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1.
Helicobacter ; 29(3): e13084, 2024.
Article in English | MEDLINE | ID: mdl-38717034

ABSTRACT

BACKGROUND: Recently, a simple tailored therapy based on clarithromycin resistance has been implemented as Helicobacter pylori (H. pylori) eradication therapy. Nonetheless, despite the tailored therapy and frequent adverse events, studies on treatment period are lacking. This study aimed to compare the H. pylori eradication rates of 7-day and 14-day tailored therapy regimens according to clarithromycin resistance. MATERIALS AND METHODS: This multicenter, prospective, randomized, noninferiority trial enrolled H. pylori-positive patients who were randomly assigned to 7-day and 14-day regimen groups, depending on the presence or absence of clarithromycin resistance by 23S rRNA gene point mutations. Standard triple therapy (STT) (20 mg rabeprazole, 1 g amoxicillin, and 500 mg clarithromycin twice daily) or bismuth quadruple therapy (BQT) (20 mg rabeprazole twice daily, 500 mg metronidazole thrice daily, 120 mg bismuth four times daily, and 500 mg tetracycline four times daily) was assigned by clarithromycin resistance. Eradication rates and adverse events were evaluated. RESULTS: A total of 314 and 278 patients were included in the intention-to-treat (ITT) and per-protocol (PP) analyses, respectively; however, 31 patients were lost to follow-up, whereas five patients violated the protocol. Both the 7-day and 14-day regimens showed similar eradication rates in the ITT (7-day vs. 14-day: 78.3% vs. 78.3%, p > 0.99) and PP (87.9% vs. 89.1%, p = 0.851) analyses. Non-inferiority was confirmed (p < 0.025). A subgroup analysis according to clarithromycin resistance (clarithromycin resistance rate: 28.7%) revealed no significant difference in eradication rates between the 7-day and 14-day STT (90.0% vs. 90.1%, p > 0.99) and BQT (82.5% vs. 86.5%, p = 0.757). Furthermore, adverse events did not significantly differ between the two groups. CONCLUSIONS: The 7-day triple and quadruple therapy according to clarithromycin resistance showed similar eradication rates, as compared to the 14-day therapy.


Subject(s)
Anti-Bacterial Agents , Clarithromycin , Drug Resistance, Bacterial , Helicobacter Infections , Helicobacter pylori , Humans , Helicobacter Infections/drug therapy , Helicobacter Infections/microbiology , Clarithromycin/therapeutic use , Clarithromycin/pharmacology , Helicobacter pylori/drug effects , Helicobacter pylori/genetics , Male , Female , Anti-Bacterial Agents/therapeutic use , Anti-Bacterial Agents/administration & dosage , Anti-Bacterial Agents/adverse effects , Anti-Bacterial Agents/pharmacology , Middle Aged , Adult , Prospective Studies , Drug Therapy, Combination , Aged , Treatment Outcome , Rabeprazole/therapeutic use , Rabeprazole/administration & dosage , Bismuth/therapeutic use , Bismuth/administration & dosage , RNA, Ribosomal, 23S/genetics
2.
Medicine (Baltimore) ; 102(49): e35926, 2023 Dec 08.
Article in English | MEDLINE | ID: mdl-38065906

