• Title/Summary/Keyword: Randomized Clinical Trials

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Recent Evidence and Initial Experiences of Transcatheter Edge-to-Edge Repair of the Mitral Valve in South Korea

  • Hong, Sung-Jin;Kim, Jung-Sun;Hong, Geu-Ru
    • Journal of Chest Surgery
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    • v.54 no.3
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    • pp.165-171
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    • 2021
  • As a percutaneous technique for the reduction of mitral regurgitation, the MitraClip system (Abbott Vascular, Abbott Park, IL, USA) for transcatheter edge-to-edge repair of the mitral valve was developed in 1998 and first used in 2003. Its main advantage is being less invasive than surgery, because it can be performed through a transcatheter approach without any hemodynamic compromise. Recent studies have shown that this procedure reduces symptoms and improves functional capacity with low complication rates. Two randomized clinical trials have investigated the use of this technique for functional mitral regurgitation. The Korean Ministry of Food and Drug Safety approved its use for degenerative mitral regurgitation in 2019, and this procedure started to be performed in Korea in January 2020. Its use for functional mitral regurgitation was also approved in Korea in 2020. In this article, recent evidence on transcatheter edge-to-edge repair of the mitral valve and our initial experiences in Korea will be reviewed.

Effectiveness of graded motor imagery in subjects with frozen shoulder: a pilot randomized controlled trial

  • Gurudut, Peeyoosha;Godse, Apurva Nitin
    • The Korean Journal of Pain
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    • v.35 no.2
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    • pp.152-159
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    • 2022
  • Background: Subjects with frozen shoulder (FS) might not be comfortable with vigorous physical therapy. Clinical trials assessing the effect of graded motor imagery (GMI) in FS are lacking. The aim of this study was to determine the effect of GMI as an adjunct to conventional physiotherapy in individuals with painful FS. Methods: Twenty subjects aged 40-65 years having stage I and II of FS were randomly divided into two study groups. The conventional physiotherapy group (n = 10) received electrotherapy and exercises while the GMI group (n = 10) received GMI along with the conventional physiotherapy thrice a week for 3 weeks. Pre- (Session 1) and post- (Session 9) intervention analysis for flexion, abduction, and external rotation range of motion (ROM) using a universal goniometer, fear of movement using the fear avoidance belief questionnaire (FABQ), pain with the visual analogue scale, and functional disability using the shoulder pain and disability index (SPADI) was done by a blinded assessor. Results: Statistically significant difference was seen within both the groups for all the outcomes. In terms of increasing abduction ROM as well as reducing fear of movement, pain, and functional disability, the GMI group was significantly better than control group. However, both groups were equally effective for improving flexion and external rotation ROM. Conclusions: Addition of GMI to the conventional physiotherapy proved to be superior to conventional physiotherapy alone in terms of reducing pain, kinesiophobia, and improving shoulder function for stage I and II of FS.

A Systematic Review and Meta-Analysis of Manual Therapy for Neck Pain Caused by Traffic Accidents (교통사고로 인한 경항통에 적용한 수기요법의 효과: 체계적 고찰 및 메타분석)

  • Kang, Seok-Beom;Shon, Woo-Seok;Kim, Young-Jun;Woo, Chang-Hoon
    • The Journal of Churna Manual Medicine for Spine and Nerves
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    • v.16 no.2
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    • pp.21-28
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    • 2021
  • Objectives To investigate the effectiveness of manual therapy for neck pain caused by traffic accidents. Methods We searched six electronic databases (OASIS, KISS, RISS, NDSL, MEDLINE, and Cochrane Library) to gather randomized controlled trials using the keywords 'manual theray OR chuna OR tuina' and 'whiplash injury OR neck sprain'. Results Eight RCTs were selected based on the inclusion criteria. Four studies were meta-analyses. The systematic review found a positive effect of manual therapy for whiplash injury. All studies showed a high risk of performance bias. Conclusions The systematic review reported favorable results using manual therapy for neck pain caused by traffic accidents. However, this study has several limitations owing to the high risk of bias. Further clinical studies and the development of a study design are required for stronger evidence.

