Sleep disorders in patients with functional dyspepsia: A multicenter study from the Korean Society of Neurogastroenterology and Motility.

BACKGROUND AND AIM: The few studies concerning the association between sleep disorders and functional dyspepsia (FD) have yielded inconsistent results. We compared the prevalence of sleep disorders in patients with FD and healthy controls, and evaluated whether FD was independently associated with sleep disorders, and the risk factors for sleep disorders in patients with FD. METHODS: This prospective, multicenter, cross-sectional study was conducted from August 2014 to December 2017 at 12 hospitals in South Korea. The inclusion criterion was the presence of FD (for ≥18 years) according to the Rome III criteria. Healthy controls were recruited from among patients who visited the Health Examination Center for check-ups. RESULTS: In total, 526 subjects were prospectively enrolled in this study (201 with FD and 325 healthy controls). The prevalence of sleep disorders was significantly higher among the patients with FD than among the healthy controls (41.8% vs 18.8%, P = 0.000). In a multivariate analysis, FD (odds ratio [OR] = 1.851; 95% confidence interval [CI] 1.194-2.870; P = 0.006), female sex (OR = 1.672; 95% CI 1.063-2.628; P = 0.026), and anxiety (OR = 3.325; 95% CI 2.140-5.166; P = 0.000) were independent risk factors for sleep disorders in the overall cohorts. In patients with FD only, low body mass index, heartburn, and anxiety were independent risk factors for sleep disorders in a further multivariate analysis. CONCLUSION: Sleep disorders were common in patients with FD. FD was significantly associated with sleep disorders in our patient population, irrespective of the presence of heartburn or psychiatric disorders.

The Novel Scoring System for 30-Day Mortality in Patients with Non-variceal Upper Gastrointestinal Bleeding.

BACKGROUND: Although the mortality rates for non-variceal upper gastrointestinal bleeding (NVUGIB) have recently decreased, it remains a significant medical problem. AIM: The main aim of this prospective multicenter database study was to construct a clinically useful predictive scoring system by using our predictors and compare its prognostic accuracy with that of the Rockall scoring system. METHODS: Data were collected from consecutive patients with NVUGIB. Logistic regression analysis was performed to identify the independent predictors of 30-day mortality. Each independent predictor was assigned an integral point proportional to the odds ratio (OR) and we used the area under the curve to compare the discrimination ability between the new predictive model and the Rockall score. RESULTS: The independent predictors of mortality included age >65 years [OR 2.627; 95 % confidence interval (CI) 1.298-5.318], hemodynamic instability (OR 2.217; 95 % CI 1.069-4.597), serum blood urea nitrogen level >40 mg/dL (OR 1.895; 95 % CI 1.029-3.490), active bleeding at endoscopy (OR 2.434; 95 % CI 1.283-4.616), transfusions (OR 3.811; 95 % CI 1.640-8.857), comorbidities (OR 3.481; 95 % CI 1.405-8.624), and rebleeding (OR 10.581; 95 % CI 5.590-20.030). The new predictive model showed a high discrimination capability and was significantly superior to the Rockall score in predicting the risk of death (OR 0.837;95 % CI 0.818-0.855 vs. 0.761; 0.739-0.782; P = 0.0123). CONCLUSIONS: The new predictive score was significantly more accurate than the Rockall score in predicting death in NVUGIB patients. We need to prospectively validate the accuracy of this score for predicting mortality in NVUGIB patients.

Risk Factors Associated with Rebleeding in Patients with High Risk Peptic Ulcer Bleeding: Focusing on the Role of Second Look Endoscopy.

