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.Efficacy and Safety of DWJ1252 Compared With Gasmotin in the Treatment of Functional Dyspepsia: A Multicenter, Randomized, Double-blind, Active-controlled Study
Jin Hwa PARK ; Kang Nyeong LEE ; Oh Young LEE ; Myung-Gyu CHOI ; Hyunsoo CHUNG ; Suck-Chei CHOI ; Nayoung KIM ; Hyojin PARK ; In-Kyung SUNG ; Chong Il SOHN ; Sam Ryong JEE ; Jae Young JANG ; Poong-Lyul RHEE ; Moo In PARK ; Joong Goo KWON ; Kyung Sik PARK ; Kwang Jae LEE ; Joon Seong LEE
Journal of Neurogastroenterology and Motility 2021;27(1):87-96
Background/Aims:
Prokinetics such as mosapride citrate CR (conventional-release; Gasmotin) are commonly used in functional dyspepsia (FD). This study aims to evaluate the efficacy and safety of once-a-day mosapride citrate SR (DWJ1252), a sustained-release formulation of mosapride citrate, compared with mosapride citrate CR 3 times a day, in patients with FD.
Methods:
In this multicenter, randomized, double-blind, active-controlled, non-inferiority study, 119 patients with FD (by the Rome III criteria, 60 for mosapride citrate SR and 59 for mosapride citrate CR) were randomly allocated to mosapride citrate SR once daily or mosapride citrate CR thrice daily for 4 weeks in 16 medical institutions. Primary end point was the change in gastrointestinal symptom (GIS) score from baseline, assessed by GIS questionnaires on 5-point Likert scale after 4-week treatment. Secondary end points and safety profiles were also analyzed.
Results:
The study included 51 and 49 subjects in the mosapride citrate SR and mosapride citrate CR groups, respectively. GIS scores at week 4 were significantly reduced in both groups (mean ± SD: − 10.04 ± 4.45 and − 10.86 ± 5.53 in the mosapride citrate SR and mosapride citrate CR groups, respectively; P < 0.001), and the GIS changes from baseline did not differ between the 2 groups (difference, 0.82 point; 95% CI, − 1.17, 2.81; P = 0.643). Changes in GIS at weeks 2 and 4 and quality of life at week 4, and the improvement rates of global assessments at weeks 2 and 4, did not differ between the groups. Adverse events were similar in the 2 groups, and there were no serious adverse events.
Conclusion
In patients with FD, mosapride citrate SR once daily is as effective as mosapride citrate CR thrice daily, with a similar safety profile.
5.Clinical Characteristics of Chronic Cough in Korea
Tai Joon AN ; Jin Woo KIM ; Eun Young CHOI ; Seung Hun JANG ; Hwa Young LEE ; Hye Seon KANG ; Hyeon Kyoung KOO ; Jong Min LEE ; Sung Kyung KIM ; Jong Wook SHIN ; So Young PARK ; Chin Kook RHEE ; Ji Yong MOON ; Yee Hyung KIM ; Hyun LEE ; Yong Hyun KIM ; Je Hyeong KIM ; Sang Haak LEE ; Deog Kyeom KIM ; Kwang Ha YOO ; Dong Gyu KIM ; Ki Suck JUNG ; Hui Jung KIM ; Hyoung Kyu YOON ;
Tuberculosis and Respiratory Diseases 2020;83(1):31-41
BACKGROUND:
Chronic cough is defined as a cough lasting more than 8 weeks and socio-economic burden of chronic cough is enormous. The characteristics of chronic cough in Korea are not well understood. The Korean Academy of Tuberculosis and Respiratory Diseases (KATRD) published guidelines on cough management in 2014. The current study evaluated the clinical characteristics of chronic cough in Korea and the efficacy of the KATRD guidelines.
METHODS:
This was a multi-center, retrospective observational study conducted in Korea. The participants were over 18 years of age. They had coughs lasting more than 8 weeks. Subjects with current pulmonary diseases, smokers, ex-smokers with more than 10 pack-years or who quit within the past 1 year, pregnant women, and users of cough-inducing medications were excluded. Evaluation and management of cough followed the KATRD cough-management guidelines.
