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

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Relationship between Postural Balance Training and Fall Risks for Elderly: a Systematic Review of Randomized Controlled Trials

  • Kim, Heesuk;Hwang, Sujin
    • Physical Therapy Rehabilitation Science
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    • v.10 no.2
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    • pp.185-196
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    • 2021
  • Objective: Falling is one of main accident to facilitate the physical injuries in order adults. The purpose of the systematic review was to determine the effects of postural balance training whether the recovery of falls in elderly with normal physical function or not throughout summing the selected studies quantitatively. Design: A systematic review Methods: MEDLINE and other four databases were searched up to April 20, 2021 and randomized controlled trials (RCTs) evaluating postural balance approaches on fall risks in elderly. The researched studies excluded the double studies, titles and abstract, and finally full-reported study. The selected RCTs studies were extracted characteristics of the studies and summary of results based on PICOS-SD (population, intervention, comparison, outcomes, and setting- study design) model to synthesize the papers qualitatively. Results: The review involved 22 RCT reports with 4,847 community older adults aged 65 years or over. Nineteen of the selected RCT studies reported dual or multimodal exercises show the beneficial effect for older adults compared to one-type treatment or no intervention. All of selected showed low risk in the selection, attrition, and reporting bias. However, detection bias showed low risk at 75% records of the involved RCTs and performance bias was low risk at only three records. Conclusions: The results of the systematic review propose that a standardized therapeutic approach and the intensity are needed for improving risk of falls in older adults.

A Review of Randomized Controlled Trials of Traditional Chinese Medicine Treatment for Coronavirus Disease 2019 Patients (Coronavirus Disease-2019 환자 치료에 대한 중의 RCT 연구 동향)

  • Park, Ju-heon;Yoon, Seong-hoon;Lee, In
    • The Journal of Internal Korean Medicine
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    • v.43 no.1
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    • pp.41-52
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    • 2022
  • Objectives: The purpose of this study is to investigate recent trends in randomized controlled trials (RCTs) on the treatment of Coronavirus disease 2019 (COVID-19) patients with traditional Chinese medicine (TCM) and analyze the results for the activation of COVID-19 Korean medicine research. Methods: We searched for RCTs published from December 2019 to October 2021 in the Chinese National Knowledge Infrastructure Database (CNKI). The investigation focused on the type of study, the purpose of the study, and the treatment methods. Results: A total of 8 RCTs were selected and analyzed from the 447 searched studies. All studies attempted to observe the effects of herbal medicine. Herbal medicine included granules, decoctions, and intravenous injections. The most frequently used herb type was drugs for clearing away heat and detoxification and releasing the exterior syndrome. In most studies, the effectiveness of TCM treatment of COVID-19 was significantly high. Conclusions: Although more quality studies are needed to support these results, TCM treatment for COVID-19 has been effective. Therefore, we hope that Korean medicine studies on infectious diseases will be actively conducted like TCM and contribute to national health.

Trend of Clinical Trials for Intradermal Acupuncture Treatment on Dry Eye Syndrome (건성안 증후군의 피내침 치료에 대한 임상연구 동향)

  • Song, Ji-Hoon;Park, Soo-Yeon
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.33 no.2
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    • pp.12-22
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    • 2020
  • Objectives : The aim of this study is to review the trend of clinical trials conducted with the intradermal acupuncture treatment on dry eye syndrome. Methods : Through 4 foreign online databases(PubMed, Cochrane Library, EMBASE, and CNKI) and 3 domestic online databases(NDSL, RISS, and OASIS), we searched for clinical studies performed acupuncture treatment for dry eye syndrome from 2000 to 2020. Only randomized controlled trials(RCT) were selected and analyzed with the research method. Results : A total of 4 studies were reviewed. Cuanzu(攢竹, BL2), Taiyang(太陽, EX-HN5), and Sibai(四白, ST2) were the most frequently used acupoints in the studies. Among the evaluation indexes, Schirmer I test(SIT), tear film break-up time(BUT) were the most frequently used outcomes. In the most of the 4 studies, intradermal acupuncture treatment showed significant therapeutic effects for dry eye syndrome. Conclusions : These results suggest that it is necessary to develop more detailed standards for intradermal acupuncture treatment method as the method of intradermal acupuncture is getting more diverse, and objective tools are needed to evaluating dry eye syndrome.

