• Journal of Pharmacopuncture
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• v.18 no.1
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• pp.79-85
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• 2015

Objectives: A vertebral compression fracture (VCF) is characterized by back pain and fracture of a vertebral body on spinal radiography. VCFs of the thoraco lumbar spine are common in the elderly. In general, appropriate analgesics should be prescribed to reduce pain and, thus, promote early mobilization. The ideal treatment approach for VCFs has not been determined. In Korea, acupuncture and herbal medication have been used to treat VCFs for many years. There is empirical evidence that acupuncture might benefit patients with a VCF. However, no randomized, controlled, clinical trials evaluating the efficacy and the safety of acupuncture for treating a VCF have been published. Therefore, we designed a randomized, controlled, pilot, clinical trial to obtain information for the design of a further full scale trial. Methods: A five week protocol for a randomized, controlled, pilot, clinical trial is presented. Fourteen patients will be recruited and randomly allocated to two groups: a control group receiving interlaminar epidural steroid injections once a week for three weeks, and an experimental group receiving interlaminar epidural steroid injections plus acupuncture treatment (three acupuncture sessions per week for three weeks, nine sessions in total). The primary outcomes will be the pain intensity (visual analogue scale and PainVision$^{TM}$ system). The secondary outcome measurements will be the answers on the short form McGill pain questionnaire and the oswestry disability index. Assessments will be made at baseline and at one, three, and five weeks. The last assessment (week five) will take place two weeks after treatment cessation. This study will provide both an indication of feasibility and a clinical foundation for a future large scale trial. The outcomes will provide additional resources for incorporating acupuncture into existing treatments, such as nonsteroidal anti-inflammatory medications, narcotics and vertebral augmentation. This article describes the protocol.

• Journal of Korean Medicine for Obesity Research
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• v.20 no.2
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• pp.138-148
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• 2020

Objectives: The aim of this study is to evaluate the effects of Bangpungtongseong-san (Fangfengtongsheng-san, BTS) and Daesiho-tang (Dachaihu-tang, DST) on weight loss and improvement in lipid metabolism and glucose metabolism. Furthermore, we intend to develop a prediction model for drug effects through the analysis of the single nucleotide polymorphism (SNP), gut-microbiota, and the expression of immune-related biomarkers. Methods: This study is a single-center, randomized, double-blind, parallel-design clinical trial. One hundred twenty-eight participants will be assigned to the BTS group (n=64) and DST group (n=64). Both groups will be administered 4 g medication three times a day for up to 2 weeks. The primary outcomes is weight loss. The secondary outcomes include bioelectrical impedance analysis, waist circumstance, body mass index, total cholesterol, high-density lipoprotein, triglyceride, insulin resistance. The exploratory outcomes include 3-day dietary recall, food frequency questionnaire, quality of life questionnaire, gut microbiota analysis, immune biomarkers analysis, and SNP analysis. Assessment will be made at baseline and at week 4, 8, and 12. Conclusions: This protocol will be implemented by approval of the Institutional Review Board of Dongguk University. The results of this trial will provide a systematic evidence for the treatment of obesity and enable more precise herbal medicine prescriptions.

• Journal of the Korean Statistical Society
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• v.32 no.1
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• pp.33-46
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• 2003

The continual reassessment method (CRM) provides a Bayesian estimation of the maximum tolerated dose (MTD) in phase I clinical trials. The CRM has been proposed as an alternative design of the standard design. The CRM has been modified to improve practical feasibility and, recently, the likelihood approach CRM has been proposed. In this paper we investigate the consistency and asymptotic normality of the modified likelihood approach CRM in which the maximum likelihood estimate is used instead of the posterior mean. Small-sample properties of the consistency is examined using complete enumeration. Both the asymptotic results and their small-sample properties show that the modified CRML outperforms the standard design.

