• Title/Summary/Keyword: Clinical Trials

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A Clinical Analysis to Study Effectiveness of Korean Medicine for Medial Collateral Ligament Injury of the Knee (무릎 내측측부인대 손상의 한의학적 치료에 대한 국내외 임상연구 동향 분석)

  • Oh, Tae Young;Han, Si Hoon;Oh, Min Seok
    • 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.

Characteristics of Focused Ultrasound Mediated Blood-Brain Barrier Opening in Magnetic Resonance Images

  • Kyung Won Chang;Seung Woo Hong;Won Seok Chang;Hyun Ho Jung;Jin Woo Chang
    • 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.

Utility of Integrated Analysis of Pharmacogenomics and Pharmacometabolomics in Early Phase Clinical Trial: A Case Study of a New Molecular Entity

  • Oh, Jaeseong;Yi, Sojeong;Gu, Namyi;Shin, Dongseong;Yu, Kyung-Sang;Yoon, Seo Hyun;Cho, Joo-Youn;Jang, In-Jin
    • 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.

Randomized Controlled Clinical Trials in the Journal of Korean Society of Chuna Manual Medicine for Spine and Nerves: A Quantitative and Qualitative Analysis (척추신경추나의학회지에 수록된 무작위대조임상 연구의 양적, 질적 분석)

  • Cho, Hyun-Woo;Lee, Hyeon-Yeop;Heo, Kwang-Ho;Hwang, Eui-Hyoung;Shin, Mi-Suk;Shin, Byung-Cheul
    • 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.

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A Systematic Review of Acupuncture-Moxibution Treatment for Functional Dyspepsia (기능성 소화불량증에 사용된 침구치료방법에 대한 체계적 문헌고찰)

  • Kim, Bo-Young;Seo, Bok-Nam;Park, Ji-Eun;Yang, Chang-Sop;Kim, Ick-Tae;Im, Ji-Won;Kim, Young-Eun
    • 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.

Clinical Effectiveness of Acupuncture in the Treatment of Non-Alcoholic Fatty Liver Disease: A Systematic Review (비알코올성 지방간 질환에 대한 침치료의 효과 : 체계적 고찰)

  • Hyun, Joon;Lee, Joo-bok;Kim, So-yeon;Han, Chang-woo
    • The Journal of Internal Korean Medicine
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    • v.39 no.6
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    • pp.1206-1224
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    • 2018
  • Purpose: This systematic review was planned and performed in order to determine the clinical effectiveness of acupuncture for non-alcoholic fatty liver disease (NAFLD). Methods: We searched related randomized controlled trials in several medical online databases, including China National Knowledge Infrastructure (CNKI), Excerpta Medica dataBASE (EMBASE), Public/Publisher MEDLINE (PubMed), Cochrane Central Register of Controlled Trials (CENTRAL), National Digital Science Library (NDSL), and Research Information Sharing Service (RISS). NAFLD related outcomes were extracted from the included trials and meta-analyzed. Results: From the 8 included trials, the values of the following examinations were extracted: liver ultrasonography, liver CT, body fat CT, aspartate transaminase (AST), alanine transaminase (ALT), gamma-glutamyltransferase (GGT), total cholesterol (TC), triglyceride (TG), low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol, fasting blood sugar (FBS), hosmeostatic model assessment for insulin resistance (HOMA-IR), weight, body mass index (BMI), waist hip ratio (WHR), obesity degree, body fat mass, body fat rate, leptin, malondialdehyde (MDA), and super oxide dismutase (SOD). In the 4 outcomes, cure rate in liver ultrasonography (RR=1.56; 95%CI=1.05~2.31; P=0.03), cure rate in liver CT (RR=2.23; 95%CI=1.33~3.72; P=0.002), TC (MD=-0.78; 95%CI=-1.41~-0.15; P=0.02), and TG (MD=-2.05; 95%CI=-3.88~-0.21; P=0.03), acupuncture was more effective than the control intervention. Conclusions: In this meta-analysis, acupuncture relieved hepatic steatosis, and reduced TC, and TG in NAFLD patients. more well-planned studies are still needed due to the heterogeneity and the considerable methodological flaws in the analyzed trials.

Review of Recent Clinical Research for Oral Herbal Medicine Treatment on Primary Hyperhidrosis in Children - Focused on Chinese Randomized Controlled Trials - (소아 일차성 다한증의 경구 한약치료에 대한 중의학 임상연구 동향 - 중국 무작위 대조군 임상연구를 중심으로 -)

  • Choil, Il Shin;Kim, Ki Bong;Cheon, Jin Hong
    • The Journal of Pediatrics of Korean Medicine
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    • v.36 no.3
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    • pp.75-86
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    • 2022
  • Objectives The purpose of the study is to review the trend of clinical trials conducted in China with oral herbal medicine treatment on childhood primary hyperhidrosis. Methods We searched the randomized controlled trials (RCTs) with oral herbal medicine treatment on childhood primary hyperhidrosis from the China National Knowledge Infrastructure (CNKI). The demographic data, duration of illness, intervention, treatment period, outcome and composition of herbal medicine were analyzed for this study. Results A total of five RCTs were selected and analyzed. The effectiveness of the oral administration of herbal medicines on childhood primary hyperhidrosis was found to be significant. In one study, there was no statistical difference between the treatment group and the control group when curative effect was evaluated two weeks after the intervention; however, the treatment group showed a statistically higher curative effect than the control group at one and two months after intervention, and also one month after the intervention was terminated. Conclusions Oral herbal medicine has been shown to be an effective treatment for childhood primary hyperhidrosis, and it takes at least one month for the administered oral herbal medicines to take effect. However, further well-designed large-scale randomized controlled trials are needed to confirm the efficacy and safety of oral herbal medicines in childhood primary hyperhidrosis.