ABSTRACT

BACKGROUND: Despite the availability of numerous treatment options, many patients with gastritis experience only partial symptom relief. CKD-495, a newly developed product with the active ingredient extracted from Cinnamomum cassia Presl., has demonstrated anti-inflammatory and antioxidant activity in vitro and an in vivo protective effect against gastric damage by stimulating mucus secretion. This study compared the efficacy and safety of CKD-495 with Artemisiae argyi folium (AAF) for the treatment of acute and chronic gastritis. AAF, a gastric mucosa protective agent that promotes gastric mucosa regeneration, has been used clinically for about 20 years. METHODS: This phase III multicenter, randomized, double-blind, parallel-group trial (ClinicalTrials.gov; NCT04255589) assigned 242 patients with endoscopically-proven gastric mucosal erosions to receive CKD-495 75 mg (n = 122) or AAF 60 mg (n = 120), respectively, with placebo (for double-blind purposes) 3 times a day for 2 weeks. The primary efficacy endpoint was the erosion improvement rate. Secondary endpoints included erosion cure rates, and improvement rates for edema, redness, hemorrhage, and gastrointestinal (GI) symptoms. Drug-related adverse events were evaluated. RESULTS: The erosion improvement rate was significantly higher in the CKD-495 group than in the AAF group for both the full analysis set (55.9% vs 39.4%, P = .0063) and per-protocol set (54.6% vs 38.2%, P = .0084). In addition, the erosion improvement rate in patients with acute or chronic gastritis showed that the CKD-495 group had better improvement of erosion than the AAF group, especially in patients with chronic gastritis. Analysis of secondary endpoints, which included erosion cure rate and the improvement rates of edema, redness, hemorrhage, and GI symptoms, showed that the CKD-495 group was more effective than the AAF group. There were no significant between-group differences in safety profiles. No serious adverse events or adverse drug reactions occurred. CONCLUSIONS: These results demonstrate that CKD-495 75 mg is superior to AAF 60 mg in terms of the endoscopic improvement rate of erosions in patients with acute or chronic gastritis. This new mucoprotective agent, CKD-495, can be considered the therapy of choice for symptomatic relief and healing of gastritis.


Subject(s)
Gastritis , Renal Insufficiency, Chronic , Humans , Double-Blind Method , Edema , Gastritis/drug therapy , Gastritis/diagnosis , Hemorrhage , Renal Insufficiency, Chronic/complications , Renal Insufficiency, Chronic/drug therapy , Treatment Outcome
3.
J Neurogastroenterol Motil ; 29(4): 460-469, 2023 10 30.
Article in English | MEDLINE | ID: mdl-37814436

ABSTRACT

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.

4.
World J Gastrointest Endosc ; 15(5): 397-406, 2023 May 16.
Article in English | MEDLINE | ID: mdl-37274560

ABSTRACT

BACKGROUND: Music has been used to reduce stress and improve task performance during medical therapy. AIM: To assess the effects of music on colonoscopy performance outcomes. METHODS: We retrospectively reviewed patients who underwent colonoscopy performed by four endoscopists with popular music. Colonoscopy performance outcomes, such as insertion time, adenoma detection rate (ADR), and polyp detection rate (PDR), were compared between the music and non-music groups. To reduce selection bias, propensity score matching was used. RESULTS: After one-to-one propensity score matching, 169 colonoscopies were selected from each group. No significant differences in insertion time (4.97 vs 5.17 min, P = 0.795) and ADR (39.1% vs 46.2%, P = 0.226) were found between the two groups. Subgroup analysis showed that the insertion time (3.6 vs 3.8 min, P = 0.852) and ADR (51.1% vs 44.7%, P = 0.488) did not significantly differ between the two groups in experts. However, in trainees, PDR (46.9% vs 66.7%, P = 0.016) and ADR (25.9% vs 47.6%, P = 0.006) were significantly lower in the music than in the non-music group. CONCLUSION: The current study found that listening to music during colonoscopy did not affect procedure performance. Moreover, it suggested that music may distract trainees from appropriately detecting adenomas and polyps.

