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Elshafei M. Experience With an Innovative Surgical Treatment Option for Gastroesophageal Reflux Disease: Results of 28 Patients in a Retrospective Analysis. J Laparoendosc Adv Surg Tech A 2025. [PMID: 40152889 DOI: 10.1089/lap.2024.0390] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 03/29/2025] Open
Abstract
Introduction: Standard-of-care gastroesophageal reflux disease (GERD) procedures are associated with adverse events (AEs) (i.e., dysphagia, gas-bloating). RefluxStop has been developed to circumvent these outcomes. This study presents the results of 28 patients managed with RefluxStop in Germany. Methods: Between July 2021 and November 2023, 28 patients with GERD underwent RefluxStop surgery, a novel laparoscopic antireflux procedure. Retrospective chart analysis with patient-informed consent was conducted to determine clinical outcomes, such as GERD Health-Related Quality of Life (GERD-HRQL) score, proton pump inhibitors (PPI) use, symptomatology, patient satisfaction, and perioperative AEs. Results: Baseline characteristics (n = 28): age 47 ± 13.1 years; 67.9% female; body mass index (BMI) 27.3 ± 4.1 kg/m2; 93% PPI use for 5.6 ± 2.7 years; and hiatal hernia in 100% of cases of mean (standard deviation [SD]) size 3.4 (0.8) cm, whereof 35.7% were large hiatal hernia (4-6 cm). At a mean (SD) follow-up of 14.1 (4.7) months, patients experienced 88.6% improvement in median (IQR) total GERD-HRQL score from a baseline of 35 (7.7) to 4 (4.2) at follow-up (P < .05). Preoperative dysphagia (35.7%) resolved completely in all patients (P < .001). The mean (SD) GERD-HRQL heartburn subdomain decreased by 90.6% from a baseline of 18.1 (6.1) to 1.7 (1.2) at follow-up and all patients (100%) had scores <5. Similarly, the mean (SD) regurgitation subdomain decreased from a baseline of 13.2 (4.7) to 2 (1.6) at follow-up and all patients (100%) had scores <5. Patient satisfaction was achieved in 96.4% of patients with no PPI use required in 93% of patients (P < .001); only one patient required PPIs for persistent GERD symptoms. No cases of reoperation or esophageal dilatation were performed. Minor intraoperative AEs occurred in seven patients (i.e., neck emphysema). Conclusion: RefluxStop provides excellent safety and effectiveness outcomes for GERD treatment. Dysphagia completely resolved (0%) with 88.6% improvement in median GERD-HRQL score and satisfaction achieved in 96.4% of patients. These promising results reproduced the outcomes noted in the RefluxStop CE trial in real-world settings.
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Affiliation(s)
- Moustafa Elshafei
- Department of General, Visceral, and Minimally Invasive Surgery, Krankenhaus Nordwest, Frankfurt, Germany
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Harsányi L, Kincses Z, Altorjay Á. Acid Reflux Management with the RefluxStop Implant: A Prospective Multicenter Trial with 3-Year Outcomes. Dig Dis Sci 2025; 70:665-674. [PMID: 39702779 PMCID: PMC11839859 DOI: 10.1007/s10620-024-08788-w] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/02/2024] [Accepted: 12/04/2024] [Indexed: 12/21/2024]
Abstract
BACKGROUND RefluxStop is a unique implant for laparoscopic treatment of gastroesophageal reflux disease (GERD). It restores normal function of the gastroesophageal junction without the unwanted effects of encircling the esophagus, circumventing adverse events (AEs) associated with conventional anti-reflux surgeries. METHODS Three-year follow-up of 50 patients with chronic GERD treated by RefluxStop was achieved in a prospective, single-arm, multicentric clinical trial analyzing safety and effectiveness of the procedure. RESULTS The 3-year results included 47 of 50 patients. No cases of device-related AEs, erosion, device migration, or explantation occurred during the entire study period. Two AEs were reported between the 1- and 3-year results (1-year results previously published), including mild dysphagia (n = 1) and heartburn (n = 1). No subjects (n = 0/47) required regular daily proton pump inhibitor (PPI) therapy at 3-year follow-up. Subjects experienced a 93.1% reduction in median total GERD-HRQL score at 3 years (2.0) from baseline (29.5). One subject (n = 1) was dissatisfied with treatment but demonstrated normal 24-h pH monitoring results. Daily regurgitation improved by 97.9% from a baseline of 86% (n = 43/50) to 2.1% (n = 1/47) at follow-up. Dysphagia GERD-HRQL subscore of > 2 (i.e., bothersome everyday) decreased from 22% at baseline to 2% at 3 years. Baseline odynophagia (16%) completely resolved at 3 years. CONCLUSION RefluxStop surgery treats GERD without encircling and applying pressure on the esophagus. Three-year follow-up demonstrates that the device is safe and effective in treating GERD with substantial improvements in quality of life via GERD-HRQL (median improvement 93%), PPI usage (0%), and 98% without dysphagia.
