• Title/Summary/Keyword: Randomized Clinical Trials

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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.

A Systematic Review and Meta-Analysis of Randomized Controlled Trials on Acupuncture for Improving Post-Operative Cognitive Dysfunction (POCD) and Chemotherapy-Related Cognitive Impairment (CRCI)

  • Kim, Ju-Young;Cho, Han-Byul;Kim, Man-Gi;Koo, Byung-Su;Kim, Geun-Woo
    • Journal of Oriental Neuropsychiatry
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    • v.33 no.1
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    • pp.49-78
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    • 2022
  • Objectives: This study was conducted to evaluate the efficacy of Korean Medicine Therapy (KMT) for the treatment of Chemotherapy-induced Cognitive Impairment (CICI) through systematic review and meta-analysis of randomized controlled trials (RCTs) as proceeding research to further research the efficacy of KMT for CICI patients. Methods: We conducted a systematic review and meta-analysis according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines (PRISMA). The RCTs on the efficacy of KMT for treatment of CICI were searched by structured search strategies in MEDLINE, EMBASE, Cochrane library, CAJD, KISS, NDSL, KoreaMed, and OASIS. The searched RCTs were screened by inclusion and exclusion criteria. We evaluated the quality of the method in the included studies using the Jadad score and Cochran ROB tool. The efficacy outcomes were the Visual Analogue Scale (VAS) and the Clinical total Effective Rate (CER) of CICI. They were analyzed using mean difference for continuous variable or Relative Risk (RR) for Dichotomous variable in the random-effect model. The RevMan 5.3 program was used for meta-analysis. Results: We included 19 RCTs, including 653 participants, in the systematic review and meta-analysis. There were favorable results for the KMT group after the intervention compared with the pharmacotherapy group, physiotherapy group, and combined treatment group. KMT group showed improvement using CER and VAS compared with exercises, but their heterogeneities were slightly significant. KMT was more effective compared to the Rehabilitation program in CER and the subgroup analysis results showed that KMT had a significant difference compared to other therapies in VAS, to Medication therapy in CER. Conclusions: KMT presented reasonable evidence on improving the Clinical total Effective Rate and Visual Analogue Scale in CICI patients. However, further evaluation in future research is required.

Respiratory Review of 2014: Pulmonary Thromboembolism

  • Lee, Jae Seung
    • Tuberculosis and Respiratory Diseases
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    • v.77 no.3
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    • pp.105-110
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    • 2014
  • Venous thromboembolism (VTE), which includes pulmonary embolism and deep vein thrombosis, is an important cause of morbidity and mortality. The aim of this review is to summarize the findings from clinically important publications over the last year in the area of VTE. In this review, we discuss 11 randomized controlled trials published from March 2013 to April 2014. The COAG and the EU-PACT trials indicate that pharmacogenetic testing has either no usefulness in the initial dosing of vitamin K antagonists or marginal usefulness in the Caucasian population. Recent clinical trials with novel oral anticoagulants (NOACs) have demonstrated that the efficacy and safety of rivaroxaban, apixaban, edoxaban, and dabigatran are not inferior to those of conventional anticoagulants for the treatment of VTE. The PEITHO and ULTIMA trials suggested that rescue thrombolysis or catheter-directed thrombolysis may maximize the clinical benefits and minimize the bleeding risk. Lastly, riociguat has a proven efficacy in treating chronic thromboembolic pulmonary hypertension. In the future, NOACs, riociguat, and catheter-directed thrombolysis have the potential to revolutionize the management of patients with VTE.

A Systematic Review of Clinical Trials on Acupuncture on the Post-stroke Muscle Spasticity (중풍 후 강직의 침구치료에 대한 계통적 연구)

  • Seo, Byung-Kwan;Baek, Yong-Hyeon;Park, Dong-Suk
    • Journal of Acupuncture Research
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    • v.27 no.6
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    • pp.1-10
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    • 2010
  • Objectives : The aim of this systematic review was to assess the efficacy of acupuncture and its relevant modality on post-stroke muscle spasticity Methods : We included 7 randomized controlled trials(RCTs) and 1 crossover study on acupuncture on the post-stroke muscle spasticity. Articles searches were performed in various databases in October 2009. Eight studies from 38 articles met the inclusion criteria and were used to assess the quality of clinical trials by means of Jadad scale, STRICTA, CONSORT statement and cochrane-handbook for systematic reviews of interventions. Results : Electrical stimulation such as electroacupuncture and TENS on acupoints was used in five studies. Repeatition of electroacupuncture showed significant decrease of the post-stroke muscle spasticity and persistence of the effect. Only three studies were assessed high quality as the methodological assessment tool(Jadad scale) and none of the studies matched STRICTA recommendations. Conclusions : This systematic review shows that there is beneficial effects of electroacupuncture on the post-stroke muscle spasticity. Further study of large population with high methodological quality will be needed.

A Systematic review for the development of cosmetic clinical trial protocol (화장품 임상시험 프로토콜 개발을 위한 체계적 문헌 고찰)

  • Jo, Ga-Won;Hwang, Chung-Yeon;Hong, Seok-Hoon;Kim, Nam-Kwen
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.26 no.1
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    • pp.104-117
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    • 2013
  • Objective : The aim of this review is to development of clinical trial protocol for against cosmetics as a treatment of dry skin condition. Methods : We searched the literature from 2002 through April 2012 using 5 databases. We included randomized controlled trials(RCTs) in which human participants with dry skin condition as chief complaint were treated with cosmetics. The methodological quality of all RCTs was using the Jadad score. Results : Nine RCTs met the inclusion criteria. Cosmetic types included cream (7 trials), lotion (1 trial), oil (1 trial) and body wash (1 trial). The methodological quality of the trials was generally low (Jadad score: mean 1.78; range, 1 to 3). Conclusions : The evidence for cosmetics as an effective treatment for dry skin condition(xerosis) is currently scarce and of poor quality, and is therefore inconclusive. More rigorous studies are warranted.

