• Korean Journal of Biological Psychiatry
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• v.15 no.4
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• pp.265-274
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• 2008

Depression is common in patients with end-stage renal disease(ESRD) and has a negative effect on the quality of life, functional ability, and mortality of the patients, with a prevalence rate as high as 20-25%. Especially, the increasing tendency of mortality in ESRD patients is associated with recent or current depression, and the suicide rate is also increased by depression in patients with ESRD. Therefore, accurate detection and appropriate treatment of depression is very important in ESRD patients. Also, a deferential diagnosis is needed concerning uremic symptoms and depression in ESRD patients. However, there has been little data so far particularly in terms of randomized clinical trials. This review focused on the recent knowledge of depression in ESRD, and could encourage clinical study and trials in this field.

• The Journal of Korean Medicine
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• v.30 no.5
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• pp.115-126
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• 2009

Objective: By assessing the quality of methodology and synthesis of results of RCTs (Randomized Controlled Clinical Trials) with herbal acupuncture (pharmacopuncture), we hope to help with administrating herbal acupuncture therapy in clinic and conducting RCT with herbal acupuncture. Methods: Reports of RCT conducted in Korea published in medical journals until February 2009 were collected. We surveyed elementary information of RCTs, evaluated randomization, double-blinding, allocation concealment and put together the results of RCTs by seven clinical topics. Results: 38 RCTs with herbal acupuncture were selected, then adequate methods for randomization and allocation concealment were found in 39% and 5% of studies. Complete double-blinding and a clear accounting of all participants were conducted in 42% and 50% of reports. The synthesis of RCTs revealed that herbal acupuncture was useful and effective on degenerative gonarthritis, omarthralgia on cerebrovascular accident, acute ankle sprain, back sprain, neck sprain, headache, rheumatoid arthritis and tennis elbow, generally. Conclusions: Although further improvement in quality of methodology of RCTs with herbal acupuncture is required, clinical usefulness of herbal acupuncture was shown especially on disorders of musculoskeletal system via RCTs.

• The Journal of Korean Medicine
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• v.31 no.5
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• pp.12-32
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• 2010

Objective: This study aimed to review herbal remedy-based RCTs on cancer patients in order to produce helpful information for clinical study of herbal medicine in the future. Methods: We collected all RCTs using herbal remedies on cancer patients from Pubmed and Cochrane databases until November 1st, 2009. Elementary information such as nation where performed, clinical question, design, randomization, double-blinding and allocation concealment were analyzed. Results: 153 RCTs were finally selected. 119 RCTs were conduced in China while only 2 were done in Korea. The most frequent targeted cancer was lung cancer as 29 RCTs. The main clinical questions included improvement of quality of life, elongation of survival rate and regression of tumor being 83, 62 and 55 respectively. 112 RCTs used herbal remedies with western therapy. Adequate methods for randomization and allocation concealment were found in 37% and 10% of trials respectively. Conclusions: We found that herbal remedies are used on cancer patients in aspects of both caring for the human body and tumor treatment itself. The study might provide us useful data for cancer-related clinical study using herbal remedies in the future.

• Annals of Clinical Neurophysiology
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• v.14 no.2
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• pp.59-63
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• 2012

Epilepsy has continued to provide challenges to epileptologists, as a significant proportion of patients continue to suffer from seizures despite medical and surgical treatments. Deep brain stimulation (DBS) has emerged as a new therapeutic modality that has the potential to improve quality of life and occasionally be curative for patients with medically refractory epilepsy who are not surgical candidates. Several groups have used DBS in drug-resistant epilepsy cases for which resective surgery cannot be applied. The promising subcortical brain structures are anterior and centromedian nucleus of the thalamus, subthalamic nucleus, and other nuclei to treat epilepsy in light of previous clinical and experimental data. Recently two randomized trials of neurostimulation for controlling refractory epilepsy employed the strategies to stimulate electrodes placed on both anterior thalamic nuclei or near seizure foci in response to electroencephalographically detected epileptiform activity. However, the more large-scale, long-term clinical trials which elucidates optimal stimulation parameters, ideal selection criteria for epilepsy DBS should be performed before long. In order to continue to advance the frontier of this field, it is imperative to have a good grasp of the current body of knowledge.