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Affiliation(s)
- László Harsányi
- Department of Surgery, Transplantation and Gastroenterology, Semmelweis University, Üllői Út 78., Budapest, H-1082, Hungary.
| | - Zsolt Kincses
- General Surgery Department, University of Debrecen Kenézy Gyula Teaching Hospital, Debrecen, Hungary
| | - Áron Altorjay
- Surgical Department, Fejér County Szent György University Teaching Hospital, Székesfehérvár, Hungary
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Lehmann T, Šimkus M, Oehler C. A retrospective study assessing RefluxStop surgery for gastroesophageal reflux disease: Clinical outcomes in 79 patients from Germany. Surg Open Sci 2025; 23:9-15. [PMID: 39816697 PMCID: PMC11733044 DOI: 10.1016/j.sopen.2024.12.003] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/05/2024] [Revised: 11/25/2024] [Accepted: 12/16/2024] [Indexed: 01/18/2025] Open
Abstract
Background This study reports outcomes of the RefluxStop procedure treating gastroesophageal reflux disease (GERD) in clinical practice at a high-volume regional hospital in Germany. Methods A retrospective analysis was conducted on 79 patients with chronic GERD that underwent the RefluxStop procedure, comprising high mediastinal dissection, loose cruroplasty, esophagogastroplication between vagal trunks, and fundus invagination of the RefluxStop implant. The primary outcome was GERD Health-Related Quality-of-Life (GERD-HRQL) score and improvement from baseline. Secondary outcomes included proton pump inhibitor (PPI) use and intra- and postoperative complications, including dysphagia, esophageal dilatation, and reoperation. Results Baseline characteristics (n = 79) included large hiatal hernia >3 cm (32.4 %) and previous antireflux surgery (20.3 %). At mean (SD) follow-up of 11 (4.4) months ranging from 4 to 19 months, the median (IQR) and mean (SD) improvements in GERD-HRQL score were 100 % (90.2-100 %) and 92.4 % (13.9 %) from baseline, respectively. Significant reduction in PPI use was observed from a baseline of 94.9 % to 2.5 % at follow-up. All cases of preoperative dysphagia (7.6 %) completely resolved. New-onset, mild dysphagia occurred in one subject (1.3 %) at final follow-up. One subject (1.3 %) experienced asymptomatic device migration into the stomach, likely due to surgical technique with a much too tight invagination, with subsequent conversion to Toupet fundoplication. Conclusion Analysis of this cohort that underwent RefluxStop surgery indicates excellent safety and effectiveness over this short-term follow-up. Significant improvements in quality of life and PPI use were observed in a population where half had either large hiatal hernia >3 cm or reoperation for previously failed antireflux surgery, a demographic with usually much higher complication rates.
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Affiliation(s)
- Thorsten Lehmann
- Klinikum Friedrichshafen GmbH, Department of Visceral Surgery, Röntgenstraße 2, 88048 Friedrichshafen, Germany
| | - Mantas Šimkus
- Klinikum Friedrichshafen GmbH, Department of Visceral Surgery, Röntgenstraße 2, 88048 Friedrichshafen, Germany
| | - Christoph Oehler
- Klinikum Friedrichshafen GmbH, Department of Visceral Surgery, Röntgenstraße 2, 88048 Friedrichshafen, Germany
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Puig-Moltó M, Lumbreras B, López-Pintor E. Improving Proton-Pump Inhibitor Adherence Intervention Between Primary Care and Community Pharmacies: A Pre-Post Intervention Study. Patient Prefer Adherence 2024; 18:2569-2580. [PMID: 39713795 PMCID: PMC11663369 DOI: 10.2147/ppa.s485307] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/02/2024] [Accepted: 11/11/2024] [Indexed: 12/24/2024] Open
Abstract
Purpose Proton-pump inhibitor (PPI) therapy stands as the primary treatment for upper gastrointestinal symptoms, yet poor adherence often results in treatment failure. Given that patients experiencing these symptoms frequently seek assistance at community pharmacies, the development of collaborative tools with primary care is becoming imperative. The objective was to assess the effectiveness of a pharmaceutical intervention, as demonstrated by a collaborative model between primary care and community pharmacies, in enhancing adherence to PPI among patients experiencing upper gastrointestinal symptoms. Patients and methods A Pre-post intervention study was carried out in Spanish community pharmacies (June-October 2022). During the baseline visit, patients' sociodemographic and clinical variables were evaluated. Patients were categorized as adherent or non-adherent using the Morisky Medication Adherence Scale (MMAS-4). In the follow-up visit (14 days later), the impact of the intervention was measured by changes in the Gastroesophageal Reflux Disease Impact Scale (GIS). Results Of the 351 patients with an active PPI prescription, 178 (50.7%) were non-adherent. Nearly 70% of these patients (122, 68.5%) received an intervention to improve adherence. The overall GIS score improved after the intervention (mean 25.34, SD 5.66 vs mean 27.64, SD 5.63, p < 0.001). All GIS score items showed improvement after the intervention except for the item regarding the taking of additional medication different from that prescribed by the clinician (p = 0.200). Conclusion The pharmaceutical intervention had a positive impact on patients' symptom relief and overall quality of life, highlighting the significance and efficacy of a collaborative model between primary care and professional pharmaceutical services. Clinical Trials Registry Clinical Trial Registration (NCT05162079).
