• Title/Summary/Keyword: Clinical Trials

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A Systematic review for the development of cosmetic clinical trial protocol (화장품 임상시험 프로토콜 개발을 위한 체계적 문헌 고찰)

  • Jo, Ga-Won;Hwang, Chung-Yeon;Hong, Seok-Hoon;Kim, Nam-Kwen
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.26 no.1
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    • pp.104-117
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    • 2013
  • Objective : The aim of this review is to development of clinical trial protocol for against cosmetics as a treatment of dry skin condition. Methods : We searched the literature from 2002 through April 2012 using 5 databases. We included randomized controlled trials(RCTs) in which human participants with dry skin condition as chief complaint were treated with cosmetics. The methodological quality of all RCTs was using the Jadad score. Results : Nine RCTs met the inclusion criteria. Cosmetic types included cream (7 trials), lotion (1 trial), oil (1 trial) and body wash (1 trial). The methodological quality of the trials was generally low (Jadad score: mean 1.78; range, 1 to 3). Conclusions : The evidence for cosmetics as an effective treatment for dry skin condition(xerosis) is currently scarce and of poor quality, and is therefore inconclusive. More rigorous studies are warranted.

Modern acupuncture-like stimulation methods: a literature review

  • Jun, Min-Ho;Kim, Young-Min;Kim, Jaeuk U.
    • Integrative Medicine Research
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    • v.4 no.4
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    • pp.195-219
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    • 2015
  • Acupuncture therapy has been proved to be effective for diverse diseases, symptoms, and conditions in numerous clinical trials. The growing popularity of acupuncture therapy has triggered the development of modern acupuncture-like stimulation devices (ASDs), which are equivalent or superior to manual acupuncture with respect to safety, decreased risk of infection, and facilitation of clinical trials. Here, we aim to summarize the research on modern ASDs, with a focus on featured devices undergoing active research and their effectiveness and target symptoms, along with annual publication rates. We searched the popular electronic databases Medline, PubMed, the Cochrane Library, and Web of Science, and analyzed English-language studies on humans. Thereby, a total of 728 studies were identified, of which 195 studies met our inclusion criteria. Electrical stimulators were found to be the earliest and most widely studied devices (133 articles), followed by laser (44 articles), magnetic (16 articles), and ultrasound (2 articles) stimulators. A total of 114 studies used randomized controlled trials, and 109 studies reported therapeutic benefits. The majority of the studies (32%) focused on analgesia and pain-relief effects, followed by effects on brain activity (16%). All types of the reviewed ASDs were associated with increasing annual publication trends; specifically, the annual growth in publications regarding noninvasive stimulation methods was more rapid than that regarding invasive methods. Based on this observation, we anticipate that the noninvasive or minimally invasive ASDs will become more popular in acupuncture therapy.

Multimodal Treatment Strategies in Esophagogastric Junction Cancer: a Western Perspective

  • Goetze, Thorsten Oliver;Al-Batran, Salah-Eddin;Berlth, Felix;Hoelscher, Arnulf Heinrich
    • Journal of Gastric Cancer
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    • v.19 no.2
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    • pp.148-156
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    • 2019
  • Esophagogastric junction (EGJ) cancer is a solid tumor entity with rapidly increasing incidence in the Western countries. Given the high proportion of advanced cancers in the West, treatment strategies routinely employed include surgery and chemotherapy perioperatively, and chemoradiation in neoadjuvant settings. Neoadjuvant chemoradiation and perioperative chemotherapy are mostly performed in esophageal cancer that extends to the EGJ and gastric as well as EGJ cancers, respectively. Recent trials have tried to combine both strategies in a perioperative context, which might have beneficial outcomes, especially in patients with EGJ cancer. However, it is difficult to recruit patients for trials, exclusively for EGJ cancers; therefore, the results have to be carefully reviewed before establishing a standard protocol. Trastuzumab was the first drug for targeted therapy that was positively evaluated for this tumor entity, and there are several ongoing trials investigating more targeted drugs in order to customize effective therapies based on tissue characteristics. The current study reviews the multimodal treatment concept for EGJ cancers in the West and summarizes the latest reports.