5.
J Korean Med Sci ; 38(16): e126, 2023 Apr 24.
Article in English | MEDLINE | ID: mdl-37096309

ABSTRACT

BACKGROUND: The quality-of-life of patients with irritable bowel syndrome is low; incorrect diagnosis/treatment causes economic burden and inappropriate consumption of medical resources. This survey-based study aimed to analyze the current status of irritable bowel syndrome treatment to examine differences in doctors' perceptions of the disease, and treatment patterns. METHODS: From October 2019 to February 2020, the irritable bowel syndrome and Intestinal Function Research Study Group of the Korean Society of Neurogastroenterology and Motility conducted a survey on doctors working in primary, secondary, and tertiary healthcare institutions. The questionnaire included 37 items and was completed anonymously using the NAVER platform (a web-based platform), e-mails, and written forms. RESULTS: A total of 272 doctors responded; respondents reported using the Rome IV diagnostic criteria (amended in 2016) for diagnosing and treating irritable bowel syndrome. Several differences were noted between the primary, secondary, and tertiary physicians' groups. The rate of colonoscopy was high in tertiary healthcare institutions. During a colonoscopy, the necessity of random biopsy was higher among physicians who worked at tertiary institutions. 'The patient did not adhere to the diet' as a reason for ineffectiveness using low-fermentable oligo-, di-, and mono-saccharides, and polyols diet treatment was higher among physicians in primary/secondary institutions, and 'There are individual differences in terms of effectiveness' was higher among physicians in tertiary institutions. In irritable bowel syndrome constipation predominant subtype, the use of serotonin type 3 receptor antagonist (ramosetron) and probiotics was higher in primary/secondary institutions, while serotonin type 4 receptor agonist was used more in tertiary institutions. In irritable bowel syndrome diarrhea predominant subtype, the use of antispasmodics was higher in primary/secondary institutions, while the use of serotonin type 3 receptor antagonist (ramosetron) was higher in tertiary institutions. CONCLUSION: Notable differences were observed between physicians in primary/secondary and tertiary institiutions regarding the rate of colonoscopy, necessity of random biopsy, the reason for the ineffectiveness of low-fermentable oligo-, di-, and mono-saccharides, and polyols diet, and use of drug therapy in irritable bowel syndrome. In South Korea, irritable bowel syndrome is diagnosed and treated according to the Rome IV diagnostic criteria, revised in 2016.


Subject(s)
Irritable Bowel Syndrome , Humans , Irritable Bowel Syndrome/diagnosis , Serotonin/therapeutic use , Constipation , Diarrhea/etiology , Surveys and Questionnaires
6.
Clin Endosc ; 56(1): 114-118, 2023 Jan.
Article in English | MEDLINE | ID: mdl-34974682

ABSTRACT

Gastric wall abscess, a localized form of phlegmonous gastritis, is a rare complication of endoscopic resection. We report the first case of gastric wall abscess developing after endoscopic submucosal dissection in Korea. A 72-year-old woman visited our clinic to receive treatment for gastric adenoma. The patient successfully underwent endoscopic submucosal dissection with no complications. The final diagnosis was well-differentiated tubular adenocarcinoma. We performed follow-up endoscopy 10 weeks later and found a large subepithelial lesion on the posterior wall of the gastric antrum. Abdominal computed tomography revealed hypodense wall thickening and a 5 cm heterogenous multilobular mass in the submucosal layer of the gastric antrum. Submucosal invasion with mucin-producing adenocarcinomas could therefore not be excluded. The patient agreed to undergo additional gastrectomy due to the possibility of a highly malignant lesion. The final diagnosis was acute suppurative inflammation with the formation of multiple abscesses in the mural layers and omentum. The patient was discharged with no complications.

7.
Medicine (Baltimore) ; 101(38): e30795, 2022 Sep 23.
Article in English | MEDLINE | ID: mdl-36197218

ABSTRACT

BACKGROUND: In colonoscopy, good bowel preparation is an important factor in determining the quality of colonoscopy. However, an increase in residual gastric volume (RGV) can lead to a higher risk of aspiration pneumonia. Therefore, the purpose of this study was to investigate the factors related to an increase in RGV with the usage of 1L polyethylene glycol (PEG). METHODS: We prospectively analyzed 268 patients who underwent both gastroscopy and colonoscopy at 2 hospitals from May to October 2021. Bowel preparation was performed using 1L in 127 patients (47.4%) and 2L PEG in 141 patients (52.6%). We investigated the time taken for bowel preparation solutions, the last water intake, total water intake, and RGV, and conducted a survey on taking compliance and satisfaction. RESULTS: The level of RGV was significantly increased in the 1L PEG group when compared to the 2L PEG group (1L, 52.26 ±â€…65.33 vs 2L, 23.55 ±â€…22.99; P < .001). There was no difference between the 2 groups in the degree of bowel preparation, but there were more bubbles formed in the 1L group (1L, 1.91 ±â€…2.74 vs 2L, 1.10 ±â€…2.02; P = .007). In the case of RGV ≥ 50 mL, in multivariate analysis, the risk was higher in water intake within 5 hours and the patients who think the dose is too high (all P < .05). CONCLUSION: Therefore, since RGV is higher in 1L PEG than in 2L PEG, it is necessary to be careful not to take water for at least 5 hours before the test.


