{"title":"A comprehensive review of gastrointestinal manifestations in cystic fibrosis in the era of highly effective modulator therapy.","authors":"Pavithra Saikumar, Sophia Izhar, Brett Rossow, Zachary Sellers, Dhiren Patel","doi":"10.14309/ajg.0000000000003571","DOIUrl":"https://doi.org/10.14309/ajg.0000000000003571","url":null,"abstract":"","PeriodicalId":7608,"journal":{"name":"American Journal of Gastroenterology","volume":" ","pages":""},"PeriodicalIF":8.0,"publicationDate":"2025-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144232951","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}
Jonathan A Busam, Nisha Batta, Eric D Shah, LiJin Joo, Caroline Marshall, Ali Rezaie, Mark Pimentel
{"title":"The Safety of Pharmacotherapy for Irritable Bowel Syndrome: A Systematic Review and Meta-Analysis.","authors":"Jonathan A Busam, Nisha Batta, Eric D Shah, LiJin Joo, Caroline Marshall, Ali Rezaie, Mark Pimentel","doi":"10.14309/ajg.0000000000003572","DOIUrl":"https://doi.org/10.14309/ajg.0000000000003572","url":null,"abstract":"<p><strong>Objective: </strong>Understanding the safety of pharmacotherapy for irritable bowel syndrome (IBS) enables individuals to make informed treatment decisions. While many studies include the number needed to treat (NNT) to highlight therapeutic benefits, adding the number needed to harm (NNH), a measure we evaluate herein, could enable more comprehensive risk-benefit assessments.</p><p><strong>Methods: </strong>PubMed, Web of Science, and Cochrane databases were searched through October 2024. Clinical trials investigating IBS pharmacotherapies including discontinuation rates due to adverse events (AEs) were included. Data were pooled using a random-effects model. The primary outcome was NNH for each pharmacotherapy, defined as the reciprocal of the absolute difference in risk of AEs leading to treatment discontinuation between the experimental and placebo groups. Secondary outcomes included the relative risk of withdrawing due to an AE and the most common AEs for each drug.</p><p><strong>Results: </strong>54 trials met inclusion criteria. For IBS-C pharmacotherapies, the NNH for linaclotide, lubiprostone, plecanatide, tegaserod, and tenapanor was 35 (p<0.01), 53 (p=0.59), 59 (p<0.01), 58 (p=0.03), and 16 (p<0.01), respectively. For IBS-D pharmacotherapies, the NNH for alosetron and eluxadoline was 14 (p<0.01) and 32 (p<0.01) while the NNH for both rifaximin and ramosetron was a negative, although statistically insignificant, value. For IBS global symptom pharmacotherapies, the tricyclics, the NNH was 24 (p<0.01). Many AEs were transient without long-term sequela.</p><p><strong>Conclusions: </strong>Among pharmacotherapies for IBS, tricyclics (especially at elevated doses), tenapanor, and alosetron have the highest absolute risk of discontinuation due to an AE when compared to rifaximin, the safest pharmacotherapy studied.</p>","PeriodicalId":7608,"journal":{"name":"American Journal of Gastroenterology","volume":" ","pages":""},"PeriodicalIF":8.0,"publicationDate":"2025-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144232969","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}
{"title":"A case of gallbladder cancer with a rare H-like morphology pancreaticobiliary maljunction.","authors":"Takafumi Tokunaga, Shinya Kohashi, Arata Sakai","doi":"10.14309/ajg.0000000000003569","DOIUrl":"https://doi.org/10.14309/ajg.0000000000003569","url":null,"abstract":"","PeriodicalId":7608,"journal":{"name":"American Journal of Gastroenterology","volume":" ","pages":""},"PeriodicalIF":8.0,"publicationDate":"2025-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144232950","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}
Lucía Guilabert, Karina Cárdenas-Jaén, James L Buxbaum, Ana García García de Paredes, Alicia Vaillo-Rocamora, Jesús Donate-Ortega, Eduardo Tavío Hernández, Edgard E Lozada-Hernández, Diego Hinojosa Ugarte, Alba Lira-Aguilar, Patricia Pedregal Pascual, Rajiv M Mehta, Dhvani D Adhvaryu, Pablo Navarro Cortés, Isabel Pascual Moreno, Claudia Sánchez-Marin, Marina Cobreros-Del-Caz, Idaira Fernández-Cabrera, Fernando Casals-Seoane, Diego Casas-Deza, Eugenia Lauret-Braña, Andrea García-Gómez, Laura M Camacho-Montaño, David Ruíz-Clavijo García, Belén González de la Higuera Carnicer, Federico Bolado, Rodrigo Jover, José J Mira, Enrique de-Madaria