A Review of Clinical Researches for Acupuncture Treatment on Tourette Syndrome (투렛장애 (Tourette syndrome)의 침 치료에 대한 중의학 임상 연구 고찰)

  • Kim, Boram;Choi, Il Shin;Kim, Ki Bong;Cheon, Jin Hong
    • The Journal of Pediatrics of Korean Medicine
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    • v.36 no.2
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    • pp.13-25
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    • 2022
  • Objective This study aimed to analyze randomized controlled trials of the effect of acupuncture on Tourette syndrome and to evaluate the efficacy of the treatment. Methods Based on the China National Knowledge Infrastructure (CNKI) and Pubmed search with the key search terms of 'Tourette syndrome, acupuncture', dated from 2000 to 2021, ten randomized controlled trials were identified and analyzed for this study. Results 1. The most commonly used acupoints were Taechung (LR3), Sinmun (HT7), Hapgok (LI4), Pungji (GB20) and Backhoe (GV20). 2. The most commonly used meridians were Bladder Meridian, Stomach Meridian and Gallbladder Meridian. 3. Acupuncture treatment was found to be significantly more or equally effective than western medicine such as haloperidol and tiapride. Conclusions Based on the results of the randomized controlled trials analyzed in this study, acupuncture was found to be effective in the treatment of Tourette syndrome. However, more clinical studies are needed to prove the effectiveness of acupuncture in Tourette syndrome.

Research Trends of Korean Medicine Treatments for Postoperative Sleep Improvement: Focusing on Herbal Medicine, Acupuncture, and Moxibustion (수술 후 환자의 수면 개선에 대한 한의치료 임상연구 동향 -한약, 침, 뜸 치료를 중심으로-)

  • Jun-Hee, Cho;Bo-Kyung, Kim;Jung-Hwa, Lim
    • Journal of Oriental Neuropsychiatry
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    • v.33 no.4
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    • pp.425-451
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    • 2022
  • Objectives: To review trends of clinical trials on Korean medicine treatments for postoperative sleep improvement. Methods: We searched randomized controlled trials (RCTs) on Korean medicine treatments for postoperative sleep improvement from ten domestic and foreign databases. Sample sizes, diseases, types of operation, diagnosis tools, pattern identification, interventions, outcome measurements, and main results of included studies were extracted and analyzed. Results: A total of 20 RCTs were selected. Most studies were published in China. The most common target disease was cancer, followed by cardiovascular disease. Most studies lacked detailed description regarding participants such as onset, duration of sleep disturbance, and preoperative sleep issues. Herbal medicine was the most frequently used in 12 studies. The most commonly used prescription was Suanzaoren decoction. The effectiveness of Korean medicine treatment on improving postoperative sleep was found to be significant in most studies. Conclusions: Korean medicine treatments might be effective in postoperative sleep improvement. However, the quality of included studies was low. Therefore, further well-designed research studies are needed to provide high quality clinical evidence on Korean medicine treatments for postoperative sleep improvement.

Spinal Cord Injury and Neuro-Regeneration (척수 손상과 신경 재생)

  • Ahn, Joo-Hyun;Park, Hyung-Youl;Kim, Young-Hoon
    • Journal of the Korean Orthopaedic Association
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    • v.54 no.6
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    • pp.498-508
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    • 2019
  • Recent advances in the understanding of the pathophysiology of spinal cord injury (SCI) and new therapeutic approaches have provided promising results for this incurable and debilitating central nervous system injury. Various neuro-protective and neuro-regenerative trials have been attempted to overcome SCIs. This review summarizes the reported experimental and clinical data regarding neuro-regenerative trials with the proven pathophysiology of SCI. In addition, the prerequisites for safe and effective clinical trials are discussed.

Establishment of Efficient Organization for Coordination Center on Clinical Research in Traditional Korean Medicine (한의학임상협연연구의 필요성과 효율적인 조직체계의 구축)

  • Ko Seong-Gyu;Jun Chan-Yong;Park Jong-Hyeong;Han Chang-Ho;Jung Woo-Sang;Moon Sang-Kwan;Cho Ki-Ho;Kim Young-Suk;Bae Hyung-Sup
    • The Journal of Korean Medicine
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    • v.27 no.1 s.65
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    • pp.196-203
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    • 2006
  • Objectives : The aim of this study is to investigate how does the methods of treatment and diagnosis of Traditional Korean Medicine(TKM) get the evidence of efficacy and safety and what type of efficient body and appropriate facility of the coordination center for clinical trial in TKM. Methods : We have got the information of clinical trial center or clinical collaboration center by site invitation, search of paper and reports and internet exploration for the domestic or foreign site. Results : Coordination center for clinical trial usually involves every steps of clinical trials, such as development of Case Report From (CRF), design of study, calculation of sample size, randomization, maintenance of blinding, monitoring and audit of the resource document, data and CRF, data entry, quality control of data, analysis and report. Conclusions : The body needs several aresa of experts, which are epidemiologists, biostatisticians, research nurses for coordination, data manager and programmer, and administrator. This body would be enhance and help he clinical researches including clinical trials in TKM.

