• Title/Summary/Keyword: Randomized controlled trials

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Analysis of Studies on Ssanghwa-tang for Establishment of Evidence Based Medicine (EBM 구축을 위한 쌍화탕의 실험 연구 문헌 분석)

  • Lee, Jun-Kyoung;Lee, Nam-Hun;Ha, Hye-Kyoung;Lee, Ho-Young;Seo, Chang-Sub;Jung, Da-Young;Lee, Jin-Ah;Shin, Hyun-Kyu
    • Korean Journal of Oriental Medicine
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    • v.14 no.3
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    • pp.41-47
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    • 2008
  • Objective : The purpose of this report was to provide the information about activity and safety of Ssanghwa-tang by analyzing domestic papers and theses about Ssanghwa-tang. Methods : Domestic papers and theses related to Ssanghwa-tang were reviewed and analyzed. These papers were then classified by year, experimental method, and activity subject. Results : The following result s were obtained in this study. 1. The study of Ssanghwa-tang started from 1981 and continued steadily 1990s and it was decreased 2000s. 2. The paper of Ssanghwatang was entire domestic paper, 20 volumes. 3. In classified by experimental method and animal of Ssanghwa-tang paper, more than a half study used rat in vivo experiment. Furthermore clinical experiments were performed about anti-fatigue effect of Ssanghwa-tang and Ssanghwatang was proved a safety herbal medicine in acute toxicity experiment. 4. Decursin, glycyrrhizin, paeoniflorin were determined in Ssanghwa-tang by using HPLC analysis. 5. As these studies were classified by subject, papers related to anti-fatigue effect were most abundant by 7 papers. Besides there were several papers related to liver funtion, anti-inflammatory, alleviation, smooth muscle relaxation effect and so on. 6. According to experimental data, it is supported that Ssanghwa-tang was safety herbal medicine and it has a several activity about anti-fatigue, anti-inflammatory, alleviation, smooth muscle relaxation. Conclusion : Many study of basic science experiments and clinical experiments were performed and reported on Ssanghwa-tang in domestic journal. Ssanghwa-tang is being used in various ways associating with anti-fatigue, anti-inflammatory, alleviation and smooth muscle relaxation. furthermore Ssanghwatang was proved a safety herbal medicine in acute toxicity experiment. However, studies on randomized controlled trials of Ssanghwatang need to be completed at the clinical level.

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An Emotional Self-Regulation Program for Obese Children: Pilot Study Using Mixed Methods (비만아동을 위한 정서적 자기조절 프로그램의 개발 및 효과: 혼합방법론의 적용)

  • Kim, Hee-Soon;Ma, Yu-Mi;Park, Ji-Young;Kim, Seung-Hyun
    • Child Health Nursing Research
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    • v.19 no.3
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    • pp.187-197
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    • 2013
  • Purpose: The purpose of the study was to develop an emotional self-regulation program for obese children and to examine the program's effectiveness on depression, eating habits, and body mass index. Methods: The emotional self-regulation program was developed from theory-based strategies and a pre-post pilot study was conducted with 46 children (19: intervention, 27: control). The program included 6 weekly group sessions over 2 months. The embedded experimental model of concurrent mixed methods was used to better understand research outcomes by converging both quantitative and qualitative data. Anthropometric measurements and surveys were performed before and after the intervention. Three focus group interviews were conducted with all participants after intervention to explore their experiences. Results: The intervention group displayed decreased depression levels in the quantitative outcomes. The participants also expressed positive outcomes such as improvements in confidence, impulse management, intimacy, happiness, and losing weight. Conclusion: These findings suggest that emotional self-regulation skills are crucial factors for obese children not only to manage their emotional problems but also to control their weight. Further research is needed with a larger sample size and randomized controlled trials.

