mm 5) Usage of EA 6) more than 10 times treatment 7) Treatment frequency of more than once a week, 8) Treatment duration longer than 6 to 8 weeks. Conclusions : High quality clinical trials of Acupuncture for OA is still in lack. Future investigators must concentrate their attentions on the quality of acupuncture treatment itself used in the trials as well as the methodological quality of trials.

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Review of Clinical Research for Herbal Medicine Treatment on Rhinosinusitis (비부비동염의 보완대체의학 약물치료에 대한 최신 임상 연구 동향 -RCT 연구를 중심으로 -)

  • Jang, Eun Ha;Min, Sang Yeon;Kim, Jang Hyun
    • The Journal of Pediatrics of Korean Medicine
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    • v.32 no.3
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    • pp.44-54
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    • 2018
  • Objectives The purpose of this study is to analyze clinical studies on effectiveness of herbal medicine in rhinosinusitis. Methods We searched the randomized controlled trials (RCTs) with herbal medicine treatment on rhinosinusitis from the Pubmed in recent 10 years (from 2008 to 2018). Results 11 RCTs were reviewed. In 10 out of 11 studies showed that the herbal medicine may be effective in the treatment of chronic rhinosinusitis without nasal polyp and uncomplicated acute rhinosinusitis. However, inclusion and exclusion criteria, and outcome measures were varied among different studies. No serious adverse reactions were reported from the herbal medicine treatment. Conclusions The results of these trials showed that herbal medicine may be effective in the treatment of rhinosinusitis. Well-designed RCTs for domestic herbal medicine treatment on rhinosinusitis are needed to prove its efficacy clearly.