Subject(s)
Cathartics , Polyethylene Glycols , Cathartics/adverse effects , Colonoscopy , Humans , Polyethylene Glycols/adverse effects , Republic of Korea , Water
8.
Korean J Gastroenterol ; 80(4): 190-194, 2022 10 25.
Article in English | MEDLINE | ID: mdl-36281552

ABSTRACT

Extranodal natural killer (NK)/T-cell lymphoma, nasal type (ENKTCL-NT) is the most common subtype of Epstein-Barr virus-associated NK/T-cell lymphomas. ENKTCL-NT occurs infrequently in the gastrointestinal tract. In particular, reports of ENKTCL-on NT arising from the stomach are extremely rare. Several clusters of differentiation (CDs) have been useful in recognizing NK-cells, T-cells, and tumor cells of NK/T-cell lymphomas. Among them, the CD56 antigen is considered the most sensitive marker for ENKTCL-NT and is expressed in almost all cases of ENKTCL-NT. Thus, the development of CD56-negative ENKTCL-NT is highly atypical. This paper reports a case of a young Asian female who presented with gastric ulcer bleeding. The patient was histologically diagnosed with ENKTCL-NT. No tumor cells for CD56 were observed, whereas no monoclonality of the T-cell receptor gamma gene rearrangement was detected in the tumor cells. The patient was scheduled for systemic chemotherapy six times and achieved complete remission. Peripheral blood-hematopoietic stem cell transplantation was performed later.


Subject(s)
Epstein-Barr Virus Infections , Lymphoma, T-Cell , Humans , Female , CD56 Antigen , Herpesvirus 4, Human , Killer Cells, Natural/pathology , Stomach/pathology , Lymphoma, T-Cell/diagnosis , Lymphoma, T-Cell/pathology
9.
Medicine (Baltimore) ; 101(33): e30069, 2022 Aug 19.
Article in English | MEDLINE | ID: mdl-35984159

ABSTRACT

BACKGROUND: Increasing clarithromycin resistance has led to changes in several guidelines for treatment of Helicobacter pylori infections. We compared the H. pylori eradication rates of the empirical concomitant therapy (CoT) and a tailored therapy (TaT) using dual-priming oligonucleotide-based polymerase chain reaction to detect mutations in the 23S rRNA gene that are related to clarithromycin resistance. METHODS: Between June 2020 and May 2021, 290 patients were enrolled and randomly assigned to 2 groups. In the CoT group, the patients received rabeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg, and metronidazole 500 mg twice daily for 14 days. In the TaT group, point mutation-negative patients received rabeprazole 20 mg, amoxicillin 1 g, and clarithromycin 500 mg twice daily for 14 days and point mutation-positive patients received rabeprazole 20 mg twice daily, metronidazole 500 mg thrice daily, and bismuth 120 mg and tetracycline 500 mg 4 times daily for 14 days. RESULTS: A total of 290 and 261 patients were included in the intention-to-treat (ITT) and per-protocol (PP) analyses, respectively. A2142G and/or A2143G point mutations were identified in 28.6% of the patients. No significant difference in eradication rates were observed between the 2 groups as per ITT (CoT, 82.8% and TaT, 85.5%, P = .520) and PP (CoT, 88.6% and TaT, 94.6%, P = .084) analyses. In point mutation-positive patients, the eradication rates in the CoT group were lower than those in the TaT group as per ITT (69.8% and 87.5%, respectively, P = .050) and PP (76.9% and 97.1%, respectively, P = .011) analyses. CONCLUSION: CoT and TaT showed similar overall eradication rates for H. pylori. However, CoT eradication rate was suboptimal, especially in point mutation-positive patients.


