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

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).

2022 Seoul Consensus on Clinical Practice Guidelines for Functional Constipation

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.

Incidence of Infection among Subjects with Helicobacter pylori Seroconversion

Background/Aims@#Helicobacter pylori (H. pylori) seroconversion may occur during screening for gastric cancer. Our study aimed to assess the number of seroconverted subjects with H. pylori and their results in follow-up tests. @*Methods@#Data were consecutively collected on subjects who were H. pylori-seronegative and presented for gastric cancer screening. Subjects who were followed up using the same serology test and pepsinogen (PG) assays on the day of endoscopy were included in the study. @*Results@#During the follow-up of 57.7 ± 21.4 months, 61 (15.0%) of 407 seronegative subjects showed seroconversion. H. pylori infection was detected in six (9.8%) of 61 seroconverted subjects. A diffuse red fundal appearance, with a significant increase in the Kyoto classification scores for gastritis, was observed in the infected subjects (p<0.001). Compared to the false-seropositive subjects, infected subjects showed higher serology titers (p<0.001) and PG II levels (p<0.001), and lower PG I/II ratios (p=0.002), in the follow-up tests. @*Conclusions@#Seroconversion occurred in 3.3% of seronegative subjects per year; however, only 9.8% had H. pylori infection. The majority (90.2%) of the seroconverted subjects showed false seropositivity without significant changes in the follow-up test results. The diffuse red fundal appearance could be an indicator of H. pylori infection.

Efficacy and Safety of Rebamipide versus Its New Formulation, AD-203, in Patients with Erosive Gastritis: A Randomized, DoubleBlind, Active Control, Noninferiority, Multicenter, Phase 3 Study

Background/Aims@#The mucoprotective drug rebamipide is used to treat gastritis and peptic ulcers. We compared the efficacy of Mucosta Ⓡ (rebamipide 100 mg) and its new formulation, AD-203 (rebamipide 150 mg), in treating erosive gastritis. @*Methods@#This double-blind, active control, noninferiority, multicenter, phase 3 clinical trial randomly assigned 475 patients with endoscopically proven erosive gastritis to two groups: AD-203 twice daily or Mucosta Ⓡ thrice daily for 2 weeks. The intention-to-treat (ITT) analysis included 454 patients (AD-203, n=229; Mucosta Ⓡ , n=225), and the per-protocol (PP) analysis included 439 patients (AD-203, n=224; Mucosta Ⓡ , n=215). The posttreatment assessments included the primary (erosion improvement rate) and secondary endpoints (erosion and edema cure rates; improvement rates of redness, hemorrhage, and gastrointestinal symptoms). Drug-related adverse events were evaluated. @*Results@#According to the ITT analysis, the erosion improvement rates (posttreatment) in AD-203-treated and Mucosta Ⓡ -treated patients were 39.7% and 43.8%, respectively. According to the PP analysis, the erosion improvement rates (posttreatment) in AD-203-treated and Mucosta Ⓡ -treated patients were 39.3% and 43.7%, respectively. The one-sided 97.5% lower limit for the improvement rate difference between the study groups was −4.01% (95% confidence interval [CI], –13.09% to 5.06%) in the ITT analysis and −4.44% (95% CI, –13.65% to 4.78%) in the PP analysis. The groups did not significantly differ in the secondary endpoints in either analysis. Twenty-four AD-203-treated and 20 Mucosta Ⓡ -treated patients reported adverse events but no serious adverse drug reactions; both groups presented similar adverse event rates. @*Conclusions@#The new formulation of rebamipide 150 mg (AD-203) twice daily was not inferior to rebamipide 100 mg (Mucosta Ⓡ ) thrice daily. Both formulations showed a similar efficacy in treating erosive gastritis.

