Pub Date : 2025-02-01Epub Date: 2024-06-28DOI: 10.14309/ajg.0000000000002921
Ellen J Anderson, Simone L Peters, Peter R Gibson, Emma P Halmos
Introduction: Gut-directed hypnotherapy (GDH) treats irritable bowel syndrome (IBS), but its accessibility is limited. This problem may be overcome by digital delivery. The aim of this study was to perform a randomized control trial comparing the efficacy of a digitally delivered program with and without GDH in IBS.
Methods: Adults with IBS were randomized to a 42-session daily digital program with the GDH Program (Nerva) or without (Active Control). Questionnaires were completed to assess gastrointestinal symptoms through IBS Symptom Severity Scale (IBS-SSS), quality of life, and psychological symptoms (Depression Anxiety and Stress Scale-21) at regular intervals during the program and 6 months following the conclusion on the intervention. The primary end point was the proportion of participants with ≥50-point decrease in IBS-SSS between the interventions at the end of the program.
Results: Of 240/244 randomized participants, 121 received GDH Program-the median age 38 (range 20-65) years, 90% female, IBS-SSS 321 (interquartile range 273-367)-and 119 Active Control-36 (21-65), 91% female, IBS-SSS 303 (255-360). At program completion, 81% met the primary end point with GDH Program vs 63% Active Control ( P = 0.002). IBS-SSS was median 208 (interquartile range 154-265) with GDH and 244 (190-308) with control ( P = 0.004), 30% reduction in pain was reported by 71% compared with 35% ( P < 0.001), and IBS quality of life improved by 14 (6-25) compared with 7 (1-15), respectively ( P < 0.001). Psychological status improved similarly in both groups.
Discussion: A digitally delivered GDH Program provided to patients with IBS was superior to the active control, with greater improvement in both gastrointestinal symptoms and quality of life and provides an equitable alternative to face-to-face behavioral strategies.
{"title":"Comparison of Digitally Delivered Gut-Directed Hypnotherapy Program With an Active Control for Irritable Bowel Syndrome.","authors":"Ellen J Anderson, Simone L Peters, Peter R Gibson, Emma P Halmos","doi":"10.14309/ajg.0000000000002921","DOIUrl":"10.14309/ajg.0000000000002921","url":null,"abstract":"<p><strong>Introduction: </strong>Gut-directed hypnotherapy (GDH) treats irritable bowel syndrome (IBS), but its accessibility is limited. This problem may be overcome by digital delivery. The aim of this study was to perform a randomized control trial comparing the efficacy of a digitally delivered program with and without GDH in IBS.</p><p><strong>Methods: </strong>Adults with IBS were randomized to a 42-session daily digital program with the GDH Program (Nerva) or without (Active Control). Questionnaires were completed to assess gastrointestinal symptoms through IBS Symptom Severity Scale (IBS-SSS), quality of life, and psychological symptoms (Depression Anxiety and Stress Scale-21) at regular intervals during the program and 6 months following the conclusion on the intervention. The primary end point was the proportion of participants with ≥50-point decrease in IBS-SSS between the interventions at the end of the program.</p><p><strong>Results: </strong>Of 240/244 randomized participants, 121 received GDH Program-the median age 38 (range 20-65) years, 90% female, IBS-SSS 321 (interquartile range 273-367)-and 119 Active Control-36 (21-65), 91% female, IBS-SSS 303 (255-360). At program completion, 81% met the primary end point with GDH Program vs 63% Active Control ( P = 0.002). IBS-SSS was median 208 (interquartile range 154-265) with GDH and 244 (190-308) with control ( P = 0.004), 30% reduction in pain was reported by 71% compared with 35% ( P < 0.001), and IBS quality of life improved by 14 (6-25) compared with 7 (1-15), respectively ( P < 0.001). Psychological status improved similarly in both groups.</p><p><strong>Discussion: </strong>A digitally delivered GDH Program provided to patients with IBS was superior to the active control, with greater improvement in both gastrointestinal symptoms and quality of life and provides an equitable alternative to face-to-face behavioral strategies.</p>","PeriodicalId":7608,"journal":{"name":"American Journal of Gastroenterology","volume":" ","pages":"440-448"},"PeriodicalIF":8.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141465598","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01Epub Date: 2024-07-03DOI: 10.14309/ajg.0000000000002929
Jung-Hwan Oh, Hyun-Soo Kim, Dae Young Cheung, Hang Lak Lee, Dong Ho Lee, Gwang Ha Kim, Suck Chei Choi, Yu Kyung Cho, Woo Chul Chung, Ji Won Kim, Eunju Yu, Hyesoo Kwon, Jun Kim, John Kim, Hwoon-Yong Jung
Introduction: Zastaprazan is a potent potassium-competitive acid blocker developed to treat gastroesophageal reflux disease. The aim of this study was to evaluate the efficacy and safety of zastaprazan compared with esomeprazole in patient with erosive esophagitis (EE).