Subject(s)
Helicobacter Infections , Helicobacter pylori , Amoxicillin/therapeutic use , Anti-Bacterial Agents/therapeutic use , Clarithromycin/therapeutic use , Drug Therapy, Combination , Helicobacter Infections/diagnosis , Helicobacter Infections/drug therapy , Helicobacter pylori/genetics , Humans , Metronidazole/therapeutic use , Point Mutation , Proton Pump Inhibitors/therapeutic use , RNA, Ribosomal, 23S/genetics , Rabeprazole/therapeutic use
10.
Korean J Gastroenterol ; 80(1): 6-16, 2022 07 25.
Article in English | MEDLINE | ID: mdl-35879058

ABSTRACT

Background/Aims: Dietary factors can aggravate the symptoms of irritable bowel syndrome (IBS). Many IBS patients try restrictive diets to relieve their symptoms, but the types of diets with an exacerbating factor are unknown. Therefore, this paper reports the results of a systematic review and network meta-analysis of randomized-controlled trials (RCTs) reviewing the efficacy of food restriction diets in IBS. Methods: The MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, and Clinicaltrials.gov databases were searched until July 21, 2021, to retrieve RCTs assessing the efficacy of restriction diets in adults with IBS. Two independent reviewers performed the eligibility assessment and data abstraction. RCTs that evaluated a restriction diet versus a control diet and assessed the improvement in global IBS symptoms were included. These trials reported a dichotomous assessment of the overall response to therapy. Results: A total of 1,949 citations were identified. After full-text screening, 14 RCTs were considered eligible for the systematic review and network meta-analysis. A starch- and sucrose-reduced diet and a diet with low-fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) showed significantly better results than a usual diet. Symptom flare-ups in patients on a gluten- free diet were also significantly lower than in those on high-gluten diets. Conclusions: These findings showed that the starch- and sucrose-reduced, low FODMAP, and gluten-free diets had superior effects in reducing IBS symptoms. Further studies, including head-to-head trials will be needed to establish the effectiveness of dietary restrictions on IBS symptoms.


Subject(s)
Irritable Bowel Syndrome , Adult , Diet , Diet, Carbohydrate-Restricted , Diet, Gluten-Free , Fermentation , Humans , Irritable Bowel Syndrome/therapy , Monosaccharides , Network Meta-Analysis , Oligosaccharides , Starch , Sucrose
11.
Gastroenterol Res Pract ; 2022: 9872230, 2022.
Article in English | MEDLINE | ID: mdl-35082846

ABSTRACT

BACKGROUND: A substantial percentage of patients with ulcerative colitis (UC) have irritable bowel syndrome- (IBS-) like symptoms despite adequate treatment and endoscopic remission. In this study, we evaluated the clinical efficacy of probiotic therapy for residual IBS-like symptoms in patients with UC in endoscopic remission. METHODS: We conducted a multicenter, observational study between April 2018 and December 2020 across two university hospitals in Korea. Patients with UC whose IBS-like symptoms persisted during endoscopic remission were included in this study. Endoscopic remission was defined as a Mayo endoscopic score ≤ 1, and IBS-like symptoms were defined as those meeting the ROME-IV diagnostic criteria. A Biotop capsule® (Lactobacillus acidophilus, 75 mg; Clostridium butyricum TO-A, 25 mg; Bacillus mesentericus TO-A, 25 mg; and Streptococcus faecalis T-110, 5 mg) was administered three times daily for one month. All patients completed bowel-related symptom questionnaires and short inflammatory bowel disease questionnaires (SIBDQs) at the start and end of the 4-week treatment period. RESULTS: A total of 43 patients were enrolled and analyzed. Statistically significant improvements from baseline were observed at the end of the 4-week treatment. The total SIBDQ score improved from 50.6 to 53.6 (P = 0.005). SIBDQ scores of bowel function (P = 0.018), systemic function (P = 0.040), and social function (P = 0.005) improved. Stool frequency and Bristol stool scale scores improved after probiotic therapy (P < 0.05). CONCLUSION: This study showed that probiotic administration improved bowel-related symptoms and quality of life in patients with UC whose IBS-like symptoms persisted during endoscopic remission. As this is an observational study and has no placebo-controlled arm, further prospective randomized controlled trials are needed to confirm these results.