Efficacy of Seven-Day Potassium-Competitive Acid Blocker-Based First-Line Helicobacter pylori Eradication Therapy Administered with Bismuth

Purpose@#To determine the efficacy of a potassium-competitive acid blocker (P-CAB)-based first-line eradication therapy with bismuth compared with that of proton pump inhibitor-based first-line therapy with bismuth. @*Materials and Methods@#Eradication-naive H. pylori-infected patients were consecutively enrolled from January to November 2020. Before approval of the P-CAB-based eradication therapy, twice daily administration of a regimen containing lansoprazole 30 mg, amoxicillin 1 g, clarithromycin 500 mg, and bismuth potassium citrate 300 mg was prescribed for 7 days. After approval, lansoprazole was replaced with tegoprazan (50 mg). Clarithromycin resistance was examined in patients who underwent gastroscopic biopsy at our center. Efficacy was assessed via the 13C-urea breath test. @*Results@#Of the 381 eradication-naive patients, eradication was successful in 88.3% (151/171) treated with tegoprazan and 82.8% (140/169) treated with lansoprazole in per-protocol analysis (p=0.151). In intention-to-treat analysis, eradication rates were 78.8% (152/193) in the tegoprazan and 74.5% (140/188) in the lansoprazole group (p=0.323). Clarithromycin resistance was observed in 30 (20.1%) of the 148 patients (74 from each group), and only four of the 16 clarithromycin-resistant patients in the tegoprazan group achieved successful eradication. Clarithromycin resistance [odds ratio (OR)=42.1, 95% confidence intervals (CIs)=12.6– 141.0] and poor patient compliance (OR=17.1, 95% CIs=1.6–189.1) were independent risk factors for eradication failure. @*Conclusion@#In eradication-naive patients, eradication success rates for 7-day first-line triple therapy regimen exceeded 82% with bismuth administration. In clarithromycin-resistant patients, neither tegoprazan 50 mg nor lansoprazole 30 mg achieved acceptable eradication rates when administered twice daily for 7 days.

Five Autoimmune Gastritis Patients with Positive Findings of Serum Anti-parietal Cell Antibodies

Autoimmune gastritis is a corpus-dominant type of gastritis with positive serum anti-parietal cell antibodies (APCA) and/or anti-intrinsic factor antibodies. Serum APCA and pepsinogen (PG) assays were performed in subjects with corpus-dominant gastritis detected by endoscopy. Serum APCA was positive in five patients. All these patients were postmenopausal women (four Koreans and one Caucasian from the Russian Federation) with a mean age of 59.0±3.2 years. They displayed low PG I levels ranging from 8.1 to 18.8 ng/mL (mean, 11.4±4.8 ng/mL) and low PG I/II ratios ranging from 0.7 to 2.4 (mean, 1.2±0.7). Three of the patients were being treated for autoimmune thyroiditis. Multiple gastric neuroendocrine tumors were observed in two Helicobacter pylori (H. pylori)-naive patients with high serum gastrin levels exceeding 700 pg/mL and serum chromogranin A levels exceeding 1,000 ng/mL. In the remaining three patients, intestinal metaplasia was observed in the biopsied specimens from the antrum, suggesting a history of H. pylori infection. Our findings indicate the value of positive serum APCA findings, low serum PG I levels, and low serum PG I/II ratios in confirming autoimmune gastritis in patients showing corpus-dominant atrophy, regardless of their H. pylori infection status.

Efficacy of Seven-Day Potassium-Competitive Acid Blocker-Based First-Line Helicobacter pylori Eradication Therapy Administered with Bismuth

Purpose@#To determine the efficacy of a potassium-competitive acid blocker (P-CAB)-based first-line eradication therapy with bismuth compared with that of proton pump inhibitor-based first-line therapy with bismuth. @*Materials and Methods@#Eradication-naive H. pylori-infected patients were consecutively enrolled from January to November 2020. Before approval of the P-CAB-based eradication therapy, twice daily administration of a regimen containing lansoprazole 30 mg, amoxicillin 1 g, clarithromycin 500 mg, and bismuth potassium citrate 300 mg was prescribed for 7 days. After approval, lansoprazole was replaced with tegoprazan (50 mg). Clarithromycin resistance was examined in patients who underwent gastroscopic biopsy at our center. Efficacy was assessed via the 13C-urea breath test. @*Results@#Of the 381 eradication-naive patients, eradication was successful in 88.3% (151/171) treated with tegoprazan and 82.8% (140/169) treated with lansoprazole in per-protocol analysis (p=0.151). In intention-to-treat analysis, eradication rates were 78.8% (152/193) in the tegoprazan and 74.5% (140/188) in the lansoprazole group (p=0.323). Clarithromycin resistance was observed in 30 (20.1%) of the 148 patients (74 from each group), and only four of the 16 clarithromycin-resistant patients in the tegoprazan group achieved successful eradication. Clarithromycin resistance [odds ratio (OR)=42.1, 95% confidence intervals (CIs)=12.6– 141.0] and poor patient compliance (OR=17.1, 95% CIs=1.6–189.1) were independent risk factors for eradication failure. @*Conclusion@#In eradication-naive patients, eradication success rates for 7-day first-line triple therapy regimen exceeded 82% with bismuth administration. In clarithromycin-resistant patients, neither tegoprazan 50 mg nor lansoprazole 30 mg achieved acceptable eradication rates when administered twice daily for 7 days.

