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.Real-world Prescription Patterns and Patient Satisfaction Regarding Maintenance Therapy of Gastroesophageal Reflux Disease: An Observational, Cross-sectional, Multicenter Study
Cheal Wung HUH ; Nak Hoon SON ; Young Hoon YOUN ; Da Hyun JUNG ; Min Kyung KIM ; Eun Jeong GONG ; Kyu Chan HUH ; Seung Young KIM ; Moo In PARK ; Ju Yup LEE ; Joong Goo KWON ; Jae Hak KIM ; Cheol Min SHIN ; Kee Wook JUNG ; Su Jin HONG ; Hee Man KIM ; Suck Chei CHOI ; Hye-Kyung JUNG ; Hyun Jin KIM ; Kwang Jae LEE
Journal of Neurogastroenterology and Motility 2023;29(4):470-477
Background/Aims:
Gastroesophageal reflux disease (GERD) is a common chronic gastrointestinal disorder that typically requires long-term maintenance therapy. However, little is known about patient preferences and satisfaction and real-world prescription patterns regarding maintenance therapy for GERD.
Methods:
This observational, cross-sectional, multicenter study involved patients from 18 referral hospitals in Korea. We surveyed patients who had been prescribed proton pump inhibitors (PPIs) for GERD for at least 90 days with a minimum follow-up duration of 1 year. The main outcome was overall patient satisfaction with different maintenance therapy modalities.
Results:
A total of 197 patients were enrolled. Overall patient satisfaction, patient preferences, and GERD health-related quality of life scores did not significantly differ among the maintenance therapy modality groups. However, the on-demand therapy group experienced a significantly longer disease duration than the continuous therapy group. The continuous therapy group demonstrated a lower level of awareness of potential adverse effects associated with PPIs than the on-demand therapy group but received higher doses of PPIs than the on-demand therapy group. The prescribed doses of PPIs also varied based on the phenotype of GERD, with higher doses prescribed for non-erosive reflux disease than erosive reflux disease.
Conclusion
Although overall patient satisfaction did not significantly differ among the different PPI maintenance therapy modality groups, awareness of potential adverse effects was significantly different between the on-demand and continuous therapy groups.
3.On-demand Versus Continuous Maintenance Treatment With a Proton Pump Inhibitor for Mild Gastroesophageal Reflux Disease: A Prospective Randomized Multicenter Study
Da Hyun JUNG ; Young Hoon YOUN ; Hye-Kyung JUNG ; Seung Young KIM ; Cheal Wung HUH ; Cheol Min SHIN ; Jung-Hwan OH ; Kyu Chan HUH ; Moo In PARK ; Suck Chei CHOI ; Ki Bae KIM ; Seon-Young PARK ; Joong Goo KWON ; Yu Kyung CHO ; Jung Ho PARK ; Jeong Eun SHIN ; Eun Jeong GONG ; Jae Hak KIM ; Su Jin HONG ; Hyun Jin KIM ; Sam Ryong JEE ; Ju Yup LEE ; Kee Wook JUNG ; Hee Man KIM ; Kwang Jae LEE
Journal of Neurogastroenterology and Motility 2023;29(4):460-469
Background/Aims:
It remains unclear which maintenance treatment modality is most appropriate for mild gastroesophageal reflux disease (GERD).We aimed to compare on-demand treatment with continuous treatment using a proton pump inhibitor (PPI) in the maintenance treatment for patients with non-erosive GERD or mild erosive esophagitis.
Methods:
Patients whose GERD symptoms improved after 4 weeks of standard dose PPI treatment were prospectively enrolled at 25 hospitals.Subsequently, the enrolled patients were randomly assigned to either an on-demand or a continuous maintenance treatment group, and followed in an 8-week interval for up to 24 weeks.
Results:
A total of 304 patients were randomized to maintenance treatment (continuous, n = 151 vs on-demand, n = 153). The primary outcome, the overall proportion of unwillingness to continue the assigned maintenance treatment modality, failed to confirm the noninferiority of on-demand treatment (45.9%) compared to continuous treatment (36.1%). Compared with the on-demand group, the GERD symptom and health-related quality of life scores significantly more improved and the overall satisfaction score was significantly higher in the continuous treatment group, particularly at week 8 and week 16 of maintenance treatment. Work impairment scores were not different in the 2 groups, but the prescription cost was less in the on-demand group. Serum gastrin levels significantly elevated in the continuous treatment group, but not in the on-demand group.
Conclusions
Continuous treatment seems to be more appropriate for the initial maintenance treatment of non-erosive GERD or mild erosive esophagitis than on-demand treatment. Stepping down to on-demand treatment needs to be considered after a sufficient period of continuous treatment.
