• Title, Summary, Keyword: RCT

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The Effect of Moxibustion Treatment for Cardiac Arrhythmia : A Systematic Review (부정맥의 뜸 치료 효과에 대한 체계적 문헌고찰)

  • Lee, Bora;Hwang, Juyeong;Kwon, Jungnam
    • The Journal of Korean Medicine
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    • v.40 no.3
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    • pp.99-111
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    • 2019
  • Objectives: The purpose of this study was to assess the effects of moxibustion treatment for Cardiac arrhythmia through a systematic review. Methods: Electronic database including Cochrane library, Pubmed, China National Knowledge Infrastructure, Embase, DBpia, and Korean studies Information Service System were searched by combining the keywords such as "arrhythmias", "cardiac arrhythmias", "心律失常", "moxibustion" and "艾灸". Through the searching, 5 randomized controlled trials(RCTs) were included except animal testing and cellular experiment etc. The quality of each RCTs was assessed using the Cochrane risk of bias tool. Results: We included 5RCTs involving 468 participants. Two RCTs compared moxibustion versus conventional treatment, another RCT compared moxibustion plus acupuncture versus conventional treatment, another RCT compared moxibustion plus herbal medicine verus conventional treatment, the other RCT compared moxibustion plus herbal medicine and ointment versus conventional treatment. These studies were evaluated by the efficacy rate of treatments. Studies measured outcomes in efficacy, heart rate, electrocardiogram and symptoms. Each of 5 trials statistically showed a significant differences in efficacy rate. One study reported about side effects and another study reported about complications. The overall risk of bias was unclear in 5 studies. Conclusions: The evidence suggests that moxibustion treatment may help to reduce cardiac arrhythmia, however, it is limited, low-certainty and we cannot rule out benefits or risks with this treatment. High-quality studies that report adverse effects are needed.

A Systematic Review of Clinical Studies on the Effects of Acupuncture on Anxiety Disorders (불안장애에 대한 침 치료 임상 연구의 체계적 고찰)

  • Kim, Kyeong-Ok;Kim, Cheon-Jung;Seo, Sang-Il;Kim, Nam-Yeol;Kim, Geun-Woo
    • Journal of Oriental Neuropsychiatry
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    • v.28 no.3
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    • pp.249-262
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    • 2017
  • Objectives: The aim of this study was to investigate the clinical studies which focus on acupuncture's effect on anxiety disorder. Methods: We selected clinical studies through six databases. We then examined the characteristics of the selected studies and conducted an assessment for Risk of Bias (ROB). Results: Seventeen randomized-controlled trials were selected to determine the effects of acupuncture on anxiety disorders. We found that the risk of bias in most studies was unclear. The intervention of 7 seventeen randomized-controlled trials (RCT) was basic acupuncture, 8 RCT involved electric acupuncture, 2 RCT consisted of acupuncture and Moxibustion. Four of the 7 basic acupuncture RCTs and 5 of the 8 electric acupuncture RCTs had a significant effect on anxiety factors for anxiety disorders. Conclusions: Acupuncture treatment for anxiety disorders was found to be effective compared to the controls, or there was no difference in effectiveness compared to the controls. However, the quality of the included studies was low, and there only were a small number of studies. Therefore, well-designed studies and a greater number of the studies are needed.

The Effectiveness of Moxibustion Treatment for Primary Dysmenorrhea: A Systematic Review and Meta-Analysis (원발성 월경곤란증의 뜸 치료에 대한 체계적 문헌고찰 및 메타분석)