RESULTS:
Participants with chronic cough in Korea showed age in the late forties and cough duration of more than 1 year. Upper airway cough syndrome was the most common cause of cough, followed by cough-variant asthma (CVA). Gastro-esophageal reflux diseases and eosinophilic bronchitis were less frequently observed. Following the KATRD cough-management guidelines, 91.2% of the subjects improved after 4 weeks of treatment. Responders were younger, had a longer duration of cough, and an initial impression of CVA. In univariate and multivariate analyses, an initial impression of CVA was the only factor related to better treatment response.
CONCLUSION
The causes of chronic cough in Korea differed from those reported in other countries. The current Korean guidelines proved efficient for treating Korean patients with chronic cough.
6.Clinical Characteristics of Chronic Cough in Korea
Tai Joon AN ; Jin Woo KIM ; Eun Young CHOI ; Seung Hun JANG ; Hwa Young LEE ; Hye Seon KANG ; Hyeon Kyoung KOO ; Jong Min LEE ; Sung Kyung KIM ; Jong Wook SHIN ; So Young PARK ; Chin Kook RHEE ; Ji Yong MOON ; Yee Hyung KIM ; Hyun LEE ; Yong Hyun KIM ; Je Hyeong KIM ; Sang Haak LEE ; Deog Kyeom KIM ; Kwang Ha YOO ; Dong Gyu KIM ; Ki Suck JUNG ; Hui Jung KIM ; Hyoung Kyu YOON ;
Tuberculosis and Respiratory Diseases 2020;83(1):31-41
7.Clinical Characteristics of Chronic Cough in Korea
Tai Joon AN ; Jin Woo KIM ; Eun Young CHOI ; Seung Hun JANG ; Hwa Young LEE ; Hye Seon KANG ; Hyeon Kyoung KOO ; Jong Min LEE ; Sung Kyung KIM ; Jong Wook SHIN ; So Young PARK ; Chin Kook RHEE ; Ji Yong MOON ; Yee Hyung KIM ; Hyun LEE ; Yong Hyun KIM ; Je Hyeong KIM ; Sang Haak LEE ; Deog Kyeom KIM ; Kwang Ha YOO ; Dong Gyu KIM ; Ki Suck JUNG ; Hui Jung KIM ; Hyoung Kyu YOON ;
Tuberculosis and Respiratory Diseases 2020;83(1):31-41
BACKGROUND:
Chronic cough is defined as a cough lasting more than 8 weeks and socio-economic burden of chronic cough is enormous. The characteristics of chronic cough in Korea are not well understood. The Korean Academy of Tuberculosis and Respiratory Diseases (KATRD) published guidelines on cough management in 2014. The current study evaluated the clinical characteristics of chronic cough in Korea and the efficacy of the KATRD guidelines.
METHODS:
This was a multi-center, retrospective observational study conducted in Korea. The participants were over 18 years of age. They had coughs lasting more than 8 weeks. Subjects with current pulmonary diseases, smokers, ex-smokers with more than 10 pack-years or who quit within the past 1 year, pregnant women, and users of cough-inducing medications were excluded. Evaluation and management of cough followed the KATRD cough-management guidelines.
RESULTS:
Participants with chronic cough in Korea showed age in the late forties and cough duration of more than 1 year. Upper airway cough syndrome was the most common cause of cough, followed by cough-variant asthma (CVA). Gastro-esophageal reflux diseases and eosinophilic bronchitis were less frequently observed. Following the KATRD cough-management guidelines, 91.2% of the subjects improved after 4 weeks of treatment. Responders were younger, had a longer duration of cough, and an initial impression of CVA. In univariate and multivariate analyses, an initial impression of CVA was the only factor related to better treatment response.
CONCLUSION
The causes of chronic cough in Korea differed from those reported in other countries. The current Korean guidelines proved efficient for treating Korean patients with chronic cough.
