1.A Randomized, Double-Blind, Active-Control, Noninferiority, Multicenter, Phase 4 Study to Evaluate the Efficacy and Safety of Esomeprazole/Sodium Bicarbonate 20/800 mg in Patients with Nonerosive Gastroesophageal Reflux Disease
Su Hyun PARK ; Kang Nyeong LEE ; Oh Young LEE ; Myung Gyu CHOI ; Jie-Hyun KIM ; In-Kyung SUNG ; Jae Young JANG ; Kyung Sik PARK ; Hoon Jai CHUN ; Eun Young KIM ; Jun Kyu LEE ; Jin Seok JANG ; Gwang Ha KIM ; Su Jin HONG ; Yong Chan LEE ; Suck-Chei CHOI ; Hyun Soo KIM ; Tae Oh KIM ; Gwang Ho BAIK ; Yong Cheol JEON
Gut and Liver 2023;17(2):226-233
Background/Aims:
Efficacy of proton pump inhibitors is limited in patients with nonerosive reflux disease (NERD). The aim of this study was to comparatively evaluate the efficacy and safety of esomeprazole with sodium bicarbonate and esomeprazole alone.
Methods:
This was a multicenter, randomized, double-blind, active-controlled, noninferiority comparative study. A total of 379 patients with NERD were randomly allocated to receive either EsoduoⓇ/sup> (esomeprazole 20 mg with sodium bicarbonate 800 mg) or NexiumⓇ/sup> (esomeprazole 20 mg) once daily for 4 weeks from January 2019 to December 2019. The patients had a history of heartburn for at least 2 days in the week before randomization as well as in the last 3 months and no esophageal mucosal breaks on endoscopy. The primary endpoint was a complete cure of heartburn at week 4. The secondary and exploratory endpoints as well as the safety profiles were compared in the groups at weeks 2 and 4.
Results:
A total of 355 patients completed the study (180 in the EsoduoⓇ/sup> group and 175 in the NexiumⓇ/sup> group). The proportions of patients without heartburn in the entire 4th week of treatment were not different between the two groups (33.33% in the EsoduoⓇ/sup> group and 35% in the NexiumⓇ/sup> group, p=0.737). There were no significant differences in most of the secondary and exploratory endpoints as well as the safety profiles.
Conclusions
EsoduoⓇ/sup> is as effective and safe as NexiumⓇ/sup> for managing typical symptoms in patients with NERD (ClinicalTrial.gov identifier: NCT03928470).
2.Evaluation of the Efficacy and Safety of DA-9601 versus Its New Formulation, DA-5204, in Patients with Gastritis: Phase III, Randomized, Double-Blind, Non-Inferiority Study.
Yoon Jin CHOI ; Dong Ho LEE ; Myung Gyu CHOI ; Sung Joon LEE ; Sung Kook KIM ; Geun Am SONG ; Poong Lyul RHEE ; Hwoon Yong JUNG ; Dae Hwan KANG ; Yong Chan LEE ; Si Hyung LEE ; Suck Chei CHOI ; Ki Nam SHIM ; Sang Yong SEOL ; Jeong Seop MOON ; Yong Woon SHIN ; Hyun Soo KIM ; Soo Teik LEE ; Jin Woong CHO ; Eun Kwang CHOI ; Oh Young LEE ; Jin Seok JANG
Journal of Korean Medical Science 2017;32(11):1807-1813
This study compared the efficacy of DA-9601 (Dong-A ST Co., Seoul, Korea) and its new formulation, DA-5204 (Dong-A ST Co.), for treating erosive gastritis. This phase III, randomized, multicenter, double-blind, non-inferiority trial randomly assigned 434 patients with endoscopically proven gastric mucosal erosions into two groups: DA-9601 3 times daily or DA-5,204 twice daily for 2 weeks. The final analysis included 421 patients (DA-5204, 209; DA-9601, 212). The primary endpoint (rate of effective gastric erosion healing) and secondary endpoints (cure rate of endoscopic erosion and gastrointestinal [GI] symptom relief) were assessed using endoscopy after the