  • Lee, Hye-In;Baek, Seon-Eun;Lee, Ho-Jung;Park, Kyoung-Sun;Lee, Jin-Moo;Yoo, Jeong-Eun
    • The Journal of Korean Obstetrics and Gynecology
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    • v.30 no.2
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    • pp.107-119
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    • 2017
  • Objectives: The purpose of this study is to investigate the effectiveness of moxibustion for primary dysmenorrhea (PD). Methods: We searched 10 electronic databases (CNKI, WANFANG, VIP, AMED, CiNii, Embase, PubMed, Cochrane, OASIS, Korea Traditional Knowledge Portal) to identify eligible studies published before November 2016. We included randomized controlled clinical trials (RCTs) using moxibustion for primary dysmenorrhea. The methodological quality of each RCT was assessed by the Cochrane risk of bias tool. Results: Ten RCT studies were eligible in our review. The overall risk of bias was evaluated as unclear. The meta-analysis of 4 trials indicated that favorable results for the use of moxibustion. Conclusions: This systematic review and meta-analysis of clinical trials suggests that moxibustion can achieve good efficacy for PD patients. However, because of studies included analysis was biased due to unclear risk of bias and unreliable study design, future high-quality RCT studies are needed to determine the association moxibustion with PD.

Using of the "Consolidated Standards of Reporting Trials:CONSORT" to heighten quality of Medical Education study (의학교육연구의 질을 향상시키기 위한 '연구보고의 표준' 의 활용)

  • Yoo, Ji-Soo
    • Korean Medical Education Review
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    • v.10 no.2
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    • pp.25-44
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    • 2008
  • Objectives: Through using of the strong research method like a Randomized Controlled Trial: RCT, we have to heighten quality of Medical Education study. I'd like to introduce "CONSORT", which stands for Consolidated Standards of Reporting Trials. Contents: Preventive Service Task Force(200l) in USA proposed Levels of evidence for enlarging evidence-based Practice: EBP. And the CONSORT was introduced, which encompasses various initiatives developed by the CONSORT Group to alleviate the problems arising from inadequate reporting of randomized controlled trials (RCTs). the CONSORT has 13 guides like these: 1. How participants were allocated to interventions 2. Scientific background and explanation of rationale 3. Eligibility criteria for participants. The settings and locations where the data were collected. 4. Precise details of the interventions intended for each group and how and when they were actually administered 5. Specific objectives and hypotheses 6. Clearly defined primary and secondary outcome measures, When applicable. any methods to enhance the quality of measurements (e.g., multiple observations, training of assessors) 7. How sample size was determined. When applicable, explanation of any interim analyses and stopping rules 8. Method used to generate the random allocation sequence, Details of any restriction [of randomization] 9. Method used to implement the random allocation sequence 10. Who generated the allocation sequence, who enrolled participants. and who assigned participants to their groups 11. Whether or not participants, those administering the interventions, and those assessing the outcomes were blinded to group assignment. If done, how the success of blinding was evaluated 12. Statistical methods used to compare groups for primary outcome(s), Methods for additional analyses, such as subgroup analyses and adjusted analyses 13. Flow of participants through each stage (a diagram is strongly recommended) Specifically, for each group report the numbers of participants randomly assigned. receiving intended treatment, completing the study protocol. and analyzed for the primary outcome. Results and Conclusion: Randomized Controlled Trial: RCT guided of CONSORT will contribute to do stronger evidence-based medical studies.

Effects of Cognitive Behavioral Therapy on Attention Deficit Hyperactivity Disorder among School-aged Children in Korea: A Meta-Analysis (한국 학령기 ADHD 아동을 위한 인지행동중재의 효과 연구: 메타분석)

  • Park, Wan-Ju;Park, Shin-Jeong;Hwang, Sung-Dong
    • Journal of Korean Academy of Nursing
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    • v.45 no.2
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    • pp.169-182
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    • 2015
  • Purpose: This study was a meta-analysis designed to identify effects of Cognitive Behavioral Therapy (CBT) interventions in alleviating main symptoms of Attention Deficit Hyperactivity Disorder (ADHD) among school-aged children in Korea. Methods: Examination of several databases including Research Information Sharing Service, Korean Studies Information Service System, Data Base Periodical Information Academic and hand-searched article references, resulted in identification of 1,298 studies done between 2000 and 2013 of which 21 met the inclusion criteria. Comprehensive Meta-Analysis version 2.0 was used to analyze effect sizes, explore possible causes of heterogeneity, and check publication bias with a funnel plot and its trim-and-fill analysis. Results: Overall effect size of CBT intervention was large (g=1.08) along with each outcome of self-control (g=1.26), lack of attention (g=1.02), social skills (g=0.92), and hyperactivity (g=0.92). For heterogeneity, moderator analysis was performed, but no significant differences were found between the RCT (Randomized Controlled Trials) group and the NRCT (Non RCT) group. Also, meta-regression was performed using sample size, number of sessions, and length of session as predictors, but no statistically significant moderators were found. Finally, a funnel plot along with trim-and-fill analysis was produced to check for publication bias, but no significant bias was detected. Conclusion: Based on these findings, there is clear evidence that CBT intervention has significant positive effects on the main symptoms of school-aged children suffering ADHD. Further research is needed to target diverse age groups with ADHD along with more RCT studies to improve the effectiveness of the CBT intervention.