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Affiliation(s)
- María Puig-Moltó
- Department of Public Health, History of Science and Gynecology, Miguel Hernandez University, San Juan de Alicante, Spain
| | - Blanca Lumbreras
- Department of Public Health, History of Science and Gynecology, Miguel Hernandez University, San Juan de Alicante, Spain
- CIBER of Epidemiology and Public Health, CIBERESP, Madrid, Spain
| | - Elsa López-Pintor
- CIBER of Epidemiology and Public Health, CIBERESP, Madrid, Spain
- Department of Engineering, Area of Pharmacy and Pharmaceutical Technology, Miguel Hernandez University, San Juan de Alicante, Spain
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Aydemir E. Immunomodulatory activity of metoclopramide HCl on murine macrophages. NAUNYN-SCHMIEDEBERG'S ARCHIVES OF PHARMACOLOGY 2024:10.1007/s00210-024-03715-2. [PMID: 39673636 DOI: 10.1007/s00210-024-03715-2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 06/30/2024] [Accepted: 12/07/2024] [Indexed: 12/16/2024]
Abstract
Metoclopramide HCl is the active ingredient of the commonly used drugs against nausea, heartburn, and acid reflux. Other than the patients with the acid reflux and stomach problems, it has been widely used in patients going through chemotherapy and radiotherapy, as well as patients suffering from migraine with stomach issues. To our knowledge, the immunomodulatory effect of metoclopramide HCl has never been tested extensively. Since patients who are going through chemotherapy and radiotherapy are prone to developing immunodeficiencies, it is imperative to analyze the activity of this active drug ingredient on the mammalian macrophages. For this purpose, the mammalian macrophages were tested for their potential to produce the pro-inflammatory cytokines, in vitro, in the presence and absence of LPS as the stimulating agent with a range of metoclopramide concentrations. Our results suggest that metoclopramide HCl did not stimulate the macrophages by itself; but in the presence of LPS stimulation, it significantly and substantially decreased the production of the pro-inflammatory TNFα, IL-6, GMCSF, and IL12p40 cytokines. Although this study involved solely in vitro model, the results imply that in the clinical setting metoclopramide HCl might induce inflammatory reaction against potential infections.
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Affiliation(s)
- Esra Aydemir
- Department of Biomedical Engineering, Biruni University, Istanbul, 34010, Turkey.
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Allaway MGR, Luo Y, Lim HK, Bhatia K, Mori K, Craven A, Keong B, Tog CH, Sweeney T, Wong D, Goodwin M, Leung C, Aly A, Hall K, Liu DS. The clinical utility of multidisciplinary team meetings for patients with complex benign upper gastrointestinal conditions. Dis Esophagus 2024; 37:doae074. [PMID: 39300804 DOI: 10.1093/dote/doae074] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/27/2024] [Revised: 08/27/2024] [Accepted: 08/30/2024] [Indexed: 09/22/2024]
Abstract
Patients with benign upper gastrointestinal (UGI) conditions such as achalasia, gastroparesis and refractory gastroesophageal reflux disease often suffer from debilitating symptoms. These conditions can be complex and challenging to diagnose and treat, making them well suited for discussion within a multidisciplinary meeting (MDM). There is, however, a paucity of data describing the value of a benign UGI MDM. The aim of this study was to assess the impact of our unit's benign UGI MDM service and its outcomes. This was a retrospective analysis of prospectively collected data for all consecutive patients reviewed in the monthly benign UGI MDM between July 2021 and February 2024. The primary outcome was the incidence that MDM review changed clinical treatment. Secondary outcomes included change in diagnosis, additional investigations and referrals to subspecialists. A total of 104 patients met inclusion criteria. A total of 73 (70.2%) patients had a change in their overall management following MDM review; 25 (24.0%), 31 (29.8%) and 48 (46.2%) patients had changes in pharmacological, endoscopic and surgical interventions respectively. Most changes in pharmacological and endoscopic intervention involved treatment escalation, whereas most changes in surgical intervention involved treatment de-escalation. A total of 84 (80.8%) patients had a documented diagnosis post-MDM with 44 (42.3%) having a change in their pre-MDM diagnosis. 50 (48.1%) patients had additional investigation/s requested and 49 (47.1%) had additional referral pathway/s recommended. Over two thirds of patients had at least one aspect of their management plan changed following MDM review. These changes occurred across pharmacological, endoscopic, and surgical interventions.