BACKGROUND: Re-bleeding after initial hemostasis in peptic ulcer bleeding can be life threatening. Identification of factors associated with re-bleeding is important. The aims of this study were to determine incidence of rebleeding in patients with high risk peptic ulcer bleeding and to evaluate factors associated with rebleeding. METHODS: Among patients diagnosed as upper gastrointestinal hemorrhage at seven hospitals in Daegu-Gyeongbuk, and one hospital in Gyeongnam, South Korea, from Feb 2011 to Dec 2013, 699 patients diagnosed as high risk peptic ulcer bleeding with Forrest classification above llb were included. The data were obtained in a prospective manner. RESULTS: Among 699 patients, re-bleeding occurred in 64 (9.2 %) patients. Second look endoscopy was significantly more performed in the non-rebleeding group than the rebleeding group (81.8 vs 62.5 %, p < 0.001). In multivariate analysis, use of non-steroidal anti-inflammatory agents, larger transfusion volume (≥5 units), and non-performance of second look endoscopy were found as risk factors for rebleeding in high risk peptic ulcer bleeding. CONCLUSION: In our study, rebleeding was observed in 9.2 % of patients with high risk peptic ulcer bleeding. Performance of second look endoscopy seems to lower the risk of rebleeding in high risk peptic ulcer bleeding patients and caution should be paid to patients receiving high volume transfusion and on medication with NSAIDs.

Concomitant and hybrid therapy for Helicobacter pylori infection: A randomized clinical trial.

BACKGROUND AND AIMS: This study aimed to validate the equivalence of first-line concomitant and hybrid regimens for Helicobacter pylori infection in an era of increasing antibiotic resistance. The study also aimed to assess regimen compliance. METHODS: H. pylori-infected patients from six hospitals in Korea were randomly assigned to either concomitant or hybrid regimens. The concomitant regimen consisted of 20 mg of esomeprazole, 1 g of amoxicillin, 500 mg of clarithromycin, and 500 mg metronidazole, twice daily for 10 days. The hybrid regimen consisted of a 5-day dual therapy (20 mg of esomeprazole and 1 g of amoxicillin, twice daily) followed by a 5-day quadruple therapy (20 mg of esomeprazole, 1 g of amoxicillin, 500 mg of clarithromycin, and 500 mg of metronidazole, twice daily). RESULTS: Eradication rates for concomitant and hybrid therapy were 78.6% (187/238) and 78.8% (190/241) in the intention-to-treat analysis, and 89.8% (176/196) and 89.6% (181/202) in the per protocol analysis. For both analyses, 95% confidence intervals fell within the ± 8% equivalence margin. Adherence was better in the hybrid group (95.0%) than in the concomitant group (90.1%), a difference that was borderline significant (P = 0.051). Adverse event rates were higher in the concomitant group than in the hybrid group for nausea (15.8% vs 8.8%; P = 0.028) and regurgitation (17.6% vs 10.7%; P = 0.040). CONCLUSION: As compared with concomitant therapy, hybrid therapy offered similar efficacy, better compliance, and fewer adverse events. Hybrid therapy could be a reasonable first-line treatment option for H. pylori in areas with high antibiotics resistance.

Non-curative endoscopic resection does not always lead to grave outcomes in submucosal invasive early gastric cancer.

BACKGROUND: Endoscopic submucosal dissection (ESD) has been widely performed for the treatment of early gastric cancer (EGC). The aim of this study is to examine the effectiveness of ESD in submucosal invasive gastric cancers (SM-GC), with a special focus on patients who underwent non-curative resection. METHODS: Data for 1,246 patients who underwent ESD for treatment of EGC at six medical centers in Daegu-Gyeongbuk, Korea, between February 2003 and May 2010 were collected. After retrospective analysis of ESD databases, 118 patients were enrolled and classified into three groups: (1) EGC with submucosal invasion less than 500 µm (SM1-GC) that met the expanded criteria (EC) (SM1 EC, n = 42); (2) SM1-GC that did not meet the EC (SM1 non-EC, n = 38); and (3) EGC with submucosal invasion greater than 500 µm (SM2-GC, n = 38). RESULTS: The en bloc and complete resection rates did not differ significantly among the three groups. However, the curative resection rate was significantly better in the SM1 EC group (69.0%) compared to that in SM1 non-EC and SM2-GC groups (0% in both cases). Out of a total of 118 patients, 89 (75.4%) underwent non-curative resection, and cancer recurrence was observed in 9 (9/89, 10.1%). We analyzed the survival rate in these non-curative patients and the overall survival and disease-free survival did not differ significantly between patients that were treated with additional surgical resection and those that were simply followed up after ESD. CONCLUSIONS: Non-curative resection in SM-GC does not always lead to cancer recurrence. Thus, if additional surgery cannot be performed because of the patient's unsuitable condition or refusal, a close follow-up with endoscopy can be considered as an alternative for carefully selected patients. Moreover, as the ESD technology continues to evolve, it might be possible to expand the criteria for curative ESD in patients with SM-GC.