Five Autoimmune Gastritis Patients with Positive Findings of Serum Anti-parietal Cell Antibodies

Autoimmune gastritis is a corpus-dominant type of gastritis with positive serum anti-parietal cell antibodies (APCA) and/or anti-intrinsic factor antibodies. Serum APCA and pepsinogen (PG) assays were performed in subjects with corpus-dominant gastritis detected by endoscopy. Serum APCA was positive in five patients. All these patients were postmenopausal women (four Koreans and one Caucasian from the Russian Federation) with a mean age of 59.0±3.2 years. They displayed low PG I levels ranging from 8.1 to 18.8 ng/mL (mean, 11.4±4.8 ng/mL) and low PG I/II ratios ranging from 0.7 to 2.4 (mean, 1.2±0.7). Three of the patients were being treated for autoimmune thyroiditis. Multiple gastric neuroendocrine tumors were observed in two Helicobacter pylori (H. pylori)-naive patients with high serum gastrin levels exceeding 700 pg/mL and serum chromogranin A levels exceeding 1,000 ng/mL. In the remaining three patients, intestinal metaplasia was observed in the biopsied specimens from the antrum, suggesting a history of H. pylori infection. Our findings indicate the value of positive serum APCA findings, low serum PG I levels, and low serum PG I/II ratios in confirming autoimmune gastritis in patients showing corpus-dominant atrophy, regardless of their H. pylori infection status.

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.

Prognosis of Seronegative Subjects with a Helicobacter pylori-infected Spouse

Background/Aims@#Helicobacter pylori (H. pylori) can disseminate between couples. The present study compared the findings of gastric cancer screening between seronegative subjects according to the presence of an infected spouse. @*Materials and Methods@#Follow-up data of seronegative subjects were analyzed among married couples who underwent gastric cancer screening via gastroscopy, serum pepsinogen, and anti-H. pylori IgG assays between January 2010 and May 2016. New detection rates of H. pylori infection and gastric neoplasm at the follow-up screening were compared between seronegative subjects according to the H. pylori-infected status of spouse. @*Results@#Among 246 seronegative subjects with an H. pylori-infected spouse, 92 underwent follow-up tests (case group). Among 278 seronegative subjects with seronegative spouse, 94 underwent follow-up tests (control group). The past infection rate was higher in the case group than in the control group (52/92 vs. 34/94; P=0.005). New H. pylori infection was diagnosed in three of the 92 cases and two of the 94 controls (3.2% vs. 2.1%; P=0.681). During the mean follow-up of 67.9±36.0 months, three adenocarcinomas and two adenomas (5/184) were newly detected among the cases and their spouses, whereas none (0/188) were detected among the controls and their spouses (2.7% vs. 0%; P=0.029). @*Conclusions@#Gastric neoplasm occurred more frequently in couples with an H. pylori-infected spouse. Because the past infection rate is higher among seronegative subjects with an infected spouse, gastric cancer screening is recommended in both partners when the spouse is infected.