12.
BMC Gastroenterol ; 21(1): 396, 2021 Oct 22.
Article in English | MEDLINE | ID: mdl-34686128

ABSTRACT

BACKGROUND: Dysbiosis of ulcerative colitis (UC) has been frequently investigated using readily accessible stool samples. However, stool samples might insufficiently represent the mucosa-associated microbiome status. We hypothesized that luminal contents including loosely adherent luminal bacteria after bowel preparation may be suitable for diagnosing the dysbiosis of UC. METHODS: This study included 16 patients with UC (9 men and 7 women, mean age: 52.13 ± 14.09 years) and 15 sex- and age-matched healthy individuals (8 men and 7 women, mean age: 50.93 ± 14.11 years). They donated stool samples before colonoscopy and underwent luminal content aspiration and endoscopic biopsy during the colonoscopy. Then, the composition of each microbiome sample was analyzed by 16S rRNA-based next-generation sequencing. RESULTS: The microbiome between stool, luminal contents, and biopsy was significantly different in alpha and beta diversities. However, a correlation existed between stool and luminal contents in the Procrustes test (p = 0.001) and Mantel test (p = 0.0001). The stool microbiome was different between patients with UC and the healthy controls. Conversely, no difference was found in the microbiome of luminal content and biopsy samples between the two subject groups. The microbiome of stool and lavage predicted UC, with AUC values of 0.85 and 0.81, respectively. CONCLUSION: The microbiome of stool, luminal contents, and biopsy was significantly different. However, the microbiome of luminal contents during colonoscopy can predict UC, with AUC values of 0.81. Colonoscopic luminal content aspiration analysis could determine microbiome differences between patients with UC and the healthy control, thereby beneficial in screening dysbiosis via endoscopy. TRIAL REGISTRATION: This trial was registered at http://cris.nih.go.kr . Registration No.: KCT0003352), Date: 2018-11-13.


Subject(s)
Colitis, Ulcerative , Gastrointestinal Microbiome , Microbiota , Adult , Aged , Dysbiosis , Female , Humans , Male , Middle Aged , RNA, Ribosomal, 16S/genetics
13.
Aliment Pharmacol Ther ; 54(4): 402-411, 2021 08.
Article in English | MEDLINE | ID: mdl-34227708

ABSTRACT

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.


Subject(s)
Gastroesophageal Reflux , Imidazoles , Benzene Derivatives , Double-Blind Method , Gastroesophageal Reflux/drug therapy , Heartburn/drug therapy , Humans , Treatment Outcome
14.
J Neurogastroenterol Motil ; 27(1): 87-96, 2021 Jan 30.
Article in English | MEDLINE | ID: mdl-32792467

ABSTRACT

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.

15.
J Neurogastroenterol Motil ; 27(1): 71-77, 2021 Jan 30.
Article in English | MEDLINE | ID: mdl-32699187

ABSTRACT

BACKGROUND/AIMS: The prevalence of eosinophilic esophagitis is increasing in Korea and there are few single-center studies regarding eosinophilic esophagitis in Korea. In particular, data about management for eosinophilic esophagitis are lacking. We aim to evaluate the practice patterns, including initial treatment and response, in the Busan city and Gyeongnam province area. METHODS: We retrospectively reviewed medical records to gain data on patient characteristics, medication, endoscopic images, and esophageal biopsy results. From January 2009 to December 2019, a total of 42 patients were diagnosed with eosinophilic esophagitis. RESULTS: The mean age was 50.7 (from 22 to 81) years and the cohort was predominantly male (78.6%, 33/42). The proton pump inhibitor was the preferred treatment as an initial trial for 64.3% (27/42) of patients, followed by swallowed topical steroids (16.7%, 7/42). Clinical improvement after proton pump inhibitor therapy was achieved in 88.9% (24/27) of patients. Two patients who did not achieve improvement showed a clinical and endoscopic response after swallowed topical steroids treatment. No patient received diet elimination or balloon dilatation therapy. CONCLUSIONS: The treatment response of eosinophilic esophagitis was good in Busan city and Gyeongnam province area in Korea. Proton pump inhibitor therapy was the preferred and most effective treatment for eosinophilic esophagitis as the initial therapy.