• The Journal of Korean Medicine
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• v.38 no.1
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• pp.46-55
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• 2017

Objectives: The aim of this study is reviewing the literature to extract the key parameter, study design, perspective, cost-effectiveness index and find the calibration parameter for the clinical study with economical evaluation protocol on facial palsy. Methods: Literature search is performed using PUBMED for literature published from January 2000 to December 2016. We included randomized controlled trials(RCTs) and modelling study with economic assessment in which human participated. Results: As a result of literature search, the 198 articles were found. After reviewing the title, abstract and full text, the 5 articles were selected. Selected articles are classified into 4 RCT studies dealing with quality of life and 1 CEA(cost-effectiveness analysis) study. Conclusions: We found reliable key parameters, calibration parameters and elements of economical assessment study, which might be necessary factors for developing research protocol of clinical trial with economic evaluation about facial palsy patients.

• The Korean Journal of Applied Statistics
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• v.11 no.2
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• pp.269-285
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• 1998

One of the most important issues in the area of clinical trial research is the determination of the sample size required to insure a specified power in detecting a real or clinically relevant difference of a stated magnitude. Increasingly, medical journals are requiring authors to provide information on the sample size needed to detect a given difference. We restrict our attention to the designs far comparirng two survival distributions. These are concerned with the survival time which is defined as the interval from a baseline(e.g. randomization) to failure (e.g. death, recurrence of disease). Survival times axe right censored when patients have not foiled by the time of analysis or have been loss to follow-up during the trial. For different types of clinical trials for comparing survival distributions, there have been marry research in sample size determination. We review the existing literature concerning commonly used sample size formulae in the design of randomized clinical trials, and compare the assumption, the power and the sample size calculation of these methods. We also compare by simulation the expected power and observed power of each method under various circumstances. As a result, guidelines in terms of practical usage are provided.

• Journal of Ginseng Research
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• v.45 no.5
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• pp.546-554
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• 2021

Background: Diabetes mellitus and hypertension often occur together, amplifying cardiovascular disease (CVD) risk and emphasizing the need for a multitargeted treatment approach. American ginseng (AG) and Korean Red Ginseng (KRG) species could improve glycemic control via complementary mechanisms. Additionally, a KRG-inherent component, ginsenoside Rg3, may moderate blood pressure (BP). Our objective was to investigate the therapeutic potential of coadministration of Rg3-enriched Korean Red Ginseng (Rg3-KRG) and AG, added to standard of care therapy, in the management of hypertension and cardiometabolic risk factors in type-2 diabetes. Methods: Within a randomized controlled, parallel design of 80 participants with type-2 diabetes (HbA1c: 6.5-8%) and hypertension (systolic BP: 140-160 mmHg or treated), supplementation with either 2.25 g/day of combined Rg3-KRG + AG or wheat-bran control was assessed over a 12-wk intervention period. The primary endpoint was ambulatory 24-h systolic BP. Additional endpoints included further hemodynamic assessment, glycemic control, plasma lipids and safety monitoring. Results: Combined ginseng intervention generated a mean ± SE decrease in primary endpoint of 24-h systolic BP (-3.98 ± 2.0 mmHg, p = 0.04). Additionally, there was a greater reduction in HbA1c (-0.35 ± 0.1% [-3.8 ± 1.1 mmol/mol], p = 0.02), and change in blood lipids: total cholesterol (-0.50 ± 0.2 mmol/l, p = 0.01), non-HDL-C (-0.54 ± 0.2 mmol/l, p = 0.01), triglycerides (-0.40 ± 0.2 mmol/l, p = 0.02) and LDL-C (-0.35 ± 0.2 mmol/l, p = 0.06) at 12 wks, relative to control. No adverse safety outcomes were observed. Conclusion: Coadministration of Rg3-KRG + AG is an effective addon for improving BP along with attaining favorable cardiometabolic outcomes in individuals with type 2 diabetes. Ginseng derivatives may offer clinical utility when included in the polypharmacy and lifestyle treatment of diabetes. Clinical trial registration: Clinicaltrials.gov identifier, NCT01578837;

• Communications for Statistical Applications and Methods
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• v.5 no.2
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• pp.459-475
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• 1998

In many clinical trials, we are interested in comparing the failure time distribution of different treatment groups. Because of ethical and economic reasons, clinical trials need to be monitored for early dramatic benefits or potential harmful effects. Prior knowledge, evolving knowledge, statistical considerations, medical judgment and ethical principles are all involved in the decision to terminate a trial early, and thus the monitoring is usually carried out by an independent scientific committee. This paper reviews the recently proposed group sequential testing procedures for clinical trials with survival data. Design considerations of such clinical trials are also discussed. This paper compares the characteristics of each of these methods and provides the biostatisticians with the guidelines for choosing the appropriate group sequential methods in a given situation.