treatment. Drug-related adverse events (AEs), including GI symptoms, were also compared. At week 2, gastric healing rates with DA-5204 and DA-9601 were 42.1% (88/209) and 42.5% (90/212), respectively. The difference between the groups was −0.4% (95% confidence interval, −9.8% to 9.1%), which was above the non-inferiority margin of −14%. The cure rate of gastric erosion in both groups was 37.3%. The improvement rates of GI symptoms with DA-5204 and DA-9601 were 40.4% and 40.8%, respectively. There were no statistically significant differences between the two groups in both secondary endpoints. AEs were reported in 18 (8.4%) patients in the DA-5204 group and 19 (8.8%) in the DA-9601 group. Rates of AE were not different between the two groups. No serious AE or adverse drug reaction (ADR) occurred. These results demonstrate the non-inferiority of DA-5204 compared to DA-9601. DA-5204 is as effective as DA-9601 in the treatment of erosive gastritis. Registered randomized clinical trial at ClinicalTrials.gov (NCT02282670)
Artemisia
;
Double-Blind Method
;
Drug-Related Side Effects and Adverse Reactions
;
Endoscopy
;
Gastritis*
;
Humans
;
Seoul
3.Efficacy of DA-9701 (Motilitone) in Functional Dyspepsia Compared to Pantoprazole: A Multicenter, Randomized, Double-blind, Non-inferiority Study.
Hye Kyung JUNG ; Kwang Jae LEE ; Myung Gyu CHOI ; Hyojin PARK ; Joon Seong LEE ; Poong Lyul RHEE ; Nayoung KIM ; Kyung Sik PARK ; Suck Chei CHOI ; Oh Young LEE ; Kyu Chan HUH ; Geun Am SONG ; Su Jin HONG ; Chong Il SOHN ; Hwoon Yong JUNG ; Yong Chan LEE ; Jong Sun REW ; Sam Ryong JEE ; Joong Goo KWON
Journal of Neurogastroenterology and Motility 2016;22(2):254-263
BACKGROUND/AIMS: The effect of proton pump inhibitors (PPI) in Asian functional dyspepsia (FD) patients has not been well established as in Western countries. DA-9701, a novel prokinetic agent, stimulates gastric emptying and modulates visceral hypersensitivity in vivo and in human studies. This study was conducted to compare the efficacy of DA-9701 with a conventional PPI in mono or combination therapy in patients with FD. METHODS: In this double-blind, randomized, non-inferiority trial, 389 patients diagnosed with FD using Rome III criteria were allocated among 3 groups: 30-mg DA-9701 t.i.d (means 3 times a day), 40-mg pantoprazole, and 30-mg DA-9701 t.i.d + 40-mg pantoprazole. The primary efficacy end-point was a global assessment of the patient binary response or response on a 5-Likert scale after 4 weeks. RESULTS: The global symptomatic improvement was 60.5% in the DA-9701 group, 65.6% in the pantoprazole group, and 63.5% in the DA-9701 + pantoprazole group using a 5-Likert scale at week 4 with no significant difference among 3 groups (P = 0.685). Symptom improvement measured by binary outcome was significantly achieved in each of the 3 groups, but not different among groups. Patients in all treatment groups reported significant improvement in the response rate and symptoms according to FD subtypes and dyspepsia-related quality of life (P < 0.001), but there were no significant differences among the 3 groups. CONCLUSIONS: DA-9701 improves global and individual symptoms and increases dyspepsia-specific quality of life in patients with FD. The efficacy of DA-9701 monotherapy is comparable with pantoprazole and there is no additive effect with combination of DA-9701 and pantoprazole in patients with FD.