8.Psychosocial Factors Influence the Functional Gastrointestinal Disorder among Psychiatric Patients
Deung Hyun KANG ; Seung Ho JANG ; Han Seung RYU ; Suck Chei CHOI ; Seung Ho RHO ; Young Suk PAIK ; Hye Jin LEE ; Sang Yeol LEE
Korean Journal of Psychosomatic Medicine 2018;26(1):1-8
OBJECTIVES: This study aimed to investigate the psychosocial characteristics of functional gastrointestinal disorder (FGID) in patients with psychiatric disorders. METHODS: This study was conducted with 144 outpatients visiting the psychiatric clinic at a university hospital. FGIDs were screened according to the Rome III questionnaire-Korean version. Demographic factors were investigated, and psychosocial factors were evaluated using the Hospital Anxiety Depression Scale, Patient Health Questionnaire-15, Childhood Trauma Questionnaire-Korean, and State-Trait Anger Expression Inventory. Chi-squared test and student's t-test were used as statistical analysis methods. RESULTS: There were differences in education level between two groups divided according to FGID status (χ²=10.139, p=0.017). Comparing the psychiatric disorder by FGID group, irritable bowel syndrome (IBS) group showed significant differences (χ²=11.408, p=0.022). According to FGID status, IBS group showed significant differences for anxiety (t=−3.106, p=0.002), depressive symptom (t=−2.105, p=0.037), somatic symptom (t=−3.565, p < 0.001), trait anger (t=−3.683, p < 0.001), anger-in (t=−2.463, p=0.015), and anger-out (t=− 2.355, p=0.020). Functional dyspepsia group showed significant differences for anxiety (t=−4.893, p < 0.001), depressive symptom (t=−3.459, p < 0.001), somatic symptom (t=−7.906, p < 0.001), trait-anger (t=−4.148, p < 0.001), state-anger (t=−2.181, p=0.031), anger-in (t=−2.684, p=0.008), and anger-out (t=−3.005, p=0.003). Nonerosive reflux disease group showed significant differences for anxiety (t=−4.286, p < 0.001), depressive symptom (t=−3.402, p < 0.001), somatic symptom (t=−7.162, p < 0.001), trait anger (t=−2.994, p=0.003), state anger (t=−2.259, p=0.025), anger-in (t=−2.772, p=0.006), and anger-out (t=−2.958, p=0.004). CONCLUSIONS: Patients with psychiatric disorders had a high prevalence of FGID, and various psychosocial factors contributed to such differences. Therefore, the psychiatric approach can offer better understandings and treatments to patients with FGID.
Anger
;
Anxiety
;
Demography
;
Depression
;
Dyspepsia
;
Education
;
Gastrointestinal Diseases
;
Humans
;
Irritable Bowel Syndrome
;
Outpatients
;
Prevalence
;
Psychology
9.Folliculotropic Mycosis Fungoides in 20 Korean Cases: Clinical and Histopathologic Features and Response to Ultraviolet A-1 and/or Photodynamic Therapy.
Min Soo JANG ; Ji Yun JANG ; Jong Bin PARK ; Dong Young KANG ; Jin Woo LEE ; Taek Geun LEE ; Hyun HWANGBO ; Kee Suck SUH
Annals of Dermatology 2018;30(2):192-201
BACKGROUND: Folliculotropic mycosis fungoides (FMF) is a variant of mycosis fungoides (MF) that is characterized clinically by variable types of skin eruptions, including plaques, acneiform lesions, and alopecic patches. Histopathologically, FMF is characterized by folliculotropic infiltrates. OBJECTIVE: This study was conducted to scrutinize the clinical and histopathologic features of FMF in Koreans and the responses to phototherapy. METHODS: Twenty Koreans diagnosed with MF who had histopathologic evidence of folliculotropism were enrolled. RESULTS: Eighteen patients had head-and-neck-region infiltration, while five had solitary lesion. In all patients, the atypical lymphocytic infiltrate had a perifollicular distribution. Twelve patients were treated with ultraviolet A (UVA)-1. Eleven of these 12 patients with early-stage FMF experienced >80% improvement (8: complete remission; 3: partial remission). Four patients, including 2 who relapsed after UVA-1, were treated with photodynamic therapy (PDT), reaching complete remission after PDT. CONCLUSION: As FMF has variable clinical presentations, skin biopsy is required to confirm the diagnosis. And both UVA-1 and methyl aminolevulinate-PDT are clinically effective in treatment of early-stage FMF.
Biopsy
;
Diagnosis
;
Humans
;
Mycosis Fungoides*
;
Photochemotherapy*
;
Phototherapy
;
Skin
10.Erratum: Folliculotropic Mycosis Fungoides in 20 Korean Cases: Clinical and Histopathologic Features and Response to Ultraviolet A-1 and/or Photodynamic Therapy.
Min Soo JANG ; Ji Yun JANG ; Jong Bin PARK ; Dong Young KANG ; Jin Woo LEE ; Taek Geun LEE ; Hyun HWANGBO ; Kee Suck SUH
Annals of Dermatology 2018;30(4):510-510
In the originally published version of this article, complete anonymity was not achieved.

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