Inter-observer agreement in the endoscopic classification of colorectal laterally spreading tumors: a multicenter study between experts and trainees.

BACKGROUND AND AIM: The risk of cancer varies with the subtype of colorectal "laterally spreading tumors" (LSTs). However, visual interpretations vary among endoscopists. The aim of this study was to evaluate inter-observer agreement and accuracy in the endoscopic classification of LST subtypes among experts and trainees. METHODS: In total, 40 LST images were collected and reviewed independently by 14 gastroenterology experts and 10 trainees. All investigators recorded their findings as one of the following four categories: homogeneous, nodular mixed, flat-elevated, and pseudo-depressed. Agreement was assessed in terms of the kappa (κ) statistic and AC1 estimate. Accuracy is reported as percentage agreement with the gold standard, based on the gross morphology of the resected specimens. RESULTS: Of the possible 91 pair-wise κ estimates among experts, 41 (45.1%) were >0.75, indicating excellent agreement, while only 2 (4.44%) of the 45 pair-wise κ estimates among trainees were >0.75. Agreements for individual LST subtypes in the trainee group were significantly lower than those in the expert group. The κ and AC1 estimates showed similar values in individual subtypes of LSTs. The overall accuracy of LST was also significantly higher for the experts than the trainees (85.9 vs. 72.5%, P < 0.001). Notably, the flat-elevated subtype showed the lowest agreement and accuracy and was frequently misclassified as the pseudo-depressed subtype by both groups. CONCLUSIONS: Inter-observer agreement and accuracy for LST subtype classification differ significantly between experts and trainees. Implementation of an adequate training system for beginners is necessary to better identify colorectal LSTs.

Clinical Trial: Efficacy of Mosapride Controlled-release and Nortriptyline in Patients With Functional Dyspepsia: A Multicenter, Double-placebo, Double-blinded, Randomized Controlled, Parallel Clinical Study.

Background/Aims: Prokinetic agents and neuromodulators are among the treatment options for functional dyspepsia (FD), but their comparative efficacy is unclear. We aimed to compare the efficacy of mosapride controlled-release (CR) and nortriptyline in patients with FD after 4 weeks of treatment. Methods: Participants with FD were randomly assigned (1:1) to receive mosapride CR (mosapride CR 15 mg and nortriptyline placebo) or nortriptyline (mosapride CR placebo and nortriptyline 10 mg) in double-placebo, double-blinded, randomized controlled, parallel clinical study. The primary endpoint was defined as the proportion of patients with overall dyspepsia improvement after 4 weeks treatment. The secondary endpoints were changes in individual symptom scores, anxiety, depression, and quality of life. Results: One hundred nine participants were recruited and assessed for eligibility, and 54 in the mosapride CR group and 50 in the nortriptyline group were included in the modified intention-to-treat protocol. The rate of overall dyspepsia improvement was similar between groups (53.7% vs 54.0%, P = 0.976). There was no difference in the efficacy of mosapride CR and nortriptyline in a subgroup analysis by FD subtype (59.3% vs 52.5% in postprandial distress syndrome, P = 0.615; 44.4% vs 40.0% in epigastric pain syndrome, P = > 0.999; 50.0% vs 59.1% in overlap, P = 0.565; respectively). Both treatments significantly improved anxiety, depression, and quality of life from baseline. Conclusion: Mosapride CR and nortriptyline showed similar efficacy in patients with FD regardless of the subtype. Both treatments could be equally helpful for improving quality of life and psychological well-being while also relieving dyspepsia.

Predictive risk factors of perforation in gastric endoscopic submucosal dissection for early gastric cancer: a large, multicenter study.