Asian Continental Ancestry Group
;
Dyspepsia*
;
Gastric Emptying
;
Humans
;
Hypersensitivity
;
Proton Pump Inhibitors
;
Quality of Life
4.Korean Asthma Guideline 2014: Summary of Major Updates to the Korean Asthma Guideline 2014.
Deog Kyeom KIM ; Yong Bum PARK ; Yeon Mok OH ; Ki Suck JUNG ; Ji Hong YOO ; Kwang Ha YOO ; Kwan Hyung KIM
Tuberculosis and Respiratory Diseases 2016;79(3):111-120
Asthma is a prevalent and serious health problem in Korea. Recently, the Korean Asthma Guideline has been updated by The Korean Academy of Tuberculosis and Respiratory Diseases (KATRD) in an effort to improve the clinical management of asthma. This guideline focuses on adult patients with asthma and aims to deliver up to date scientific evidence and recommendations to general physicians for the management of asthma. For this purpose, this guideline was updated following systematic review and meta-analysis of recent studies and adapting some points of international guidelines (Global Initiative for Asthma [GINA] report 2014, National Asthma Education and Prevention Program [NAEPP] 2007, British Thoracic Society [BTS/SIGN] asthma guideline 2012, and Canadian asthma guideline 2012). Updated issues include recommendations derived using the population, intervention, comparison, and outcomes (PICO) model, which produced 20 clinical questions on the management of asthma. It also covers a new definition of asthma, the importance of confirming various airflow limitations with spirometry, the epidemiology and the diagnostic flow of asthma in Korea, the importance and evidence for inhaled corticosteroids (ICS) and ICS/formoterol as a single maintenance and acute therapy in the stepwise management of asthma, assessment of severity of asthma and management of exacerbation, and an action plan to cope with exacerbation. This guideline includes clinical assessments, and treatment of asthma-chronic obstructive pulmonary disease overlap syndrome, management of asthma in specific conditions including severe asthma, elderly asthma, cough variant asthma, exercise-induced bronchial contraction, etc. The revised Korean Asthma Guideline is expected to be a useful resource in the management of asthma.
Adrenal Cortex Hormones
;
Adult
;
Aged
;
Asian Continental Ancestry Group
;
Asthma*
;
Asthma, Exercise-Induced
;
Cough
;
Education
;
Epidemiology
;
Humans
;
Korea
;
Lung Diseases, Obstructive
;
Spirometry
;
Tuberculosis
5.Moringa oleifera Prolongs Lifespan via DAF-16/FOXO Transcriptional Factor in Caenorhabditis elegans.
Jun Sang IM ; Ha Na LEE ; Jong Woo OH ; Young Jin YOON ; Jin Suck PARK ; Ji Won PARK ; Jung Hoon KIM ; Yong Sung KIM ; Dong Seok CHA ; Hoon JEON
Natural Product Sciences 2016;22(3):201-208
Here in this study, we investigated the lifespan-extending effect and underlying mechanism of methanolic extract of Moringa olelifa leaves (MML) using Caenorhabditis elegans (C. elegans) model system. To define the longevity properties of MML we conducted lifespan assay and MML showed significant increase in lifespan under normal culture condition. In addition, MML elevated stress tolerance of C. elegans to endure against thermal, oxidative and osmotic stress conditions. Our data also revealed that increased activities of antioxidant enzymes and expressions of stress resistance proteins were attributed to MML-mediated enhanced stress resistance. We further investigated the involvement of MML on the aging-related factors such as growth, food intake, fertility, and motility. Interestingly, MML significantly reduced growth and egg-laying, suggesting these factors were closely linked with MML-mediated longevity. We also observed the movement of aged worms to estimate the effects of MML on the health span. Herein, MML efficiently elevated motility of aged worms, indicating MML may affect health span as well as lifespan. Our genetic analysis using knockout mutants showed that lifespan-extension activity of MML was interconnected with several genes such as skn-1, sir-2.1, daf-2, age-1 and daf-16. Based on these results, we could conclude that MML prolongs the lifespan of worms via activation of SKN-1 and SIR-2.1 and inhibition of insulin/IGF pathway, followed by DAF-16 activation.