A Literature Review of Treatments of Stomatitis in Korean Medicine (구내염의 한방 치료에 대한 문헌 고찰)

  • Yu-Ra Im;Ho-Jun Jeong
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.36 no.1
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    • pp.110-123
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    • 2023
  • Objectives : The purpose of this study is to investigate the treatments of Stomatitis in Korean medicine. Methods : We reviewed domestic journals through databases on RISS, KISS, OASIS, KISTI to search case reports and follow-up studies about 'Stomatitis' and '口瘡' using the terms with 'Korean medicine' or 'Korean medicine treatment'. Also, we used CNKI to find Randomized controlled trials(RCTs) from Chinese journals by using the term '口腔炎'. Results : A total of 16 articles were searched. Those of 7 are case report, 2 are follow-up study, 7 are RCTs. The way to treat stomatitis were through using herb medicine, acupuncture, electro-acupuncture, herbal acupuncture, external preparation, indirect moxibustion and so on. All papers reported that after Korean medicine treatment, symptoms of stomatitis are relieved. Conclusions : According to these journals, Korean medicine is helpful to treat Stomatitis. In the future, more clinical studies are needed to establish the foundation of Korean medicine to treat stomatitis.

Effect of Vibration Exercise Application on the Trunk Muscle Thickness in Children with Spastic Cerebral Palsy

  • Mun, Dal-Ju;Park, Jae-Chul;Oh, Hyun-Ju
    • The Journal of Korean Physical Therapy
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    • v.34 no.2
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    • pp.68-72
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    • 2022
  • Purpose: This study examined the effect of vibration exercise on the thickness of the oblique extrinsic, oblique abdominal, and biceps muscles, which are trunk muscles, targeting children with spastic cerebral palsy. Methods: The participants in this study were 20 children (8 male and 12 female) with cerebral palsy aged 5-10 years. They were classified into two groups using a randomized allocation method, and the trunk muscle thickness was measured using an ultrasound-imaging device before and six weeks after the experiment. A paired t-test was used for the within-group changes, and an independent t-test was used for the inter-group changes. The significance level was set to α=0.05. Results: There was a significant increase in the inter-group change in the experimental group and control group in the intra-group change in the external oblique muscle and internal oblique muscle. After six weeks, there was a significant increase in the experimental group compared to the control group. Conclusion: Vibration exercise had a positive effect on the trunk muscle thickness of children with cerebral palsy. Vibration exercise produced a significant difference in the changes in the trunk muscle thickness in children with cerebral palsy compared to no vibration exercise. These results may provide basic data for future research and as a training method for strengthening the trunk muscles in clinical trials.

Effectiveness of Electroacupuncture in Patients with Chronic Fatigue Syndrome: A Systematic Review and Meta-analysis

  • Yang, Jaewoo;Shin, Donghoon;Oh, Jihoon;Lim, Jinwoong
    • Journal of Acupuncture Research
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    • v.39 no.3
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    • pp.170-181
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    • 2022
  • This review evaluated the efficacy of electroacupuncture (EA) for chronic fatigue syndrome. Randomized controlled trials (RCTs) using EA as an intervention for patients with chronic fatigue syndrome were identified in 6 databases (PUBMED, EMBASE, CNKI, J-STAGE, KMBASE, OASIS). Fatigue indicators were used as the primary outcome measures. The quality-of-life index, efficiency rate, and level of pain were used as secondary outcome measures. There were 408 patients from seven RCTs included in this study. Meta-analysis showed that EA was significantly associated with fatigue relief compared with the control group (n = 141 SMD = -1.55, 95% CI; -2.58 - -0.52, p = 0.003, I2 = 92%). In addition, EA had a statistically significant improvement in quality of life compared with the control group (n = 176, SMD = -2.29, 95% CI; -3.68 - -0.90, p = 0.001, I2 = 96%). One study reported ten cases of bleeding, however, no serious adverse events were reported in any of the included studies. This review determined that EA may have a greater clinical effect than the control group for fatigue relief and improved quality of life. However, there were several risks of bias identified. Not all of the RCTs accurately reported the research method, all studies were conducted in 1 country (China), and the number of studies included were small.