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Affiliation(s)
- Matthew G R Allaway
- Upper Gastrointestinal Surgery Unit, Division of Surgery, Anaesthesia and Procedural Medicine, Austin Health, Heidelberg, Victoria, Australia
- Western Sydney University School of Medicine, Blacktown & Mount Druitt Medical School, Blacktown, New South Wales, Australia
| | - Yuchen Luo
- Upper Gastrointestinal Surgery Unit, Division of Surgery, Anaesthesia and Procedural Medicine, Austin Health, Heidelberg, Victoria, Australia
| | - Hou Kiat Lim
- Upper Gastrointestinal Surgery Unit, Division of Surgery, Anaesthesia and Procedural Medicine, Austin Health, Heidelberg, Victoria, Australia
| | - Kiron Bhatia
- Upper Gastrointestinal Surgery Unit, Division of Surgery, Anaesthesia and Procedural Medicine, Austin Health, Heidelberg, Victoria, Australia
| | - Krinal Mori
- Upper Gastrointestinal Surgery Unit, Division of Surgery, Anaesthesia and Procedural Medicine, Austin Health, Heidelberg, Victoria, Australia
| | - Alex Craven
- Upper Gastrointestinal Surgery Unit, Division of Surgery, Anaesthesia and Procedural Medicine, Austin Health, Heidelberg, Victoria, Australia
| | - Ben Keong
- Upper Gastrointestinal Surgery Unit, Division of Surgery, Anaesthesia and Procedural Medicine, Austin Health, Heidelberg, Victoria, Australia
| | - Chek Heng Tog
- Upper Gastrointestinal Surgery Unit, Division of Surgery, Anaesthesia and Procedural Medicine, Austin Health, Heidelberg, Victoria, Australia
| | - Thomas Sweeney
- Upper Gastrointestinal Surgery Unit, Division of Surgery, Anaesthesia and Procedural Medicine, Austin Health, Heidelberg, Victoria, Australia
| | - Darren Wong
- Department of Gastroenterology, Austin Health, Heidelberg, Victoria, Australia
| | - Michelle Goodwin
- Department of Gastroenterology, Austin Health, Heidelberg, Victoria, Australia
| | - Christopher Leung
- Department of Gastroenterology, Austin Health, Heidelberg, Victoria, Australia
| | - Ahmad Aly
- Upper Gastrointestinal Surgery Unit, Division of Surgery, Anaesthesia and Procedural Medicine, Austin Health, Heidelberg, Victoria, Australia
| | - Katheryn Hall
- General and Gastrointestinal Surgery Research and Trials Unit, Department of Surgery, University of Melbourne Austin Precinct, Heidelberg, Victoria, Australia
| | - David S Liu
- Upper Gastrointestinal Surgery Unit, Division of Surgery, Anaesthesia and Procedural Medicine, Austin Health, Heidelberg, Victoria, Australia
- General and Gastrointestinal Surgery Research and Trials Unit, Department of Surgery, University of Melbourne Austin Precinct, Heidelberg, Victoria, Australia
- Division of Cancer Surgery, Peter MacCallum Cancer Centre, Parkville, Victoria, Australia
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Harper S, Kartha M, Mealing S, Pavanello M, Bonavina L. The Economic Impact of Introducing RefluxStop for Refractory Gastroesophageal Reflux Disease on the Italian Healthcare System. PHARMACOECONOMICS - OPEN 2024; 8:935-943. [PMID: 39190268 PMCID: PMC11499547 DOI: 10.1007/s41669-024-00521-7] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Accepted: 08/12/2024] [Indexed: 08/28/2024]
Abstract
INTRODUCTION Gastroesophageal reflux disease (GERD) is a common ailment associated with troublesome symptoms. The standard of care in Italy involves initial treatment with proton pump inhibitor (PPI)-based medical management or laparoscopic Nissen fundoplication (LNF) for patients unwilling to continue or intolerant of long-term PPI therapy. RefluxStop is a novel medical device, intended for laparoscopic implantation, that has recently proven to be an efficacious and cost-effective treatment option for patients with GERD. This analysis aims to describe the short-term budget impact of introducing RefluxStop as a GERD treatment option within the Italian National Health Service (SSN). METHODS A model adherent to international best practice recommendations was developed to estimate the budget impact of introducing RefluxStop over a 5-year time horizon. Two scenarios were considered: one without RefluxStop (i.e., comprising PPI therapy, LNF, and magnetic sphincter augmentation using the LINX system); and one with RefluxStop (i.e., addition of RefluxStop to the three treatment options previously mentioned). Clinical benefits and costs associated with each intervention were included in the analysis. RESULTS Over 5 years, the introduction of RefluxStop resulted in avoidance of 95 surgical failures, 11 reoperations, and 64 endoscopic esophageal dilations. Introduction of RefluxStop resulted in an almost neutral impact on the existing budget with a 0.316% increase in the annual Italian SSN spending on GERD treatment. CONCLUSION Introduction of RefluxStop as a GERD treatment option in Italy is likely to be associated with substantial clinical benefits and a marginal budget impact.