Methods: A phase III, multicenter, randomized, double-blind, noninferiority clinical study was conducted with 300 subjects with confirmed EE. Subjects were randomized to receive zastaprazan 20 mg or esomeprazole 40 mg once daily up to 8 weeks. The primary end point was the cumulative proportion of subject with healed EE confirmed by endoscopy at week 8. The secondary end points included the healing rate at week 4, symptom response, and quality of life assessment. Safety profiles and serum gastrin levels were also assessed.
Results: In the full analysis set, the cumulative healing rate at week 8 were 97.92% (141/144) for zastaprazan and 94.93% (131/138) ( P = 0.178) for esomeprazole. The healing rate at week 4 in the zastaprazan group was higher than the esomeprazole group (95.14% [137/144] vs 87.68% [121/138]; P = 0.026). There was no significant difference between groups in healing rates (the per-protocol set) at week 8 and week 4, symptom responses, quality of life assessments, and safety profiles. In addition, serum gastrin levels increased during treatment in both groups, with a significant difference between the 2 groups ( P = 0.047), but both decreased after treatment.
Discussion: An 8-week therapy of zastaprazan 20 mg is noninferior to esomeprazole 40 mg in subjects with predominantly low-grade EE. The healing rate at week 4 appears to be higher for zastaprazan than esomeprazole.
{"title":"Randomized, Double-Blind, Active-Controlled Phase 3 Study to Evaluate Efficacy and Safety of Zastaprazan Compared With Esomeprazole in Erosive Esophagitis.","authors":"Jung-Hwan Oh, Hyun-Soo Kim, Dae Young Cheung, Hang Lak Lee, Dong Ho Lee, Gwang Ha Kim, Suck Chei Choi, Yu Kyung Cho, Woo Chul Chung, Ji Won Kim, Eunju Yu, Hyesoo Kwon, Jun Kim, John Kim, Hwoon-Yong Jung","doi":"10.14309/ajg.0000000000002929","DOIUrl":"10.14309/ajg.0000000000002929","url":null,"abstract":"<p><strong>Introduction: </strong>Zastaprazan is a potent potassium-competitive acid blocker developed to treat gastroesophageal reflux disease. The aim of this study was to evaluate the efficacy and safety of zastaprazan compared with esomeprazole in patient with erosive esophagitis (EE).</p><p><strong>Methods: </strong>A phase III, multicenter, randomized, double-blind, noninferiority clinical study was conducted with 300 subjects with confirmed EE. Subjects were randomized to receive zastaprazan 20 mg or esomeprazole 40 mg once daily up to 8 weeks. The primary end point was the cumulative proportion of subject with healed EE confirmed by endoscopy at week 8. The secondary end points included the healing rate at week 4, symptom response, and quality of life assessment. Safety profiles and serum gastrin levels were also assessed.</p><p><strong>Results: </strong>In the full analysis set, the cumulative healing rate at week 8 were 97.92% (141/144) for zastaprazan and 94.93% (131/138) ( P = 0.178) for esomeprazole. The healing rate at week 4 in the zastaprazan group was higher than the esomeprazole group (95.14% [137/144] vs 87.68% [121/138]; P = 0.026). There was no significant difference between groups in healing rates (the per-protocol set) at week 8 and week 4, symptom responses, quality of life assessments, and safety profiles. In addition, serum gastrin levels increased during treatment in both groups, with a significant difference between the 2 groups ( P = 0.047), but both decreased after treatment.</p><p><strong>Discussion: </strong>An 8-week therapy of zastaprazan 20 mg is noninferior to esomeprazole 40 mg in subjects with predominantly low-grade EE. The healing rate at week 4 appears to be higher for zastaprazan than esomeprazole.</p>","PeriodicalId":7608,"journal":{"name":"American Journal of Gastroenterology","volume":" ","pages":"353-361"},"PeriodicalIF":8.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141557819","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01Epub Date: 2024-07-23DOI: 10.14309/ajg.0000000000002971
Jagannath A Kadiyala, Calvin X Geng, Andrew P Copland
{"title":"Hidden in Plain Sight: Hymenolepsis Tapeworm Found on Polyp Biopsy During Routine Colonoscopy.","authors":"Jagannath A Kadiyala, Calvin X Geng, Andrew P Copland","doi":"10.14309/ajg.0000000000002971","DOIUrl":"10.14309/ajg.0000000000002971","url":null,"abstract":"","PeriodicalId":7608,"journal":{"name":"American Journal of Gastroenterology","volume":" ","pages":"278"},"PeriodicalIF":8.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141747228","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01Epub Date: 2024-08-09DOI: 10.14309/ajg.0000000000002949
Ion A Hobai
