• Title/Summary/Keyword: Randomized Controlled Clinical Trials

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Impact of Transcranial Direct Current Stimulation Combined With Constraint-Induced Movement Therapy on Upper Limb Function in Chronic Stroke: A Systematic Review (뇌졸중 환자의 상지기능 향상을 위한 경두개 직류 자극과 강제 유도 운동 치료의 결합 중재 효과에 대한 체계적 고찰)

  • Kim, Sun-Ho
    • Therapeutic Science for Rehabilitation
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    • v.8 no.4
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    • pp.7-18
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    • 2019
  • Objective : This systematic review aimed to investigate the impact of transcranial direct current stimulation combined with constraint-induced movement therapy (CIMT) in patients with stroke Methods : PubMed and NDSL databases were employed to review literature published between January 2009 and December 2018. The main search terms were "Transcranial direct current stimulation" or "tDCS," "Constraint-induced movement therapy" or "CIMT," "Upper extremity function," "Upper limb," and "Stroke." Based on the inclusion and exclusion criteria, 6 articles were selected. Furthermore, intervention effects on upper extremity function, activities of daily living, and cortical activity were assessed. Results : The current intensity, application time, and protocol of the CIMT varied the between studies. However, the intervention procedures to perform CIMT immediately after transcranial direct current stimulation was the same. Transcranial direct current stimulation combined with CIMT was effective in improving upper limb function and activities of daily living in patients with stoke and had a significant effect on cerebral cortex activation. Conclusions : This study provides information on transcranial direct current stimulation combined with CIMT for use by clinical therapists. Further studies are needed to standardize the stimulation time, current intensity, and electrode attachment position. Furthermore, randomized controlled trials, including long-term follow up, are needed for larger populations using the most appropriate CIMT protocol.

A Review on Domestic Study Trends on Hot Flush in Menopausal Women with Traditional Korean Medicine (갱년기 여성의 안면홍조 증상에 대한 국내 한의학 연구 동향 분석)

  • Hong, Noo-Ri;Jang, Yeong-Suk;Yang, Su-Hyeon;Choi, Yun-Young;Oh, Da-Yoon;Lee, Soo-Jin;Namgoong, Jin;Kim, Jin-Hwan
    • The Journal of Korean Obstetrics and Gynecology
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    • v.33 no.1
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    • pp.86-103
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    • 2020
  • Objectives: The purpose of this study is to analyse the domestic trends of Traditional Korean Medicine on Hot flush in menopausal women. Methods: We searched six databases and selected relevant papers according to the criteria. Results: 12 papers included case report, literature review, randomized controlled clinical trials (RCTs), Non-RCTs, and retrospective chart analysis study design. 1. The daily diary, Kupperman's Index, Menopause Rating Scale, Menopause-specific Quality of Life Questionnaire, Digital Infrared Thermographic Imaging were used as a measure of the symptoms of hot flush. 2. There were significant correlations between Thermographic images, Pulse energy, Lifestyle Habits, Low frequency power/High frequency power (LF/HF) ratio and certain items of Menopausal Symptoms Measurement. 3. The case report using Er-Xian decoction and Hwangryunhaedoktang-Gamibang showed significant effect. 4. Domestic RCT studies using herbal or acupuncture treatments showed a significant value of 3.4 on average in the quality assessment conducted in the study. However, the number of domestic studies included was five, which is not enough compared to foreign countries. Conclusions: This study examined domestic research trends on hot flushes of menopausal women and found that various evaluation tools and diagnostic methods were applied. It is necessary to conduct various RCT studies in Korea, where the number of studies is insufficient compared to overseas.

Efficacy of alpha-lipoic acid in patients with burning mouth syndrome compared to that of placebo or other interventions: a systematic review with meta-analyses