4.2020 Seoul Consensus on the Diagnosis and Management of Gastroesophageal Reflux Disease
Hye-Kyung JUNG ; Chung Hyun TAE ; Kyung Ho SONG ; Seung Joo KANG ; Jong Kyu PARK ; Eun Jeong GONG ; Jeong Eun SHIN ; Hyun Chul LIM ; Sang Kil LEE ; Da Hyun JUNG ; Yoon Jin CHOI ; Seung In SEO ; Joon Sung KIM ; Jung Min LEE ; Beom Jin KIM ; Sun Hyung KANG ; Chan Hyuk PARK ; Suck Chei CHOI ; Joong Goo KWON ; Kyung Sik PARK ; Moo In PARK ; Tae Hee LEE ; Seung Young KIM ; Young Sin CHO ; Han Hong LEE ; Kee Wook JUNG ; Do Hoon KIM ; Hee Seok MOON ; Mi-Young CHOI ; Kwang Jae LEE ;
Korean Journal of Medicine 2022;97(2):70-92
Gastroesophageal reflux disease (GERD) is a condition in which gastric contents regurgitate into the esophagus or beyond, resulting in either troublesome symptoms or complications. GERD is heterogeneous in terms of varied manifestations, test findings, and treatment responsiveness. GERD diagnosis can be established with symptomatology, pathology, or physiology. Recently the Lyon consensus defined the “proven GERD” with concrete evidence for reflux, including advanced grade erosive esophagitis (Los Angeles classification grades C and or D esophagitis), long-segment Barrett’s mucosa or peptic strictures on endoscopy or distal esophageal acid exposure time > 6% on 24-hour ambulatory pH-impedance monitoring. However, some Asian researchers have different opinions on whether the same standards should be applied to the Asian population. The prevalence of GERD is increasing in Asia. The present evidence-based guidelines were developed using a systematic review and meta-analysis approach. In GERD with typical symptoms, a proton pump inhibitor test can be recommended as a sensitive, cost-effective, and practical test for GERD diagnosis. Based on a meta-analysis of 19 estimated acid-exposure time values in Asians, the reference range upper limit for esophageal acid exposure time was 3.2% (95% confidence interval 2.7-3.9%) in the Asian countries. Esophageal manometry and novel impedance measurements, including mucosal impedance and a post-reflux swallow-induced peristaltic wave, are promising in discrimination of GERD among different reflux phenotypes, thus increasing its diagnostic yield. We also propose a long-term strategy of evidence-based GERD treatment with proton pump inhibitors and other drugs.
5.2020 Seoul Consensus on the Diagnosis and Management of Gastroesophageal Reflux Disease
Hye-Kyung JUNG ; Chung Hyun TAE ; Kyung Ho SONG ; Seung Joo KANG ; Jong Kyu PARK ; Eun Jeong GONG ; Jeong Eun SHIN ; Hyun Chul LIM ; Sang Kil LEE ; Da Hyun JUNG ; Yoon Jin CHOI ; Seung In SEO ; Joon Sung KIM ; Jung Min LEE ; Beom Jin KIM ; Sun Hyung KANG ; Chan Hyuk PARK ; Suck Chei CHOI ; Joong Goo KWON ; Kyung Sik PARK ; Moo In PARK ; Tae Hee LEE ; Seung Young KIM ; Young Sin CHO ; Han Hong LEE ; Kee Wook JUNG ; Do Hoon KIM ; Hee Seok MOON ; Hirota MIWA ; Chien-Lin CHEN ; Sutep GONLACHANVIT ; Uday C GHOSHAL ; Justin C Y WU ; Kewin T H SIAH ; Xiaohua HOU ; Tadayuki OSHIMA ; Mi-Young CHOI ; Kwang Jae LEE ; The Korean Society of Neurogastroenterology and Motility
Journal of Neurogastroenterology and Motility 2021;27(4):453-481
Gastroesophageal reflux disease (GERD) is a condition in which gastric contents regurgitate into the esophagus or beyond, resulting in either troublesome symptoms or complications. GERD is heterogeneous in terms of varied manifestations, test findings, and treatment responsiveness. GERD diagnosis can be established with symptomatology, pathology, or physiology. Recently the Lyon consensus defined the “proven GERD” with concrete evidence for reflux, including advanced grade erosive esophagitis (Los Angeles classification grades C and or D esophagitis), long-segment Barrett’s mucosa or peptic strictures on endoscopy or distal esophageal acid exposure time > 6% on 24-hour ambulatory pH-impedance monitoring. However, some Asian researchers have different opinions on whether the same standards should be applied to the Asian population. The prevalence of GERD is increasing in Asia. The present evidence-based guidelines were developed using a systematic review and meta-analysis approach. In GERD with typical symptoms, a proton pump inhibitor test can be recommended as a sensitive, cost-effective, and practical test for GERD diagnosis.Based on a meta-analysis of 19 estimated acid-exposure time values in Asians, the reference range upper limit for esophageal acid exposure time was 3.2% (95% confidence interval, 2.7-3.9%) in the Asian countries. Esophageal manometry and novel impedance measurements, including mucosal impedance and a post-reflux swallow-induced peristaltic wave, are promising in discrimination of GERD among different reflux phenotypes, thus increasing its diagnostic yield. We also propose a long-term strategy of evidence-based GERD treatment with proton pump inhibitors and other drugs.