Electroacupuncture Treatment for Women with Primary Obesity: A Review of Randomized Controlled Trials

  • Lee, Soo Jin;Oh, Da Yoon;Park, Jae Eun;Lee, Min Cheol;Jeon, Myung Kyu;Jang, Yeong Suk;Kim, Hyeon Jin;Ahn, Jae Young;Hong, Noo ri;Kim, Woo Young
    • Journal of Acupuncture Research
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    • v.37 no.2
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    • pp.79-87
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    • 2020
  • The purpose of this review was to evaluate the effectiveness of electroacupuncture treatment for women with "primary obesity." Primary obesity is caused by an imbalance in energy intake and consumption due to abnormal eating and living habits in the absence of specific diseases causing the obesity. A literature review (up to December 2019) of randomized controlled trials (RCT) of electroacupuncture treatment for women with "primary obesity" was performed. Relevant clinical studies were retrieved from several databases, and interventions and results were analyzed. There were 6 RCT that fitted the inclusion criteria for this review. The intervention for the treatment group of the selected 6 RCT was electrical stimulation applied to acupoints. Interventions for the control groups included non-treatment, general acupuncture, and so on. Indicators for assessing treatment effects varied from study to study. Four out of 5 studies used body mass index (BMI) as an assessment tool and showed a significant decrease in BMI following electroacupuncture treatment. There were 4 studies using waist circumference as an indicator of abdominal obesity and these studies showed a significant decrease in waist circumference following electroacupuncture treatment. Electroacupuncture treatment used in primary obese women had a clinically significant effect, however, further RCT are needed.

A Systematic Review of Randomized Controlled Trials on Acupuncture for Shoulder Pain Based on Jadad Scale and revised STRICTA recommendations (견비통에 대한 침치료 임상연구의 체계적 문헌 고찰 - Jadad Scale 및 개정된 STRICTA 권고안을 중심으로 -)

  • Park, Tae-Hyun;Oh, Chang-Keun;Park, Yu-Lee;Yang, Seung-Bum;Kim, Jae-Hyo
    • Korean Journal of Acupuncture
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    • v.29 no.1
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    • pp.93-108
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    • 2012
  • Objectives : This study aims to review randomized controlled trials on acupuncture for shoulder pain according to Jadad Scale and revised STRICTA. Methods : Seven electronic databases including PUBMED, SCOPUS, RISS were searched for randomized controlled trials (RCT) of acupuncture for shoulder pain. Results : 16 RCTs were included: 14 were published in English and 2 were published in Korean. According to Jadad scale, 15 RCTs had high quality. However, most of the studies could not meet the double blindness criteria. All RCTs meet 12.9 items on average in STRICTA. Conclusions : This systematic review shows four conclusions as follows. Traditional Chinese Medicine is often used in style of acupuncture. Spots of LI15, TE14, GB21 and LI11, stainless steel needle($0.3mm{\times}40mm$), 20 retention time, manual stimulation, $Deqi$, and 2 times a week treatment (total 12) are often used. Double-blinded clinical trials needs to be conducted. It is controversial to use minimal acupunctures on controlled groups of RCTs on acupuncture for shoulder pain. Description about practitioner's background needs clarifying.

Regulatory innovation for expansion of indications and pediatric drug development

  • Park, Min Soo
    • Translational and Clinical Pharmacology
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    • v.26 no.4
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    • pp.155-159
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    • 2018
  • For regulatory approval of a new drug, the most preferred and reliable source of evidence would be randomized controlled trials (RCT). However, a great number of drugs, being developed as well as already marketed and being used, usually lack proper indications for children. It is imperative to develop properly evaluated drugs for children. And expanding the use of already approved drugs for other indications will benefit patients and the society. Nevertheless, to get an approval for expansion of indications, most often with off-label experiences, for drugs that have been approved or for the development of pediatric indications, either during or after completing the main drug development, conducting RCTs may not be the only, if not right, way to take. Extrapolation strategies and modelling & simulation for pediatric drug development are paving the road to the better approval scheme. Making the use of data sources other than RCT such as EHR and claims data in ways that improve the efficiency and validity of the results (e.g., randomized pragmatic trial and randomized registry trial) has been the topic of great interest all around the world. Regulatory authorities should adopt new methodologies for regulatory approval processes to adapt to the changes brought by increasing availability of big and real world data utilizing new tools of technological advancement.

Trend for Acupuncture treatment Clinical Trial on Atopic Dermatitis (아토피피부염의 침 치료 임상연구 동향)

  • Park, Soo-Yeon;Choi, Jung-Hwa;Jeong, Min-Yeong;Lee, Gi-Hyun
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.33 no.1
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    • pp.45-55
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    • 2020
  • Objectives : The objective of this study is to review the Trend of clinical trials conducted with the acupuncture treatment on Atopic Dermatitis. Methods : Through 4 foreign online databases(PubMed, Cochrane library, EMBASE, CNKI) and 3 domestic online databases(NDSL, RISS, OASIS), we searched for clinical studies performed acupuncture treatment for Atopic Dermatitis from 2010 to December 2019. Only randomized controlled trials(RCT) was selected and anlayzed according to the research method. Results : A total 4 studies were reviewed. LI11, ST36, SP10 were most frequently used acupoints in acupuncture treatment. Among the evaluation indexes, SCORAD, VAS, DLQI were used most. In most of the 4 studies, acupuncture treatment showed significant therapeutic effects. Conclusions : These results suggest that it is necessary to develop more detailed standards about Acupuncture treatment method as the method of acupuncture is getting more diverse, and objective tools are needed in evaluating Atopic Dermatitis.