{"title":"Evaluation of the PAN-PROMISE symptom scale in a randomized controlled trial of fluid resuscitation in acute pancreatitis.","authors":"Lucía Guilabert, Karina Cárdenas-Jaén, James L Buxbaum, Ana García García de Paredes, Alicia Vaillo-Rocamora, Jesús Donate-Ortega, Eduardo Tavío Hernández, Edgard E Lozada-Hernández, Diego Hinojosa Ugarte, Alba Lira-Aguilar, Patricia Pedregal Pascual, Rajiv M Mehta, Dhvani D Adhvaryu, Pablo Navarro Cortés, Isabel Pascual Moreno, Claudia Sánchez-Marin, Marina Cobreros-Del-Caz, Idaira Fernández-Cabrera, Fernando Casals-Seoane, Diego Casas-Deza, Eugenia Lauret-Braña, Andrea García-Gómez, Laura M Camacho-Montaño, David Ruíz-Clavijo García, Belén González de la Higuera Carnicer, Federico Bolado, Rodrigo Jover, José J Mira, Enrique de-Madaria","doi":"10.14309/ajg.0000000000003570","DOIUrl":"https://doi.org/10.14309/ajg.0000000000003570","url":null,"abstract":"<p><strong>Background and objectives: </strong>The PAN-PROMISE symptom score is the first patient-reported outcome (PRO) in acute pancreatitis (AP), and it was developed and validated in a prospective cohort of patients to be used as an endpoint in research. The aim of this study was to assess the performance of the score in a large randomized controlled trial (RCT) and its association with well-established AP endpoints.</p><p><strong>Methods: </strong>This is an ancillary study of the WATERFALL trial, where PAN-PROMISE was evaluated at baseline, 24, 48 and 72 hours. The study examined the association between PAN-PROMISE with stablished endpoints in AP: severity, pancreatic and/or peripancreatic fat necrosis (necrosis), infected necrosis, intensive care unit (ICU) admission, persistent organ failure (POF), prolonged hospital stay and mortality. Areas under the ROC curve (AUC) were calculated and used to compare baseline PAN-PROMISE and baseline Bedside Index for Severity in AP (BISAP) for the prediction of these endpoints.</p><p><strong>Results: </strong>248 patients from the WATERFALL trial were included. A statistically significant association was found between PAN-PROMISE and severity, necrosis, POF, ICU admission, and prolonged hospital stay at all checkpoints (p<0.05). Higher scores were also significantly associated with infected pancreatic necrosis at 24, 48, and 72h and death at baseline and 24 hours. PAN-PROMISE baseline score had a slightly higher AUC than BISAP for severity and necrosis, but results were not statistically significant.</p><p><strong>Conclusions: </strong>In the context of a RCT, the PAN-PROMISE score, a patient-centered measure, has been validated with established AP outcomes and as an endpoint for future clinical trials.</p>","PeriodicalId":7608,"journal":{"name":"American Journal of Gastroenterology","volume":" ","pages":""},"PeriodicalIF":8.0,"publicationDate":"2025-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144232964","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}
{"title":"Optimizing the cost-effective evaluation of gastroesophageal reflux by typical symptom phenotypes after failure of empiric acid suppression trial.","authors":"Eric D Shah, C Prakash Gyawali, Walter W Chan","doi":"10.14309/ajg.0000000000003576","DOIUrl":"https://doi.org/10.14309/ajg.0000000000003576","url":null,"abstract":"<p><strong>Introduction: </strong>Concern for gastroesophageal reflux disease (GERD) is the most common reason to consult gastroenterology. We aimed to optimize routine GERD evaluation on cost-effectiveness according to the dominant typical symptom among patients with persistent symptoms failing empiric proton pump inhibitors (PPI).