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.Clinical Characteristics of Cytomegalovirus Disease of the Upper Gastrointestinal Tract: A 10-Year Multicenter Retrospective Study
Ga-Ram YOU ; Seon-Young PARK ; Hye-Su YOU ; Seung-Young SEO ; Sung-Kyun YIM ; Byung-Chul JIN ; Jung-In LEE ; Young-Dae KIM ; Suck-Chei CHOI ; Chan-Guk PARK ; Wan-Sik LEE
The Korean Journal of Helicobacter and Upper Gastrointestinal Research 2023;23(4):294-301
Objectives:
Gastrointestinal cytomegalovirus (CMV) disease is a major contributor to mortality in immunocompromised patients. Few studies have discussed upper gastrointestinal CMV (UGICMV) disease in immunocompetent patients. We compared the clinical outcomes of UGI-CMV between immunocompromised and immunocompetent patients.
Methods:
This retrospective study included patients with UGI-CMV disease from five tertiary hospitals across Korea (2010– 2022). Patients’ clinical data and outcomes were recorded.
Results:
UGI-CMV was diagnosed in 54 patients; 27 (50.0%) had esophageal, 24 (44.4%) had gastric, and 3 patients (5.6%) had duodenal involvement. Patients’ median age was 64 years (interquartile range 53–75 years), and the most common comorbidities included hypertension (57.4%) and diabetes (38.9%). The predominant symptom was abdominal pain (46.3%), and the most common endoscopic finding was ulcers (70.4%). Antiviral treatment was administered to 31 patients, and 23 patients underwent observation without treatment. We investigated 32 immunocompromised (59.3%) and 22 immunocompetent (40.7%) patients and observed no intergroup differences in comorbidities and in laboratory and endoscopic findings. Immunocompromised patients had longer length of hospitalization (median 46.2 days vs. 20.0 days, p=0.001). However, treatment outcomes, including the need for intensive care unit admission and mortality did not significantly differ. The overall mortality rate was 13.0%; one patient from the immunocompromised group died of UGI-CMV disease. The treatment success rate was higher in immunocompromised patients who received antiviral therapy (p=0.011).
Conclusions
UGI-CMV disease is not uncommon in immunocompetent patients, although symptoms are milder than those in immunocompromised patients. Our findings emphasize the importance of clinical vigilance for accurate diagnosis of CMV infection, particularly in susceptible symptomatic patients and highlight the need for active antiviral treatment for management of immunocompromised patients.
3.2022 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.
4.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.
5.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.
6.Correction: A Bone Metastasis Nude Mouse Model Created by Ultrasound Guided Intracardiac Injection of Breast Cancer Cells: the Micro-CT, MRI and Bioluminescence Imaging Analysis
Young Jin PARK ; Eun Hye SONG ; Seol Hwa KIM ; Sang Hyun CHOI ; Ho-Taek SONG ; Jin-Suck SUH
Journal of the Korean Radiological Society 2022;83(3):750-750
7.2020 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.
8.2020 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.
9.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.
10.2020 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.

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