• Journal of Gastric Cancer
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• v.18 no.1
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• pp.1-19
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• 2018

Gastric cancer (GC) is the second leading cause of cancer mortality and the fourth most commonly diagnosed malignant diseases. While continued efforts have been focused on GC treatment, the introduction of trastuzumab marked the beginning of a new era of target-specific treatments. Considering the diversity of mutations in GC, satisfactory results obtained from various target-specific therapies were expected, yet most of them were unsuccessful in controlled clinical trials. There are several possible reasons underlying the failures, including the absence of patient selection depending on validated predictive biomarkers, the inappropriate combination of drugs, and tumor heterogeneity. In contrast to targeted agents, immuno-oncologic agents are designed to regulate and boost immunity, are not target-specific, and may overcome tumor heterogeneity. With the successful establishment of predictive biomarkers, including Epstein-Barr virus pattern, microsatellite instability status, and programmed death-ligand 1 (PD-L1) expression, as well as ideal combination regimens, a new frontier in the immuno-oncology of GC treatment is on the horizon. Since the field of immuno-oncology has witnessed innovative, practice-changing successes in other cancer types, several trials on GC are ongoing. Among immuno-oncologic therapies, immune checkpoint inhibitors are the mainstay of clinical trials performed on GC. In this article, we review target-specific agents currently used in clinics or are undergoing clinical trials, and highlight the future clinical application of immuno-oncologic agents in inoperable GC.

• The Journal of Internal Korean Medicine
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• v.43 no.3
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• pp.423-435
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• 2022

Purpose: The purpose of this study was to confirm the clinical efficacy of Gyeongok-go. Methods: Public/Publisher MEDLINE (PubMed), Cochrane Central Register of Controlled Trials (CENTRAL), Excerpta Medica dataBASE (EMBASE), Research Information Sharing Service (RISS), ScienceON, Korean Traditional Knowledge Portal (KTKP), and China National Knowledge Infrastructure (CNKI) were searched for randomized controlled clinical trials administering Gyeongok-go as an intervention, published from inception to December 31, 2021. The risk-of-bias of the included trials was assessed with the Cochrane risk-of-bias tool for randomized trials version 2. From the experimental and control groups of the selected trials, the mean value (or rate) of each outcome was extracted and statistically compared. Results: Statistically significant mean differences were in VO₂max (MD 6.82), post-exercise heart rate (MD -8.76 at 5 min, -11.58 at 30 min, -14.6 at 60 min), senescence scale (MD -6.52), Th1 cells and Th2 cells in pulmonary tuberculosis (MD 2.79 and -1.64), yin-deficient and qi-deficient score (MD -9.64 and -9.76), and phlegm-dampness score (MD 5.56). Overall risk-of-bias was 20% low risk, 80% some concerns, and 0% high risk. There were no reports of adverse events. Conclusions: Gyeongok-go is likely to have the effect of improving cardiorespiratory endurance, increasing fatigue recovery ability, reducing senescence, and enhancing immune function in tuberculosis patients. Also, it is more suitable for those who are yin-deficient or qi-deficient, and those with phlegm-dampness probably need caution.

• The Journal of Korean Obstetrics and Gynecology
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• v.32 no.2
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• pp.50-70
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• 2019

Objectives: The purpose of this study was to show effectiveness of Korean medicine external treatment on bacterial vaginosis by analyzing randomized controlled clinical trials. Methods: We searched randomized controlled clinical trials related with Korean external treatment on bacterial vaginosis through national and overseas database and analyzed them in detail. Results: 15 articles were included according to our selection criteria and 2,176 women were involved. 1. All treatment groups were treated with intervention including Korean medicine external treatment and their results were statistically more effective than control groups. 2. External washing was the most frequently used method followed by vaginal tablet, fumigation and powder. 3. The most frequently used herbal medicine was Sophorae Radix followed by Phellodendri Cortex, Cindi Fructus, Dictamni Radicix Cortex and Kochiae Fructusa. 4. There were 4 studies reporting side effects of treatment and no significant side effects were observed. Conclusions: There was significant difference in the effectiveness of the intervention including Korean external therapy. Based on the analysis, it could be an effective way for the treatment of bacterial vaginosis in clinical practice.