Effects of Nature-Based Programs for Workers in Korea: A Systematic Review

  • Shin, Jong-Yeon;Shin, Won-Sop
    • Journal of People, Plants, and Environment
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    • v.23 no.2
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    • pp.125-138
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    • 2020
  • The aim of this study was to review previous literature to determine the effects of nature-based program for workers. This systematic review was conducted in accordance with National Evidence-based Healthcare Collaborating Agency's guidance for undertaking systematic reviews for intervention. Literature search was performed using National Assembly Digital Library, Korean Studies Information Service System, and Korea Education & Research Information Service for literature published until March 2019. The participants were full-time workers, and intervention of nature-based programs was conducted in the outdoor, indoor, and indirect nature contact exposures, with comparators in the control group who did not receive the treatment. The results showed that the programs were effective in physical, psychological, and social health. The methodological quality of randomized controlled trials (RCT) was assessed using the Cochrane Risk of Bias(RoB) tool, while non-randomized controlled trials (N-RCT) were assessed using the Cochrane Risk of bias assessment tool for non-randomized studuies (RoBANS). A total of 16 studies were selected for assessment: two RCTs, 10 N-RCTs, and four one-group pretest-posttest designs. Most interventions were provided at the workplace and in the community. There were many kinds of nature-based interventions, and forest therapy and horticultural therapy programs were most common. Various interventions for workers effectively improved job stress, depression, serum cortisol and stress-response. However, the included studies lacked methodological rigor. Future research is needed to evaluate the long-term effectiveness of nature-based programs for workers using rigorous research designs.

The Review on the Randomized Controlled Clinical Trials of Bee Venom in the Journal of Korean Medicine (봉독을 이용한 무작위배정 임상연구의 국내 현황)

  • Lee, Yong-Seok;Lee, Young-Joon;Han, Chang-Hyun
    • Journal of Korean Medicine Rehabilitation
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    • v.23 no.3
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    • pp.87-106
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    • 2013
  • Objectives We will provide basic information on bee venom clinical tests and aid the practical use of bee venom in such tests, through examination of RCT research related to bee venom that was reported domestically. Methods We collected 365 articles on Bee venom study result from the OASIS system using the Keyword 'bee venom, apitoxin, apitherapy, bee sting'. The initially selected theses were primarily screened for clinical research. Out of these, case studies and non randomized controlled trial (non-RCT) were ruled out. As a result, 39 studies of randomized controlled trial (RCT) research were chosen as the subjects of study. Results RCT research related to bee venom was first presented in 2003, and 39 studies have been published until 2012. 18 studies were tests to confirm the effectiveness of bee venom, 7 studies were comparisons between SBV and BV, and 13 studies were comparisons with other types of treatment. Research conducted through appropriate randomization methods were 20 studies, and inappropriate randomization methods were used in 19 studies. In therms of Jadad score, 12 studies received 4~5 points, 15 studies received 1-3 points, and 12 studies received zero point. Conclusions In order to assure good quality RCT research, appropriate guidelines should be provided, and proper evaluation standards should be established. In-depth study is needed concerning the difference of responses to treatment according to the types of treatment received. A standardization of treatment should be reached as a result.

Review of Randomized Controlled Clinical Trials Targeting Treatment of Diabetic Peripheral Neuropathy (당뇨병성 말초 신경병증에 대한 RCT 분석 연구)

  • Kim, Jin-Mi;Son, Chang-Gue;Cho, Chung-Sik;Kim, Chul-Jung
    • The Journal of Korean Medicine
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    • v.31 no.4
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    • pp.164-170
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    • 2010
  • Objective: This study aimed to produce an overview of RCT for treatments of diabetic peripheral neuropathy. Method: All RCT studies for treatments of diabetic peripheral neuropathy were selected via PubMed. The general trend of RCT number, subject and result, including Oriental medicine, were analyzed. Result: A total 147 RCT studies were found. The number of RCT has rapidly increased since 2003. 114 RCTs were conducted with western drugs, while RCTs with electrical stimulation and Oriental medicine were eight and ten respectively. All RCTs with acupuncture, moxibustion and herbal drugs showed positive results. Conclusion: Oriental medicine-derived RCTs for diabetic peripheral neuropathy are very rare, even their potential was sufficient. This study may provide valuable information for development of Oriental medicine against diabetic peripheral neuropathy in the future.