  • Christy, Jessica;Noorani, Salman;Sy, Frank;Al-Eryani, Kamal;Enciso, Reyes
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.22 no.5
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    • pp.323-338
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    • 2022
  • Burning mouth syndrome (BMS) is a chronic oral disorder of unknown etiology which presents therapeutic challenges. Alpha-lipoic acid (ALA) has been studied as a potential treatment for BMS. The objective of this systematic review and meta-analysis was to evaluate the effectiveness of ALA compared to that of placebo or other interventions in individuals with BMS. Randomized controlled trials (RCT) using ALA to treat BMS were identified from MEDLINE, Cochrane Library, EMBASE, and Web of Science up to February 3, 2021. The assessment of the risk of bias in the included studies was based on the Cochrane guidelines. The primary outcome evaluated was the visual analog scale (VAS) pain intensity. ALA was compared with placebo, clonazepam, gabapentin, pregabalin, ALA plus gabapentin, capsaicin, Biotène®, and laser therapy. Altogether, 137 records were scanned for inclusion/exclusion, and nine RCTs (two unclear and seven at high risk of bias) were included in the qualitative and quantitative analyses, with a total of 594 patients with BMS included in this review. All studies reported an improvement in VAS pain scores ranging from -0.72 to -2.77. Meta-analysis results showed a non-significant reduction in pain intensity for ALA (P = 0.616) compared to that of placebo on a VAS of 0-10. Patients taking ALA were 1.923 times more likely to show an improvement in self-reported BMS symptoms (P = 0.031) than those in the placebo group. Clonazepam and pregabalin showed a significant VAS pain reduction of 4.08 and 4.68 (P < 0.001), respectively, compared to that with ALA. Although ALA intervention provided a non-significant improvement in the pain score and was more likely to produce a reduction in BMS symptoms, the evidence was of low quality. Further research is needed to establish clear guidelines for the use of ALA for BMS treatment.

The effectiveness and safety of acupuncture combination treatment on smoking cessation: A protocol for systematic review (금연에 대한 침술 병용 치료의 효과 및 안전성 : 체계적 검토를 위한 프로토콜)

  • In Suh Choi;Won-Suk Sung;Min-gi Jo;Jung-Hyun Kim;Yeon-Cheol Park;Eun-Jung Kim;Yong-Hyeon Baek;Geun-Woo Kim;Byung-Kwan Seo
    • Journal of Convergence Korean Medicine
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    • v.3 no.1
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    • pp.5-13
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    • 2022
  • Objectives: Smoking had a long negative impact on public health. The ingredients of a cigarette are major risk factors for several diseases. Owing to the problems about economic and quality of life, we need to ensure smoking cessation (SC). There are several approaches for SC including pharmacological therapy, nicotine replacement therapy, education, and behavioral intervention. However, due to some limitations, other alternative approaches are gaining popularity. Acupuncture has been reported to have few side effects and be more effective than some conventional treatments in several articles. However, there are no systematic reviews on the comparison of acupuncture combination treatment with other conventional monotherapies. Methods: Randomized controlled trials that used acupuncture as an adjunct treatment for SC will be searched and data will be summarized according to the predefined criteria. The primary outcome will be the abstinence rate, and secondary outcomes will be adverse events and biochemical indicators. We will use Review Manager to perform a meta-analysis, Cochrane Collaboration Risk of Bias tool for the risk of bias assessment, and the Grades of Recommendation, Assessment, Development and Evaluation approach to determine the quality of evidence. We will investigate the efficacy and safety of acupuncture combination treatment for SC with this study. Ethics and dissemination: This study will provide reliable clinical evidence on additional effect of acupuncture on smoking cessation. We will publish our results in a peer-review journal.

Analysis of Research Trends in Traditional Chinese Medicine Treatments for Pes Anserine Bursitis from 2014 to 2024: Using the Search Results of China National Knowledge Infrastructure (거위발 점액낭염의 중의학적 치료에 대한 2014-2024년도의 연구 동향 분석: China National Knowledge Infrastructure를 중심으로)

  • Ja-Yean Son;Seok-Gyu Yang;Hea-Ju Kim;Seol Jung;Dong-Gyu Kim;Young-Hoon Lee;Kangmoo Goo;Na-young Kim;Dong Hwan Lee;Yu-Ra Im;Hyun-Woo Cho
    • Journal of Korean Medicine Rehabilitation
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    • v.34 no.2
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    • pp.135-147
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    • 2024
  • Objectives The aim of this study is to investigate the research trends in traditional Chinese medicine (TCM) treatment for pes anserine bursitis using the search results from the China National Knowledge Infrastructure (CNKI). Methods We searched for clinical studies on pes anserine bursitis in the CNKI electronic database. We analyzed the publication year, study type, participant demographics, treatment methods and duration, evaluation criteria, adverse events, and the results of each article. Results Seventeen studies published from January 1, 2014 to January 1, 2024 were selected. Among the 17 selected studies, 14 were randomized controlled trials and 2 were case reports. The most frequently used treatment intervention was acupuncture. Nine types of acupuncture were identified, including electro-acupuncture, pharmacopuncture, acupotomy, floating acupuncture, and other new types of acupuncture. The most commonly used evaluation outcome was effective rate. Conclusions Various TCM treatments for pes anserine bursitis were introduced, and we could identify the effectiveness of TCM in treating pes anserine bursitis. However, it is anticipated that more well-designed and high-quality evaluation studies will be required in the future.

