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).
2.2022 Seoul Consensus on Clinical Practice Guidelines for Functional Constipation
Young Sin CHO ; Yoo Jin LEE ; Jeong Eun SHIN ; Hye-Kyung JUNG ; Seon-Young PARK ; Seung Joo KANG ; Kyung Ho SONG ; Jung-Wook KIM ; Hyun Chul LIM ; Hee Sun PARK ; Seong-Jung KIM ; Ra Ri CHA ; Ki Bae BANG ; Chang Seok BANG ; Sung Kyun YIM ; Seung-Bum RYOO ; Bong Hyeon KYE ; Woong Bae JI ; Miyoung CHOI ; In-Kyung SUNG ; Suck Chei CHOI ;
Journal of Neurogastroenterology and Motility 2023;29(3):271-305
Chronic constipation is one of the most common digestive diseases encountered in clinical practice. Constipation manifests as a variety of symptoms, such as infrequent bowel movements, hard stools, feeling of incomplete evacuation, straining at defecation, a sense of anorectal blockage during defecation, and use of digital maneuvers to assist defecation. During the diagnosis of chronic constipation, the Bristol Stool Form Scale, colonoscopy, and a digital rectal examination are useful for objective symptom evaluation and differential diagnosis of secondary constipation. Physiological tests for functional constipation have complementary roles and are recommended for patients who have failed to respond to treatment with available laxatives and those who are strongly suspected of having a defecatory disorder. As new evidence on the diagnosis and management of functional constipation emerged, the need to revise the previous guideline was suggested. Therefore, these evidence-based guidelines have proposed recommendations developed using a systematic review and meta-analysis of the treatment options available for functional constipation. The benefits and cautions of new pharmacological agents (such as lubiprostone and linaclotide) and conventional laxatives have been described through a meta-analysis. The guidelines consist of 34 recommendations, including 3 concerning the definition and epidemiology of functional constipation, 9 regarding diagnoses, and 22 regarding managements. Clinicians (including primary physicians, general health professionals, medical students, residents, and other healthcare professionals) and patients can refer to these guidelines to make informed decisions regarding the management of functional constipation.
3.2020 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.
4.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.
5.2020 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.Relation between Lichen Planus and Hepatitis C Virus Infection
Jong Bin PARK ; Seol Hwa SEONG ; Kang Hoon LEE ; Kee Suck SUH ; Byeong Chul YU ; Min Soo JANG
Korean Journal of Dermatology 2020;58(10):662-668
Background:
The etiology and pathogenesis of lichen planus (LP) are not fully understood. Several studies have reported varying prevalence of anti-hepatitis C virus antibody (anti-HCV Ab) in LP. The relationship between LP and HCV infection remains controversial.
Objective:
To investigate the relationship between LP and HCV infection in Busan and Gyeongnam, Korea.
Methods:
We reviewed the medical records of 84 outpatients with LP and 84 control subjects (age- and sex-matched) from 2000 to 2020. Data on age, sex, duration of disease, distribution, shape, systemic diseases, and serology of anti-HCV Ab were collected.
Results:
The prevalence of anti-HCV Ab was 1.2% and 9.5% in the control group and patients with LP, respectively. Compared with the control group, patients with LP had a higher risk of HCV infection with an odds ratio of 8.737 (p=0.034). The mean duration of disease for the eight patients with HCV-associated LP was 5.8 months, which was shorter than 15.8 months in 84 patients with LP alone. Mucosal erosive LP was observed most frequently in HCV-associated LP with an odds ratio of 9.273 (p=0.003).
Conclusion
HCV infection may be clinically relevant to the development of LP. Furthermore, HCV infection may accelerate the progression of LP and is possibly related to the mucosal erosive subtype. Therefore, dermatologists should perform an anti-HCV Ab screening test for patients with LP, disclosing the potential association between LP and HCV infection.
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.Relation between Lichen Planus and Hepatitis C Virus Infection
Jong Bin PARK ; Seol Hwa SEONG ; Kang Hoon LEE ; Kee Suck SUH ; Byeong Chul YU ; Min Soo JANG
Korean Journal of Dermatology 2020;58(10):662-668
Background:
The etiology and pathogenesis of lichen planus (LP) are not fully understood. Several studies have reported varying prevalence of anti-hepatitis C virus antibody (anti-HCV Ab) in LP. The relationship between LP and HCV infection remains controversial.
Objective:
To investigate the relationship between LP and HCV infection in Busan and Gyeongnam, Korea.
Methods:
We reviewed the medical records of 84 outpatients with LP and 84 control subjects (age- and sex-matched) from 2000 to 2020. Data on age, sex, duration of disease, distribution, shape, systemic diseases, and serology of anti-HCV Ab were collected.
Results:
The prevalence of anti-HCV Ab was 1.2% and 9.5% in the control group and patients with LP, respectively. Compared with the control group, patients with LP had a higher risk of HCV infection with an odds ratio of 8.737 (p=0.034). The mean duration of disease for the eight patients with HCV-associated LP was 5.8 months, which was shorter than 15.8 months in 84 patients with LP alone. Mucosal erosive LP was observed most frequently in HCV-associated LP with an odds ratio of 9.273 (p=0.003).
Conclusion
HCV infection may be clinically relevant to the development of LP. Furthermore, HCV infection may accelerate the progression of LP and is possibly related to the mucosal erosive subtype. Therefore, dermatologists should perform an anti-HCV Ab screening test for patients with LP, disclosing the potential association between LP and HCV infection.

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