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Affiliation(s)
- Sam Harper
- York Health Economics Consortium, York, UK
| | | | | | | | - Luigi Bonavina
- Division of General and Foregut Surgery, IRCCS Policlinico San Donato, University of Milan Medical School, Milan, Italy
- University of Milan Medical School, Milan, Italy
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Kim SI, Lee YC, Cha W, Jung AR, Jang JY, Choi JS, Lee DK, Lee HH, Kwon MS, Lee YS, Eun YG. Efficacy and safety of fexuprazan in patients with symptoms and signs of laryngopharyngeal reflux disease: a randomized clinical trial. Eur Arch Otorhinolaryngol 2024; 281:5873-5883. [PMID: 39115573 DOI: 10.1007/s00405-024-08877-6] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/28/2024] [Accepted: 07/26/2024] [Indexed: 10/28/2024]
Abstract
PURPOSE Laryngopharyngeal reflux disease (LPRD) is mainly treated with proton pump inhibitors (PPI) such as esomeprazole, which have shortcomings like delayed absorption and increased osteoporosis. Fexuprazan is a novel potent potassium-competitive acid blocker that inhibits gastric acid secretion with rapid onset and long duration of action. To assess the efficacy and safety of fexuprazan compared to esomeprazole in patients with LPRD. METHODS This prospective, randomized, double-blinded, multicenter, active-controlled trial was conducted in nine otolaryngologic clinics. Patients with reflux symptom index (RSI) ≥ 13 and reflux finding score (RFS) ≥ 7 were randomly assigned to the fexuprazan or esomeprazole groups, and received fexuprazan 40-mg or esomeprazole 40-mg once daily for 8 weeks. The outcomes were (1) mean change, change rate, and valid rate in RSI, RFS, and LPR-related questionnaires; and (2) adverse events. RESULTS A total of 136 patients (fexuprazan n = 68, esomeprazole n = 68) were followed up for ≥ 1 month. Each parameter significantly improved after 4 and 8 weeks in each group, with no significant differences between the two groups. For those with severe symptoms (RSI ≥ 18), the fexuprazan group (n = 32) showed more improvement in the mean change and change rate in the RSI than esomeprazole group (n = 31) after 4 weeks (p = .036 and .045, respectively). This phenomenon was especially observed in hoarseness and troublesome cough. CONCLUSION Fexuprazan improved symptoms and signs without no serious adverse events in patients with LPRD. In patients with severe symptoms, fexuprazan resulted in a faster symptom improvement than PPI. TRIAL REGISTRATION KCT0007251, https://cris.nih.go.kr/cris/search/detailSearch.do?seq=22100 .
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Affiliation(s)
- Su Il Kim
- Department of Otolaryngology-Head and Neck Surgery, Kyung Hee University School of Medicine, Kyung Hee University Hospital at Gangdong, Seoul, Korea
| | - Young Chan Lee
- Department of Otolaryngology-Head and Neck Surgery, Kyung Hee University School of Medicine, Kyung Hee University Hospital at Gangdong, Seoul, Korea
| | - Wonjae Cha
- Department of Otorhinolaryngology-Head & Neck Surgery, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea
| | - Ah Ra Jung
- Department of Otolaryngology-Head and Neck Surgery, Nowon Eulji Medical Center, Eulji University School of Medicine, Seoul, Korea
| | - Jeon Yeob Jang
- Department of Otolaryngology, Ajou University School of Medicine, Suwon, Korea
| | - Jeong-Seok Choi
- Department of Otorhinolaryngology-Head and Neck Surgery, Inha University College of Medicine, Incheon, Korea
| | - Dong Kun Lee
- Department of Otorhinolaryngology, Head and Neck Surgery, Dong-A University College of Medicine, Busan, Korea
| | - Hwan Ho Lee
- Department of Otolaryngology-Head and Neck Surgery, Kosin University College of Medicine, Busan, Korea
| | - Min Su Kwon
- Department of Otolaryngology-Head and Neck Surgery, Asan Medical Center, College of Medicine, University of Ulsan, 88 Olympic-Ro 43-Gil, Songpa-Gu, Seoul, 05505, Korea
| | - Yoon Se Lee
- Department of Otolaryngology-Head and Neck Surgery, Asan Medical Center, College of Medicine, University of Ulsan, 88 Olympic-Ro 43-Gil, Songpa-Gu, Seoul, 05505, Korea.
| | - Young-Gyu Eun
- Department of Otolaryngology-Head and Neck Surgery, Kyung Hee University School of Medicine, Kyung Hee University Medical Center, 23 Kyungheedae-Ro, Dongdaemun-Gu, Seoul, 02447, Korea.
