• Journal of Genetic Medicine
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• v.8 no.1
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• pp.28-34
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• 2011

Most clinicians understand clinical trials as the evaluation process for new medicine before their use. However, clinical trials can also be applied to laboratory diagnostic tests (LDTs) to verify diagnostic accuracy and efficacy before their clinical laboratory implementation for patients. The clinical trial of LDT has two distinctive characteristics that are different from the case of pharmaceuticals and thus worth special consideration. One of them is the level of evidence. The well-designed randomized controlled trials (RCTs) are known to provide the best evidence to prove the clinical efficacy of any pharmaceutical products. However, RCTs lose practicality when applied to LDTs due to various issues including ethical complications. For this reason, comparative study format is considered more feasible approach for LDTs. In addition pharmaceuticals and LDTs are different in that the user's intervention is not required for the former but critical to the latter. Moreover, in the case of pharmaceuticals, end-products are produced by manufacturers before being used by clinicians. However, in LDTs, once reagents and instruments are provided by manufacturers, they are first utilized by clinical laboratories to produce test results in order for clinicians to use them later. In other words, when it comes to LDTs, clinical laboratories play the role of manufacturers, providing reliable test results with improved quality assurance. Considering the distinctive characteristics of LDTs, we would like to offer detailed suggestions to successfully perform clinical trials in LDTs, which include analytical performance measures, clinical test performance measures, diagnostic test accuracy measures, clinical effectiveness measures, and post-implementation surveillance.

• Tuberculosis and Respiratory Diseases
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• v.67 no.5
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• pp.422-429
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• 2009

Background: The discomfort caused by chronic cough, that is persistent for more than 3 weeks, causes a number of patients to seek medical attention. However, the underlying disorder often remains undetermined despite thorough examinations, and is considered to be idiopathic. This study compared the efficacy of inhaled corticosteroid with conventional cough suppressants on chronic idiopathic cough. Methods: Eligible patients with chronic idiopathic cough were randomly assigned to either the inhaled fluticasone group or the codeine plus levodropropizine oral administration group. The subjects in each group took their planned medication for 2 weeks. After the trial, comparative analyses of outcomes were performed in terms of the remnant cough (%) at the end of treatment, drug compliance, and adverse drug events. Results: Seventy-seven patients were enrolled in this randomized trial; 38 to the inhaled fluticasone group and 39 to the codeine plus levodropropizine group. The remnant cough was 41.0${\pm}$35.8% in the inhaled fluticasone group, and 32.4${\pm}$32.0% in the codeine+levodropropizine group (p=0.288). Drug compliance was 95.4${\pm}$7.4% and 81.8${\pm}$18.6% in the inhaled fluticasone and the codeine+levodropropizine group, respectively (p<0.001). Nine patients had adverse drug events in the codeine+levodropropizine group compared to one in the inhaled fluticasone group (p<0.001). Conclusion: Short-term inhaled corticosteroid is not inferior to conventional antitussive agents in controlling chronic idiopathic cough without significant adverse events.

• Animal Bioscience
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• v.36 no.3
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• pp.484-491
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• 2023

Objective: The aim of this trial was to investigate the effect of supplementation and withdrawal of selenium-enriched kale sprouts (SeKS) on productivity and egg Se concentration of laying hens. Selenium from commercial Se-enriched yeast (SeY) was used as a comparative Se source. Methods: One-hundred and eighty 61-week-old laying hens were randomly divided into 5 treatment groups with 4 replicates (9 hens each) in a 2×2+1 Augmented Factorial Experiment in a completely randomized design. The experimental diets were basal diet, basal diet supplemented with 0.2 and 0.4 mg Se/kg from SeKS and SeY, respectively. The 8-week feeding trial was divided into 2 periods, namely the Se supplemental period (week 1 to 4) and the Se withdrawal period (week 5 to 8). Results: Productive performance, egg quality and egg Se concentration of laying hens were not affected by sources of Se (SeKS and SeY) during both, the Se supplemental and withdrawal periods. Egg production and egg Se concentration increased (p<0.05) with increasing levels of Se supplementation. The egg Se concentration increased and reached a peak 1 week after Se supplementation. However, concentration of Se in eggs of hens fed Se from both sources decreased rapidly from the second week of the Se withdrawal period to reach the same egg Se concentration of hens fed the basal diet by the fourth week of the Se withdrawal period. Conclusion: The efficacy of Se from SeKS on productivity and egg Se concentration in laying hens was comparable to commercial SeY. Thus, SeKS can provide an alternate organic Se source for production of Se-enriched eggs.