COMPARISON OF TRAMADOL/ACETAMINOPHEN AND CODEINE/ACETAMINOPHEN/IBUPROFEN IN ONSET OF ANALGESIA AND ANALGESIC EFFICACY FOR POSTOPERATIVE ACUTE PAIN (수술후 급성 동통에 대한 Tramadol/Acetaminophen과 Codeine/Acetaminophen/Ibuprofen의 효과 발현시점과 진통효과의 비교)

  • Jung, Young-Soo;Kim, Dong-Kee;Kim, Moon-Key;Kim, Hyung-Jun;Cha, In-Ho;Han, Moo-Young;Lee, Eui-Wung
    • Journal of the Korean Association of Oral and Maxillofacial Surgeons
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    • v.30 no.2
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    • pp.143-149
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    • 2004
  • Background: Some clinical trials have reported that a new analgesic combination of tramadol and acetaminophen provides good efficacy in various pain models. For the more clinical uses of this agent, comparisons about the onset of analgesia and analgesic efficacy in the acute state of pain with the other drugs known as strong analgesics were needed. Purpose: The goal of this study was to compare the times to onset of analgesia and the other analgesic efficacy of 75 mg tramadol/650 mg acetaminophen and 20 mg codeine/500 mg acetaminophen/400 mg ibuprofen in the treatment of acute pain after oral surgery. Patients and Methods: Using a randomized, single-dose, parallel-group, single-center, and active-controlled test design, this clinical study compared the times to onset of analgesia using a two-stopwatch technique and the other analgesic efficacy of the single-dose tramadol/acetaminophen and codeine/acetaminophen/ibuprofen. These were assessed in 128 healthy subjects with pain from oral surgical procedures involving extraction of one or more impacted third molars requiring bone removal. From the time of pain development, the times to onset of perceptible and meaningful pain relief, pain intensity, pain relief, an overall assessment, and adverse events of the study medications were recorded for 6 hours. Results: The demographic distribution and baseline pain data in the two groups were statistically similar. The median times to onset of perceptible pain relief were 21.0 and 24.4 minutes in the tramadol/acetaminophen and codeine/acetaminophen/ibuprofen groups respectively and those to onset of meaningful pain relief were 56.4 and 57.3 minutes, which were statistically similar. The other efficacy variables such as mean total pain relief (TOTPAR) and the sum of pain intensity differences (SPID) were also similar in the early period after pain development and drug dosing. The safety of tramadol/acetaminophen was well tolerated and very comparable to that of codeine/acetaminophen/ibuprofen. Conclusions: In this acute dental pain model, the onset of analgesia and analgesic efficacy of tramadol/acetaminophen was comparable to that of codeine/acetaminophen/ibuprofen. These results showed that tramadol/acetaminophen was recommendable for fast and effective treatment in the management of postoperative acute pain.

The Effects of High Fidelity Simulation-Based Education on Clinical Competence and Confidence in Nursing Students: A Systematic Review (고충실도 시뮬레이션 기반 교육이 간호학생의 임상수행능력과 간호수행 자신감에 미치는 효과: 체계적 문헌 고찰)

  • Lee, Chong-Mi;So, Hyang-Sook;Kim, Younkyoung;Kim, Jeong-Ee;An, Minjeong
    • The Journal of the Korea Contents Association
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    • v.14 no.10
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    • pp.850-861
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    • 2014
  • The purpose of this review was to evaluate the effects of simulation-based education on clinical competence and confidence in nursing students and summarize the available evidence on the simulation-based intervention. A systematic review using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses: the PRISMA Statement was conducted. Studies published between 2005 and 2014 were reviewed using the following databases: RISS, KISS, and Google Scholar. The keywords used were nursing and either simulation or simulator. Selected studies were assessed for methodological quality using Quality Assessment Tool for Quantitative Studies. Seventeen studies were identified, including a total of 1,912 nursing students. All the 16 studies found simulation as a valid strategy on clinical competence and confidence in nursing education. This review provides updated evidence for simulation-based learning in nursing education. Further studies are needed to increase generalizability using randomized controlled trials, enough sample size, and longitudinal study design. In addition, valid measurements are needed to assess the main outcomes.

