• Title/Summary/Keyword: randomized controlled trial

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Systematic Review for the Development of the Clinical Study with Economical Assessment Protocol on Facial palsy (얼굴마비의 임상연구병행 경제성평가 프로토콜 개발을 위한 체계적 문헌고찰연구)

  • Gong, Na-Gyeong;Seo, Eunsung;Seon, Ji-Hye;Kim, Nam-Kwen
    • The Journal of Korean Medicine
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    • v.38 no.1
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    • pp.46-55
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    • 2017
  • Objectives: The aim of this study is reviewing the literature to extract the key parameter, study design, perspective, cost-effectiveness index and find the calibration parameter for the clinical study with economical evaluation protocol on facial palsy. Methods: Literature search is performed using PUBMED for literature published from January 2000 to December 2016. We included randomized controlled trials(RCTs) and modelling study with economic assessment in which human participated. Results: As a result of literature search, the 198 articles were found. After reviewing the title, abstract and full text, the 5 articles were selected. Selected articles are classified into 4 RCT studies dealing with quality of life and 1 CEA(cost-effectiveness analysis) study. Conclusions: We found reliable key parameters, calibration parameters and elements of economical assessment study, which might be necessary factors for developing research protocol of clinical trial with economic evaluation about facial palsy patients.

Effect of onion peel extract supplementation on the lipid profile and antioxidative status of healthy young women: a randomized, placebo-controlled, double-blind, crossover trial

  • Kim, Jungmi;Cha, Yong-Jun;Lee, Kyung-Hea;Park, Eunju
    • Nutrition Research and Practice
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    • v.7 no.5
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    • pp.373-379
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    • 2013
  • The consumption of fruits and vegetables that have high polyphenol content has been previously associated with a reduced risk for cardiovascular disease. We investigated the effects of onion peel extract on plasma total antioxidant capacity, lipid peroxidation, and leukocyte DNA damage. This study was a randomized, double-blind, placebo-controlled, crossover trial. Healthy female subjects received either onion peel extract or placebo (dextrin) for two weeks, underwent a 1-week washout period, and then received the other treatment for an additional two weeks. After two weeks of onion peel extract supplementation, the total cholesterol level, low-density lipoprotein cholesterol level, and atherogenic index significantly decreased (P < 0.05). No changes were observed in activities of erythrocyte antioxidant enzymes or levels of lipid peroxidation markers following onion peel extract supplementation. Additionally, no significant difference was found in plasma antioxidant vitamin (retinol, tocopherols, carotenoids, and coenzyme Q10) levels or ex vivo $H_2O_2$-provoked oxidative DNA damage after onion peel extract supplementation. The present interventional study provides evidence of the health benefits of onion peel extract and demonstrates its effects in modulating lipid profiles in healthy young Korean women.

Recent Clinical Research Trends on Acupuncture Treatment of Meniere's Disease (메니에르 병의 침 치료에 관한 최근 임상 연구 동향)

  • Lee, Kyou-Young;Hong, Chul-Hee
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.31 no.3
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    • pp.26-38
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    • 2018
  • Objectives : The purpose of this study is to investigate the possibility of applying acupuncture to the treatment of meniere's disease, which has no definite treatment methods, by analyzing the latest clinical researches about acupuncture treatment of meniere's disease. Methods : A case study and Randomized Controlled Trial (RCT) related to the acupuncture treatment of meniere's disease were searched using domestic and international thesis search engines including OASIS, CNKI, J-STAGE, PubMed. This study include acupuncture treatment and acupuncture combined with other treatments such as herbal medicine. The search was limitied to the publication date from 2000 to 2018 with free full text. Results : 17 cases were selected. There were 7 case studies in Korea, 5 case studies in China, and 5 RCT papers in China. All 12 cases reported improvement in meniere's disease and all RCT studies showed significantly higher treatment effects in the experimental group than in the control group. Conclusions : Acupuncture treatment showed significant effects for meniere's disease when applied alone or in combination with other treatments. In the future, various systematic studies should be conducted only for acupuncture treatment.

Amiodarone Versus Propafenone to Treat Atrial Fibrillation after Coronary Artery Bypass Grafting: A Randomized Double Blind Controlled Trial