{"title":"Gastric Motility Assays May Not Capture the Entire Clinical Picture in Patients Using Glucagon-Like Peptide-1 Receptor Agonists.","authors":"Ion A Hobai","doi":"10.14309/ajg.0000000000002949","DOIUrl":"10.14309/ajg.0000000000002949","url":null,"abstract":"","PeriodicalId":7608,"journal":{"name":"American Journal of Gastroenterology","volume":" ","pages":"482"},"PeriodicalIF":8.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141905592","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01Epub Date: 2024-08-14DOI: 10.14309/ajg.0000000000002991
Yasutoshi Shiratori, Naoki Ishii, Anthony Kalloo
{"title":"Active vs Passive Screening for Colorectal Cancer: Insights From the National Colonoscopy Study.","authors":"Yasutoshi Shiratori, Naoki Ishii, Anthony Kalloo","doi":"10.14309/ajg.0000000000002991","DOIUrl":"10.14309/ajg.0000000000002991","url":null,"abstract":"","PeriodicalId":7608,"journal":{"name":"American Journal of Gastroenterology","volume":" ","pages":"484"},"PeriodicalIF":8.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141974852","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01Epub Date: 2024-08-20DOI: 10.14309/ajg.0000000000003046
Pierfrancesco Visaggi, Edoardo Savarino, Giulio Del Corso, Naoimh Herlihy, Matteo Ghisa, Jason M Dunn, Emanuele Marciano, Terry Wong, Michael Green, Nicola de Bortoli, Sebastian Zeki
Introduction: Lymphocytic esophagitis (LyE) and eosinophilic esophagitis (EoE) are immune-mediated esophageal diseases. Clinical characteristics, endoscopic findings, and treatment outcomes of LyE were compared with EoE.
Methods: This was an international retrospective study on adults enrolled at 3 centers in Europe. We recorded clinical characteristics and endoscopy findings at baseline and symptoms, histology, and endoscopy outcomes after treatment of patients with LyE and EoE.
Results: Demographics, clinical presentation, comorbidities, and endoscopy findings were largely different in 35 patients with LyE compared with 59 patients with EoE. Proton pump inhibitor response was generally lower in LyE.
Discussion: LyE is clinically different from EoE, but differences in treatment response need further investigation.
{"title":"Clinical Characteristics, Endoscopic Findings, and Treatment Outcomes in Lymphocytic Esophagitis Compared With Eosinophilic Esophagitis.","authors":"Pierfrancesco Visaggi, Edoardo Savarino, Giulio Del Corso, Naoimh Herlihy, Matteo Ghisa, Jason M Dunn, Emanuele Marciano, Terry Wong, Michael Green, Nicola de Bortoli, Sebastian Zeki","doi":"10.14309/ajg.0000000000003046","DOIUrl":"10.14309/ajg.0000000000003046","url":null,"abstract":"<p><strong>Introduction: </strong>Lymphocytic esophagitis (LyE) and eosinophilic esophagitis (EoE) are immune-mediated esophageal diseases. Clinical characteristics, endoscopic findings, and treatment outcomes of LyE were compared with EoE.</p><p><strong>Methods: </strong>This was an international retrospective study on adults enrolled at 3 centers in Europe. We recorded clinical characteristics and endoscopy findings at baseline and symptoms, histology, and endoscopy outcomes after treatment of patients with LyE and EoE.</p><p><strong>Results: </strong>Demographics, clinical presentation, comorbidities, and endoscopy findings were largely different in 35 patients with LyE compared with 59 patients with EoE. Proton pump inhibitor response was generally lower in LyE.</p><p><strong>Discussion: </strong>LyE is clinically different from EoE, but differences in treatment response need further investigation.</p>","PeriodicalId":7608,"journal":{"name":"American Journal of Gastroenterology","volume":" ","pages":"469-472"},"PeriodicalIF":8.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142003401","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01Epub Date: 2024-06-26DOI: 10.14309/ajg.0000000000002914
Stefan D Holubar, Joseph Keller, Laura Cooper
{"title":"When Patients With IBD Require an Ostomy: Evidence-Based Answers to 10 Common Clinical Questions in IBD Surgery.","authors":"Stefan D Holubar, Joseph Keller, Laura Cooper","doi":"10.14309/ajg.0000000000002914","DOIUrl":"https://doi.org/10.14309/ajg.0000000000002914","url":null,"abstract":"","PeriodicalId":7608,"journal":{"name":"American Journal of Gastroenterology","volume":"120 2","pages":"268-271"},"PeriodicalIF":8.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143063125","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Introduction: The prevalence of metabolic dysfunction-associated steatotic liver disease (MASLD) is increasing among the chronic hepatitis B (CHB) population. This study aimed to explore the impact of metabolic dysfunction (MD) on cirrhosis and cirrhotic complication risks in CHB.