• Biomedical Science Letters
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• v.28 no.2
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• pp.67-82
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• 2022

The prevalence of SARS-CoV-2 led to inconsistent public health policies that resulted in COVID-19 containment failure. These factors resulted in increased hospitalization and death. To prevent viral spread and achieve herd immunity, the only safe and effective measure is to provide to vaccinates. Ever since the release of the SARS-CoV-2 nucleotide sequence in January of 2020, research centers and pharmaceutical companies from many countries have developed different types of vaccines including mRNA, recombinant protein, and viral vector vaccines. Prior to initiating vaccinations, phase 3 clinical trials are necessary. However, no vaccine has yet to complete a phase 3 clinical trial. Many products obtained "emergency use authorization" from governmental agencies such as WHO, FDA etc. The Korean government authorized the use of five different vaccines. The viral vector vaccine of Oxford/AstraZeneca and the Janssen showed effectiveness of 76% and 66.9%, respectively. The mRNA vaccine of Pfizer-BioNTech and Moderna showed effectiveness of 95% and 94.1%, respectively. The protein recombinant vaccine of Novavax showed an effectiveness of 90.4%. In this review, we compared the characteristics, production platform, synthesis principles, authorization, protective effects, immune responses, clinical trials and adverse effects of five different vaccines currently used in Korea. Through this review, we conceptualize the importance of selecting the optimal vaccine to prevent the COVID-19 pandemic.

• The Journal of Churna Manual Medicine for Spine and Nerves
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• v.17 no.1
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• pp.35-46
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• 2022

Objectives This study aimed to review clinical studies on traditional Korean medicine treatment for medial collateral ligament injury of the knee. Methods Clinical studies on Korean traditional medicine treatment of medial collateral ligament injury were conducted. We used five Korean online databases (OASIS, KISS, RISS, DBPia, and ScienceOn) and three foreign databases (PubMed, Cochrane Library, and CNKI). Out of 99 studies that were found, we excluded repeated articles, studies that were not related to Korean medicine, and those not relevant to the topic of the study. Results Ten randomized controlled trials and 20 case studies were selected. Eight traditional Korean medicine treatments, including acupuncture, herbal medicine, chuna, and herbal ointment, were used in these studies. The most commonly used treatment was found to be acupuncture. Conclusions Our study showed that traditional Korean medicine for medial collateral ligament injuries was effective. However, there were some limitations. Further clinical studies and randomized controlled clinical trials are needed for more evidence on Korean traditional medicine.

• Journal of Korean Neurosurgical Society
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• v.66 no.2
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• pp.172-182
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• 2023

Objective : The blood-brain barrier (BBB) is an obstacle for molecules to pass through from blood to the brain. Focused ultrasound is a new method which temporarily opens the BBB, which makes pharmaceutical delivery or removal of neurodegenerative proteins possible. This study was demonstrated to review our BBB opening procedure with magnetic resonance guided images and find specific patterns in the BBB opening. Methods : In this study, we reviewed the procedures and results of two clinical studies on BBB opening using focused ultrasound regarding its safety and clinical efficacy. Magnetic resonance images were also reviewed to discover any specific findings. Results : Two clinical trials showed clinical benefits. All clinical trials demonstrated safe BBB opening, with no specific side effects. Magnetic resonance imaging showed temporary T1 contrast enhancement in the sonication area, verifying the BBB opening. Several low-signal intensity spots were observed in the T2 susceptibility-weighted angiography images, which were also reversible and temporary. Although these spots can be considered as microbleeding, evidence suggests these are not ordinary microbleeding but an indicator for adequate BBB opening. Conclusion : Magnetic resonance images proved safe and efficient BBB opening in humans, using focused ultrasound.