Cognitive Function Effects of Acupuncture Treatment for Mild Cognitive Impairment : Systematic Literature Review and Meta-Analysis (경도인지장애 침치료 인지기능효과 : 체계적 문헌고찰 메타분석)

  • Won Soon Kim
    • Journal of Society of Preventive Korean Medicine
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    • v.28 no.2
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    • pp.151-164
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    • 2024
  • Objectives : Using MMSE and MoCA cognitive tools, this study tried to measure the effect of acupuncture differing by cognitive types. Through the method of PRISMA literature review, this study aimed to understand and improve the acupuncture's effectiveness in its application. Methods : The research method was a literature review and Cochrane meta-analysis of papers on the effectiveness of acupuncture treatments for mild cognitive impairment conducted from 2012 to 2023. The Cochrane risk of bias (RoB) tool was used as a quality analysis tool, and the meta-analysis tool was Cochrane RevMan V5.4.1 software. Results : As a result of the study, a total of 967 subjects were used for analysis, and 16 papers on randomized acupuncture trials were analyzed. The results are as follows: As a result of meta-analysis of acupuncture intervention for mild cognitive impairment, the MMSE score had an average of 1.61 with a 95% confidence interval ranging from 0.14 to 3.07, and a statistically significant result with p<0.001. The Z-score was 2.15, which corresponded to a p-value of 0.03. The MoCA score had an average range between 0.39 and 2.49, also showing statistical significance with p<0.001, and a Z-score of 2.70 (p=0.007). The effect of acupuncture in subjects with mild cognitive impairment was significant. Conclusion : The suggestions and conclusion indicate that acupuncture intervention has a significant effect on mild cognitive impairment. This study propose future experimental research on various types of acupuncture interventions for mild cognitive impairment. The significance of this study is that it presented basic data for the development of a preventive convergence cognitive intervention program for patients with mild cognitive impairment in the community.

NEW ANTIDEPRESSANTS IN CHILD AND ADOLESCENT PSYCHIATRY (소아청소년정신과영역의 새로운 항우울제)

  • Lee, Soo-Jung
    • Journal of the Korean Academy of Child and Adolescent Psychiatry
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    • v.14 no.1
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    • pp.12-25
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    • 2003
  • Objectives:As increasing number of new antidepressants have been being introduced in clinical practice, pharmacological understanding has been broadened. These changes mandate new information and theories to be incorporated into the treatment process of children with depressive disorders. In light of newly coming knowledge, this review intended to recapitulate the characteristics of new antidepressants and to consider the pivotal issues to develope guidelines for the treatment of depression in childhood and adolescence. Methods:Searching the Pub-Med online database for the articles with the key words of 'new', 'antidepressants' and 'children' ninety-seven headings of review articles were obtained. The author selected the articles of pertinent subjects in terms of either treatment guideline or psychopharmacology of new antidepressants. When required, articles about the clinical effectiveness of individual antidepressants were separatedly searched. In addition, the safety information of new antidepressants was acquired by browsing the official sites of the United States Food and Drugs Administration and Department of Health and Human Services. Results:1) For the clinical course, treatment phase, and treatment outcome, the reviews or treatment guidelines adopted the information from adult treatment guidelines. 2) Systematic and critical reviews unambiguously concluded that selective serotonin reuptake inhibitors(SSRIs) excelled tricyclic antidepressants( TCAs) for both efficacy and side effect profiles, and were recommend for the first-line choice for the treatment of children with depressive disorders. 3) New antidepressants generally lacked treatment experiences and randomized controlled clinical trials. 4) SSRIs and other new antidepressants, when used together, might result in pharmacokinetic and/or pharmacodynamic drug-to-drug interaction. 5) The difference of the clinical effectiveness of antidepressants between children and adults should be addressed from developmental aspects, which required further evidence. Conclusion:Treatment guidelines for the pharmacological treatment of childhood and adolescence depression could be constructed on the basis of clinical trial findings and practical experiences. Treatment guidelines are to best serve as the frame of reference for a clinician to make reasonable decisions for a particular therapeutic situation. In order to fulfill this role, guidelines should be updated as soon as new research data become available.