Chromosomal Microarray Analysis as a First-Tier Clinical Diagnostic Test in Patients With Developmental Delay/Intellectual Disability, Autism Spectrum Disorders, and Multiple Congenital Anomalies: A Prospective Multicenter Study in Korea

BACKGROUND: To validate the clinical application of chromosomal microarray analysis (CMA) as a first-tier clinical diagnostic test and to determine the impact of CMA results on patient clinical management, we conducted a multicenter prospective study in Korean patients diagnosed as having developmental delay/intellectual disability (DD/ID), autism spectrum disorders (ASD), and multiple congenital anomalies (MCA). METHODS: We performed both CMA and G-banding cytogenetics as the first-tier tests in 617 patients. To determine whether the CMA results directly influenced treatment recommendations, the referring clinicians were asked to complete a 39-item questionnaire for each patient separately after receiving the CMA results. RESULTS: A total of 122 patients (19.8%) had abnormal CMA results, with either pathogenic variants (N=65) or variants of possible significance (VPS, N=57). Thirty-five well-known diseases were detected: 16p11.2 microdeletion syndrome was the most common, followed by Prader-Willi syndrome, 15q11-q13 duplication, Down syndrome, and Duchenne muscular dystrophy. Variants of unknown significance (VUS) were discovered in 51 patients (8.3%). VUS of genes putatively associated with developmental disorders were found in five patients: IMMP2L deletion, PTCH1 duplication, and ATRNL1 deletion. CMA results influenced clinical management, such as imaging studies, specialist referral, and laboratory testing in 71.4% of patients overall, and in 86.0%, 83.3%, 75.0%, and 67.3% of patients with VPS, pathogenic variants, VUS, and benign variants, respectively. CONCLUSIONS: Clinical application of CMA as a first-tier test improves diagnostic yields and the quality of clinical management in patients with DD/ID, ASD, and MCA.

Nodular Gastritis as a Precursor Lesion of Atrophic and Metaplastic Gastritis / 대한소화기학회지

BACKGROUND/AIMS: Chronic atrophic gastritis (CAG) and metaplastic gastritis (MG) are precancerous conditions of Helicobacter pylori (H. pylori)-related gastric cancer. This study aimed to identify the characteristics of nodular gastritis (NG) showing CAG or MG after nodule regression.METHODS: H. pylori-infected patients with NG were included after upper gastrointestinal endoscopy. Patients were excluded if their latest endoscopy had been performed ≤36 months after the initial diagnosis of NG. Small-granular-type NG was defined as the condition with 1–2 mm regular subepithelial nodules. Large-nodular-type NG was defined as those with 3–4 mm, irregular subepithelial nodules. The endoscopic findings after nodule regression were recorded.RESULTS: Among the 97 H. pylori-infected patients with NG, 61 showed nodule regression after a mean follow-up of 73.0±22.0 months. After nodule regression, 16 patients showed a salt-and-pepper appearance and/or transparent submucosal vessels, indicating CAG. Twenty-nine patients showed diffuse irregular elevations and/or whitish plaques, indicating MG. Sixteen patients with other endoscopic findings (14 normal, one erosive gastritis, and one chronic superficial gastritis) showed a higher proportion of H. pylori eradication (12/16, 75.0%) than those in the CAG group (5/16, 31.3%) and MG group (6/29, 20.7%; p=0.001). Patients with small-granular-type NG tended to progress toward CAG (14/27, 51.9%), whereas those with large-nodular-type NG tended to progress toward MG (25/34, 73.5%; p<0.001).CONCLUSIONS: In patients with a persistent H. pylori infection, NG tended to progress to CAG or MG when the nodules regressed. Small-granular-type NG tended to progress to CAG, whereas large-nodular-type NG tended to progress to MG.

ABC Classification Is Less Useful for Older Koreans Born before 1960

BACKGROUND/AIMS: In the ABC classification system, group A consists of seronegative subjects without gastric corpus atrophy. This study aimed to determine the prevalence and characteristics of pseudo group A subjects. METHODS: Group A subjects were identified among consecutive Korean adults who underwent a serum anti-Helicobacter pylori immunoglobulin G (IgG) test and pepsinogen (PG) assay on the day of endoscopy. Past infection was defined as the presence of either eradication history or endoscopic findings suggesting past infection (i.e., gastric xanthoma, metaplastic gastritis, or advanced atrophy >closed-type 1). RESULTS: Among 2,620 group A subjects, 448 (17.1%) had eradication history, and 133 (5.1%) showed endoscopic findings suggesting past infection. Older age (odds ratio [OR], 1.148; 95% confidence interval [CI], 1.067 to 1.236) and earlier year of birth (OR, 1.086; 95% CI, 1.009 to 1.168) were independent risk factors for classification into pseudo group A, with cutoff points at 50.5 years and birth year of 1959.5, respectively. Positive H. pylori test findings were found in 22 subjects (3.1%) among the 715 subjects who underwent the urea breath test or Giemsa staining on the same day. Current infection was positively correlated with PG I and PG II levels (p<0.001) but not with age, anti-H. pylori IgG titer, or classification into pseudo group A. CONCLUSIONS: Among the group A subjects, 22.2% had past infection. The risk was higher in subjects older than 50 years, especially those born before 1960. Furthermore, current infection was found in 3.1% of the subjects and was correlated with increased gastric secretory ability.

