• Title/Summary/Keyword: Controlled clinical trials

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Review of Clinical Research on Effect of Traditional Chinese Medicine for Febrile Seizure (열성 경련에 대한 중의학 임상 연구 동향 - RCT를 중심으로 -)

  • Lee, Bo Ram;Lee, Eun Ju;Lee, Ji Hong;Chang, Gyu Tae
    • The Journal of Pediatrics of Korean Medicine
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    • v.30 no.3
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    • pp.78-96
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    • 2016
  • Objectives The purpose of this study is to provide clinical evidence of Korean medicine for febrile seizure by review of randomized controlled trials on the effect of TCM (traditional Chinese medicine) for febrile seizure. Methods We searched randomized controlled trials about TCM treatment of febrile seizure from the China National Knowledge Infrastructure (CNKI) (January 2008 to June 2016). The selected literatures were assessed by Jadad scale. Results 40 papers were selected from 160 studies. Analyses of selected studies indicated that the TCM treatment group has significantly higher cure rate for febrile seizure than first aid or western medicine group. The most commonly used herbs were Gardeniae Fructus (梔子), Uncariae Ramulus cum Uncis (鉤藤), Cornus Gazeliae (羚羊角), Margarita (珍珠), Scutellariae Radix (黃芩), Glycyrrhizae Radix (甘草). The most commonly used acupoints were GV26 (人中), LI4 (合谷), KI1 (湧泉), GV20 (百會). There were no serious adverse events reported from the TCM treatment group during the treatment period. Conclusions TCM has been shown as not only effective but also safe treatment on febrile seizure. This finding can be widely utilized in clinical practice and can form the basis for development of clinical practice guidelines in future.

Yukgunja-tang for Irritable Bowel Syndrome: A Protocol for a Systematic Review and Meta-Analysis

  • Kangwook Lee;Seok-Jae Ko;Minjeong Kim;Chaehyun Park;Min-Seok Cho;Jae-Woo Park
    • The Journal of Internal Korean Medicine
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    • v.44 no.3
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    • pp.285-293
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    • 2023
  • Background: Irritable bowel syndrome (IBS) is a digestive disorder characterized by abdominal discomfort or pain accompanied by a change in stool condition. Owing to its complicated mechanisms, a standard treatment for IBS has not yet been established. Yukgunja-tang (YGT) is a Korean herbal medicine known in Asia to be effective in the treatment of gastrointestinal symptoms. In this study, we will conduct a systematic review of randomized controlled trials (RCTs) to assess the efficacy and safety of YGT in IBS treatment. Methods and analysis: English databases, such as Embase, Medline (via PubMed), Allied and Complementary Medicine Database, and Cochrane Central Register of Controlled Trials, will be searched for articles published up to April 2023. Additional databases, such as five Korean, one Chinese, and one Japanese database, will be included. RCTs and quasi-RCTs will also be included in the assessment of the efficacy of YGT. The overall efficacy rate will be the primary outcome, and data such as IBS quality-of-life measurements, global symptom scores, and adverse events will be the secondary outcomes. Review Manager Version 5.3 will be used for evaluation, and the risk of bias (RoB) will be evaluated using Cochrane Collaboration's RoB tool. The Grading of Recommendations Assessment, Development, and Evaluation approach will be used to score the quality of evidence. Conclusion: This study will demonstrate the efficacy and safety of YGT for treating patients with IBS.

Review of Recent Clinical Trials for Depression in Traditional Chinese Medicine-Based on Randomized Controlled Trials and Systematic Reviews- (우울증 치료의 중의학 최신 임상연구 동향-무작위 대조군 임상연구와 체계적 문헌 고찰을 중심으로-)

  • Woo, Jeong A;Nam, Yu Jin;Park, Yoon Jin;Kwon, Young Kyu
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.29 no.6
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    • pp.458-466
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    • 2015
  • The purpose of this study was to review the research on treating depression in Traditional Chinese Medicine(TCM) over the last 5 years to set the foundation for further studies. We searched for and analyzed articles about depression in CNKI(China National Knowledge Infrastructure) from January 2010 to December 2014. The results were as follows : The most frequently used diagnostic criteria was CCMD-3(The Chinese Classification of Mental Disorders-3), and the most used evaluation criteria was HAMD(Hamilton Depression Rating Scale). Prescription of decoction of medical herbs was most frequently used as a therapeutic method. Acupuncture, traditional Chinese psychotherapy, and music therapy were also used for some studies. The most frequent TCM Syndrome Differentiation Type was stagnation of liver-QI. For decoction of Chinese herbs, Soyo-san(Xiaoyao-san) and Sihosogan-san(Chaihushugan-san) were most often prescribed, and Bupleuri Radix, Paeoniae Radix Alba, Curcumae Radix, Poria cocos wolf, Angelicae Gigantis Radix, Atractylodis Rhizoma Alba were mainly used for medical herbs. BaekHoi(GV20) and Yindang(Ex-HN3) were often used as acupuncture sites. Post-Stroke Depression was the most common case of intercurrent or secondary depression. According to the Jadad Quality Assessment Scale, the quality of the reports was not high as most of the reports had a score of 3 or below. Most systematic reviews on depression were conducted by Chinese researchers. The problem with Clinical research on depression, according to those reviews, was that there were no standardized criteria for the diagnosis and treatment and the trials were usually not randomized nor controlled. We found out there are various clinical methods for treating depression in TCM, and hope that this research could provide the preliminary data for designing and conducting clinical trials for depression.