</p><p><strong>Methods: </strong>We developed a decision analytic model evaluating all permutations of GERD diagnostics including empiric trials of PPI optimization or discontinuation, upper endoscopy, wireless pH-monitoring, and pH-impedance monitoring. The model was applied to patients with heartburn, regurgitation, and chest pain in general gastroenterology to identify the appropriate combination and order of testing from insurer and patient perspectives. Health outcomes were informed by systematic reviews of clinical trials. Cost outcomes were informed by Centers for Medicare and Medicaid Services and commercial datasets and national observational studies. The time horizon was one year and willingness-to-pay threshold was $100,000/quality-adjusted-life-year (QALY) gained.</p><p><strong>Results: </strong>For patients with typical persistent GERD symptoms failing empiric PPI, routine up-front ambulatory reflux testing saved $2,500-$4,500 compared to endoscopy alone when no erosive esophagitis is found. The most cost-effective initial ambulatory reflux test was 96-hour wireless pH-monitoring for patients with heartburn and chest pain and 24-hour pH-impedance monitoring for patients with regurgitation, both performed OFF-PPI. Adding ON-PPI pH-impedance monitoring optimized cost-effectiveness for patients with documented evidence of GERD and PPI-refractory symptoms. Patient and insurer perspectives aligned on these optimal diagnostic strategies.</p><p><strong>Discussion: </strong>Compared to a one-size-fits-all strategy, a tailored approach based on Lyon 2.0 optimizes cost-effective evaluation and management of GERD by phenotyping the appropriate diagnostics to dominant symptom.</p>","PeriodicalId":7608,"journal":{"name":"American Journal of Gastroenterology","volume":" ","pages":""},"PeriodicalIF":8.0,"publicationDate":"2025-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144232967","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}
{"title":"Comment on a Risk Stratification Tool for Relapse After Intravenous-to-Subcutaneous Switching of Infliximab in Patients With Inflammatory Bowel Diseases.","authors":"Thomas Aviles, Phillip Minar","doi":"10.14309/ajg.0000000000003521","DOIUrl":"https://doi.org/10.14309/ajg.0000000000003521","url":null,"abstract":"","PeriodicalId":7608,"journal":{"name":"American Journal of Gastroenterology","volume":" ","pages":""},"PeriodicalIF":8.0,"publicationDate":"2025-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144214666","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}
{"title":"Response to Ge and Chen.","authors":"Akira Higashimori, Natsumi Maeda, Yasuhiro Fujiwara","doi":"10.14309/ajg.0000000000003513","DOIUrl":"https://doi.org/10.14309/ajg.0000000000003513","url":null,"abstract":"","PeriodicalId":7608,"journal":{"name":"American Journal of Gastroenterology","volume":" ","pages":""},"PeriodicalIF":8.0,"publicationDate":"2025-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144214667","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}
{"title":"Rethinking Surveillance Timing in MSH6-Associated Lynch Syndrome: Is a Later Start Justified?","authors":"Maartje Nielsen, Sanne Willie Bajwa-Ten Broeke","doi":"10.14309/ajg.0000000000003515","DOIUrl":"https://doi.org/10.14309/ajg.0000000000003515","url":null,"abstract":"","PeriodicalId":7608,"journal":{"name":"American Journal of Gastroenterology","volume":" ","pages":""},"PeriodicalIF":8.0,"publicationDate":"2025-06-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144198061","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}
Marco Vincenzo Lenti, Emanuela Miceli, M Constanza Camargo, Antonio Di Sabatino
{"title":"Letter to the Editor.","authors":"Marco Vincenzo Lenti, Emanuela Miceli, M Constanza Camargo, Antonio Di Sabatino","doi":"10.14309/ajg.0000000000003522","DOIUrl":"https://doi.org/10.14309/ajg.0000000000003522","url":null,"abstract":"","PeriodicalId":7608,"journal":{"name":"American Journal of Gastroenterology","volume":" ","pages":""},"PeriodicalIF":8.0,"publicationDate":"2025-06-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144198060","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}