• Title/Summary/Keyword: randomized clinical controlled trial

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Review on RCT Research Papers Related Nausea and Vomiting in Pregnancy - Focusing on Acupoint Treatment - (임신오조(姙娠惡阻) 관련 무작위대조군연구(RCT)에 관한 고찰 - 경혈을 이용한 치료를 중심으로 -)

  • Jang, Suk-Woo;Ahn, In-Suk;Choi, Min-Sun;Kim, Dong-Il
    • The Journal of Korean Obstetrics and Gynecology
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    • v.26 no.2
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    • pp.138-150
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    • 2013
  • Objectives: To observe randomized controlled trials(RCTs) related to investigating the effects of acupoint treatments on nausea and vomiting in pregnancy to establish the basis of korean medical treatments, and suggest the problems of future clinical research. Methods: After searching for national and international papers published after 2000 and restricting the parameters to 'clinical trial', 'controlled clinical trial', 'randomized controlled trial', then comparing the subjects, methods, research tools, and results to understand the effects and re-comparing the conflicting results to assume the cause. Results: Of the 9 research papers that applied acupressure, four of them used control and experimental groups, and three(75%) research papers indicated significant reduction in vomiting and nausea, and of the seven research papers that utilized the experimental and placebo groups, five(71.4%) reported significant reducing effects. Of the four research papers the used acupuncture treatments, four research papers using control and placebo groups, two showed improvements in symptoms but did not have significant results compared to sham acupuncture groups, and two showed significant reduction of symptoms compared to the control groups. The one research paper that used electrical stimulation showed significant results in the reduction of vomiting and nausea compared to the control group. Conclusions: Acupressure and electrical stimulation showed efficacy reducing the symptoms. Acupuncture treatments did not indicate efficacy some experiments. Therefore it is thought that future acupuncture treatments should use methods that resemble actual clinical medicine to establish efficacy to produce significant results.

Preliminary Study on Effectiveness of Dexamethasone-Soaked Gelatin Sponges for Reducing Pain after Lumbar Microdiscectomy : A Randomized Controlled Trial

  • Shin, Dong-Ah;Gong, Tae-Sik;Shin, Dong-Gyu;Kwon, Chang-Young;Kim, Hyoung-Ihl
    • Journal of Korean Neurosurgical Society
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    • v.39 no.1
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    • pp.11-15
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    • 2006
  • Objective : A prospective, randomized, controlled clinical study is performed to verify the effectiveness of epidural dexamethasone-soaked gelatin sponges to reduce postoperative pain following lumbar microdiscectomy. Methods : Twenty-three patients (10 men and 13 women) undergoing lumbar microdiscectomy were included. Five pieces of gelatin sponge measuring $1{\times}1cm$ [Gelfoam; Pharmacia & Upjohn. Kalamazoo, MI, USA], soaked with either 5mg dexamethasone or an equal amount [2mL] of saline, were left on the decompressed nerve root after unilateral hemilami-nectomy, flavectomy and discectomy. Results : Subjective visual analog scale[VAS] scores of leg pain in the dexamethasone group on the first, third and first postoperative days [2.5, 2.5, 1.7, respectively] were significantly lower than in the control group [5.0, 4.8, 3.6][P<0.05]. No side effects related to the dexamethasone-soaked gelatin sponges were observed. Conclusion : The intraoperative application of dexamethasone-soaked gelatin sponges during lumber microdiscetomy can provide effective-postoperative analgesia without complications.

Review of Clinical Studies of Oral Herbal Medicine Treatment for Pediatric Chickenpox using CNKI Database - Focused on Chinese Randomized Controlled Trials after 2000s - (CNKI로 검색한 소아 수두의 한약 내복 치료에 대한 임상연구 동향 - 2000년대 이후 RCT 연구를 중심으로-)

  • Choi, Jung Yoon;Kim, Jang Hyun;Min, Sang Yeon
    • The Journal of Pediatrics of Korean Medicine
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    • v.34 no.3
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    • pp.18-36
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    • 2020
  • Objectives The purpose of this study is to analyze Chinese randomized controlled trials (RCTs), and to evaluate the effectiveness and safety of the oral herbal medicine treatment for pediatric chickenpox. Methods We searched RCTs after 2000s from the China National Knowledge Infrastructure (CNKI). Afterwards, the year of publication, demographic information, duration of chickenpox, intervention, treatment duration, outcome measure, results and adverse events were investigated and analyzed for this study. Results 21 RCTs out of 219 studies were collected and analyzed. Although each composition of the herbal medicine was different, they have common ingredients such as 清熱解毒, 散結消腫, 疏散風熱, 涼血解毒, 解表散風 in order to make efficacy of 清熱解毒, 散結消腫, 疏散風熱, 涼血解毒, 解表散風. The oral herbal medicine showed better efficacy and safety to improve clinical symptoms such as total efficacy, cure rate, antipyretic time, antipruritic time, scab time, anti-rash time, hospitalization period and herpes recovery time compared to the western medicine treatment. Conclusions These results show that the oral herbal medicine treatment on chickenpox in children may be more effective in reducing of clinical symptoms compared to the western medicine treatment.