BACKGROUND: Although endoscopic submucosal dissection (ESD) is standard therapy for early gastric cancer, the complication rate is unsatisfactory, with perforation as the major complication during ESD. There have been several reports regarding the complications of ESD for gastric tumor especially perforation; however, little is known about the predictors for complications in patients undergoing ESD. The purpose of this retrospective study was to determine the risk factors for perforation in patients with early gastric cancer during ESD. METHODS: Between February 2003 and May 2010, we performed ESD for 1,289 lesions in 1,246 patients at six tertiary academic hospitals in Daegu, Kyungpook, Korea. Patient-related variables (age, sex, and underlying disease), endoscopic-related variables (indication of ESD, lesion size, location, type, and mucosal ulceration), procedure-related variables (operation time, complete resection, and invasion of submucosa/vessel/lymph node), and the pathologic diagnosis were evaluated as potential risk factors. RESULTS: The mean age of the patients was 64 years. The mean size of the endoscopic lesion was 19.4 mm. The overall en bloc resection rate was 93.3 %. Perforation (microperforation and macroperforation) was seen in 35 lesions. The location of the lesion (long axis: body/short axis: greater and lesser curvature) and piecemeal resection were associated with perforation (p = 0.01/0.047 and p = 0.049). Upon multivariate analysis, the location (body vs. antrum) of the lesion (odds ratio (OR) 2.636; 95 % confidence interval (CI) 1.319-5.267; p = 0.006) and piecemeal resection (OR 2.651; 95 % CI 1.056-6.656; p = 0.038) were significant predictive factors for perforation. CONCLUSIONS: The result of this study demonstrated that the location of the lesion (body) and piecemeal resection were related to perforation during ESD.

Endoscopic submucosal dissection for early gastric cancer with undifferentiated histology: could we extend the criteria beyond?

BACKGROUND: Endoscopic submucosal desection (ESD) is an effective treatment for selected patients with early gastric cancer (EGC). The purpose of this study was to examine the short-term and long-term outcomes of ESD of undifferentiated early gastric cancer. METHODS: Data for 1,241 patients who underwent ESD for treatment of EGC between February 2003 and May 2010 were collected. We performed a retrospective analysis of the medical records of 74 patients diagnosed with undifferentiated EGC. We divided the enrolled cases into two groups: the expanded-criteria group (EC group) versus the non-EC group, according to lesion size, presence of ulceration, and pathologic review. RESULTS: Of a total of 74 lesions with undifferentiated EGC, as a result of pathologic examination the EC group included 29 cases and the non-EC group included 45 cases. The mean diameter of lesions was 19.86 ± 12.5 mm. The overall rates of en bloc resection and complete resection were 90.5% (67/74) and 73% (54/74), respectively. The curative resection rate was low at 31.1%. If limited to the pathologically diagnosed EC group, the curative resection rate was 79.3% (23/29). During median follow-up periods of 34 months (range 7-81), local recurrences were observed in 5.5% (4/74) of patients. All of these were in the non-EC group and all underwent noncurative resection. There was no mortality related to ESD for treatment of EGC during follow-up. CONCLUSIONS: ESD may be a feasible treatment for selected patients with undifferentiated EGC; this should be validated by development of new criteria for ESD for treatment of EGC.

Multi-center study regarding the risk factors for bleeding in gastrointestinal stromal tumor.

BACKGROUNDS/AIMS: In spite of several case reports about gastrointestinal stromal tumor (GIST) complicated with hemorrhage, study regarding the risk factors of bleeding in this tumor is scanty. Therefore, we analyzed the clinical characteristics of bled GISTs and tried to find risk factors of bleeding by comparing with non-bled cases. METHODOLOGY: Medical records of 49 bled GIST cases from 5 university hospitals in Korea between year 2001 to 2010 were compared with 96 non-bled cases. Whole pathological slides were reviewed by an experienced pathologist. RESULTS: Female predominance (58.6%) was noted and the mean age of the included patients was 58.4±13.1 years. In univariate analysis, location of jejunum, prolonged prothrombin time, presence of surface dimpling in CT, cellular pleomorphism and positivity of S100 was significantly dominant in the bled cases. Multivariate analysis showed significant differences in the location of jejunum (p=0.004, OR=3.533), prolonged prothrombin time (p=0003, OR=19.643), presence of surface dimpling (p=0.026, OR=6.250) in CT, and positivity of S100 (p=0.001, OR=12.941). CONCLUSIONS: Location of jejunum, prolonged prothrombin time, presence of surface dimpling in CT, and positivity of S100 are independent risk factors associated with bleeding in GI GIST patients.