• Journal of Acupuncture Research
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• v.30 no.2
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• pp.43-53
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• 2013

Objectives : The purpose of this study is to review of Clinical trials related to the treatment of chemotherapy induced-toxicity by acupuncture therapy. Methods : We searched PubMed by using word of "chemotherapy induced, acupuncture" (Limits : Full text available, 10 years, Clinical trials, Humans, English). We analyzed 15 research paper and examined published journals, years, countries, topic, study design, their results, interventions, participants and instruments of assessment. Results : Eleven journals with fifteen papers were searched. These papers were published in USA, Germany, etc. On the topic of these clinical trials, seven of them were about nausea(vomiting), two about peripheral neuropathy, two about hot flash, two about arthralgia and one about neutropenia, one about fatigue. Six of these studies were single blinded, randomized controlled trial. Twelve studies reported significant effect. The median for number of final participants was 35.5 persons. Assessment for outcomes were versatile questionnaire, nerve conduction studies, WBC, ANC, G-CSF examination, etc. Conclusions : Their median for impact factor was 3.650 and average modified Jadad score of six RCTs was 4.33. In order to provide appropriate evidence regarding the effectiveness of acupuncture in treatment for chemotherapy-induced toxicity, more rigorous and well-designed studies are necessary.

• Journal of Acupuncture Research
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• v.29 no.3
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• pp.19-28
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• 2012

Objectives : The aim of this study is to evaluate present clinical evidence of oriental medical treatment for cancer in Korea. Method : A search was performed in the Korean Studies Information, Korea Institute of Science and Technology Information, KoreaMed, Oriental Medicine Advanced Searching Integrated System, National Assembly Library, RISS4u, DBPIA, and Oasis using the keyword 'cancer', 'leukemia', 'malignant tumor', 'lymphoma', 'multiple myeloma', 'melanoma'. The search period spanned between Jan 1, 1980~June 30, 2011 and the results were analyzed and evaluated according to the publication date, journal, method of treatment, type of study, and the primary outcome. Randomized clinical trials (RCTs) and Non randomized clinical trial(NRCT) were reviewed separately. Result : The results yielded 133 trials during the period of Jan 1, 1980~June 30, 2011. Most of the trials were concerned with lung cancer and 94 of the trials were simple case studies or case series studies. 61 trials used herbal Formula/herbal medicine as the primary method of treatment. A total of 4 RCTs existed compared to only one NRCT. Conclusion : The use of oriental medicine for the treatment of cancer is gaining popularity in the field of medical scientific research. However most of the studies that have been published up to date are mostly case studies or case series studies, and RCT/NRCT are rare. In order to provide appropriate evidence regarding the effectiveness of oriental medicine in the treatment of cancer, more rigorous and well-designed studies are warranted.

• Communications for Statistical Applications and Methods
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• v.15 no.3
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• pp.353-365
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• 2008

The sample size in a clinical trial is determined by the hypothesis, the variance of observations, the effect size, the power and the significance level. Dropouts in clinical trials are inevitable, so we need to consider dropouts on the determination of sample size. It is common that some proportion corresponding to the expected dropout rate would be added to the sample size calculated from a mathematical equation. This paper proposes new equations for calculating sample size dealing with dropouts. Since we observe data longitudinally in most clinical trials, we can use a last observation to impute for missing one in the intention to treat (ITT) trials, and this technique is called last observation carried forward(LOCF). But LOCF might make deviations on the assumed variance and effect size, so that we could not guarantee the power of test with the sample size obtained from the existing equation. This study suggests the formulas for sample size involving information about dropouts and shows the properties of the proposed method in testing equality of means.