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Harper S, Kartha M, Mealing S, Lundell L. A cost-effectiveness analysis of RefluxStop against relevant therapeutic alternatives for chronic gastroesophageal reflux disease in Sweden. Expert Rev Pharmacoecon Outcomes Res 2024:1-13. [PMID: 39428644 DOI: 10.1080/14737167.2024.2417774] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/27/2024] [Accepted: 09/24/2024] [Indexed: 10/22/2024]
Abstract
INTRODUCTION The standard treatment for gastroesophageal reflux disease (GERD) is proton pump inhibitors (PPIs). In selected cases, Nissen fundoplication is offered as a surgical treatment option, but alternative endoscopic and minimally invasive surgical alternatives are emerging. RefluxStop is a new technology for the treatment of GERD. RESEARCH DESIGN AND METHODS A cost-effectiveness analysis of RefluxStop in comparison to PPI therapy and Nissen fundoplication in the Swedish healthcare setting was conducted using a Markov model and available comprehensive population and clinical trial-based long-term data. Benefits were measured in quality-adjusted life-years (QALYs). Uncertainty was determined by deterministic and probabilistic sensitivity analyses. RESULTS The base case incremental cost-effectiveness ratios (ICERs) for RefluxStop in comparison to PPIs and Nissen fundoplications were SEK 48,152 (€ 4,531) and SEK 62,966 (€ 5,925) per QALY gained, respectively. At a cost-effectiveness threshold of SEK 500,000 per QALY gained, RefluxStop has a high likelihood of being cost-effective, with probabilities of 96% and 100% against Nissen fundoplication and PPIs, respectively. The results of the model remained robust with sensitivity analysis. CONCLUSIONS RefluxStop may offer a highly cost-effective long-term treatment alternative for chronic GERD patients over lifelong PPI therapy, but also in comparison with laparoscopic Nissen fundoplication.
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Affiliation(s)
- Sam Harper
- York Health Economics Consortium, University of York, York, UK
| | | | - Stuart Mealing
- York Health Economics Consortium, University of York, York, UK
| | - Lars Lundell
- Division of Surgery and Oncology, Karolinska Institutet, Stockholm, Sweden
- Department of Surgery, Odense University Hospital, Odense, Denmark
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Labenz J, Schoppmann SF. Improving treatment of people with gastro-esophageal reflux disease refractory to proton pump inhibitors. COMMUNICATIONS MEDICINE 2024; 4:200. [PMID: 39397153 PMCID: PMC11471847 DOI: 10.1038/s43856-024-00632-6] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/22/2023] [Accepted: 10/07/2024] [Indexed: 10/15/2024] Open
Abstract
Proton pump inhibitors (PPIs) are the main treatment recommended and used for gastro-esophageal reflux disease (GERD). However, they fail to control symptoms in a substantial proportion of patients who have PPI-refractory GERD, which is defined as persistent symptoms attributable to objective findings of gastro-esophageal reflux. There remains a lack of dedicated guidelines to direct the management of these patients, some of whom could benefit greatly from surgical treatment. Too often patients remain long-term on ineffective treatment or stop treatment with lack of active review often resulting in their dissatisfaction going unnoticed. Also, concerns over efficacy and side effects of surgical procedures can be off-putting for both patients and physicians. It has been suggested that response to PPIs is predictive of surgical outcome. In this Perspective article we instead recommend that the key determinant should be whether symptoms are caused by GERD. We also discuss the traditional and newer surgical treatment options for people with PPI-refractory GERD.
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Affiliation(s)
- Joachim Labenz
- Refluxzentrum Siegerland, Siegen, Germany.
- Medical Faculty of Duisburg-Essen University, Essen, Germany.
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Ergun P, Samuels TL, Mathison AJ, Plehhova K, Coyle C, Horvath L, Johnston N. Global Transcriptomic Analysis of Topical Sodium Alginate Protection against Peptic Damage in an In Vitro Model of Treatment-Resistant Gastroesophageal Reflux Disease. Int J Mol Sci 2024; 25:10714. [PMID: 39409043 PMCID: PMC11605242 DOI: 10.3390/ijms251910714] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/19/2024] [Revised: 10/01/2024] [Accepted: 10/03/2024] [Indexed: 12/01/2024] Open
Abstract
Breakthrough symptoms are thought to occur in roughly half of all gastroesophageal reflux disease (GERD) patients despite maximal acid suppression (proton pump inhibitor, PPI) therapy. Topical alginates have recently been shown to enhance mucosal defense against acid-pepsin insult during GERD. We aimed to examine potential alginate protection of transcriptomic changes in a cell culture model of PPI-recalcitrant GERD. Immortalized normal-derived human esophageal epithelial cells underwent pretreatment with commercial alginate-based anti-reflux medications (Gaviscon Advance or Gaviscon Double Action), a matched-viscosity placebo control, or pH 7.4 buffer (sham) alone for 1 min, followed by exposure to pH 6.0 + pepsin or buffer alone for 3 min. RNA sequencing was conducted, and Ingenuity Pathway Analysis was performed with a false discovery rate of ≤0.01 and absolute fold-change of ≥1.3. Pepsin-acid exposure disrupted gene expressions associated with epithelial barrier function, chromatin structure, carcinogenesis, and inflammation. Alginate formulations demonstrated protection by mitigating these changes and promoting extracellular matrix repair, downregulating proto-oncogenes, and enhancing tumor suppressor expression. These data suggest molecular mechanisms by which alginates provide topical protection against injury during weakly acidic reflux and support a potential role for alginates in the prevention of GERD-related carcinogenesis.