Research Trends of Korean Medicine Treatments for Postoperative Sleep Improvement: Focusing on Herbal Medicine, Acupuncture, and Moxibustion (수술 후 환자의 수면 개선에 대한 한의치료 임상연구 동향 -한약, 침, 뜸 치료를 중심으로-)

  • Jun-Hee, Cho;Bo-Kyung, Kim;Jung-Hwa, Lim
    • Journal of Oriental Neuropsychiatry
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    • v.33 no.4
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    • pp.425-451
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    • 2022
  • Objectives: To review trends of clinical trials on Korean medicine treatments for postoperative sleep improvement. Methods: We searched randomized controlled trials (RCTs) on Korean medicine treatments for postoperative sleep improvement from ten domestic and foreign databases. Sample sizes, diseases, types of operation, diagnosis tools, pattern identification, interventions, outcome measurements, and main results of included studies were extracted and analyzed. Results: A total of 20 RCTs were selected. Most studies were published in China. The most common target disease was cancer, followed by cardiovascular disease. Most studies lacked detailed description regarding participants such as onset, duration of sleep disturbance, and preoperative sleep issues. Herbal medicine was the most frequently used in 12 studies. The most commonly used prescription was Suanzaoren decoction. The effectiveness of Korean medicine treatment on improving postoperative sleep was found to be significant in most studies. Conclusions: Korean medicine treatments might be effective in postoperative sleep improvement. However, the quality of included studies was low. Therefore, further well-designed research studies are needed to provide high quality clinical evidence on Korean medicine treatments for postoperative sleep improvement.

Effects of Tai Chi on Fall Risk Factors: A Meta-Analysis (낙상 위험요인에 대한 타이치 운동 효과의 메타분석)

  • Park, Moonkyoung;Song, Rhayun
    • Journal of Korean Academy of Nursing
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    • v.43 no.3
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    • pp.341-351
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    • 2013
  • Purpose: This study was done to analyze the effects of Tai Chi on fall-related risk factors through meta-analysis of randomized clinical trials published in English and Korean between 2000 and 2010. Methods: Using health related database and hand search of references and Google, 28 randomized studies were collected from doctoral dissertation and published peer reviewed articles. The Comprehensive Meta-analysis version 2.0 was used for the analysis. Results: The effect sizes for Tai Chi for 3 months were significant with ES=0.54 for static balance, ES=0.24 for dynamic balance, ES=0.69 for balance measured by scale, and ES=0.40 for flexibility, ES=0.48 for muscle strength, ES=0.71 for ADL, and ES=0.37 for fear of falling. Also, the effect sizes of Tai Chi for 6 months were significant for most fall-related variables. The 6 month data for flexibility was not analyzed since only one study was published. Conclusion: The analysis of studies of randomized clinical trials indicate that Tai Chi is effective in improving balance, flexibility, muscle strength, activities of daily living, and fear of falling when applied for 3 or 6 months. The findings provide the objective evidence to apply Tai Chi as a fall preventive intervention.

A Review of Recent Clinical Studies of Herbal Medicine Treatment for Children's Stomatitis : Focusing on Randomized Controlled Trials in Traditional Chinese Medicine (소아 구내염의 한약치료에 대한 임상연구 동향: 중의학 무작위대조군 임상시험을 중심으로)

  • Heo, Yu Jin;Lee, Shin Hee;Cho, Yun Soo
    • The Journal of Pediatrics of Korean Medicine
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    • v.35 no.4
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    • pp.125-140
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    • 2021
  • Objectives This study aims to find out the recent trend of the herbal medicine treatment in children's stomatitis in China, and propose better methods to treat children's stomatitis in Korea. Methods The randomized controlled trials (RCT) relevant to 'Herbal medicine treatment on children's stomatitis' were searched using China Academic Journal (CAJ). The search method we used included search formula, (SU = '口內炎' + '口腔炎' + 'stomatitis') and (SU = '儿童' + '小儿' + 'children' + 'child') from 2000 to September 2021. Results A total of 9 RCTs were selected and analyzed. All reports showed that oral administration of herbal medicine were effective and improved clinical symptoms. The most-used herbal medicine category was Heat-clearing medicine (淸熱藥). Conclusions The literatures from China have shown that herbal medicine improves children's stomatitis. These outcomes may be helpful for the treatment of children's stomatitis in Korea. However, further studies are needed to develop treatment guidelines for children's stomatitis.

Review on Clinical Trials of Catgut Embedding for Obesity Treatment (비만치료에 응용되는 매선요법의 최근 연구 동향 고찰)

  • Song, Mi-Young;Kim, Ho-Jun
    • Journal of Korean Medicine for Obesity Research
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    • v.12 no.2
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    • pp.1-7
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    • 2012
  • Objectives: The purpose of this report was to review the clinical trials of the catgut embedding for obesity treatment. Methods: We searched the clinical trial papers with key words of obesity and catgut embedding via searching Pubmed, Scopus and KISS etc. Results: We reviewed 8 searched articles, 7 articles were conducted in China and only 1 article was published in Korea. Most of Chinese articles used acupuncture as a control group and revealed the equality or superiority of catgut embedding in body weight loss. The only Korean article, which was uncontrolled, implanted catgut in localized fat area, it had changes partially in fat thick, body size. Conclusions: The acupoint catgut embedding has the efficacy of body weight loss, but to confirm the efficacy of localized fat loss, more randomized controlled trials are needed.