6.2020 Seoul Consensus on the Diagnosis and Management of Gastroesophageal Reflux Disease
Hye-Kyung JUNG ; Chung Hyun TAE ; Kyung Ho SONG ; Seung Joo KANG ; Jong Kyu PARK ; Eun Jeong GONG ; Jeong Eun SHIN ; Hyun Chul LIM ; Sang Kil LEE ; Da Hyun JUNG ; Yoon Jin CHOI ; Seung In SEO ; Joon Sung KIM ; Jung Min LEE ; Beom Jin KIM ; Sun Hyung KANG ; Chan Hyuk PARK ; Suck Chei CHOI ; Joong Goo KWON ; Kyung Sik PARK ; Moo In PARK ; Tae Hee LEE ; Seung Young KIM ; Young Sin CHO ; Han Hong LEE ; Kee Wook JUNG ; Do Hoon KIM ; Hee Seok MOON ; Hirota MIWA ; Chien-Lin CHEN ; Sutep GONLACHANVIT ; Uday C GHOSHAL ; Justin C Y WU ; Kewin T H SIAH ; Xiaohua HOU ; Tadayuki OSHIMA ; Mi-Young CHOI ; Kwang Jae LEE ; The Korean Society of Neurogastroenterology and Motility
Journal of Neurogastroenterology and Motility 2021;27(4):453-481
Gastroesophageal reflux disease (GERD) is a condition in which gastric contents regurgitate into the esophagus or beyond, resulting in either troublesome symptoms or complications. GERD is heterogeneous in terms of varied manifestations, test findings, and treatment responsiveness. GERD diagnosis can be established with symptomatology, pathology, or physiology. Recently the Lyon consensus defined the “proven GERD” with concrete evidence for reflux, including advanced grade erosive esophagitis (Los Angeles classification grades C and or D esophagitis), long-segment Barrett’s mucosa or peptic strictures on endoscopy or distal esophageal acid exposure time > 6% on 24-hour ambulatory pH-impedance monitoring. However, some Asian researchers have different opinions on whether the same standards should be applied to the Asian population. The prevalence of GERD is increasing in Asia. The present evidence-based guidelines were developed using a systematic review and meta-analysis approach. In GERD with typical symptoms, a proton pump inhibitor test can be recommended as a sensitive, cost-effective, and practical test for GERD diagnosis.Based on a meta-analysis of 19 estimated acid-exposure time values in Asians, the reference range upper limit for esophageal acid exposure time was 3.2% (95% confidence interval, 2.7-3.9%) in the Asian countries. Esophageal manometry and novel impedance measurements, including mucosal impedance and a post-reflux swallow-induced peristaltic wave, are promising in discrimination of GERD among different reflux phenotypes, thus increasing its diagnostic yield. We also propose a long-term strategy of evidence-based GERD treatment with proton pump inhibitors and other drugs.
7.A Study on the Difference of Psychosocial Characteristics and Quality of Life according to the Type of Functional Gastrointestinal Disorder
Seung-Kyu PARK ; Sang-Yeol LEE ; Han-Seung RYU ; Suck-Chei CHOI ; Chan-Mo YANG ; Seung-Ho JANG ; Dong Han YEOM ; Kuy-Haeng LEE
Korean Journal of Psychosomatic Medicine 2021;29(1):58-66
Objectives:
:The purpose of this study is to compare the psychosocial characteristics of patients diagnosed with functional gastrointestinal disorder (FGID) by classifying them into irritable bowel syndrome (IBS), functional dyspepsia (FD), functional constipation (FC), functional heartburn (FH) groups, and overlap group (two or more functional diseases) and to examine the factors associated with the quality of life (QoL) of patients with FGID.
Methods:
:A total of 144 patients who were diagnosed with FGID were selected as the subjects. The demographical factors were investigated; Korean-Beck Depression Inventory-II (K-BDI-II), Korean-Beck Anxiety Inventory (K-BAI), Korean version of Childhood Trauma Questionnaire (K-CTQ), Multi-dimensional Scale of Perceived Social Support (MSPSS), Korean Version of Connor-Davidson Resilience Scale (K-CD-RISC), and World Health Organization Quality of Life Assessment Instrument Brief Form (WHOQOL-BREF) were used to evaluate the psychosocial factors.
Results:
:TThe overlap group had a significantly higher K-BDI-II score (F=11.09, p<0.001) and K-BAI score (F=8.93, p<0.001) compared to other groups. In childhood trauma, the IBS patients had a difference in emotional neglect (F=2.54, p=0.04) than the FD patients. The QoL of FGID patients had a negative correlation with depression (r=-0.196, p<0.01), anxiety (r=-0.235, p<0.01), and childhood trauma (r=-0.222, p<0.01), and a positive correlation with social support (r=0.512, p<0.01) and resilience (r=0.581, p<0.01).
Conclusions
:Overlap group had a higher level of depression and anxiety, and the IBS patient group had a higher level of emotional neglect than the FD patient group in terms of childhood trauma.
8.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
9.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.
10.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.

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