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Affiliation(s)
- Pelin Ergun
- Department of Otolaryngology and Communication Sciences, Medical College of Wisconsin, Milwaukee, WI 53226, USA; (P.E.); (T.L.S.)
| | - Tina L. Samuels
- Department of Otolaryngology and Communication Sciences, Medical College of Wisconsin, Milwaukee, WI 53226, USA; (P.E.); (T.L.S.)
| | - Angela J. Mathison
- Mellowes Center for Genomic Science and Precision Medicine, Medical College of Wisconsin, Milwaukee, WI 53226, USA;
| | - Kate Plehhova
- Reckitt Benckiser Healthcare UK Ltd., Slough SL1 3UH, UK; (K.P.); (C.C.); (L.H.)
| | - Cathal Coyle
- Reckitt Benckiser Healthcare UK Ltd., Slough SL1 3UH, UK; (K.P.); (C.C.); (L.H.)
| | - Lizzie Horvath
- Reckitt Benckiser Healthcare UK Ltd., Slough SL1 3UH, UK; (K.P.); (C.C.); (L.H.)
| | - Nikki Johnston
- Department of Otolaryngology and Communication Sciences, Medical College of Wisconsin, Milwaukee, WI 53226, USA; (P.E.); (T.L.S.)
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12
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Wei MH, Chen CC, Lee HC, Lee YC, Wang HP, Wu MS, Wu JF, Tseng PH. Prevalence of functional esophageal disorders and associated clinical characteristics in patients with proton-pump-inhibitor-unresponsive reflux symptoms. J Gastroenterol Hepatol 2024; 39:2097-2104. [PMID: 38860301 DOI: 10.1111/jgh.16654] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/08/2024] [Revised: 05/08/2024] [Accepted: 05/29/2024] [Indexed: 06/12/2024]
Abstract
BACKGROUND AND AIM Patients with proton-pump-inhibitor (PPI)-unresponsive reflux symptoms, often caused by functional esophageal disorders (FED), are frequently encountered in clinical practice. We aimed to investigate the prevalence of FED and its associated clinical characteristics in patients with PPI-unresponsive reflux symptoms. METHODS We retrospectively identified patients who were evaluated for persistent typical reflux symptoms, despite ≥8 weeks of PPI treatment, at the National Taiwan University Hospital from 2014 to 2023. All patients underwent a comprehensive evaluation comprising validated gastroesophageal reflux disease (GERD) symptom questionnaires, 5-item Brief Symptom Rating Scale (BSRS-5), Pittsburgh Sleep Quality Index (PSQI), esophagogastroduodenoscopy, high-resolution impedance manometry, and 24-h impedance-pH monitoring off PPI therapy. Diagnosis of FED and non-erosive reflux disease (NERD) was based on the Rome IV criteria. RESULTS We analyzed 190 patients [46.8% male, median age 52 (interquartile range, 42-61) years], of whom 32 (16.8%) had NERD and 158 (83.2%) had FED (57.9% with functional heartburn and 25.3% with reflux hypersensitivity). Patients with FED had a lower body mass index than those with NERD and a higher prevalence of psychological comorbidities and poor sleep quality than healthy volunteers. The severity of reflux symptoms among FED patients was significantly associated with the severity of psychological comorbidities and sleep quality. CONCLUSIONS A notably high prevalence (83.2%) of FED was observed among patients experiencing PPI-unresponsive reflux symptoms. Patients with FED had a higher level of psychological distress and diminished sleep quality, both of which were associated with reflux symptom severity.
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Affiliation(s)
- Ming-Han Wei
- Department of Internal Medicine, National Taiwan University Hospital Hsin-Chu Branch, Zhubei City, Taiwan
| | - Chien-Chuan Chen
- Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan
| | - Hui-Chuan Lee
- Department of Pediatrics, National Taiwan University Children's Hospital, Taipei, Taiwan
| | - Yi-Chia Lee
- Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan
| | - Hsiu-Po Wang
- Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan
| | - Ming-Shiang Wu
- Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan
| | - Jia-Feng Wu
- Department of Pediatrics, National Taiwan University Children's Hospital, Taipei, Taiwan
| | - Ping-Huei Tseng
- Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan
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13
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Li M. Exploring antidepressant-based therapeutic strategy for digestive disorders based on brain-gut axis. WORLD CHINESE JOURNAL OF DIGESTOLOGY 2024; 32:556-560. [DOI: 10.11569/wcjd.v32.i8.556] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 12/29/2024]
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14
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Al-Frejat Z, Martini N, Esper A, Al-Frejat D, Younes S, Hanna M. GERD: Latest update on acid-suppressant drugs. CURRENT RESEARCH IN PHARMACOLOGY AND DRUG DISCOVERY 2024; 7:100198. [PMID: 39282236 PMCID: PMC11393603 DOI: 10.1016/j.crphar.2024.100198] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/18/2024] [Revised: 08/07/2024] [Accepted: 08/19/2024] [Indexed: 09/18/2024] Open
Abstract
GERD is a very familiar diagnosis among health care providers due to its massive spread, and its symptoms can affect the quality of life for a respectable slice of its patients. Therefore, what can only be described as a logical consequence, a pursuit of a treatment that can both relieve symptoms and have minimal side effects is still ongoing to cover the large demographic affected by GERD. In the following review, analysis will be made of GERD, including possible regulatory activity, of certain drugs to the already discussed pathways involved in GERD patients.