Systemic Review of RCTs focusing on Chronic Fatigue

  • Son, Chang-Gue
    • The Journal of Korean Medicine
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    • v.30 no.6
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    • pp.80-85
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    • 2009
  • Objective: This study aimed to build an overview of randomized clinical controlled trials (RCTs) for chronic fatigue-related symptoms to extract the useful data for management of patients and development of therapeutics using Korean traditional medicine in the future. Methods: All RCT-derived papers for chronic fatigue-related symptoms were collected via PubMed Database. We surveyed elementary information of RCTs such as clinical question, study design, and its quality and results. Results: A total of fifty-three RCTs met these review criteria. Most of the RCTs were performed in Western countries, particularly the UK and USA. The major portion of RCTs focused on chronic fatigue syndrome using immune modulators, psychotherapeutic and anti-depressants. Five RCTs using complementary and alternative medicine, including herbal remedies, showed positive results. Conclusions: Fatigue-related symptoms are a main target of Oriental medicine. This study provides helpful information for planning clinical study of chronic fatigue-related symptoms using traditional Korean medicine.

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Review of Clinical Trials about Herbal Medicine for Vascular Dementia (혈관성 치매 치료 한약물 임상연구 고찰)

  • Kim, Ka-Na;Cho, Seung-Hun
    • Journal of Oriental Neuropsychiatry
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    • v.23 no.4
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    • pp.37-48
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    • 2012
  • Objectives : The purpose of this study is to investigate the frequently used herbal materials among herbal prescription for vascular dementia. Methods : Every article relevant to vascular dementia was initially obtained from a Korean database and PubMed. Keywords searched were 'vascular dementia', 'herbal medicine' and 'human'. Results : Clinical study, which vascular dementia were treated with herbal medicine, were 12. Among these 12 articles, 6 were case study, 1 was Controlled Clinical Trial and 5 were Ramdomized Controlled Trial (RCT). High frequently used herbal materials were Ginseng Radix (9 times), Cnidii Rhizoma (8 times), Glycyrrhizae Radix, Citri Pericarpium, Astragali Radix and Angelicae Gigantis Radix (6 times). Conclusions : We could know frequent-used herbal medicine for vascular dementia. To be aware of the frequently used herbal medicine for vascular dementia can be helpful in adding herbal materials to prescription in a clinical treatment and development of new drugs.

Acupuncture Trials for Peripheral Facial Palsy in Republic of Korea: A Systematic Review (국내 말초성 안면마비의 침 임상시험에 대한 체계적 고찰)

  • Lee, Cham Kyul
    • Journal of Acupuncture Research
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    • v.30 no.3
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    • pp.51-59
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    • 2013
  • Objectives : This study was designed to evaluate clinical evidence of acupuncture treatment for peripheral facial palsy in South Korea. Methods : All process was independently proceeded by two investigators. Literature search was performed in 9 databases from their inception to February 2013. Searched reports was twice excluded for title, abstract and body. And then, data extract and analysis was done before assessing risk of bias by Cochrane Handbook. Results : 10 randomized controlled trials(RCT) were finally included. 4 RCT handled postauricular pain with facial palsy. All articles at least used in combination with two treatments. Interventions like pharmacopuncture, electroacupuncture, scalp acupuncture etcetera were conducted as treatment to evaluate efficacy, and some study reported advantageous effects of treatment group compared to baseline or control group. Adverse events didn't referd to in any studies. In assessing risk of bias, indefinite and uncertain information made all included trials to have a high risk of bias. Conclusions : Because of methodological deficit, there is no sufficient evidence to allow any conclusion about the efficacy of acupuncture for peripheral facial palsy. Therefore, well designed trials with high quality is needed from now on.

Effects of a Plastic Ankle Foot Orthosis on Balance and Gait of Adult with Poststroke Hemiplegia: A Systematic Review of Forcusing on Korea's Thesis (플라스틱 단하지보조기 중재가 뇌졸중 후 편마비 성인의 보행과 균형에 미치는 효과: 국내 학위 논문을 중심으로 고찰)

  • Cho, Byeongmo
    • Journal of The Korean Society of Integrative Medicine
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    • v.4 no.4
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    • pp.33-39
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    • 2016
  • Purpose : The aim of this study was to investigate the effects of plastic ankle foot orthosis on adult post-stroke hemiplegic patients walking ability and balance. Method : The searched for the case controlled clinical trials about the effects of plastic ankle foot orthosis(pAFO) for walking ability and balance using quantitative gait analysis in adult post-stroke patients. Ten trials were selected from Riss4U databases published until June 2016 in Korea. The selected trials contained a control group with pre-test and post-test design, measured walking ability and balance as a dependent variable. Result : The selected ten trials involved a total of 180 patients. The walking speed, cadence, the portion of double limb supporting, stride length on affected side were improved by plastic ankle foot orthosis. Conclusion : The plastic ankle foot orthosis has some evidence to improve the walking ability and balance in post-stroke hemiplegic patients.