The Review of Clinical Studies Published in The Journal of Korean Medical Ophthalmology & Otolaryngology & Dermatology (한방안이비인후피부과학회지에 게재된 임상실험연구에 대한 고찰)

  • Kim, Chul-Yun;Seo, Hyung-Sik;Kim, Nam-Kwen;Lee, Dong-Jin;Kwon, Kang
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.27 no.4
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    • pp.1-15
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    • 2014
  • Objective : This study was carried out to analyze the quality and quantity of Clinical Trials that have been published in the journal of korean medical ophthalmology, otolaryngology, dermatology(JKOOD). Methods : We analyzed 25 clinical trials that published in JKOOD from 1988 to 2014. We excluded case reports, protocol and retrospective studies and classified searched papers into three categories; Randomized Clinical Trials(RCT), Non Randomized Clinical Trials(NRCT), Before After Study(BAS) by using study Design Algorithm for Medical literature of Intervention(DMAI). All articles were analyzed according to diagnosis, statistics program and intervention period. The bias of RCTs were evaluated by Cochrane Risk of Bias(RoB). Result : 1. The number of searched journals is 25 papers; 13 RCT, 2 NRCT, 10 BAS 2. Distribution of clinical trial; 'Atopic dermatitis' ranked the highest(44%) in disease, 'External application' raked the highest(71%) in treatment method. 3. 'allocation sequence' and 'prevention of allocated intervent to patients and therapists' are graded 'Low' but 'incomplete outcome date' and 'selective outcome' are graded 'Uncertain'. Conclusions : It is necessary to study more RCT. It will be helpful to study systematic reviews and meta analysis in JKOOD.

Effects of High Polyunsaturated Fat Diet on Human Plasma Cholesterol Esterification and Transfer (고 불포화 지방산 식이가 인체 혈청 Cholesterol의 Esterification과 Transfer에 미치는 영향)

  • Lee Myoung Sook
    • Journal of Nutrition and Health
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    • v.26 no.7
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    • pp.819-828
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    • 1993
  • The reaction of lecithin cholesterol acyltransferase(LCAT) and cholesteryl ester transfer protein (CETP) are important in cholesterol esterification and transfer for the reverse cholesterol transport(RCT) system. The purpose of this study were to assess the effects of fatty acid unsaturation on RCT system. After 12 female human subjects consumed a prescribed high saturated fat diet prior to the period, two groups of six subjects were provided with a high PUFA(corn oil) or a high SFA(butter) as major fats in a 40 en % fat diet. Butter feeding increased plasma total-(34%), esterified-(96%), HDL_3$-(23%), LDL-(20%), and VLDL plus LDL(35%) cholesterol while corn oil feeding decreased esterified-(25%), LDL(15%) cholesterol and TG(27%). There were significant differences of fats on total-(p=0.0001), esterified-(p=0.0001), total HDL-(p=0.005), $HDL_2$-(p=0.01)and LDL-(p=0.0001) cholesterol. LCAT activity did not change during the period but highly correlated to apo A-I in HDL which was increased in the corn oil group. The 2.5 fold increased CETP activity in the butter group during the period might be related to changes in plasma VLDL plus LDL cholesterol level which were increased in the butter group.