• Korean Journal of Biological Psychiatry
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• v.4 no.2
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• pp.265-271
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• 1997

Objective : A 4-week, single-blind, parallel group study was conducted to evaluate the efficacy and safety of tofisopam and lorazepam in 32 outpatients with anxiety disorder. Methods : Patients were randomized to receive either tofisopam(N=17) or lorazepam(N=15). The starting dose of tofisopam was 50mg t.i.d. daily, which could be increased to a maximum of 100mg t.i.d. according to the patient's clinical response and side effect. The starting dose of lorazepam was 0.75mg b.i.d. daily, which could be increased to a maximum of 1.5mg b.i.d. depending on the patient's clinical response and side effect. Efficacy evaluations at baseline, week 1, 2, and 4 used the 14-item Hamilton Rating Scale for Anxiety(HAM-A) and Clinical Global Impression(CGI). Tolerability was assessed by response to a nonleading question concerning adverse events. Laboratory parameters including vital sign, EKG, hematological, and biochemical values were measured during trial. Results : No significant differences between HAM-A total scores, two HAM-A factors(psychic, somatic) and CGI severity scores were recorded at any point during tofisopam and lorazepam treatments. However, in each group there was a significant decrease in HAM-A total scores, two HAM-A factor s(psychic, somatic), CGI severity scores over time. The pecentages of patients with tofisopam who at least minimally improved increased from 64.7% at week 1 to 94.1% at week 4. The pecentages of patients with lorazepam who at least minimally improved increased from 40.0% at week 1 to 66.7% at week 4. The pecentages of patients with tofisopam who had not any adverse event increased from 58.8% at week 1 to 87.9% at week 4. The pecentages of patients with lorazepam who had not any adverse event were not changed from 46.7% at week 1 to 46.7% at week 4. Laboratory parameters including vital sign, EKG, hematological, and biochemical values showed no significant changes during the trial in both groups. Conclusion : These data suggest that tofisopam may be effective in reducing anxiety and is a anti-anxiety drug of identical potency with lorazepam. Tolerability of tofisopam was superior to lorazepam. These findings should be confirmed by using double-blind crossover study with a large member of patients.

• Journal of Korean Medicine Rehabilitation
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• v.24 no.4
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• pp.145-153
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• 2014

Objectives The purpose of this study is to compare the effects of HWANGRYUNHAEDOKTANG Pharmacopuncture and Essential Bee Venom pharmacopuncture on cervical pain caused by traffic accident. Methods The clincal study was conducted to traffic accident patients who had admitted to Dae-Jeon University Cheonan Oriental Hospital from May 17, 2014 to September 2, 2014. The patients were simple randomization and divided into two groups. In one group, patients were treated with the oriental medicine and HWANGRYUNHAEDOKTANG Pharmacopuncture, While in the other group, patients were treated with the oriental medicine therapy and Essential Bee Venom pharmacopuncture therapy. visual analogue scale (VAS), pain threshold and neck disablity index (NDI) were used To estimate the efficacy of Pharmacopuncture treatment. Results 1) HWANGRYUNHAEDOKTANG Pharmacopuncture Group showed significant decrease of VAS and NDI after 3rd times treatment than before treatment (p<0.001). Essential Bee Venom Pharmacopuncture showed significant decrease of VAS, NDI and improve ment of pain threshold after 3rd times treatment than before treatment (p<0.01, p<0.001). 2) There was no significant difference between HWANGRYUNHAEDOKTANG Pharmacopuncture group and Essential Bee Venom Pharmacopuncture group in VAS, pain threshold and NDI. Conclusions We found out that HWANGRYUNHAEDOKTANG Pharmacopuncture and Essential Bee Venom Pharmacopuncture treatment are considered to be effective and useful in cervical pain caused by traffic accident.