Caenorhabditis elegans*
;
Caenorhabditis*
;
Eating
;
Fertility
;
Longevity
;
Methanol
;
Moringa oleifera*
;
Moringa*
;
Osmotic Pressure
6.Randomized, Controlled, Multi-center Trial: Comparing the Safety and Efficacy of DA-9701 and Itopride Hydrochloride in Patients With Functional Dyspepsia.
Myung Gyu CHOI ; Poong Lyul RHEE ; Hyojin PARK ; Oh Young LEE ; Kwang Jae LEE ; Suck Chei CHOI ; Sang Young SEOL ; Hoon Jai CHUN ; Jong Sun REW ; Dong Ho LEE ; Geun Am SONG ; Hwoon Yong JUNG ; Hyung Yong JEONG ; In Kyung SUNG ; Joon Seong LEE ; Soo Teik LEE ; Sung Kook KIM ; Yong Woon SHIN
Journal of Neurogastroenterology and Motility 2015;21(3):414-422
BACKGROUND/AIMS: Therapies of functional dyspepsia (FD) are limited. DA-9701 is a novel prokinetic agent formulated with Pharbitis semen and Corydalis Tuber. We aimed to assess the efficacy of DA-9701 compared with itopride in FD patients. METHODS: Patients with FD randomly received either itopride 50 mg or DA-9701 30 mg t.i.d after a 2-week baseline period. After 4 weeks of treatment, 2 primary efficacy endpoints were analyzed: the change from baseline in composite score of the 8 dyspeptic symptoms and the overall treatment effect. Impact on patients' quality of life was assessed using the Nepean Dyspepsia Index (NDI) questionnaire. RESULTS: We randomly assigned 464 patients with 455 having outcome data. The difference of the composite score change of the 8 symptoms between the 2 groups was 0.62, indicating that DA-9701 was not inferior to itopride. The overall treatment effect response rate was not different between the groups. When responder was defined as > or = 5 of the 7 Likert scale, responder rates were 37% of DA-9701 and 36% of itopride group. Patients receiving DA-9701 experienced similar mean percentage of days with adequate relief during the 4-week treatment period compared with those receiving itopride (56.8% vs 59.1%). Both drugs increased the NDI score of 5 domains without any difference in change of the NDI score between the groups. The safety profile of both drugs was comparable. CONCLUSIONS: DA-9701 significantly improves symptoms in patients with FD. DA-9701 showed non-inferior efficacy to itopride with comparable safety.
Corydalis
;
Dyspepsia*
;
Humans
;
Quality of Life
;
Surveys and Questionnaires
;
Semen
7.Comparison of Korean COPD Guideline and GOLD Initiative Report in Term of Acute Exacerbation: A Validation Study for Korean COPD Guideline.
Yong Il HWANG ; Yong Bum PARK ; Yeon Mok OH ; Ji Hyun LEE ; Tae Hyung KIM ; Kwang Ha YOO ; Hyoung Kyu YOON ; Chin Kook RHEE ; Deog Kyeom KIM ; Kyeong Cheol SHIN ; Sang Yeub LEE ; Ki Suck JUNG
Journal of Korean Medical Science 2014;29(8):1108-1112
The purpose of this study was to compare the Korean COPD guideline to GOLD consensus report in terms of acute exacerbation. A total of 361 patients were enrolled in this study, and 16.9% of them experienced acute exacerbation during the follow-up. A total of 6.3% of patients in GOLD A, 9.5% in GOLD B, 7.7% in GOLD C and 17.0% of GOLD D experienced exacerbation during the first year of follow-up, respectively (P=0.09). There was no one who experienced exacerbation during the first year of follow-up in the Korean group 'ga'. The 12-month exacerbation rates of Korean group 'na' and 'da' were 4.5% and 16.0%, respectively (P<0.001). We explore the experience of exacerbation in patients with change of their risk group after applying Korean COPD guideline. A total of 16.0% of the patients who were reclassified from GOLD A to Korean group 'da' experienced acute exacerbation,and 15.3% from GOLD B to Korean group 'da' experienced acute exacerbation. In summary, the Korean COPD guideline is useful to differentiate the high risk from low risk for exacerbation in terms of spirometry. This indicates that application of Korean COPD guideline is appropriate to treat Korean COPD patients.