Efficacy of 7-day Tailored Therapy for Helicobacter pylori Eradication based on Clarithromycin Resistance.

Background/Aims: Increasing resistance to clarithromycin (CAM) of Helicobacter pylori (H. pylori) is one of the main causes of recent decrease in eradication rate of standard triple therapy. The aim of this study was to evaluate the usefulness of 7-day tailored therapy based on the existence of CAM resistance. Methods: From January 2017 to May 2022, a total of 481 consecutive patients with H. pylori infection were recruited in Daegu Catholic University Medical Center. Treatment regimen was selected based on the result of CAM resistance test. Patients with CAM resistance (R group) were treated with bismuth-based quadruple therapy for 7 days. Patients without CAM resistance (S group) were treated with standard triple therapy for 7 days. Results: The overall H. pylori eradication rate was 89.4% (379 of 424) by per-protocol (PP) analysis. Patients with CAM resistance mutation included 166 patients (34.5%). The eradication rates of each group were 88.8% (135 of 152) and 89.7% (244 of 272) by PP analysis, for R and S group respectively. By intention-to-treat (ITT) analysis, the eradication rates were 81.3% (135 of 166) and 77.5% (244 of 315) for R and S group. CAM resistance was identified with a dual-priming oligonucleotide-based multiplex PCR. Conclusions: In spite of this high CAM resistance (34.5%), the eradication rate of 7-day tailored therapy based on the existence of CAM resistance was 89.4%. The 7-day tailored therapy based on CAM resistance could be an acceptable treatment selection strategy for H. pylori eradication.

[Brain-Gut-Microbiota Axis].

Patients frequently report that stress causes or exacerbates gastrointestinal (GI) symptoms, indicating a functional relationship between the brain and the GI tract. The brain and GI tract are closely related embryologically and functionally, interacting in various ways. The concept of the brain-gut axis was originally established in the 19th and early 20th centuries based on physiological observations and experiments conducted in animals and humans. In recent years, with the growing recognition that gut microbiota plays a vital role in human health and disease, this concept has been expanded to the brain-gut-microbiota axis. The brain influences the motility, secretion, and immunity of the GI tract, with consequent effects on the composition and function of the gut microbiota. On the other hand, gut microbiota plays an essential role in the development and function of the brain and enteric nervous system. Although knowledge of the mechanisms through which the gut microbiota influences distant brain function is incomplete, studies have demonstrated communication between these organs through the neuronal, immune, and endocrine systems. The brain-gut-microbiota axis is an essential aspect of the pathophysiology of functional GI disorders such as irritable bowel syndrome, and is also involved in other GI diseases, including inflammatory bowel disease. This review summarizes the evolving concept of the brain-gut-microbiota axis and its implications for GI diseases, providing clinicians with new knowledge to apply in clinical practice.

Real-world Prescription Patterns and Patient Satisfaction Regarding Maintenance Therapy of Gastroesophageal Reflux Disease: An Observational, Cross-sectional, Multicenter Study.

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.

On-demand Versus Continuous Maintenance Treatment With a Proton Pump Inhibitor for Mild Gastroesophageal Reflux Disease: A Prospective Randomized Multicenter Study.

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 non-inferiority 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.

Self-reported Non-celiac Gluten Sensitivity in the Korean Population: Demographic and Clinical Characteristics.