• Journal of the Korea Convergence Society
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• v.12 no.5
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• pp.39-50
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• 2021

In this study, a meta-analysis was conducted to find out the effects of convergent "untact" exercise programs on the balance, gait, and falls efficacy of Parkinson's patients. In this study, the PICO were Parkinson's disease, virtual reality program and an e-exercise program intervention, a comparative intervention with the contact interventions applied, and without any interventions applied, outcomes were balance, gait, and fall efficacy. The survey period was between January and February 2021, and five papers were selected and subjected to meta-analysis. Risk of bias, a tool commonly used for randomized control trial studies, was used. Furthermore, RevMan program was used to investigate effect size of untact exercise programs. The result of the meta-analysis showed that the effect size of balance of the untact exercise program group was 1.27 (SMD=1.27; 95% CI 0.72 to 1.83) (Z=4.51, p<0.001), the effect size of fall efficacy was 0.52 (SMD=0.52; 95% CI -0.000 to 1.03) (Z=1.96, p=0.05), and the effect size of gait was -0.40 (SMD=-0.40; 95% CI -1.00 to 0.10)(Z=1.32, p>0.05). A total of 5 literature analysis showed that untact exercise program is more effective in improving balance and falls efficacy than contact exercise program, but no difference in effectiveness was shown on gait.

• Radiation Oncology Journal
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• v.19 no.2
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• pp.127-135
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• 2001

Purpose : This study is a prospective randomized clinical trial comparing the efficacy and complication of anti-emetic drugs for prevention of nausea and vomiting after radiotherapy which has moderate emetogenic potential. The aim of this study was to investigate whether the anti-emetic efficacy of ondansetron $(Zofran^{\circledR})$ 8 mg bid dose (Group O) is better than the efficacy of metoclopramide 5 mg lid dose (Group M) in patients undergoing fractionated radiotherapy to the abdominal region. Materials and Methods : Study entry was restricted to those patients who met the following eligibility criteria: histologically confirmed malignant disease; no distant metastasis; performance status of not more than ECOG grade 2; no previous chemotherapy and radiotherapy. Between March 1997 and February 1998, 60 patients enrolled in this study. All patients signed a written statement of informed consent prior to enrollment. Blinding was maintained by dosing identical number of tablets including one dose of matching placebo for Group O. The extent of nausea, appetite loss, and the number of emetic episodes were recorded everyday using diary card. The mean score of nausea, appetite loss and the mean number of emetic episodes were obtained in a weekly interval. Results : Prescription error occurred in one patient. And diary cards have not returned in 3 patients due to premature refusal of treatment. Card from one patient was excluded from the analysis because she had a history of treatment for neurosis. As a result, the analysis consisted of 55 patients. Patient characteristics and radiotherapy characteristics were similar except mean age was $52.9{\pm}11.2$ in group M, $46.5{\pm}9.5$ in group O. The difference of age was statistically significant. The mean score of nausea, appetite loss and emetic episodes in a weekly interval was higher in group M than O. In group M, the symptoms were most significant at 5th week. In a panel data analysis using mixed procedure, treatment group was only significant factor detecting the difference of weekly score for all three symptoms. Ondansetron $(Zofran^{\circledR})$ 8 mg bid dose and metoclopramide 5 mg lid dose were well tolerated without significant side effects. There were no clinically important changes In vital signs or clinical laboratory parameters with either drug. Conclusion : Concerning the fact that patients with younger age have higher emetogenic potential, there are possibilities that age difference between two treatment groups lowered the statistical power of analysis. There were significant difference favoring ondansetron group with respect to the severity of nausea, vomiting and loss of appetite. We concluded that ondansetron is more effective anti-emetic agents in the control of radiotherapy-induced nausea, vomiting, loss of appetite without significant toxicity, compared with commonly used drug, i.e., metoclopramide. However, there were patients suffering emesis despite the administration of ondansetron. The possible strategies to improve the prevention and the treatment of radiotherapy-induced emesis must be further studied.