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Acupuncture Experience in Patients with Chronic Low Back Pain(2): A Qualitative Study - Focused on Participants in Randomized Controlled Trial (만성 요통 환자의 침 치료 경험(2): 질적 연구 - 무작위 대조군 연구 피험자를 대상으로)

  • Kim, Song-Yi;Lee, Kee-Byoung;Lee, Hyangsook;Son, Haeng-Mi;Song, Mi-Yeon;Lee, Hyejung;Park, Hi-Joon
    • Korean Journal of Acupuncture
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    • v.29 no.4
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    • pp.581-597
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    • 2012
  • Objectives : To explore the experiences of patients with chronic low back pain(CLBP) in a randomized controlled trial(RCT) of acupuncture. Methods : Five qualitative focus group interviews were conducted at three Korean Medicine Hospitals. Two to 4 participants from the same group(real or sham acupuncture) in the RCT of acupuncture for CLBP discussed their experiences and perceptions of the clinical trial and the acupuncture treatment. Transcribed data were read independently by researchers and analyzed to categorize information and identify themes. Results : A total of 14 participants were included. Most of them discovered positive aspects of being a study subject and a patient. They recognized the differences between experimental and real-world clinical settings such as formal procedures of treatment, and different acupuncture device. Participants also expressed the weaker sensation of acupuncture compared to the previous experience. Especially, they were well aware of the 'subjects' role themselves, thus they observed their changes of symptom closely. As subjects were generally satisfied with their treatment and they had a good feeling to acupuncture after the trial, they expressed their willingness to participate in the future clinical trial of acupuncture. Conclusions : Our finding suggests that the Korean patients' experience of participating in an RCT was generally positive. Their tendency to perform the 'subject' role might affect the trial's process or overall results.

A Randomized Controlled Trial Comparing Clinical Outcomes and Toxicity of Lobaplatin- Versus Cisplatin-Based Concurrent Chemotherapy Plus Radiotherapy and High-Dose-Rate Brachytherapy for FIGO Stage II and III Cervical Cancer

  • Wang, Ji-Quan;Wang, Tao;Shi, Fan;Yang, Yun-Yi;Su, Jin;Chai, Yan-Lan;Liu, Zi
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.14
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    • pp.5957-5961
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    • 2015
  • Background: We designed this randomized controlled trial (RCT) to assess whether lobaplatin-based concurrent chemotherapy might be superior to cisplatin-based concurrent chemotherapy for FIGO stage II and III cervical cancer in terms of efficacy and safety. Materials and Methods: This prospective, open-label RCT aims to enroll 180 patients with FIGO stage II and III cervical cancer, randomly allocated to one of the three treatment groups (cisplatin $15mg/m^2$, cisplatin $20mg/m^2$ and lobaplatin $35mg/m^2$), with 60 patients in each group. All patients will receive external beam irradiation (EBRT) and high-dose-rate intracavitary brachytherapy (HDR-ICBT). Patients in cisplatin $15mg/m^2$ and $20mg/m^2$ groups will be administered four cycles of $15mg/m^2$ or $20mg/m^2$ cisplatin intravenously once weekly from the second week to the fifth week during EBRT, while patients inthe lobaplatin $35mg/m^2$ group will be administered two cycles of $35mg/m^2$ lobaplatin intravenously in the second and fifth week respectively during pelvic EBRT. All participants will be followed up for at least 12 months. Complete remission rate and progression-free survival (PFS) will be the primary endpoints. Overall survival (OS), incidence of adverse events (AEs), and quality of life will be the secondary endpoints. Results: Between March 2013 and March 2014, a total of 61 patients with FIGO stage II and III cervical cancer were randomly assigned to cisplatin $15mg/m^2$ group (n=21), cisplatin $20mg/m^2$ group (n=21) and lobaplatin $35mg/m^2$ group (n=19). We conducted a preliminary analysis of the results. Similar rates of complete remission and grades 3-4 gastrointestinal reactions were observed for the three treatment groups (P=0.801 and 0.793, respectively). Grade 3-4 hematologic toxicity was more frequent in the lobaplatin group than the cisplatin group. Conclusions: This proposed study will be the first RCT to evaluate whether lobaplatin-based chemoraiotherapy will have beneficial effects, compared with cisplatin-based chemoradiotherapy, on complete remission rate, PFS, OS, AEs and quality of life for FIGO stage II and III cervical cancer.