• Korean Journal of Acupuncture
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• v.38 no.2
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• pp.100-109
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• 2021

Objectives : Source acupoint is one of the representative acupoints to treat various diseases in each meridian. We aimed to identify the patterns of selection of Source acupoints and their associations with diseases using clinical trials data. Methods : We extracted the frequency of Source acupoints across 30 diseases from clinical trials database. Acupuncture treatment regimens were retrieved from the Cochrane Database of Systematic Reviews. The frequency of Source acupoint use was calculated as the number of studies using a certain acupoint divided by the total number of included studies. Using hierarchical clustering and multidimensional scaling, the characteristics of Source acupoints were analyzed based on the similarity of the relationships between the Source acupoints and the diseases. Results : A total of 421 clinical trials were included for this analysis. LR3, HT7, KI3, and LI4 acupoints were most frequently used for the treatment of 30 diseases. Cluster analysis showed that LR3 and LI4 acupoints were grouped together and HT7 and KI3 acupoints were grouped together. Multidimensional scaling revealed that LR3, LI4, HT7, and KI3 acupoints have intrinsic properties in the two-dimensional space. Conclusions : The present study identified the selection patterns of the Source acupoints using clinical trials data. Our finding will provide the understanding of the characteristics of Source acupoints.

• Biomolecules & Therapeutics
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• v.32 no.1
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• pp.146-153
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• 2024

The LEPR (leptin receptor) genotype is associated with obesity. Gut microbiome composition differs between obese and non-obese adults. However, the impact of LEPR genotype on gut microbiome composition in humans has not yet been studied. In this study, the association between LEPR single nucleotide polymorphism (rs1173100, rs1137101, and rs790419) and the gut microbiome composition in 65 non-obese Korean adults was investigated. Leptin, triglyceride, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol levels were also measured in all participants. Mean ± SD (standard deviation) of age, body mass index, and leptin hormone levels of participants was 35.2 ± 8.1 years, 21.4 ± 1.8 kg/m², and 7989.1 ± 6687.4 pg/mL, respectively. Gut microbiome analysis was performed at the phylum level by 16S rRNA sequencing. Among the 11 phyla detected, only one showed significantly different relative abundances between LEPR genotypes. The relative abundance of Candidatus Saccharibacteria was higher in the G/A genotype group than in the G/G genotype group for the rs1137101 single nucleotide polymorphism (p=0.0322). Participant characteristics, including body mass index, leptin levels, and other lipid levels, were similar between the rs1137101 G/G and G/A genotypes. In addition, the relative abundances of Fusobacteria and Tenericutes showed significant positive relationship with plasma leptin concentrations (p=0.0036 and p=0.0000, respectively). In conclusion, LEPR genotype and gut microbiome may be associated even in normal-weight Korean adults. However, further studies with a greater number of obese adults are needed to confirm whether LEPR genotype is related to gut microbiome composition.

• The Journal of Pediatrics of Korean Medicine
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• v.35 no.3
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• pp.67-88
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• 2021

Objectives The purpose of this study is to analyze randomized clinical trials (RCTs) on traditional Chinese medicine to summarize its efficacy and safety for the treatment of functional gastrointestinal disorders (FGIDs) in children. Methods We searched literatures published up to March 19, 2021 using two Chinese electronic databases. Data regarding patients, interventions, results, and adverse events were extracted from RCTs of herbal medicine for children with FGIDs. Results A total of 34 RCTs were included: 16 trials on functional dyspepsia, 7 trials on functional constipation, 6 trials on functional abdominal pain, 4 trials on irritable bowel syndrome, and 1 trial on functional diarrhea. 26 of 29 trials that reported total effective rate, the treatment group showed a significant improvement compared to the control group. Most of other evaluation indicators, such as symptom score, symptom disappearance time, and recurrence rate also demonstrated statistically significant improvement. Of the 16 studies which reported safety, 5 studies reported no adverse reactions in either group, and 4 studies reported no statistically significant differences in the incidence of adverse events between two groups. Also, reported adverse events were mostly mild. Conclusions Herbal medicine may help improve symptoms of FGIDs in children. However, due to limited types of studies on sub-diseases of FGIDs and small sample sizes in each study, additional large scale clinical studies on various other FGIDs are necessary.

• Journal of the Korean Data and Information Science Society
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• v.18 no.2
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• pp.411-418
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• 2007

Sample size calculation is very important in clinical trials. In this paper, we propose sample size calculation method for non-inferiority trials using sample size calculation method suggested by Wang et al.(2003) based on Wilcoxon's rank sum test. Also, sample size comparison between parametric method and proposed method are presented.