Background/Aims: Non-celiac gluten sensitivity is characterized by intestinal and extra intestinal symptoms associated with the consumption of gluten-containing food. Since biomarkers for non-celiac gluten sensitivity are lacking, its prevalence is estimated based on self-reported symptoms. However, no data exist on self-reported non-celiac gluten sensitivity in the Korean population. Thus, we aim to investigate the prevalence of self-reported non-celiac gluten sensitivity in the Korean population and to determine its demographic and clinical characteristics. Methods: This study surveyed Korean participants aged 18-80 years who visited gastroenterology outpatient clinics at 9 tertiary hospitals in South Korea from January 2016 to February 2017. They were questioned regarding symptoms related to gluten ingestion: degree of discomfort (visual analog scale score), frequency, time of symptom onset, and duration. Abdominal discomfort caused by 11 different kinds of gluten-containing Korean food items was investigated. Results: More non-celiac gluten sensitivity self-reporters were identified among those with irritable bowel syndrome (33.6%) than among controls (5.8%). Major gastrointestinal symptoms included bloating (75.0%), abdominal discomfort (71.3%), and belching (45.0%). Common extra-intestinal symptoms included fatigue (20.0%) and headache (13.7%). More than half of those who self-reported non-celiac gluten sensitivity (66.3%) developed symptoms within 1 hour of food ingestion, and symptoms were localized in the upper abdomen (37.5%) and entire abdomen (30.0%). Conclusion: Our findings suggest that if there are gluten-related symptoms in irritable bowel syndrome, the possibility of accompanying non-celiac gluten sensitivity should be considered.

Development and Validity Assessment of a Self-evaluation Questionnaire for Functional Dyspepsia: A Multicenter Prospective Study in Korea.

BACKGROUND/AIMS: Patient-reported outcomes (PROs) are essential for clinical decision making, conduction of clinical research, and drug application acquisition in functional gastrointestinal disorders. The aim of this study is to develop a PRO instrument and to determine the respondents' perception of the efficacy of therapeutic agents for functional dyspepsia (FD). METHODS: A self-evaluation questionnaire for dyspepsia (SEQ-DYSPEPSIA) was developed and validated through a structured process. The 2-week reproducibility was evaluated, and the construct validity was assessed by correlating the scores of SEQ-DYSPEPSIA (including typical and major FD symptom subscales). Finally, the response to medication was assessed by comparing the changes after 4 weeks of treatment. RESULTS: A total of 193 Korean patients (age 48.5 ± 13.6 years, 69.4% women) completed the questionnaire. SEQ-DYSPEPSIA with 11 items had a good internal consistency (alpha = 0.770-0.905) and an acceptable test-retest reliability (intraclass correlation coefficient = 0.733-0.859). The self-evaluation questionnaire (SEQ)-major FD score highly correlated with the postprandial fullness/early satiety domain of the Patient Assessment of Gastrointestinal Symptom Severity Index (correlation coefficient r = 0.741, P < 0.001), Nepean Dyspepsia Index-Korean version (NDI-K) (r = 0.839, P < 0.001), and NDI-K quality of life (r = -0.275 to -0.344, P < 0.001). After medical treatment, decrease in the SEQ-typical FD and SEQ-major FD was significantly greater in the responder group than in nonresponder group (P = 0.019 and P = 0.009, respectively). CONCLUSION: This study suggests that the Korean version of SEQ-DYSPEPSIA has good reliability and validity, and can be a useful PRO measurement tool in patients with FD.

Value of Fecal Calprotectin Measurement During the Initial Period of Therapeutic Anti-Tubercular Trial.

BACKGROUND/AIMS: The diagnosis of intestinal tuberculosis (ITB) is often challenging. Therapeutic anti-tubercular trial (TATT) is sometimes used for the diagnosis of ITB. We aimed to evaluate the changing pattern of fecal calprotectin (FC) levels during TATT in patients with ITB. METHODS: A retrospective review was performed on the data of 39 patients who underwent TATT between September 2015 and November 2018 in five university hospitals in Daegu, South Korea. The analysis was performed for 33 patients with serial FC measurement reports. RESULTS: The mean age of the participants was 48.8 years. The final diagnosis of ITB was confirmed in 30 patients based on complete mucosal healing on follow-up colonoscopy performed after 2 months of TATT. Before starting TATT, the mean FC level of the ITB patients was 170.2 µg/g (range, 11.5-646.5). It dropped to 25.4 µg/g (range, 11.5-75.3) and then 23.3 µg/g (range, 11.5-172.2) after one and two months of TATT, respectively. The difference in mean FC before and one month after TATT was statistically significant (p<0.001), and FC levels decreased to below 100 µg/g in all patients after one month of TATT. CONCLUSION: All ITB patients showed FC decline after only 1 month of TATT, and this finding correlated with complete mucosal healing in the follow-up colonoscopy after 2 months of TATT.

