• Journal of Oriental Neuropsychiatry
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• v.24 no.3
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• pp.201-210
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• 2013

Objectives : To review the recent trend of randomized controlled clinical trials on insomnia and to provide information for future clinical trials. Methods : A total of 667 pieces of literature were searched using the key words 'insomnia' and 'randomized controlled trial' and using the title 'insomnia' with the topic 'trial or trials', published from 2008 to 2012 through Web of Science. Studies including randomized controlled clinical trials were sorted from the search result and finally 104 pieces of the literature were selected and examined. Results : Besides 104 clinical trials, 14 trials related to CAM (Complementary and Alternative Medicine) were also reviewed. On average, 20 trials were annually conducted and they showed a growing trend. Participants were between 31 and 90 (34.6%), and were observed for less than 30 days (28.8%) in most trials. As intervention methods for clinical trials, non-pharmaceutical methods were used in 59 studies (56.7%), pharmaceutical drug in 43 studies (41.3%) and combinations in 2 studies (1.9%). In 60 studies, only insomnia without any underlying diseases was examined and other 44 studies involved other diseases. As diagnosis assessment tools, Sleep diary and Polysomnography were used. Conclusions : Randomized controlled trials relevant to insomnia were on the increase, but only a small number of clinical trials on Oriental Medicine have been performed. Larger scientific and well-founded randomized controlled trials are required for developing Oriental Medicine and establishing high-quality guideline going forward.

• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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• v.27 no.4
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• pp.45-57
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• 2014

Objective : This study aims to provide fundamental data for new directions(the improvement directions) from searching research papers of randomized controlled trials among thesis of Atopic Dermatitis related to oriental medicine in Korea from 2004 to 2014 and identifying the problem and level of a clinical study through an assessment of the quality, CONSORT statement. Methods : Data was collected through the Koreanstudies Information Service System(KISS). Two experts in Oriental Medicine reviewed the title and abstract in thesis, the results of searching the title, "Atopic dermatitis" and topic, "oriental medicine" at KISS, and then they handsearched Randomized Controlled Trials related to oriental medicine in Korea. According to guidelines defined by CONSORT statement, they assessed whether 37 items were followed by guidelines at yes or no answers in order to evaluate the quality as well. They assessed the definition of each item independently. After comparing, they made a decision on the item of different outcomes through an agreement with a third party. Results : Total number of randomized controlled trials in Atopic Dermatitis related to oriental medicine is eleven. A randomized controlled trial was first published in 2007. One or two papers associated it were released every year except 2013. 9 papers of them were approved by Institutional Review Board and were received written consent. The study included between 20 to 40 subjects for 2-arm parallel study design. The effect of treatment was observed for 4 to 8 weeks. On average, the number followed guidelines was 18.64 among those of 37 CONSORT statement and 50.38% of them was followed overall. Conclusion : As an interest about randomized controlled trials was increased, it was needed to care the standard providing information of CONSORT statement on randomized controlled trials related to oriental medicine in Korea. It is suggested to provide more clear information about it, so that it can be a motive for improving quality of the journal in oriental medicine.

• Tuberculosis and Respiratory Diseases
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• v.81 no.3
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• pp.167-174
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• 2018

Despite recent clinical guidelines, the optimal therapeutic strategy for the management of refractory chronic cough is still a challenge. The present systematic review was designed to assess the evidence for efficacy and safety of gabapentin in the treatment of chronic cough. A systematic search of PubMed, Embase, Cochrane Library databases, and publications cited in bibliographies was performed. Articles were searched by two reviewers with a priori criteria for study selection. Seven relevant articles were identified, including two randomized controlled trials, one prospective case-series designed with consecutive patients, one retrospective case series of consecutive patients, one retrospective case series with unknown consecutive status, and two case reports comprising six and two patients, respectively. Improvements were detected in cough-specific quality of life (Leicester Cough Questionnaire score) and cough severity (visual analogue scale score) following gabapentin treatment in randomized controlled trials. The results of prospective case-series showed that the rate of overall improvement of cough and sensory neuropathy with gabapentin was 68%. Gabapentin treatment of patients with chronic cough showed superior efficacy and a good safety record compared with placebo or standard medications. Additional randomized and controlled trials are needed.