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.

Systematic Review for the Development of the Clinical Study with Economical Assessment Protocol on Atopic Dermatitis (아토피 피부염의 임상연구병행 경제성평가 프로토콜 개발을 위한 체계적 문헌고찰연구)

  • Gwon, Ji-Yae;Seon, Ji-Hye;Yun, Hwa-Jeong;Kim, Nam-Kwen
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.30 no.1
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    • pp.17-28
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    • 2017
  • Objectives : The aim of this study is reviewing the literature to extracting the key parameter and finding the calibration parameter for the clinical study with economical assessment protocol on atopic dermatitis. Methods : Literature search is performed using PUBMED for literature published from Janurary 2000 to December 2016. We included randomized controlled trials(RCTs) with economic assessment in which human participants. Results : Among the articles published from January 2000 to December 2016, The 1464 articles were found. After reviewing the title, abstract and full text, the five articles were selected. Selected articles are classified 3 CEA(cost effective analysis)study, 1 CMA(cost minimizing analysis)study and 1 cost analysis study. Conclusions : We found highly reliable key parameters and calibration parameters, which might be necessary factors for developing research protocol of economic evaluation alongside clinical trial about atopic dermatitis patients.

Analysis of papers on Oriental herbal medicines(prescriptions and herbs) for dementia (치매 치료 한약(처방 및 한약재) 연구 논문 동향 분석)

  • Koo, Jin-Suk;Seo, Bu-Il;Park, Ji-Ha;Roh, Seong-Soo
    • The Korea Journal of Herbology
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    • v.25 no.3
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    • pp.131-137
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    • 2010
  • Objectives:In this study, we surveyed papers about Oriental herbal medicines(prescriptions and herbs) for dementia. Method:We collected 64 research papers on Oriental herbal medicines(prescriptions and herbs) for dementia in the internet site OASIS using the keyword dementia. Then we analysed them according to year, research method, etc. Result & Conclusion:The absolute majority of research papers on Oriental herbal medicines(prescriptions and herbs) for dementia was experimental papers. And there were not enough clinical papers. In the future, we have to perform more studies such as RCT(Randomized Controlled Trial) and research papers on combined medication of the oriental and the western medicines for dementia.

Overview of RCT for Non-Alcoholic Fatty Liver Disease and Non-Alcoholic Steatohepatitis

  • Son, Chang-Gue
    • The Journal of Korean Medicine
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    • v.32 no.3
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    • pp.44-49
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    • 2011
  • Objective: This study aimed to get information on the current status of therapies to date for non-alcoholic fatty liver disease (NAFLD), including non-alcoholic steatohepatitis (NASH). Methods: All randomized clinical controlled trial (RCT)-derived papers for NAFLD or NASH were reviewed via PubMed Database. Results: 39 RCTs met the review criteria, of which 15 and 24 papers were for NAFLD and NASH, respectively. 83% of the papers were released since 2006, and 30 studies were conducted for western medicines, antioxidants and lifestyle intervention whereas nine trials were done using herbal medicine or acupuncture which showed positive outcome. Conclusions: NAFLD and NASH are new epidemic disorders which can be a target of traditional Oriental medicine. This study will be helpful for the Oriental medicine-based strategies or therapeutic development for them.

Analysis of Recent Clinical Studies to Establish Korean Herbal Medicine Clinical Trial Guidelines for the Common Cold (감기 임상시험 가이드라인 제정을 위한 최신 임상시험 연구 분석)