Acute Disease
;
Aged
;
Disease Progression
;
Female
;
Humans
;
Male
;
*Practice Guidelines as Topic
;
Pulmonary Disease, Chronic Obstructive/*classification/*diagnosis
;
Pulmonary Medicine/*standards
;
Reproducibility of Results
;
Republic of Korea
;
Sensitivity and Specificity
;
*Severity of Illness Index
;
Spirometry/*standards
8.The Predicting Factors for Recurrence of Chronic Subdural Hematoma Treated with Burr Hole and Drainage.
Dae Hyo SONG ; Young Soo KIM ; Hyoung Joon CHUN ; Hyeong Joong YI ; Koang Hum BAK ; Yong KO ; Suck Jun OH
Korean Journal of Neurotrauma 2014;10(2):41-48
OBJECTIVE: Chronic subdural hematoma (CSDH) is common in elderly patients. So, with an increasing number of elderly people in the general population, there is a need to investigate risk factors which increase recurrence rate. In this study, factors affecting the postoperative recurrence are investigated based on the reoperative CSDH cases. METHODS: Total of ninety-seven patients was enrolled in this study who had have operation for CSDH. In all patients, one burr hole trephination and drainage was the method of choice for the initial treatment of CSDH. We retrospectively evaluated several factors which affect to recurrence of CSDH. RESULTS: Retrospective analysis was performed in 97 patients. Sixteen patients experienced reoperation within 3 months (16/97, 16.5%) for recurrence of CSDH. And, when hematoma was divided by internal architecture, heterogeneous density group seems to be have close relationship with recurrence more significantly than homogeneous density group (p=0.002). Hypertension, diabetes mellitus, early removal of drainage tube, bilaterality of hematoma also have significant relationship with recurrence. CONCLUSION: Recurrence rate of CSDH treated with one burr hole drainage is related with some various factors. There was statistically significant difference between recurred group and non-recurred group. Not only demographic factors but also internal architecture on preoperative brain computed tomography is a significant predicting factor of recurrence in CSDH patients who underwent a surgery. In this study, heterogeneous type hematoma have significantly related with recurrence of CSDH. We should give attention to these predicting factors for more effective care.
Aged
;
Brain
;
Demography
;
Diabetes Mellitus
;
Drainage*
;
Hematoma
;
Hematoma, Subdural, Chronic*
;
Humans
;
Hypertension
;
Recurrence*
;
Reoperation
;
Retrospective Studies
;
Risk Factors
;
Trephining
9.Efficacy and Safety of Tiropramide in the Treatment of Patients With Irritable Bowel Syndrome: A Multicenter, Randomized, Double-blind, Non-inferiority Trial, Compared With Octylonium.