Safety and Effectiveness of Long Acting Injectable Antipsychotic Paliperidone Palmitate Treatment in Schizophrenics : A 24-Week Open-Label Study (조현병 환자에서 장기지속형 항정신병 주사제 팔리페리돈 팔미테이트의 효능과 안전 : 24주 개방형 연구)

  • Kang, Hyun-Ku;Hahm, Woong;Shon, In-Ki;Paik, In-Ho
    • Korean Journal of Biological Psychiatry
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    • v.20 no.3
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    • pp.111-117
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    • 2013
  • Objectives We investigated the effectiveness and safety when treated in schizophrenics with paliperidone palmitate, a long acting injectable antipsychotic. Methods This was a 24-week open-label study, performed at one center in Korea. The eligible patients with schizophrenia diagnosed by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria were enrolled. Patients received long-acting paliperidone palmitate injection (234 mg, baseline; 156 mg, week 1 ; then once 4 weeks flexible dosing). Effectiveness assessments were measured by the Positive and Negative Syndrome Scale (PANSS), The Clinical Global Impression Severity Scale (CGI-S), The Personal and Social Performance (PSP) at baseline, week 1, every 4 weeks untill 24 weeks or endpoint. Safety assessments were measured by The Extrapyramidal Symptom Rating Scale (ESRS), body weight (BW) and incidence of adverse events. Oral antipsychotics were stopped or tapered off within next 14 days. Results Of 20 patients recruited, 9 patients (45%) completed the study. Paliperidone palmitate produced a significant improvement in PANSS total score from baseline to endpoint. The response rate was 75% [mean change (${\pm}SD$) $-25.9{\pm}14.4$, all p < 0.001]. The CGI-S and PSP total scores significantly improved during 24 weeks (All p < 0.001). Eighty percent of patients reported adverse events and most common adverse events (${\geq}10%$) in paliperidone palmitate were anticholinergic adverse event, extrapyramidal symptoms, weight gain, akathisia, insomnia, headache, agitation, anxiety and GI trouble. ESRS score is not statistically significant, but tends to get better at the end of the study when compared to baseline. Conclusions Our study results demonstrated maintained effectiveness and safety of paliperidone palmitate treatment in schizophrenics. And provides both clinicians and patients with a new choice of treatment that can improve the outcome of long term therapy. Their potential effectiveness and safety should be better addressed by future randomized-controlled trials.

Literature Review on clinical studies for cold hypersensitivity of hands and feet -Focusing on journals published in Korea (수족냉증의 임상연구에 관한 문헌적 고찰 - 국내에 출판된 논문을 중심으로 -)

  • Lee, Hye-Sol;Han, In-Sik;Sun, Seung-Ho;Kim, Geun-yeob;Go, Ho-Yeon;Kim, Tae-Hoon;Lee, Jin-Moo;Jang, Jun-Bok;Song, Yun-Kyung;Ko, Seong-Gyu;Choi, You-Kyung;Jeong, Jong-Jin;Ko, Youme;Jeong, Keum Ran;Jeon, Chan-Yong
    • Journal of Society of Preventive Korean Medicine
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    • v.21 no.1
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    • pp.83-93
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    • 2017
  • Objectives : This study's aim is to investigate clinical studies of cold hypersensitivity of hands and feet (CHHF) published in Korea and to explore the direct of future research. Methods : We searched clinical studies of CHHF using the database, such as DBpia(http://www.dbpia.co.kr/), NDSL(www.ndsl.kr), OASIS(http://oasis.kiom.re.kr), and RISS(www.riss.kr). The search words were 'cold hypersensitivity(冷症)' and 'syncope(厥證)'. Inclusion criteria were randomized controlled trials (RCTs), non RCTs, Before and after clinical study (B&A) about CHHF. Selection journals and data extraction were conducted by HS Lee and SH Sun independently. Results : Total twenty-one articles were selected finally. RCTs, non-RCTs, and B&A were 3, 12, and 6, respectively. The topics for CHHF were classified into three categories: effect of treatment (n=2) characteristics (n=11), and diagnosis (n=8). Conclusions : This results showed that RCT about CHHF and treatment effect of cold hypersensitivity of hands and feet were small in number. Further systemic and larger studies about CHHF will be needed.