Usefulness of Carbohydrate Antigen 19-9 Test in Healthy People and Necessity of Medical Follow-up in Individuals with Elevated Carbohydrate Antigen 19-9 Level / 가정의학회지

BACKGROUND: Carbohydrate antigen 19-9 (CA 19-9) is a tumor marker whose level is elevated in many types of cancers and other benign conditions. CA 19-9 levels are frequently found to be elevated in individuals during general health examinations. This study aimed to investigate the clinical characteristics of such individuals and to determine the need for medical follow-up. METHODS: We investigated individuals who underwent a health inspection, including a serum CA 19-9 test, at our center. Their CA 19-9 levels, age, sex, body mass index (BMI), and personal and past histories were investigated. Additionally, subgroup analyses were performed for those who underwent follow-up study for the elevated CA 19-9 levels. RESULTS: Of 58,498 subjects, 581 (1.0%) had elevated CA 19-9 levels. Multivariate analyses revealed that older age, female sex, lower BMI, and diabetes were independent predisposing factors for elevated CA 19-9 level. A subgroup analysis revealed that the causative conditions were identified in 129 of 351 subjects (36.8%). Among them, the causative conditions in 31 subjects (8.8%, including four cases of cancer and 15 of benign tumors) were not detected at the initial check-up and were found during the follow-up period. CONCLUSION: The use of CA 19-9 as a marker for cancer in healthy individuals is inappropriate. However, medical follow-up in individuals with elevated CA 19-9 levels may be useful because some causative diseases may be detected during follow-up.

Nodular Gastritis as a Precursor Lesion of Atrophic and Metaplastic Gastritis / 대한소화기병학회잡지

BACKGROUND/AIMS: Chronic atrophic gastritis (CAG) and metaplastic gastritis (MG) are precancerous conditions of Helicobacter pylori (H. pylori)-related gastric cancer. This study aimed to identify the characteristics of nodular gastritis (NG) showing CAG or MG after nodule regression. METHODS: H. pylori-infected patients with NG were included after upper gastrointestinal endoscopy. Patients were excluded if their latest endoscopy had been performed ≤36 months after the initial diagnosis of NG. Small-granular-type NG was defined as the condition with 1–2 mm regular subepithelial nodules. Large-nodular-type NG was defined as those with 3–4 mm, irregular subepithelial nodules. The endoscopic findings after nodule regression were recorded. RESULTS: Among the 97 H. pylori-infected patients with NG, 61 showed nodule regression after a mean follow-up of 73.0±22.0 months. After nodule regression, 16 patients showed a salt-and-pepper appearance and/or transparent submucosal vessels, indicating CAG. Twenty-nine patients showed diffuse irregular elevations and/or whitish plaques, indicating MG. Sixteen patients with other endoscopic findings (14 normal, one erosive gastritis, and one chronic superficial gastritis) showed a higher proportion of H. pylori eradication (12/16, 75.0%) than those in the CAG group (5/16, 31.3%) and MG group (6/29, 20.7%; p=0.001). Patients with small-granular-type NG tended to progress toward CAG (14/27, 51.9%), whereas those with large-nodular-type NG tended to progress toward MG (25/34, 73.5%; p<0.001). CONCLUSIONS: In patients with a persistent H. pylori infection, NG tended to progress to CAG or MG when the nodules regressed. Small-granular-type NG tended to progress to CAG, whereas large-nodular-type NG tended to progress to MG.