Kang Nyeong LEE ; Oh Young LEE ; Myung Gyu CHOI ; Chong Il SOHN ; Kyu Chan HUH ; Kyung Sik PARK ; Joong Goo KWON ; Nayoung KIM ; Poong Lyul RHEE ; Seung Jae MYUNG ; Joon Seong LEE ; Kwang Jae LEE ; Hyojin PARK ; Yong Chan LEE ; Suck Chei CHOI ; Hye Kyung JUNG ; Sam Ryong JEE ; Chang Hwan CHOI ; Gwang Ha KIM ; Moo In PARK ; In Kyung SUNG
Journal of Neurogastroenterology and Motility 2014;20(1):113-121
BACKGROUND/AIMS: Antispasmodics such as octylonium are widely used to manage irritable bowel syndrome (IBS) symptoms. However, the efficacy and safety of another antispasmodic, tiropramide, remain uncertain. We aimed to evaluate the efficacy and safety of tiropramide compared with octylonium in patients with IBS. METHODS: In this multicenter, randomized, non-inferiority trial, 287 patients with IBS (143 receiving tiropramide and 144 octylonium) were randomly allocated to either tiropramide 100 mg or octylonium 20 mg t.i.d (means 3 times a day) for 4 weeks. Primary endpoint was the mean change of abdominal pain from baseline assessed by visual analogue scales (VAS) score after 4 weeks of treatment. Secondary endpoints were the changes in abdominal pain from baseline at week 2 and in abdominal discomfort at weeks 2 and 4, using VAS scores, patient-reported symptom improvement including stool frequency and consistency, using symptom diaries, IBS-quality of life (IBS-QoL), and depression and anxiety, at week 4. RESULTS: The VAS scores of abdominal pain at week 4, were significantly decreased in both tiropramide and octylonium groups, but the change from baseline did not differ between the 2 groups (difference,-0.26 mm; 95% CI,-4.33-3.82; P = 0.901). Abdominal pain and discomfort assessed using VAS scores, diaries, and IBS-QoL were also improved by both treatments, and the changes from baseline did not differ. The incidence of adverse events was similar in the 2 groups, and no severe adverse events involving either drug were observed. CONCLUSIONS: Tiropramide is as effective as octylonium in managing abdominal pain in IBS, with a similar safety profile.
Abdominal Pain
;
Anxiety
;
Depression
;
Humans
;
Incidence
;
Irritable Bowel Syndrome*
;
Parasympatholytics
;
Weights and Measures
10.Regional Differences in Chronic Stress-induced Alterations in Mast Cell and Protease-activated Receptor-2-positive Cell Numbers in the Colon of Ws/Ws Rats.
Yong Sung KIM ; Moon Young LEE ; Han Seung RYU ; Eul Sig CHOI ; Jung Taek OH ; Ki Jung YUN ; Suck Chei CHOI
Journal of Neurogastroenterology and Motility 2014;20(1):54-63
BACKGROUND/AIMS: There have been no reports on the effect of chronic psychological stress on colonic immune cells or the regional differences. We aimed to investigate the effect of chronic psychological stress on the number of mast cells and protease-activated receptor (PAR)-2-positive cells in the rat colonic mucosa. METHODS: Six-week-old and 14-week-old Ws/Ws rats, which lack mast cells after 10 weeks, were used as control and mast cell-deficient groups, respectively. The rats were divided into stress and sham-treated groups. Rats in the stressed group were exposed to water avoidance stress (WAS, 1 hour/day) for 13 days. Fecal pellet output and the number of mast cells and PAR-2-positive cells in colonic mucosa were compared between the WAS and sham groups. RESULTS: In 6-week-old rats, the WAS group showed a significantly higher number of mast cells compared to the sham group. In 14-week-old rats, mast cells were nearly absent in the colonic mucosa. WAS significantly increased PAR-2-positive cells in 14-week-old rats, but not in 6-week-old rats. Indirect estimation of PAR-2-positive mast cells in 6-week-old rats suggested that the majority of increased mast cells following WAS did not express PAR-2. WAS increased mast cells and PAR-2-positive cells mainly in the proximal colon. Fecal pellet output was continuously higher in the WAS group than in the sham group, and the difference was significant for both 6-week-old and 14-week-old rats. CONCLUSIONS: Chronic psychological stress increased the number of mast cells and PAR-2-positive cells in rat colonic mucosa, and these increases were more prominent in the proximal colon.
Animals
;
Cell Count*
;
Colon*
;
Mast Cells*
;
Mucous Membrane
;
Rats*
;
Receptor, PAR-2
;
Stress, Psychological

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