Study on the Current Situation and Issues for Clinical Research in Korean Medicine worldwide - Future Clinical Research Strategy I - (한의 임상 연구에 대한 국내외 현황 및 논쟁에 관한 고찰 - 미래 임상 연구 전략 I -)

  • Jung, Ki Yong;Go, Ho Yeon;Sun, Seung Ho;Jeong, Jong Jin;Park, Jeong Su;Song, Yun Kyung;Kim, Tae Hoon;Hong, Sung In;Choi, You Kyung;Go, Seong Gyu;Lim, Eun Mee;Lee, Choong Yeol;Park, Jong Hyeong;Jeon, Chan Yong
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.28 no.2
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    • pp.137-145
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    • 2014
  • The purpose of this paper is to explore the strategy of future Korean medicine(KM) clinical research through the study on the current situation and issues for KM clinical research worldwide. In this study, the papers published in English through Pubmed were investigated mainly. And we analyzed the methodological issues from the clinical research reports in the KM fields. As a result of examining the current situation of the RCTs(Randomized Controlled Trials) studies in KM, the sample size for most studies was small and the overall methodological quality appeared to be low. And there was a discussion about whether or not to apply RCTs method to the KM clinical research. The majority of studies have argued the use of RCTs method for KM clinical research. In addition, we could find some problems through the analysis of KM clinical studies. First, the majority of RCTs in KM were of low quality. Second, RCTs method was applied to the KM clinical studies according to the Western medicine methods only. Third, the actual KM diagnosis was not used in the KM studies and inadequate outcomes measurement methods were utilized without considering the characteristics of KM practice. The methodological issues in the KM clinical research were caused by the conflict between the characteristics of KM practice and clinical research method based on the western medicine.

Effectiveness of Cognitive Behavioral Therapy Techniques for Control of Pain in Lung Cancer Patients: An Integrated Review

  • Phianmongkhol, Yupin;Thongubon, Kannika;Woottiluk, Pakapan
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.14
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    • pp.6033-6038
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    • 2015
  • Background: Experience of lung cancer includes negative impacts on both physical and psychological health. Pain is one of the negative experiences of lung cancer. Cognitive behavioral therapy techniques are often recommended as treatments for lung cancer pain. The objective of this review was to synthesize the evidence on the effectiveness of cognitive behavioral therapy techniques in treating lung cancer pain. This review considered studies that included lung cancer patients who were required to 1) be at least 18 years old; 2) speak and read English or Thai; 3) have a life expectancy of at least two months; 4) experience daily cancer pain requiring an opioid medication; 5) have a positive response to opioid medication; 6) have "average or usual" pain between 4 and 7 on a scale of 0-10 for the day before the clinic visit or for a typical day; and 7) able to participate in a pain evaluation and treatment program. This review considered studies to examine interventions for use in treatment of pain in lung cancer patients, including: biofeedback, cognitive/attentional distraction, imagery, hypnosis, and meditation. Any randomized controlled trials (RCTs) that examined cognitive behavioral therapy techniques for pain specifically in lung cancer patients were included. In the absence of RCTs, quasi-experimental designs were reviewed for possible conclusion in a narrative summary. Outcome measures were pain intensity before and after cognitive behavioural therapy techniques. The search strategy aimed to find both published and unpublished literature. A three-step search was utilised by using identified keywords and text term. An initial limited search of MEDLINE and CINAHL was undertaken followed by analysis of the text words contained in the title and abstract, and of the index terms used to describe the article. A second search using all the identified keywords and index terms was then undertaken across all included databases. Thirdly, the reference list of all identified reports and articles were searched for additional studies. Searches were conducted during January 1991- March 2014 limited to English and Thai languages with no date restriction. Materials and Methods: All studies that met the inclusion criteria were assessed for methodological quality by three reviewers using a standardized critical appraisal tool from the Joanna Briggs Institute (JBI). Three reviewers extracted data independently, using a standardized data extraction tool from the Joanna Briggs Institute (JBI). Ideally for quantitative data meta-analysis was to be conducted where all results were subject to double data entry. Odds ratios (for categorical data) and weighted mean differences (for continuous data) and their 95% confidence intervals were to be calculated for analysis and heterogeneity was to be assessed using the standard Chi-square. Where statistical pooling was not possible the finding were be presented in narrative form. Results: There were no studies located that met the inclusion requirements of this review. There were also no text and opinion pieces that were specific to cognitive behavioral therapy techniques pain and lung cancer patients.Conclusions: There is currently no evidence available to determine the effectiveness of cognitive behavioural therapy techniques for pain in lung cancer patients.