• Tuberculosis and Respiratory Diseases
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• v.66 no.2
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• pp.93-97
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• 2009

Background: Belotecan (Camtobell, CKD-602, Chongkundang Pharm., Korea), a camptothecin derivative, has anticancer effects by inhibiting topoisomerase I such as topotecan. This study observed the response, survival and toxicity of belotecan monotherapy after the failure of etoposide and platinum (EP). Methods: Forty nine small cell lung cancer (SCLC) patients (M/F=41/8; age, 64.5${\pm}$7.6 (mean${\pm}$SD) years), who failed in their first line chemotherapy were enrolled in this study. Twenty one SCLC patients showed relapsed lung cancer more than 90 days after their priorEP chemotherapy (sensitive relapse group, SR) and 28 patients relapsed within 90 days (refractory relapse group, RR). Results: The response rate was 25%. Eleven patients showed partial responses and 5 patients could not be checked. The response rate of the SR and RR patients was similar. The relative dose intensity was lower in the responders (78${\pm}$15%) than non-responders (83${\pm}$13%, p=0.03). The median survival time (MST) was 10.3 months (290 days). The MST of the non-responders and responders was 186 days (95% CI; 67-305) and 401 days (95% CI; 234-568, p=0.07), respectively. The median progression free survival (MPFS) was similar in the SR (79 days) and RR (67 days) patients. Grade 3-4 neutropenia, anemia, and thrombocytopenia were observed in 59.6%, 12.8% and 23.4% of patients, respectively. Conclusion: The efficacy and survival were demonstrated in the second-line setting. However, a randomized comparative trial with topotecan will be needed.

• Tuberculosis and Respiratory Diseases
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• v.44 no.6
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• pp.1296-1307
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• 1997

Background : Erdosteine is a thiol derivative developed for the treatement of chronic obstructive bronchitis, including acute infective exacerbation of chronic bronchitis. Erdosteine has mucomodulating and antioxidant properties and especially exhibits excellent gastrointestinal tolerability. Methods : The study was conducted as a prospective evaluation, with 2 comparative groups orally treated with erdosteine 300mg (bid.) or ambroxol 30mg (b.i.d.) for 7 days and the design of trial was double-blind. The treatments have been assigned randomly to patients (n=80) with acute or chronic bronchitis. The primary end-point used to determine efficacy in this study was subjective symptoms including expectorating frequence, expectoration volume, expectorating difficulty, expectoration viscosity, cough intensity and dyspnea. The secondary end-points of efficacy was the result of arterial blood gas analysis and pulmonary function test. Safety was evaluated with adverse drug reactions and laboratory tests monitoring. 61 patients was included in the efficacy analysis, due to the fact that 19 patients drop-out for different reasons. The obtained values have been analyzed with paired Hest., ANOVA test., multivariate $t^2$-test, repeated measures analysis of covariance, two sample t-test, loglinear-logit model analysis, Fisher's exact test. Results : 1) There was no significant difference on demographic data and vital signs between erdosteine and ambroxol treated groups. 2) The comparison between erdosteine and ambroxol treated groups showed no significant difference in improvement of each symptom in spite of the more favorable efficacy obtained with erdosteine. No difference on the contrary was observed for arterial blood gas analysis and pulmonary function test. 3) As safety is concerned, no clinical significant changes in laboratory test and symptom were induced in erdosteine and ambroxol treated group and two patients in ambroxol treated group drop-out for adverse reactions in symptom. 4) In the evaluation of final clinical efficacy, erdosteine improved more effectively patient's overall symptoms {very good effect (11/31), good effect (12/31), moderate effect (6/31), no effect (2/31), aggravation (0/31)} than ambroxol {very good effect (6/30), good effect (14/30), moderate effect (5/30), no effect (4/30), aggravation (2/30)}. And the probability of symptomatic improvement by erdosteine compared to ambroxol was 2.5 times. (p<0.05). Conclusion : This study showed that erdosteine was clinically effective and safe drug for treatment of acute and chronic bronchitis.