Effect of Alcohol Consumption on Seroconversion in Helicobacter pylori-Seronegative Koreans / 대한내과학회지

BACKGROUND/AIMS: Helicobacter pylori (H. pylori) seroconversion may develop in seronegative adults. Although a positive correlation has been reported between alcohol consumption and seroconversion in Korea, an inverse correlation has been reported in other countries. The aim of this study was to investigate the risk factors for seroconversion in Korea. METHODS: We included Korean adults who were H. pylori-negative negative in their annual serum immunoglobulin G and pepsinogen assays, and in upper gastrointestinal endoscopy. Subjects with a history of H. pylori eradication or gastrectomy were excluded. The criteria for heavy alcohol consumption were ≥ 15 drinks/week for males and ≥ 8 drinks/week for females. RESULTS: Of 267 H. pylori-seronegative subjects, 26 (9.7%) exhibited seroconversion at a mean follow-up time of 39.0 ± 19.1 months. Seroconversion was positively correlated with alcohol consumption (p = 0.001), nonsteroidal anti-inflammatory drug use (p = 0.015), a higher body mass index (p = 0.033), a longer follow-up period (p = 0.038), and a greater number of follow-up tests (p = 0.004). Heavy drinking (odds ratio 6.754, 95% confidence interval 1.892–24.102, p = 0.003) and social drinking (odds ratio 4.360, 95% confidence interval 1.130–16.826, p = 0.033) were independent risk factors for seroconversion. During follow-up, subjects with seroconversion had higher serum levels of pepsinogen II (12.0 ± 7.8 ng/mL) than others (9.1 ± 5.3 ng/mL) (p = 0.038). CONCLUSIONS: Alcohol consumption is related to seroconversion in Koreans. H. pylori transmission might be prevented by reducing alcohol consumption and controlling drinking habits.

Efficacy and Safety of UI05MSP015CT in Functional Dyspepsia: A Randomized, Controlled Trial

BACKGROUND/AIMS: To evaluate the efficacy and safety of a controlled release, once-daily formulation of mosapride (UI05MSP015CT) in patients with functional dyspepsia (FD). METHODS: Patients with FD were randomly assigned (1:1) to receive either UI05MSP015CT (15 mg once a day, study group) or mosapride (5 mg three times a day, control group) and corresponding placebo for 4 weeks. The primary endpoint was a change in the gastrointestinal symptom score (GIS) evaluated at enrollment and after 4 weeks. Secondary endpoints were changes in the Nepean Dyspepsia Index-Korean version (NDI-K), rate of satisfactory symptom relief, and rate of adverse events. RESULTS: A total of 138 patients were enrolled (female, 73.9%; mean age, 44.0±15.4 years). After excluding patients who violated the study protocol, 59 and 58 patients from the study and control groups, respectively, were included in the per-protocol analysis. No difference was observed in drug compliance between the control and study groups (97.07%±4.52% vs 96.85%±6.05%, p=0.870). Changes in GIS scores were 9.69±6.44 and 10.01±5.92 in the study and control groups. The mean difference in GIS change between groups was 0.33 (95% confidence interval, 1.75 to 2.41), demonstrating non-inferiority of UI-05MSP015CT (p=0.755). The rate of satisfactory symptom relief was not different between the study and control groups (39.0% vs 56.9%, p=0.053). No differences in change in NDI-K score (14.3 vs 16.9, p=0.263) or rates of adverse events (12.9% vs. 4.4%, p=0.062) were observed between the study and control groups. CONCLUSIONS: Once-daily mosapride is not inferior to conventional mosapride in efficacy and is safe in patients with FD.

Descending Aorta Blood Flow Characteristics before the Development of Necrotizing Enterocolitis in Preterm Neonates

PURPOSE: To investigate the hemodynamic risk factors for necrotizing enterocolitis (NEC), we analyzed the characteristics of descending aorta (DA) blood flow in preterm neonates, who later developed NEC. METHODS: This was an observational case-control study on 53 preterm neonates at a tertiary referral center. Clinical and echocardiographic data were collected from 23 preterm neonates with NEC (NEC group), and compared with those of 30 preterm neonates without NEC (control group). Echocardiography was done at a median (interquartile range) of 5 (3–9) days after birth and 2 (1–2.5) days before the diagnosis of NEC. RESULTS: Basic clinical characteristics including gestational age, birth weight, Apgar score, breast feeding status, use of umbilical catheters, and mode of invasive ventilator care were similar between the groups. Compared with the control group, the lowest diastolic velocity of DA was significantly decreased, whereas the diastolic reverse flow and the ratio of diastolic reverse to systolic forward flows were significantly increased in the NEC group. In addition, the resistive index (RI) of DA was significantly increased in the NEC group and showed a positive association with the development of NEC. Multivariate logistic regression analysis showed that increasing RI of DA was an independent risk factor for the development of NEC (P=0.008). CONCLUSION: Significant changes in DA flow characteristics including decreased diastolic velocity and increased diastolic reverse flow along with increased peripheral vascular resistance were observed before the development of NEC in preterm neonates. These findings may help clinicians stratify in advance neonates at a risk of developing NEC and may help improve outcomes in these neonates.