  • Nemati, Mohammad Hassan;Astaneh, Behrooz
    • Journal of Chest Surgery
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    • v.49 no.3
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    • pp.177-184
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    • 2016
  • Background: Atrial fibrillation (AF) is one of the most common complications after cardiac surgery. Several therapeutic and preventive strategies have been introduced for postoperative AF, but the treatment and prophylaxis of AF remain controversial. We aimed to compare the efficacy of intravenous amiodarone and oral propafenone in the treatment of AF after coronary artery bypass grafting (CABG). Methods: This was a randomized controlled trial performed in two hospitals in Shiraz, Iran from 2009 to 2012. We included all patients who underwent elective CABG and developed AF postoperatively. The patients were randomly assigned to receive propafenone or amiodarone. The duration of AF, the success rate of the treatment, the need for cardioversion, the frequency of repeated AF, and the need for repeating the treatment were compared. Results: The duration of the first (p=0.361), second (p=0.832), and third (p=0.298) episodes of AF, the need for cardioversion (p=0.998), and the need to repeat the first and second doses of drugs (p=0.557, 0.699) were comparable between the study groups. Repeated AF was observed in 17 patients (30.9%) in the propafenone group and 23 patients (34.3%) in the amiodarone group (p=0.704). Conclusion: Oral propafenone and intravenous amiodarone are equally effective in the treatment and conversion of recent-onset AF after CABG.

A Review on Clinical Studies of the Acupuncture and Moxibustion Therapy for Gastroesophageal Reflux Disease in China by Searching CAJ (CAJ 검색을 통해 살펴 본 중국에서의 역류성 식도질환 침구치료 임상연구 동향에 대한 고찰)

  • Kang, Sei-Young
    • Korean Journal of Acupuncture
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    • v.32 no.1
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    • pp.1-12
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    • 2015
  • Objectives : The purpose of this study was to review the acupuncture and moxibustion therapy for gastroesophageal reflux disease(GERD) in China. Methods : The literatures were searched using the database-China Academic Journals(CAJ)(~2015.1.). Clinical studies of acupuncture and moxibustion therapy for GERD such as randomized controlled trial(RCT), non-randomized controlled trial(NRCT), case series, or case report were included. Results : Thirty studies met our inclusion criteria: 24 RCTs, 4 NRCTs, 1 case series, 1 case report. Various kinds of treatment such as body acupuncture, abdominal acupuncture, acupuncture therapy with finger on back-shu point, electroacupuncture, acupoint injection, auricular acupuncture, and moxibustion were used in the clinical studies. The treatment groups take herbal medicines at the same time in 16 studies, and proton pump inhibitor(PPI) and histamine 2 receptor antagonist were used as a comparative treatment in the most of studies. Acupuncture or moxibustion treatments were done daily or 2~3 times a week for 5 days~18 weeks. All of studies reported higher effective rate in the acupuncture or moxibustion treatment group compared to the western medication control group. Conclusions : The results of this study could be used for the future practice and the clinical research about the acupuncture and moxibustion therapy for GERD.

Acupuncture for Parkinson's Disease in China (중국에서의 파킨슨병 침치료 임상연구 동향)

  • Kim, Lak-Hyung;Jang, In-Soo;Kang, Sei-Young
    • Korean Journal of Acupuncture
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    • v.28 no.4
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    • pp.147-158
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    • 2011
  • Objectives : The purpose of this study was to obtain some knowledge about the acupuncture treatments on Parkinson's disease for the future practice and the research from the clinical studies in China. Methods : The literatures were searched using the data base-China Academic Journals (CAJ) (1994-2011). Clinical studies of acupuncture for Parkinson's disease such as randomized controlled trial (RCT), non-randomized controlled trial (NRCT), case series, case report were included. Results : Of 145 articles, 52 Clinical studies met our inclusion criteria: 20 RCTs, 7 NRCTs, 22 case series and 3 case reports. Various kinds of acupuncture treatments such as scalp acupuncture, body acupuncture, abdominal acupuncture, acupoint injection, eye acupuncture and thick needle acupuncture (粗鍼) were used in the clinical studies. The treatment and control groups take Madopa Tablet (Levodopa + Benserazide HCl) in the same time in many studies, and Madopa treatment was used as a comparative treatment in the most of studies. Acupuncture treatment was done daily or 2~3 times a week for 2~20 weeks. All of studies reported high effective rate in the treatment group compared to control group. Conclusions : The results of this study could be used for the future study about the acupuncture therapy for Parkinson's disease.

Effectiveness of Nutrition Education in Improving Maternal Knowledge and Attitudes towards Complementary Feeding Practices: A cluster-randomized controlled trial in Ondo State, Nigeria

  • Akinrinmade, Remilekun;NJOGU, Eunice;OGADA, Irene Awuor;KESHINRO, Olufunke Oluremi
    • The Korean Journal of Food & Health Convergence
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    • v.5 no.4
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    • pp.1-10
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    • 2019
  • Significant low knowledge and poor attitudes on complementary feeding undermine the practices. This study was a cluster randomized controlled trial in which 284 study participants were assigned into two groups. One intervention group and a control group in a ratio of 1:1. Nutrition education on complementary feeding was carried out among the caregivers in the intervention group but the caregivers in the control group were not educated. To determine complementary feeding knowledge and attitudes, data was collected from caregiver at baseline, midline and at endline using researcher-administered questionnaires. Quantitative data were analyzed using SPSS version 22.0. From the analysis, there was a significant difference in complementary feeding knowledge of the caregivers after the intervention. The baseline difference was -0.06, the midline difference was 3.85 the endline difference was 4.00 and the DID of the baseline and endline was 4.06 which was significant at p=0.001. There was a significant difference in the attitude of the caregivers towards complementary feeding at baseline (-0.14), midline (2.09), endline (3.82) and the DID of baseline and endline was 3.96 which was significant at p=0.001. The intervention improved the caregivers' knowledge on complementary feeding and it improved the attitudes of the caregivers towards adequate complementary feeding.