Effectiveness of methylene blue photosensitizers compared to that of corticosteroids in the management of oral lichen planus: a systematic review and meta-analysis

  • Waingade, Manjushri;Medikeri, Raghavendra S;Rathod, Pooja
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.22 no.3
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    • pp.175-186
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    • 2022
  • This study aimed to systematically review the effectiveness of methylene blue (MB) photosensitizers in the management of symptomatic oral lichen planus (OLP). Electronic online databases and manual searches were performed for randomized controlled trials (RCTs) published in English between January 2010 and February 2022. RCTs comparing photodynamic therapy (PDT) and corticosteroid therapy at baseline and follow-up period were identified. The Cochrane risk of bias tool was used to assess the quality of the included studies. A meta-analysis was performed regarding visual analog scale (VAS) scores, Thongprasom sign scores, lesion size, response to treatment, and exacerbation of lesions after therapy. The clinical severity was analyzed qualitatively. Five RCTs consisting of 180 samples fulfilled the inclusion and exclusion criteria. All parameters of VAS score, Thongprasom sign score, lesion size, and response to treatment were statistically non-significant. Our results indicate that both MB-PDT and corticosteroid therapy are effective for the management of OLP. Moreover, MB-PDT is an effective alternative treatment option for OLP when corticosteroids are contraindicated. However, conclusive evidence cannot be ascertained owing to the heterogeneity among the studies.

Recent Research Analysis in Acupotomy

  • Ji Hoon, Han;Hyang Gi, Lim;Jae Hyung, Kim;Eun Sil, Heo;Ga-Young, Choi;Seong Hun, Choi;Sang Ha, Woo;Jung Hee, Lee;Yun Kyu, Lee;Jae Soo, Kim;Hyun-Jong, Lee
    • Journal of Acupuncture Research
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    • v.40 no.1
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    • pp.1-15
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    • 2023
  • Between May 2014 and April 2022, a total of 926 articles were retrieved from the international database, and a total of 233 articles were retrieved from the Korean database. From there, 14 studies were selected, and evaluated by the published year, terminology of the acupotomy, sample size, disease type, retention time, treatment sites, insertion depth and size of the acupotomy, treatment frequency, and duration, type of acupotomy manipulation method, evaluation index, therapeutic effects, adverse effects, and assessment of the risk of bias in randomized controlled trials. This study examined the need for additional acupotomy studies to secure an objective basis for the application of clinical treatment. Furthermore, the detailed description of the study methods and results and unified terminology can provide evidence for the efficacy of acupotomy.

Fire Acupuncture for Varicose Veins in the Lower Extremities: A Review of Randomized Controlled Trials

  • Onyou Jo;Jiyoon Lee;Sangmin Park;Jaewook Shin;Saerom Choi;Seongyong Choi
    • Journal of Acupuncture Research
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    • v.40 no.3
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    • pp.177-187
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    • 2023
  • Varicose veins have a substantial burden on individuals' aesthetics and overall quality of life. The current body of research on Korean medical interventions for varicose veins is limited in Korea, and exploration into clinical trends is lacking. This review specifically analyzed fire acupuncture, which is an understudied intervention in Korea that demonstrated efficacy in alleviating pain and paralysis while promoting tissue regeneration. A comprehensive investigation of the China National Knowledge Infrastructure database was conducted, utilizing terms such as "varicose vein," "fire needle," "fire acupuncture," "burning acupuncture," "burning needle," "huǒzhēn," "xiàzhī jìngmài," and "jìngmài qūzhāng." This review included 14 studies investigating the role of fire acupuncture in treating varicose veins. We extracted variables, including age, sex, disease duration, intervention method, treatment frequency, treatment period, acupoints, and outcomes. Fire acupuncture appeared as the primary intervention method, followed by general acupuncture. The protruding part of varicose veins is the main treatment area for fire acupuncture, while the acupoints BL57 and ST36 were most frequently utilized for general acupuncture. Treatment results revealed significant improvement in all studies. However, there are limitations, such as scarce studies, limited side effects studies, and potential bias. Consequently, extensive and well-structured future studies are necessary to demonstrate the role of fire acupuncture in varicose veins.