16.
Korean J Gastroenterol ; 76(6): 331-336, 2020 12 25.
Article in English | MEDLINE | ID: mdl-33361709

ABSTRACT

Duodenal varices are a serious complication of portal hypertension. Bleeding from duodenal varices is rare, but when bleeding does occur, it is massive and can be fatal. Unfortunately, the optimal therapeutic modality for duodenal variceal bleeding is unclear. This paper presents a patient with duodenal variceal bleeding that was managed successfully using percutaneous trans-splenic variceal obliteration (PTVO). A 56-year-old man with a history of alcoholic cirrhosis presented with a 6-day history of melena. Emergency esophagogastroduodenoscopy revealed a large, bluish mass with a nipple sign in the second portion of the duodenum. Coil embolization of the duodenal varix was performed via a trans-splenic approach (i.e., PTVO). The patient no longer complained of melena after treatment. The duodenal varix was no longer visible at the follow-up esophagogastroduodenoscopy performed three months after PTVO. The use of PTVO might be a viable option for the treatment of duodenal variceal bleeding.


Subject(s)
Duodenal Diseases , Gastrointestinal Hemorrhage , Varicose Veins , Duodenal Diseases/diagnosis , Duodenal Diseases/etiology , Duodenal Diseases/therapy , Duodenum , Embolization, Therapeutic , Esophageal and Gastric Varices/diagnosis , Gastrointestinal Hemorrhage/diagnosis , Gastrointestinal Hemorrhage/etiology , Gastrointestinal Hemorrhage/therapy , Humans , Male , Middle Aged , Spleen , Varicose Veins/complications , Varicose Veins/diagnosis
17.
Korean J Gastroenterol ; 75(5): 292-295, 2020 05 25.
Article in English | MEDLINE | ID: mdl-32448859

ABSTRACT

Peptic ulcer disease is common and can be diagnosed easily if the patient has an ulcer history or characteristic abdominal symptoms. On the other hand, it may take a long time for the patient to visit the hospital due to severe complications if the patient is old or insensitive to symptoms caused by peptic ulcers. In the present case, a 72-year-old female visited the hospital due to general weakness and inadequate oral intake, which started two weeks ago. Endoscopy and abdominal CT revealed huge gastric ulcer findings. Through a tissue examination by endoscopy, hepatic cells were identified, and the patient was diagnosed with peptic ulcer perforation to the liver and later received surgical treatment.


Subject(s)
Liver/pathology , Peptic Ulcer Perforation/diagnosis , Peptic Ulcer/pathology , Abdomen/diagnostic imaging , Aged , Female , Gastroscopy , Humans , Peptic Ulcer/complications , Peptic Ulcer Perforation/etiology , Peptic Ulcer Perforation/therapy , Tomography, X-Ray Computed
18.
Intest Res ; 17(4): 561-564, 2019 Oct.
Article in English | MEDLINE | ID: mdl-31302994

ABSTRACT

Primary malignant melanoma (PMM) of the gastrointestinal tract is rare. Reported cases of PMM of the lower gastrointestinal tract typically describe anal and rectal involvement rather than colonic lesions. This report describes a rare case of a 50-year-old woman with PMM originating in the colon. The patient presented to Inje University Busan Paik Hospital with a 3-day history of blood-tinged stools. She underwent colonoscopy for a diagnosis of hematochezia. The colonoscopic examination revealed a large-sized semi-pedunculated sigmoid colon polyp with a reddish-colored mucosal surface. Endoscopic mucosal resection was performed, and the final histopathological findings were consistent with a diagnosis of malignant melanoma. Systemic work-up was performed for assessment of metastasis and to identify the primary tumor considering the high metastatic rate of gastrointestinal malignant melanoma; however, no other malignant lesion was detected. Thus, she was diagnosed with colonic PMM. She underwent laparoscopic low anterior resection and lymph node dissection and has been recurrence-free for > 2 years.