Acupuncture Treatment in Clinical Studies for Parkinson's Disease : A Literature Review

  • Sohn, Soo Ah;Lee, Kyoung Yun;Kim, Chang Wan;Lee, Yu Jin
    • Journal of Acupuncture Research
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    • v.35 no.4
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    • pp.149-157
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    • 2018
  • Background: Parkinson's disease is the second most common degenerative brain disease after Alzheimer's disease. This study reviewed clinical practice of acupuncture and moxibustion treatment for Parkinson's disease to assess the future direction of these treatments. Methods: The literature search used 5 Korean Internet databases. The search terms were "Parkinson's disease." and "Parkinson (Korean)." 36 papers were selected: 27 case reports, 2 respropective studies, 3 uncontrolled clinical trials, 3 randomized controlled trial, 1 non-randomized controlled trial. Results: Filiform needles were used in most of studies. Pharmacopuncture, electro-acupuncture, and auricular acupuncture therapy were also used in combination with Filiform needles. 2. The most commonly used basic acupoints for Parkinson's disease was Saamchimbeop. The most commonly used form of pharmacopuncture involved Bee-venom. Conclusion: It is expected that treatment of Parkinson's disease with a variety of acupuncture and moxibustion therapies will continue to be studied, in addition to treatments that utilize existing Filiform needle treatments in clinical practice.

Effect of a Randomized Controlled Trial Walking Program on Walking, Stress, Depressive Symptoms and Cardiovascular Biomarkers in Elderly Korean Immigrants

  • Sin, Mo-Kyung;Ibarra, Brandon;Tae, Thomas;Murphy, Patrick J.M.
    • Journal of Korean Biological Nursing Science
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    • v.17 no.2
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    • pp.89-96
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    • 2015
  • Purpose: Despite well-known benefits of walking on cardiovascular health, no structured walking exercise program has been formally tested on elderly Korean immigrants (EKIs). This pilot randomized controlled trial study assessed the effect of a walking program on walking behavior (pedometer steps count), stress (cortisol), depressive symptoms (CESD-10), and cardiovascular disease biomarkers (hs-CRP and fibrinogen) via venipuncture in EKIs. Methods: Seventy EKIs recruited from a Korean community were randomly assigned to a 12-week walking group or control group in a 3:2 ratio. The working program included a pedometer, buddy, monthly coffee card, weekly call for goal setting, and physical activity consultation. Walking group EKIs maintained the Centers for Disease Control and Prevention recommended exercise guidelines and good mental health status over 12 weeks. Results: There was no significant difference in the outcomes between control and walking groups. Conclusion: Social networking with Koreans in the senior center and church from a well-established Korean community might have positive effects on mental health.

Effects of a Cognitive Rehearsal Program on Interpersonal Relationships, Workplace Bullying, Symptom Experience, and Turnover Intention among Nurses: A Randomized Controlled Trial

  • Kang, Jiyeon;Kim, Jeung-Im;Yun, Seonyoung
    • Journal of Korean Academy of Nursing
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    • v.47 no.5
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    • pp.689-699
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    • 2017
  • Purpose: This research aimed to investigate the effects of a cognitive rehearsal program (CRP) on workplace bullying among nurses. Methods: A randomized controlled trial was performed. Participants were 40 nurses working in different university hospitals in B city, South Korea. The experimental group was provided with a 20-hour CRP comprising scenarios on bullying situations, standard communication, and role-playing. To evaluate effects of the CRP, we measured interpersonal relationships, workplace bullying, symptom experience, and turnover intention at preand post-intervention. Follow-up effect was measured in the experimental group only at 4 weeks after the intervention. Results: After the intervention, there were significant differences in interpersonal relationships (F=6.21, p=.022) and turnover intention (F=5.55, p=.024) between experimental and wait-list groups. However, there was no significant difference in workplace bullying or symptom experience between the 2 groups. The beneficial effects on interpersonal relationships and turnover intention lasted at least up to 4 weeks after CRP. Conclusion: The CRP for workplace bullying improves interpersonal relationships and decreases turnover intention. So it can be utilized as one of the personal coping strategies to reduce the the turnover among nurses. Further studies on the effects of unit- or hospital-based CRP and on the long-term effects of CRP are necessary.