• Korean Journal of Occupational Health Nursing
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• v.28 no.2
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• pp.83-93
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• 2019

Purpose: Cancer patients are at a higher risk of being unemployed or facing difficulty in returning to work (RTW) than individuals without health concerns. The aim of this study is to identify and describe interventions developed specifically to assist cancer patients to RTW after treatment. Methods: A comprehensive search was conducted from September to October 2018 in different international databases: PubMed, Medline, and Embase. Studies using qualitative, quantitative, or mixed designs were included if they satisfied the following criteria: (a) described an intervention to assist cancer patients to RTW during or after treatment; (b) conducted on patients aged 18 and over and diagnosed with cancer; (c) written in English; (d) published in peer-reviewed journals. Results: Fourteen studies met the inclusion criteria. Counseling with physical activity intervention, behavioral training to reduce fatigue, and multi-disciplinary rehabilitation programs were found to be effective. Conclusion: Interventions adopting a multidisciplinary approach were effective for RTW in cancer patients. This literature review emphasizes the need for more tailored interventions based on survivors' needs and characteristics in the RTW field.

• Journal of Ginseng Research
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• v.46 no.4
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• pp.543-549
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• 2022

Background: In physical activity or labor, the human body is in a state of high intensity stress, and all parts or physiological functions of the body respond positively to maintain or balance the need for movement. The human body has many physiological changes in the process of movement, and fatigue is the external manifestation of various complex changes inside the human body. Fatigue is also a physiological mechanism of self-protection after the body reaches a certain level of activity, which can prevent the occurrence of life-threatening excessive functional failure. The generation of fatigue is a very complex process, and its mechanism has not been concluded yet. Therefore, it is an important work to search and screen the effective components of natural plants that have anti-fatigue effect and to explore their mechanism. Methods: This was a 8-week, randomized, double-blind, placebo-controlled clinical trial. A total of 110 subjects who passed physical examination were included according to the scheme design, and randomly divided into a test group which was given KRG and a placebo control group. The calculation is carried out according to the standard of sub-high-intensity exercise test. Results: There was no adverse effect on safety index of subjects after taking red ginseng capsule. After KRG treatment, subjective strength grade is significant lower than placebo treatment. Blood lactic acid content is significantly get lower after trial in KRG group, and significant lower than placebo group. Creatine phosphokinase(CK) content is significantly get lower after trial in KRG group, and significant lower than placebo group. Conclusion: According to the criterion in the test scheme, the result shows that KRG is helpful on relieving physical fatigue.

• Journal of Haehwa Medicine
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• v.26 no.1
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• pp.49-57
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• 2017

Objectives : The purpose of this study was to investigate the efficacy of inhalation therapy using Zizyphus jujuba var. spinosa blended oil and spa therapy on stress in adults. Methods : The study design was a double blind, randomized, single center clinical trial. A total of 30 volunteers who were highly stressed and were over 9 points on POMS(profile of mood states) participated in this study. Inhalation therapy using Zizyphus jujuba var. spinosa blended oil and spa therapy were applicate for the experimental group and Jojoba oil inhalation and spa therapy was given for the control group. During the 2 weeks, the participants were treated about inhalation and spa therapy twice a week. The treatment sequence is spa therapy after inhalation therapy. Result : The improvement of stress was evaluated by POMS, HRV(Heart Rate Variability), EEG(Electroencephalography), PSQI(Pittsburgh Sleep Quality Index), salivary cortisol. After treatment, POMS was significantly decreased between the experimental group and the control group. In other measurement(HRV, EEG, PSQI, salivary cortisol) except POMS, there were not significant. Overall, however, they showed a tendency to alleviate stress in the experimental group. Conclusions : We suggest that inhalation therapy using Zizyphus jujuba var. spinosa blended oil and spa therapy might be effective on stress.