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Neurofeedback Training for Anxiety: A Systematic Review (불안 감소를 위한 생기능자기조절 훈련(뉴로피드백) 임상연구: 체계적 문헌고찰)

  • Cho, Min-kyu;Lim, Wan-hyun;Lee, Go-Eun;Lim, Jung-Hwa
    • Journal of Oriental Neuropsychiatry
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    • v.29 no.2
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    • pp.79-97
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    • 2018
  • Objectives: The purpose of this systematic review was to investigate the clinical effects of neurofeedback training on reducing anxiety. Methods: Eight databases were used to extract clinical reports on neurofeedback intervention for anxiety reduction published until 2016. We analyzed the characteristics of selected studies and evaluated biases using the Risk of Bias (RoB) assessment. Results: A total of 22 clinical trials were extracted for the analysis. The risk of bias in most studies was high or unclear. The Chinese Classification of Mental Disorders-3 (CCMD-3) was the most frequently used diagnostic criteria, the Hamilton Rating Scale for Anxiety (HAMA) was the most frequently used assessment tool, and the alpha wave activity increase, sensorimotor rhythm (SMR), and theta wave training were the most frequently used intervention methods. All papers showed a statistically significant decrease of anxiety symptoms; however, significant adverse events were not reported. Conclusions: Neurofeedback intervention might be beneficial for reducing anxiety. However, the quality of the studies used in the analysis was low, and the heterogeneity of the population and interventions was revealed. Therefore, more scientifically designed clinical studies regarding neurofeedback training are required.

Ginseng for managing menopause symptoms: a systematic review of randomized clinical trials

  • Kim, Myung-Sunny;Lim, Hyun-Ja;Yang, Hye Jeong;Lee, Myeong Soo;Shin, Byung-Cheul;Ernst, Edzard
    • Journal of Ginseng Research
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    • v.37 no.1
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    • pp.30-36
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    • 2013
  • The aim of this review was to assess the effectiveness of ginseng as a treatment option for managing menopause symptoms. We searched the literature using ll databases from their inception to 26 September 2012 and included all randomised clinical trials (RCTs) that compared any type of ginseng to a placebo controls in postmenopausal women. The methodological quality of all studies was assessed using a Cochrane risk of bias tool. Four RCTs met our inclusion criteria. Most RCTs had high risk of bias. One RCT showed that Korean red ginseng (KRG) significantly improved sexual arousal and global health compared with placebo. Another RCT reported the superiority of KRG over placebo for treating menopause symptoms on Kupperman's index and menopausal rating score. The third RCT failed to show a significant effect of KRG on hot flash frequency compared to placebo. The fourth RCT found beneficial effects of ginseng compared to placebo on depression and well-being. In conclusion, the evidence on ginseng as an effective treatment for managing menopause symptoms is limited. Most of the RCTs are burdened with a high risk of bias. Thus firm conclusions cannot be drawn. Rigorous studies seem warranted.

Assessment of the Quality of Case Reports in the Journal of Acupuncture Research Using the CARE and STRICTA Guidelines

  • Nam, Eun-Young;Hwang, Ji Hye
    • Journal of Acupuncture Research
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    • v.37 no.4
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    • pp.224-232
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    • 2020
  • The purpose of this study was to assess the quality of the case reports in the Journal of Acupuncture Research (JAR). All case reports were retrieved from November 2017 to June 2020. There were 19 case reports included in this assessment based on the case report (CARE) guidelines and case report and standards for reporting interventions in clinical trials of acupuncture (STRICTA) guidelines. The overall quality of reporting was relatively high (83.08% on Case Report guidelines and 77.78% on Standards for Reporting Interventions in Clinical Trials of Acupuncture guidelines), but several crucial items remained substantially underreported, such as identifying as a case report (keywords), patient information and perspective, clinical findings, diagnostic assessment, and intervention information. In 18 out of 19 included case reports of acupuncture-related interventions, several items remained considerably underreported such as acupuncture regimen variation, depth of needle insertion, response sought, and experience of acupuncturists. In the classification by disease, condition, or syndrome, 13 out of 19 included case reports were for musculoskeletal disorders (68.4%), which is the main clinical medical field of Korean medicine services. The results of this study may help develop more appropriate reporting guidelines for case reports published in JAR.