Identification of Nodular Gastritis among Patients Diagnosed with Lymphofollicular Gastritis on a Gastric Biopsied Specimen / 대한소화기학회지

BACKGROUND/AIMS: Nodular gastritis (NG) is a well-known endoscopic finding observed in patients with a Helicobacter pylori infection, which may lead to invasive gastric cancer. Lymphofollicular gastritis consists of lymphoid follicles or lymphoid cell aggregates, and is common in children. The aim of this study was to identify patients with NG from those in whom gastric biopsied specimens showed lymphoid follicles and lymphoid cell aggregates. METHODS: Subjects, whose gastric biopsy specimens showed lymphoid follicles or lymphoid cell aggregates, were included in this study. The inclusion criterion was that they underwent a serum pepsinogen assay on the day of upper gastrointestinal endoscopy. NG was diagnosed if the endoscopy findings revealed regular-sized, multiple, colorless subepithelial nodules. RESULTS: Among 108 subjects who showed lymphoid follicles or lymphoid cell aggregates, 13 (12.0%) revealed NG on endoscopy, and all these subjects showed positive Giemsa staining. Patients diagnosed with NG were younger (p=0.012) and showed a female predominance (p=0.001) compared to those without NG. The mean serum pepsinogen levels were higher (p=0.001) and lymphoid follicle-dominant subjects were more common (p<0.001) in the NG subjects than in those without NG. Logistic regression analysis revealed a younger age (p=0.041) and female gender (p=0.002) to be significant independent risk factors for NG. CONCLUSIONS: NG should be distinguished from lymphofollicular gastritis because only 12% of patients showing gastric biopsy findings of lymphoid follicles and lymphoid cell aggregates demonstrated NG on endoscopy. NG is an endoscopic finding that is more common in women and in the younger population, irrespective of the biopsy findings and gastric secretory ability.

Serological Changes after Equivocal Helicobacter pylori-serology Test Findings Dependent on Gastric Secreting Ability / 대한소화기학회지

BACKGROUND/AIMS: The serum anti-Helicobacter pylori (H. pylori) immunoglobulin G (IgG) and serum pepsinogen (PG) assays are widely used to screen for gastric cancer. An equivocal serology test finding indicates IgG titer between the positive and negative test findings. This study aims to evaluate the long-term follow-up result after an equivocal test finding on the serum anti-H. pylori IgG assay. METHODS: Koreans aged 18 years or older with an equivocal serum anti-H. pylori IgG assay finding were included. Subjects were excluded if they did not undergo H. pylori serology test, serum PG assay, and upper gastrointestinal (UGI) endoscopy on the same day at our center. The annual test findings were followed-up using the same methods. RESULTS: Of the 7,178 subjects who underwent the serum assays and UGI endoscopy on the same day, 274 (3.8%) subjects showed an equivocal H. pylori serology test finding. Of the 98 subjects who were followed-up, 58 (59.2%) showed seropositive finding at the mean follow-up period of 30.6±12.4 months. Subjects with seroconversion showed a higher initial serum PG I (p=0.023) and PG II (p=0.036) levels than those without seroconversion. CONCLUSIONS: An equivocal H. pylori serology test finding was not rare (3.8%) in Korean adults, and 60% of equivocal subjects showed seroconversion within 3 years. Higher seroconversion rates in subjects with high PG I and PG II levels suggest that intact gastric secreting ability plays a role in the survival of H. pylori. Therefore, equivocal subjects with increased serum PG levels should be considered as potential seropositive subjects.