  • Kim, Kwan-il;Lee, Ho-jung;Lee, Beom-joon;Jung, Hee-jae;Jung, Sung-ki;Lee, Jun-hee
    • The Journal of Internal Korean Medicine
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    • v.37 no.1
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    • pp.109-134
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    • 2016
  • Objectives: The aim of this study was to help develop a guideline for the common cold. We searched recent clinical studies of the common cold in Western medicine and reviewed their objectives, inclusion and exclusion criteria, primary outcome, secondary outcome, and assessment tools to establish evidenced-based guideline.Methods: We searched electronic databases (Cochrane Library, MEDLINE, EMBASE) to identify eligible randomized controlled trials (RCTs) about the common cold for the last 10 years. We included 29 RCTs and showed their research summary via their objectives, participants, interventions, control, treatment duration, and results. We also analyzed the definition of the common cold presented in the article, inclusion and exclusion criteria, primary and secondary outcomes, and assessment tools.Results: We reported the aforementioned areas in detail. At first, the definition of the common cold was confused across the articles. Second, herbal medication clinical trials for the common cold have been extensively studied recently. Third, the eligibility criteria frequently included the Jackson Symptom score. Fourth, validated assessment tools (i.e., the Wisconsin Upper Respiratory Symptom Survey-21) have only been used in a few recent studies.Conclusions: Our research will be helpful to establish Korean herbal medicine clinical trial guidelines for the common cold.

Systematic Review on Complementary and Alternative Medicine for Female Sexual Dysfunction (여성 성기능장애의 보완대체의학적 치료에 관한 논문 연구)

  • Jeong, Young-Min;Kim, Song-Baek;Choi, Chang-Min;Seo, Yun-Jung;Cho, Han-Baek
    • The Journal of Korean Obstetrics and Gynecology
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    • v.26 no.2
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    • pp.66-87
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    • 2013
  • Objectives: The aim of this study was to review systemically clinical trials on the trends of studies for Complementary and Alternative Medicine in the treatment of female sexual dysfunction and provide basic resource for future treatment and suggestions for improving research methods. Methods: Through medical website 'Pubmed', foreign clinical literatures about female sexual dysfunction were searched and domestic clinical literatures about female sexual dysfunction were searched using internet websites 'National assembly library', 'KISS', 'RISS', 'Korean traditional knowledge portal'. Results: Total 19 literatures were selected from January 2000 to June 2012. 15 foreign literatures were selected through medical website and 4 domestic literatures were chosen using internet websites or hand-searching. 5 literatures were published in 2008 and 13 literatures mentioned about age group of patients. FSFI is most common tool for female sexual dysfunction. 9 of 19 literatures were using Herbal medicine for treatment. 5 literatures were about CBT, 6 literatures were about Biofeedback and other one literatures are about Perineal massage. There were 14 Randomized controlled trials and 5 Non-randomized controlled trials. And randomized controlled trials were relatively low in risk of bias than non-randomized controlled trials. Conclusions: Upon these results, in similar future more clinical trials should be done and accumulate Evidence-based literatures.

Randomized, Double-blind, and Placebo-controlled a Clinical Study for Chronic Fatigue via the Analysis of Efficacy and Safety of Gongjin-dan and Ssanghwa-tang : Study Protocol (만성피로에 대한 공진단과 쌍화탕의 안전성 및 유효성 평가를 위한 무작위배정, 이중눈가림, 위약대조 임상시험 : 임상연구 프로토콜)

  • Jun-Yong, Choi;Byungmook, Lim;Hyeun-kyoo, Shin;Kibong, Kim
    • Journal of Society of Preventive Korean Medicine
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    • v.26 no.3
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    • pp.97-108
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    • 2022
  • Objectives : The purpose of this study is to confirm the efficacy and safety of Gongjin-dan and Ssanghwatang for chronic fatigue. Methods : A total of 90 people, between 19 and 65 years old, will be recruited to participate in a randomized, double-blind, and placebo-controlled a clinical trial. Participants in the Gongjin-dan group will take one pill of Gongjin-dan along with three packs of placebo oral liquid Ssanghwa-tang per day for 4 weeks. Participants in the Ssanghwa-tang group will take three packages of liquid Ssanghwa-tang and one placebo Gongjindan pill per day for 4 weeks. In the placebo group, participants will take one pill of placebo Gongjin-dan and three packs of placebo liquid Ssanghwa-tang per day, for 4 weeks. Outcomes will be measured at the baseline, 4th week, and 6th week. The primary outcome is the change in the Fatigue Severity Scale (FSS). Secondary outcomes are the change of Multidimensional Fatigue Inventory-20 (MFI-20), Chalder Fatigue Scale (CFQ), Short-Form 36 Health Survey (SF-36), Korean Version of Schedule of Fatigue and Anergy/General Physician (SOFA/GP), Glucose, Lactate, Ammonia, Free Fatty Acid (FAA), d-ROMs&BAP, Selenium, and Cortisol. Results : This trial was approved by the institutional review board of Pusan National University Korean Medicine Hospital (registry number: PNUKHIRB 2021-10-005). Recruitment opened in November 2021 and is supposed to be completed by December 2022. Conclusions : This trial will provide clinical information to determine the efficacy and safety of Gongjindan and Ssanghwa-tang for chronic fatigue.