The effects of EMG-triggered functional electrical stimulation on upper extremity function in stroke patients

  • Kim, Young
    • Physical Therapy Rehabilitation Science
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    • v.2 no.1
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    • pp.1-6
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    • 2013
  • Objective: The aim of this review is to explore the latest intervention trends and effects of EMG-triggered functional electrical stimulation on the upper extremity functions in stroke patients. Design: Systematic review on clinical trials. Methods: A systematic literature search was performed to identify clinical trials evaluating the effects of EMG-triggered functional electrical stimulation (EMG-FES) and task-oriented EMG-triggered FES on the hand functions in stroke patients. Literature review was conducted with the following key words: hand function, functional electrical stimulation, task-oriented, stroke. Results: Ten clinical trials were included; 8 of them were randomized controlled trial, 1 was block-randomized, and 1 was a pre-post comparison study. A positive effect of electrical stimulation was reported in the patient groups that were treated with functional electrical stimulation combined with specific tasks, and volitional muscle contraction-triggered stimulation that was synchronized with tasks. Motor capabilities of the hand and arm were improved after the rehabilitation. Conclusions: EMG-triggered electrical stimulation may be more effective than non-triggered electrical stimulation in facilitating the hand functions in stroke patients in terms of muscle strength and voluntary muscle contraction of the paretic hand and arm. Triggered electrical stimulation can be even more effective when it is combined with specific tasks.

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Study on Clinical Research Methodologies for Acupuncture: Based on Review of Clinical Studies on Back Pain (침 임상연구방법론 연구: 요통 임상연구 사례를 중심으로)

  • Park, Yu Lee
    • Korean Journal of Acupuncture
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    • v.31 no.4
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    • pp.158-167
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    • 2014
  • Objectives : The results from randomized controlled trials on traditional medicine have been negative or ambiguous. The appropriateness of the research methodology started to be questioned. However, the research methodology appropriate for studying traditional medicine has not been well-established. This study aims to explore the appropriate research methodologies for clinical studies on acupuncture. Methods : Clinical researches evaluating the efficacy and effectiveness of acupuncture for back pain were systematically searched and evaluated focusing on research methodology. The acupuncture treatment protocol is evaluated by 9 items which is individual treatment based on diagnosis, combining proximal and distal acupoints, exact location of acupoint, De Qi, adequate stimulation, duration of acupuncture, treatment sessions, treatment interval, and establishing relationship between patients and doctors. Results : Systematic review of acupuncture researches on low back pain suggested that observational studies and pragmatic trials rather than explanatory studies could incorporate these elements. Qualitative studies also could help understanding complex characteristics of acupuncture treatment which could not be evaluated by quantitative studies. Conclusions : In designing clinical researches on acupuncture, various study designs, especially observational study and pragmatic study, should be considered according to research objectives and subjects. The efforts to incorporate the core characteristics of acupuncture practiced in everyday clinical setting are also essential.

Herbal Medicine for Pediatric Epilepsy: Clinical Research Trends in Traditional Chinese Medicine

  • Kim, Sang-Ho;Kim, Da-Woon
    • Journal of Oriental Neuropsychiatry
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    • v.33 no.2
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    • pp.181-214
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    • 2022
  • Pediatric epilepsy, a chronic, recurrent brain disorder, is the most common neurological disorder in children. Its prevalence is increasing. Early management is very important since 30~40% of cases persist into adulthood. To provide basic data for future clinical research on pediatric epilepsy using Korean medicine treatment and cooperation between Western medicine doctors and Korean medicine doctors, we reviewed recent clinical research in traditional Chinese medicine (TCM) using herbal medicine for pediatric epilepsy. A total of 23 articles (1 clinical practice guideline, 3 systematic reviews, 15 randomized controlled trials (RCTs), and 4 non-RCTs) were reviewed in this study. The authors summarized characteristics of included studies regarding study subjects, diagnostic tools, pattern identification tools, treatment period, evaluation tools, detail of herbal medicines, treatment effects, and adverse events. Combination therapy using both herbal medicine (HM) and anti-epileptic drugs (AEDs) was performed more frequently than herbal medicine alone. Liver-pacifying medicinal, water-draining medicine, and orifice-opening medicine were frequently used. The main single HMs were Cheonma, Boglyeong, Jogudeung, and Seogchangpo. Combined therapy using HM and AEDs had significant benefits in improving total effective rate. It also appeared to be safer than AEDs. However, since the quality of clinical trials was poor and only studies in the last 10 years were included, the clinical evidence was uncertain. Finally, the authors provided limitations of this study and several suggestions for future research based on our analysis results.