• The Korean Journal of Pain
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• v.31 no.4
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• pp.253-260
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• 2018

Background: One of the most frequent problems caused by diabetes is the so called painful diabetic neuropathy. This condition can be treated through numerous types of therapy. The purpose of this study was to analyze, as a meta-analysis, different treatments used to alleviate painful diabetic neuropathy, with the aim of generating results that help making decisions when applying such treatments to tackle this pathology. Methods: A search was conducted in the main databases for Health Sciences, such as PUBMED, Web of Science (WOS), and IME biomedicina (Spanish Medical Reports in Biomedicine), to gather randomized controlled trials about treatments used for painful diabetic neuropathy. The analyzed studies were required to meet the inclusion criteria selected, especially those results related to pain intensity. Results: Nine randomized controlled trials were chosen. The meta-analysis shows significant positive effects for those treatments based on tapentadol [g: -1.333, 95% CI (-1.594; -1.072), P < 0.05], duloxetine [g: -1.622, 95 % CI (-1.650; -1.594), P < 0.05], pregabalin [g: -0.607, 95% CI (-0.980; -0.325), P < 0.05], and clonidine [g: -0.242, 95 % CI (-0.543; -0.058), P < 0.05]. Conclusions: This meta-analysis indicates the effectiveness of the treatments based on duloxetine, gabapentin and pregabalin, as well as other drugs, such as tapentadol and topic clonidine, whose use is better prescribed in more specific situations. The results provided can help increase the knowledge about the treatment of painful diabetic neuropathy and also in the making of clinical practice guidelines for healthcare professionals.

• Translational and Clinical Pharmacology
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• v.26 no.4
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• pp.155-159
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• 2018

For regulatory approval of a new drug, the most preferred and reliable source of evidence would be randomized controlled trials (RCT). However, a great number of drugs, being developed as well as already marketed and being used, usually lack proper indications for children. It is imperative to develop properly evaluated drugs for children. And expanding the use of already approved drugs for other indications will benefit patients and the society. Nevertheless, to get an approval for expansion of indications, most often with off-label experiences, for drugs that have been approved or for the development of pediatric indications, either during or after completing the main drug development, conducting RCTs may not be the only, if not right, way to take. Extrapolation strategies and modelling & simulation for pediatric drug development are paving the road to the better approval scheme. Making the use of data sources other than RCT such as EHR and claims data in ways that improve the efficiency and validity of the results (e.g., randomized pragmatic trial and randomized registry trial) has been the topic of great interest all around the world. Regulatory authorities should adopt new methodologies for regulatory approval processes to adapt to the changes brought by increasing availability of big and real world data utilizing new tools of technological advancement.

• Quality Improvement in Health Care
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• v.30 no.1
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• pp.76-87
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• 2024

Purpose: We investigated the effects of a video-based education program for cerebral angiography on patients' state anxiety, uncertainty, nursing care satisfaction, and complications. Methods: The randomized experimental study included patients who underwent cerebral angiography at a university hospital in Bucheon, Gyeonggi-do between January 2023 and August 2023. Patients were assigned to the experimental group (n=50) and the control group (n=48). The program included video- and pamphlet-based education. The intervention included video-based education provided to the experimental group and conventional pamphlet-based education provided to the control group. Data were obtained pre-, post-, and 2-7 days post-intervention. Data were analyzed using the x²-test and the repeated measures analysis of variance test with the SPSS software, version 28.0. Results: The experimental group showed lower levels of state anxiety (x²=4.316, p=.038) and uncertainty (x²=3.974, p=.046) than the control group. However, we observed no significant intergroup differences in satisfaction with nursing care and complication rates. Conclusion: The results suggest that a video-based education program for cerebral angiography can effectively reduce state anxiety and uncertainty in patients undergoing cerebral angiography. Video-aided educational interventions can improve the quality of nursing care with regard to reducing state anxiety and uncertainty in patients who undergo cerebral angiography.