19.
PLoS One ; 14(3): e0214129, 2019.
Article in English | MEDLINE | ID: mdl-30901362

ABSTRACT

BACKGROUND/AIMS: It is well known that 5-aminosalicylic acid (5-ASA) is the standard first-line treatment for ulcerative colitis (UC). Medication adherence is an important factor in the treatment of UC. We aimed to identify predictors of low adherence to oral 5-ASA in Koreans with UC. METHODS: Between July 2017 and January 2018, we performed a multicenter, cross-sectional study across 6 University Hospitals in Korea. Medication adherence was assessed using the modified Morisky Medication Adherence Scale (MMAS-8) questionnaire. Our study included 264 patients with UC. Patients were requested to complete the self-reported MMAS-8 questionnaire and a survey assessing sociodemographic data. Adherence was categorized as low (scores<6), medium (scores 6-7), and high (score 8). RESULTS: The mean age of patients was 44±14 years, women comprised 43.6% of the study population and 49.8% of the studied population showed low adherence to oral 5-ASA. Age <40 years, alcohol consumption, and current smoking were significantly associated with low adherence to oral 5-ASA (age <40 years: odds ratio [OR] 1.76, 95% confidence interval [CI] 1.04-2.96, p = .034; alcohol consumption: OR 1.66, 95% CI 1.00-2.74, p = .049; current smoking: OR 4.06, 95% CI 1.08-15.18, p = .038). When data were classified based on gender, we observed that only in men, alcohol consumption and current smoking showed a significant association with low adherence to oral 5-ASA (alcohol consumption: OR 2.14, 95% CI 1.08-4.23, p = .029; current smoking: OR 5.07, 95% CI 1.32-19.41, p = .018). In women, only age <40 years was significantly associated with low adherence to oral 5-ASA (age <40 years: OR 3.71, 95% CI 1.59-8.66, p = .002). CONCLUSION: Approximately 50% of patients with UC showed low adherence to oral 5-ASA. Predictors of low adherence were age <40 years, alcohol consumption, and current smoking habits. In men, alcohol consumption and current smoking were significant predictors of low adherence, whereas in women only age <40 years was significantly associated with low adherence.


Subject(s)
Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Colitis, Ulcerative/drug therapy , Mesalamine/therapeutic use , Administration, Oral , Adult , Anti-Inflammatory Agents, Non-Steroidal/administration & dosage , Cross-Sectional Studies , Female , Humans , Male , Medication Adherence , Mesalamine/administration & dosage , Middle Aged
20.
Aliment Pharmacol Ther ; 49(7): 864-872, 2019 04.
Article in English | MEDLINE | ID: mdl-30843245

ABSTRACT

BACKGROUND: Tegoprazan is a novel potassium-competitive acid blocker that has a fast onset of action and can control gastric pH for a prolonged period, which could offer clinical benefit in acid-related disorders. AIM: To confirm the non-inferiority of tegoprazan to esomeprazole in patients with erosive oesophagitis (EE). METHODS: In this multicentre, randomised, double-blind, parallel-group comparison study, 302 Korean patients with endoscopically confirmed EE (Los Angeles Classification Grades A-D) were randomly allocated to either tegoprazan (50 or 100 mg) or esomeprazole (40 mg) treatment groups for 4 or 8 weeks. The primary endpoint was the cumulative proportion of patients with healed EE confirmed by endoscopy up to 8 weeks from treatment initiation. Symptoms, safety and tolerability were also assessed. RESULTS: The cumulative healing rates at week 8 were 98.9% (91/92), 98.9% (90/91) and 98.9% (87/88) for tegoprazan 50 mg, tegoprazan 100 mg and esomeprazole 40 mg, respectively. Both doses of tegoprazan were non-inferior to esomeprazole 40 mg. The incidence of adverse events was comparable among the groups, and tegoprazan was well-tolerated. CONCLUSION: Once daily administration of tegoprazan 50 or 100 mg showed non-inferior efficacy in healing EE and tolerability to that of esomeprazole 40 mg.


Subject(s)
Anti-Ulcer Agents/administration & dosage , Benzene Derivatives/administration & dosage , Esomeprazole/administration & dosage , Esophagitis/diagnosis , Esophagitis/drug therapy , Imidazoles/administration & dosage , Proton Pump Inhibitors/administration & dosage , Adult , Aged , Double-Blind Method , Female , Humans , Male , Middle Aged , Potassium , Treatment Outcome , Wound Healing/drug effects , Wound Healing/physiology , Young Adult
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