• Genomics & Informatics
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• v.16 no.3
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• pp.52-58
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• 2018

In this report, we present a case study of how pharmacogenomics and pharmacometabolomics can be useful to characterize safety and pharmacokinetic profiles in early phase new drug development clinical trials. During conducting a first-in-human trial for a new molecular entity, we were able to determine the mechanism of dichotomized variability in plasma drug concentrations, which appeared closely related to adverse drug reactions (ADRs) through integrated omics analysis. The pharmacogenomics screening was performed from whole blood samples using the Affymetrix DMET (Drug-Metabolizing Enzymes and Transporters) Plus microarray, and confirmation of genetic variants was performed using real-time polymerase chain reaction. Metabolomics profiling was performed from plasma samples using liquid chromatography coupled with quadrupole time-of-flight mass spectrometry. A GSTM1 null polymorphism was identified in pharmacogenomics test and the drug concentrations was higher in GSTM1 null subjects than GSTM1 functional subjects. The apparent drug clearance was 13-fold lower in GSTM1 null subjects than GSTM1 functional subjects (p < 0.001). By metabolomics analysis, we identified that the study drug was metabolized by cysteinylglycine conjugation in GSTM functional subjects but those not in GSTM1 null subjects. The incidence rate and the severity of ADRs were higher in the GSTM1 null subjects than the GSTM1 functional subjects. Through the integrated omics analysis, we could understand the mechanism of inter-individual variability in drug exposure and in adverse response. In conclusion, integrated multi-omics analysis can be useful for elucidating the various characteristics of new drug candidates in early phase clinical trials.

• The Journal of Churna Manual Medicine for Spine and Nerves
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• v.7 no.2
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• pp.15-23
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• 2012

Objectives: The aim of this study is to assess the quantity and quality of randomized controlled clinical trials (RCTs) published in the journal of Korean Society of Chuna Manual Medicine for Spine and Nerves (KSCMSN). Methods: All relevant RCTs were selected and extracted. Data extract of RCTs from all the articles published in the jounal of KSCMSN up to now, quantity assessment was made on the study design, sample size, intervention, control group and medical condition. of the consolidated standards of reporting trials (CONSORT) check list. Assessment was performed by 2 independent reviewers and disagreement was discussed based on concensus. Results: Among the 276 articles, 10 RCTs were published. 1st articles were published in 2003 and half of RCTs were published in 2011. All RCTs were parallel 2-arm designed. Average sample size was 29.2 per study and 14.6 per arm. Main intervention was consisted as acupuncture 40%, pharmacopuncture 30% and Chuna 30%. Average of adequacy of CONSORT check list was 10.3% and overall reports were insufficient. Conclusions: Though RCTs published in jounal of KSCMSN were increasing, the quality remains low. KSCMSN should make a effort to follow the CONSORT statement and improve the quantity and quality of studies.

• Korean Journal of Acupuncture
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• v.34 no.1
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• pp.8-36
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• 2017

Objectives : The aim of this study is to review the methodology of clinical trials conducted with the acupuncture and moxibustion treatment on functional dyspepsia. Methods : We searched four international databases and three Korean databases including English, Korean and Chinese, through March 2016 for randomized controlled trials(RCT) and non-randomized case-control trials(CCT) that evaluated the effects of the acupuncture and moxibustion on functional dyspepsia. We abstracted the designs of the trials and the method of acupuncture and moxibustion treatment according to the Standards for Reporting Interventions in Clinical Trials of Acupuncture. Results : A total 117 papers were reviewed. The 106 studies were conducted in China. There were 111 RCTs(95%), and 6 CCTs(5%). Sixty eight studies(59%) were conducted with the manual acupuncture, 29 studies of electro-acupuncture(25%), 11 studies of moxibustion(9%), 5 studies of acupoints embedding therapy(4%), 4 studies of acupoint injection therapy(3%) were conducted. ST36, CV12, ST25 were most frequently used for acupoints to treat functional dyspepsia. In 59 studies(50%), western medication was used in the control group, and the effects of acupuncture and moxibustion were evaluated with the symptoms in most studies. Conclusions : These results suggest that it is necessary to develop more detailed reporting standards about acupuncture and moxibustion treatment method as the method of acupuncture and moxibustion is getting more diverse, and more objective tools are needed in evaluating functional dyspepsia.