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Economic Value of the Sirolimus Eluting Stent($CYPHER^{TM}$) in Treating Acute Coronary Heart Disease (관상동맥질환 치료를 위한 시롤리무스 방출 스텐트 ($CYPHER^{TM}$)의 경제성 분석)

  • Lee, Hoo-Yeon;Park, Eun-Cheol;Park, Ki-Dong;Park, Ji-Eun;Kim, Young;Lee, Sang-Soo;Kang, Hye-Young
    • Journal of Preventive Medicine and Public Health
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    • v.36 no.4
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    • pp.339-348
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    • 2003
  • Objective : To quantify the economic value of the Sirolimus fluting Stent ($CYPHER^{TM}$) in treating acute coronary heart disease (CMD), and to assist in determining an adequate level of reimbursement for $CYPHER^{TM}$ in Korea. Methods : A decision-analytical model, developed by the Belgium Health Economics Disease Management group, was used to investigate the incremental cost-effectiveness of $CYPHER^{TM}$ versus conventional stenting. The time horizon was five years. The probabilities for clinical events at each node of the decision model were obtained from the results of large, randomized, controlled clinical trials. The initial care and follow-up direct medical costs were analyzed. The initial costs consisted of those for the initial procedure and hospitalization, The follow-vp costs included those for routine follow-up treatments, adverse reactions, revascularization and death. Defending on the perspective of the analysis, the costs were defined as insurance covered or total medical costs (=sum of insurance covered and uncovered medical costs). The cost data were obtained from the administrative data of 449 patients that received conventional stenting from five participating Korean hospitals during June 2002. Sensitivity analyses were peformed for discount rates of 3, 5 and 7%. Since the major clinical advantage of $CYPHER^{TM}$ over conventional stenting was the reduction in the revascularization rates, the economic value of $CYPHER^{TM}$, in relation to the direct medical costs of revascularization, were evaluated. If the incremental cost of $CYPHER^{TM}$ per revascularization avoided, compared to conventional stenting, was no higher than that of a revascularization itself, $CYPHER^{TM}$ would be considered as being cost-effective. Therefore, the maximum acceptable level for the reimbursement price of $CYPHER^{TM}$ making the incremental cost-effectiveness ratio equal to the cost of a revascularization was identified. Results : The average weighted initial insurance covered and total medical costs of conventional stenting were about 6,275,000 and 8,058,000 Won, respectively. The average weighted sum of the initial and 5-year follow-up insurance covered and total medical costs of conventional stenting were about 13,659,000 and 17,353,000 Won, respectively. The estimated maximum level of reimbursement price of $CYPHER^{TM}$ from the perspectives of the insurer and society were $4,126,897{\sim}4,325,161$ and $4,939,939{\sim}5,078,181$ Won, respectively. Conclusion : By evaluating the economic value of $CYPHER^{TM}$, as an alternative to conventional stenting, the results of this study are expected to provide a scientific basis for determining the acceptable level of reimbursement for $CYPHER^{TM}$.

Literature review and future tasks necessary to establish of Korean Dietary Reference Intake for choline (콜린의 한국인 영양소 섭취기준 제정 검토를 위한 문헌 고찰 및 향후 과제)

  • Shim, Eugene;Park, Jae-Hee;Lee, Yunjung;Park, Eunju
    • Journal of Nutrition and Health
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    • v.55 no.2
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    • pp.211-226
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    • 2022
  • Choline, an essential nutrient for humans, is required for the structural integrity of the cell membranes, methyl-group metabolism, synthesis of the neurotransmitter acetylcholine, synthesis of the membrane phospholipid components of the cell membranes, and the transport of lipids and cholesterol. Choline can be synthesized in the body, but it is insufficient to meet the daily requirements and hence it must be obtained through the diet. In the United States/Canada, Australia/New Zealand, Europe, China, and Taiwan, the adequate intake (AI) and tolerable upper intake level (UL) of choline have been established, while the establishment of the 2020 Dietary Reference Intakes for Koreans (KDRI) for choline was postponed due to the lack of a choline database for Korean foods and studies on the choline intake of Koreans. However, as part of the preparation work for the 2020 DRI revision and finalization, choline intake and the possibility of disease occurrence were verified through analysis of published data. The groundwork for the subsequent establishment of a choline DRI was laid through a literature search, evaluation, and review of the literature reported from 1949 up to 2019. This can be regarded as the culmination of this project. According to the results of randomized controlled trials (RCTs), cohort studies, case-control studies, and cross-sectional observational studies in humans, approximately 400-500 mg/day of choline intake was effective in preventing liver function damage (fatty liver), neural tube damage, cardiovascular disease, breast cancer, and cognitive function improvement. The same amount of choline intake, however, also correlated with the risk of prostate and colorectal cancer. At present, there is limited information available on choline intake and health outcomes, particularly for the Korean population. More human studies, including clinical trials on the requirements and the physiological benefits associated with dietary intake, are needed to establish the KDRI for choline.