• Neurospine
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• v.15 no.4
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• pp.296-305
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• 2018

Cervical disc arthroplasty (CDA), or total disc replacement, has emerged as an option in the past two decades for the management of 1- and 2-level cervical disc herniation and spondylosis causing radiculopathy, myelopathy, or both. Multiple prospective randomized controlled trials have demonstrated CDA to be as safe and effective as anterior cervical discectomy and fusion, which has been the standard of care for decades. Moreover, CDA successfully preserved segmental mobility in the majority of surgical levels for 5-10 years. Although CDA has been suggested to have long-term efficacy for the reduction of adjacent segment disease in some studies, more data are needed on this topic. Surgery for CDA is more demanding for decompression, because indirect decompression by placement of a tall bone graft is not possible in CDA. The artificial discs should be properly sized, centered, and installed to allow movement of the vertebrae, and are commonly 6 mm high or less in most patients. The key to successful CDA surgery includes strict patient selection, generous decompression of the neural elements, accurate sizing of the device, and appropriately centered implant placement.

• Journal of Acupuncture Research
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• v.34 no.3
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• pp.71-90
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• 2017

Objectives : This study was performed to review articles concerning acupuncture and moxibustion treatment for De Quervain's Stenosing Tenosynovitis. Methods : On-line databases including Cochrane Library, Pubmed, CNKI, NDSL and OASIS were searched to identify articles concerning acupuncture and moxibustion treatment for De Quervain's Stenosing Tenosynovitis (DQST). Several duplicated articles and those not relevant to this topic were excluded, as were review articles and commentaries. Results : Fifty-one studies were identified, which included 28 clinical case studies with 1,227 patients and 23 randomized controlled trials with 2,040 patients. In these studies, acupuncture, acupotomy, moxibustion, pharmacopuncture, and laser acupuncture were used as DQST interventions. Although DQST is a common disease seen in clinical practice, only four of the 51 studies we identified in our search were published in Korean academic journals, all of which used pharmacopuncture. Conclusion : Although the results of the studies to date provide evidence that acupuncture and moxibustion are effective treatments for De Quervain's Stenosing Tenosynovitis, the absence of a standard, objective evaluation tool, and a lack of reporting on the negative side-effects associated with treatment remain important factors that should be addressed in future studies.

• Journal of Korean Biological Nursing Science
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• v.21 no.4
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• pp.239-248
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• 2019

Purpose: Postmenopausal women are a unique population with high risk for the degeneration of muscle. The aim of the present meta-analysis was to accurately evaluate the effects of vitamin D on muscular strength in postmenopausal women. Methods: A review was conducted using electronic databases, including PubMed, EMBASE, Ovid Medline, CINAHL complete, and the Cochrane Library from inception through 19 March 2019. Included studies were selected by two independent reviewers. The meta-analysis were performed using Review Manager 5.3 software. Results: A total of nine randomized controlled clinical trials were included in this review. Vitamin D interventions led to no changes in the upper limb muscle strength (mean difference -0.16, 95% CI: -1.09 to 0.77), lower body muscle strength (standard mean difference 0.08, 95% CI: -0.11 to 0.26), and back/hip muscle strength (standard mean difference 0.06, 95% CI: -0.05 to 0.17). Conclusion: Pooled results from eight studies indicated that supplementation of vitamin D did not increase muscle strength in postmenopausal women. Apparently, the present review suggests that supplementation of vitamin D alone had no didn't show any beneficial effects on muscle strength in postmenopausal women.

• Tuberculosis and Respiratory Diseases
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• v.82 no.4
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• pp.285-297
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• 2019

Connective tissue disease (CTD) is a collection of disorders characterized by various signs and symptoms such as circulation of autoantibodies in the entire system causing damage to internal organs. Interstitial lung disease (ILD) which is associated with CTD is referred to as CTD-ILD. Patients diagnosed with ILD should be thoroughly examined for the cooccurrence of CTD, since the treatment procedures and prognosis of CTD-ILD are vary from those of idiopathic interstitial pneumonia. The representative types of CTD which may accompany ILD include rheumatoid arthritis, systemic sclerosis (SSc), Sjogren's syndrome, mixed CTD, idiopathic inflammatory myopathies, and systemic lupus erythematous. Of these, ILD most frequently co-exists with SSc. If an ILD is observed in the chest, high resolution computed tomography and specific diagnostic criteria for any type of CTD are met, then a diagnosis of CTD-ILD is made. It is challenging to conduct a properly designed randomized study on CTD-ILD, due to low incidence. Therefore, CTD-ILD treatment approach is yet to been established in absence of randomized controlled clinical trials, with the exception of SSc-ILD. When a patient is presented with acute CTD-ILD or if symptoms occur due to progression of the disease, steroid and immunosuppressive therapy are generally considered.