Methods: Patients with CHB were consecutively recruited between 2006 and 2021. The presence of MD was based on the 5 cardiometabolic criteria specified in the MASLD definition. Patients were categorized into MD/non-MD groups based on these criteria.
Results: Eleven thousand five hundred two treatment-naive noncirrhotic patients with CHB were included with a median follow-up of 5.3 years. Patients in the MD group (n = 7,314) were older and had lower hepatitis B virus DNA levels than non-MD patients (n = 4,188). After adjustment for clinical and viral factors, MD patients had significantly higher risks of cirrhosis (adjusted hazard ratio [aHR]: 1.82, 95% confidence interval [CI]: 1.40-2.37, P < 0.001) and cirrhotic complications (aHR: 1.30 per MD, 95% CI: 1.03-1.63, P = 0.025) in a dose-dependent manner. Furthermore, new-onset diabetes mellitus during the follow-up aggravated the risk of cirrhotic complications (aHR: 2.87, 95% CI: 1.34-6.11, P = 0.006). Hepatic steatosis was associated with lower risks of cirrhosis (aHR: 0.57 within 5 years, 95% CI: 0.44-0.74, P < 0.001) and cirrhotic complications (aHR: 0.45, 95% CI 0.23-0.88, P = 0.020). Among individuals with hepatic steatosis, patients with MASLD exhibited a higher cirrhosis risk than non-MD patients.
Discussion: Concurrent and new-onset MDs increase the risks of cirrhosis and cirrhotic complications in patients with CHB, independent of hepatic steatosis. Proactively investigating metabolic comorbidities in CHB is critical to stratify the risk of liver disease progression.
{"title":"Pre-Existing and New-Onset Metabolic Dysfunctions Increase Cirrhosis and Its Complication Risks in Chronic Hepatitis B.","authors":"Shang-Chin Huang, Tung-Hung Su, Tai-Chung Tseng, Sih-Han Liao, Shih-Jer Hsu, Chun-Ming Hong, Ting-Yuan Lan, Chen-Hua Liu, Hung-Chih Yang, Chun-Jen Liu, Jia-Horng Kao","doi":"10.14309/ajg.0000000000002915","DOIUrl":"10.14309/ajg.0000000000002915","url":null,"abstract":"<p><strong>Introduction: </strong>The prevalence of metabolic dysfunction-associated steatotic liver disease (MASLD) is increasing among the chronic hepatitis B (CHB) population. This study aimed to explore the impact of metabolic dysfunction (MD) on cirrhosis and cirrhotic complication risks in CHB.</p><p><strong>Methods: </strong>Patients with CHB were consecutively recruited between 2006 and 2021. The presence of MD was based on the 5 cardiometabolic criteria specified in the MASLD definition. Patients were categorized into MD/non-MD groups based on these criteria.</p><p><strong>Results: </strong>Eleven thousand five hundred two treatment-naive noncirrhotic patients with CHB were included with a median follow-up of 5.3 years. Patients in the MD group (n = 7,314) were older and had lower hepatitis B virus DNA levels than non-MD patients (n = 4,188). After adjustment for clinical and viral factors, MD patients had significantly higher risks of cirrhosis (adjusted hazard ratio [aHR]: 1.82, 95% confidence interval [CI]: 1.40-2.37, P < 0.001) and cirrhotic complications (aHR: 1.30 per MD, 95% CI: 1.03-1.63, P = 0.025) in a dose-dependent manner. Furthermore, new-onset diabetes mellitus during the follow-up aggravated the risk of cirrhotic complications (aHR: 2.87, 95% CI: 1.34-6.11, P = 0.006). Hepatic steatosis was associated with lower risks of cirrhosis (aHR: 0.57 within 5 years, 95% CI: 0.44-0.74, P < 0.001) and cirrhotic complications (aHR: 0.45, 95% CI 0.23-0.88, P = 0.020). Among individuals with hepatic steatosis, patients with MASLD exhibited a higher cirrhosis risk than non-MD patients.</p><p><strong>Discussion: </strong>Concurrent and new-onset MDs increase the risks of cirrhosis and cirrhotic complications in patients with CHB, independent of hepatic steatosis. Proactively investigating metabolic comorbidities in CHB is critical to stratify the risk of liver disease progression.</p>","PeriodicalId":7608,"journal":{"name":"American Journal of Gastroenterology","volume":" ","pages":"401-409"},"PeriodicalIF":8.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141449415","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}