Kidney-sparing Management Versus Nephroureterectomy for Upper Tract Urothelial Carcinoma: a Systematic Review and Meta-analysis

  • Luo, You;She, Dong-Li;Xiong, Hu;Fu, Sheng-Jun;Yang, Li
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.14
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    • pp.5907-5912
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    • 2015
  • Purpose: To evaluate and update evidence for prognostic effects of kidney-sparing (KS) management and nephroureterectomy (NU) for upper tract urothelial carcinomas. Materials and Methods: Pubmed, Embase and the Cochrane Library were retrieved for the identification of comparative studies of kidney-sparing procedure and nephroureterectomy for upper tract urothelial carcinoma prior to December 2014. The data were extracted independently by 2 reviewers and the quality of the included studies was assessed. Review Manager 5.3 and STATA 13 were used to perform the meta-analysis. Results: Twenty-three observational studies including 1,587 KS and 3,996 NU were evaluated. The results of the meta-analysis showed that nephroureterectomy had no significant benefit with regard to intravesical recurrence (IRFS), metastasis (MFS), cancer specific survival (CSS) and overall survival (OS) except the total tumor recurrence (RFS) when compared with kidney sparing management. The respectively pooled outcomes were HR 1.36 (0.69-2.68, P=0.38) for IRFS, 1.09 (0.59-2.01, P=0.78) for MFS, 1.17 (0.77-1.79, P=0.47) for CSS, 1.50 (0.90-2.48, P=0.12) for OS and 1.61 (1.03-2.51, P=0.04) for RFS. Conclusions: On the whole, kidney-sparing management had equivalent prognostic effect on upper tract urothelial carcinoma as the standard nephroureterectomy except in tumor recurrence. However, the results should be interpreted with caution for lack of stage and grade stratification and multi-center randomized controlled trials are still needed to verify our results.

A Systematic Review of Randomized Controlled Trials on Acupuncture Treatment for Low Back Pain Based on FEAS (요통에 대한 침치료 무작위대조군임상연구(RCT)의 FEAS 분석을 통한 계통적 분석 연구)

  • Nam, Dong-Woo;Kang, Jung-Won;Kim, Eun-Jung;Kim, Hyun-Wook;Song, Ho-Sueb;Kim, Sun-Woong;Kim, Kap-Sung;Lee, Geon-Mok;Choi, Dong-Young;Lee, Jae-Dong
    • Journal of Acupuncture Research
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    • v.26 no.3
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    • pp.133-147
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    • 2009
  • Objectives : To review RCTs on acupuncture treatment for low back pain in order to establish a standard acupuncture treatment model in treating low back pain. Methods : RCT articles on traditional acupuncture treatment for low back pain were searched through online database. Study Quality was assessed using the FEAS. Results : Ten out of the one hundred six articles searched were reviewed. Among the ten articles reviewed, six articles compared acupuncture treatment with no treatment or non-penetrating sham acupuncture. All six articles concluded significantly positive effect of acupuncture compared to the control. Conclusions : The ideal acupuncture treatment model for low back pain was obtained as follows. A sterile disposable stainless steel(0.30mm${\times}$40mm) should be inserted to more than six acupuncture points on the BL, GV and GB meridians such as $BL_23$, $BL_25$, $BL_40$, $BL_60$, $GV_4$ and $GB_30$. Sparrow pecking method to obtain 'de-qi' is recommended and repeated stimulation during the 20 minute retention time is necessary. Ideal treatment frequency would be more than one a week for about 7 weeks.

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