Randomized controlled trial to evaluate the efficacy and safety of fexuprazan compared with esomeprazole in erosive esophagitis.

BACKGROUND: Fexuprazan, a novel potassium-competitive acid blocker, reversibly suppresses the K+/H+-ATPase enzyme in proton pumps within gastric parietal cells. Fexuprazan's suppression of gastric acid was maintained in healthy individuals for 24 h in a dose-dependent manner. AIM: To compare fexuprazan to esomeprazole and establish its efficacy and safety in patients with erosive esophagitis (EE). METHODS: Korean adult patients with endoscopically confirmed EE were randomized 1:1 to receive fexuprazan 40 mg or esomeprazole 40 mg once daily for eight weeks. The primary endpoint was the proportion of patients with healed EE confirmed by endoscopy at week 8. The secondary endpoints included the healing rate of EE at week 4, symptom response, and quality of life assessment. Safety profiles and serum gastrin levels were compared between the groups. RESULTS: Of the 263 randomized, 218 completed the study per protocol (fexuprazan 40 mg, n = 107; esomeprazole 40 mg, n = 111). Fexuprazan was non-inferior to esomeprazole regarding the healing rate at week 8 [99.1% (106/107) vs 99.1% (110/111)]. There were no between-group differences in the EE healing rate at week 4 [90.3% (93/103) vs 88.5% (92/104)], symptom responses, and quality of life assessments. Additionally, serum gastrin levels at weeks 4 and 8 and drug-related side effects did not significantly differ between the groups. CONCLUSION: Fexuprazan 40 mg is non-inferior to esomeprazole 40 mg in EE healing at week 8. We suggest that fexuprazan is an alternative promising treatment option to PPIs for patients with EE.

Efficacy and Safety of DWJ1252 Compared With Gasmotin in the Treatment of Functional Dyspepsia: A Multicenter, Randomized, Double-blind, Active-controlled Study.

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.

Randomised clinical trial: comparison of tegoprazan and placebo in non-erosive reflux disease.

BACKGROUND: Tegoprazan is a novel, fast- and long-acting potassium-competitive acid blocker that suppresses gastric acid secretion, which could benefit patients with non-erosive reflux disease (NERD), a type of gastroesophageal reflux disease. AIM: To evaluate the efficacy and safety profiles of tegoprazan compared with those of a placebo in Korean patients with NERD. METHODS: In this phase 3, double-blind, placebo-controlled, multicentre study, 324 Korean patients with NERD were randomised into three treatment groups: tegoprazan 50 mg, tegoprazan 100 mg and placebo. These drugs were provided once daily for 4 weeks. The primary endpoint was the proportion of patients with complete resolution of major symptoms (both heartburn and regurgitation) for the last 7 days of the 4-week treatment period. Other outcomes related to efficacy, safety and tolerability were also evaluated. RESULTS: Among all, 42.5% (45/106), 48.5% (48/99) and 24.2% (24/99) of patients showed complete resolution of major symptoms at week 4 after receiving tegoprazan 50 mg, tegoprazan 100 mg, and placebo, respectively. Both doses of tegoprazan showed superior efficacy than the placebo (P = 0.0058 and P = 0.0004, respectively). The complete resolution rates of heartburn and proportions of heartburn-free days (as other efficacy outcomes) were significantly higher in both tegoprazan groups than in the placebo group (P < 0.05 for all). No significant difference in the incidence of treatment-emergent adverse events were noted. CONCLUSIONS: Tegoprazan 50 and 100 mg showed superior therapeutic efficacy compared with the placebo, as well as a favourable safety profile in patients with NERD. Registration number: ClinicalTrials.gov identifier NCT02556021.