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Affiliation(s)
- Zyad Al-Frejat
- Faculty of Medicine, Al Baath University, Homs, Syria
- Faculty of Medicine, Damascus University, Damascus, Syria
| | - Nafiza Martini
- Faculty of Medicine, Damascus University, Damascus, Syria
- Stemosis for Scientific Research, Damascus, Syria
| | - Alia Esper
- Faculty of Medicine, Al Baath University, Homs, Syria
- Stemosis for Scientific Research, Damascus, Syria
| | - Diana Al-Frejat
- Faculty of Medicine, Damascus University, Damascus, Syria
- Faculty of Dentistry, Syrian Private University, Damascus, Syria
| | - Samer Younes
- Faculty of Pharmacy, Tartous University, Tartous, Syria
- Stemosis for Scientific Research, Damascus, Syria
| | - Majd Hanna
- Faculty of Medicine, Damascus University, Damascus, Syria
- Stemosis for Scientific Research, Damascus, Syria
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15
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Leng X, Liao WZ, Zheng FP. Gastroesophageal reflux disease and non-alcoholic fatty liver disease: a two-sample Mendelian randomization combined with meta-analysis. Sci Rep 2024; 14:12633. [PMID: 38824176 PMCID: PMC11144195 DOI: 10.1038/s41598-024-63646-z] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/13/2023] [Accepted: 05/30/2024] [Indexed: 06/03/2024] Open
Abstract
Accumulating evidence from observational studies have suggested an association between gastroesophageal reflux disease (GERD) and non-alcoholic fatty liver disease (NAFLD). However, due to that such studies are prone to biases, we imported Mendelian randomization (MR) to explore whether the causal association between two diseases exsit. Hence, we aimed to analysis the potential association with MR. The single nucleotide polymorphisms (SNPs) of GERD were retrieved from the genome-wide association study dataset as the exposure. The SNPs of NAFLD were taken from the FinnGen dataset as the outcome. The relationship was analyzed with the assistance of inverse variance weighted, MR-Egger, and weighted median. We also uitilized the MR-Egger intercept, Cochran's Q test, leave-one-out analysis, MR-PRESSO, and Steiger directionality test to evaluate the robustness of the causal association. The meta-analysis were also implemented to give an overall evaluation. Finally, our analysis showed a causal relationship between GERD and NAFLD with aid of MR and meta-analysis (OR 1.71 95% CI 1.40-2.09; P < 0.0001).
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Affiliation(s)
- Xuan Leng
- Department of Endocrinology, Zhejiang University School of Medicine Sir Run Run Shaw Hospital, Hangzhou, 310000, Zhejiang Province, China
- Zhejiang University School of Medicine, Hangzhou, 310006, China
| | - Wan-Zhe Liao
- Department of Clinical Medicine, The Nanshan College of Guangzhou Medical University, Guangzhou, 511436, China
| | - Fen-Ping Zheng
- Department of Endocrinology, Zhejiang University School of Medicine Sir Run Run Shaw Hospital, Hangzhou, 310000, Zhejiang Province, China.
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16
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Yuan HX, Dong LJ. Traditional Chinese medicine diagnosis and treatment strategies for gastroesophageal reflux disease. WORLD CHINESE JOURNAL OF DIGESTOLOGY 2024; 32:313-319. [DOI: 10.11569/wcjd.v32.i5.313] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 05/29/2024]
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17
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Battaglia E, Bertolusso L, Del Prete M, Monzani M, Astegiano M. Overlapping approach Proton Pump Inhibitors/Nux vomica-Heel as new intervention for gastro-esophageal reflux management: Delphi consensus study. World J Gastroenterol 2024; 30:2467-2478. [PMID: 38764766 PMCID: PMC11099396 DOI: 10.3748/wjg.v30.i18.2467] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/21/2024] [Revised: 02/28/2024] [Accepted: 04/16/2024] [Indexed: 05/11/2024] Open
Abstract
BACKGROUND Gastro-esophageal reflux disease (GERD) may affect the upper digestive tract; up to 20% of population in Western nations are affected by GERD. Antacids, histamine H2-receptor antagonists, and Proton Pump Inhibitors (PPIs) are considered the referring medications for GERD. Nevertheless, PPIs must be managed carefully because their use, especially chronic, could be linked with some adverse effects. An effective and safe alternative pharmacological tool for GERD is needed. After the identification of potentially new medications to flank PPIs, it is mandatory to revise and improve good clinical practices even through a consensus process. AIM To optimize diagnosis and treatment guidelines for GERD through a consensus based on Delphi method. METHODS The availability of clinical studies describing the action of the multicomponent/multitarget medication Nux vomica-Heel, subject of the consensus, is the basic prerequisite for the consensus itself. A modified Delphi process was used to reach a consensus among a panel of Italian GERD specialists on the overlapping approach PPIs/Nux vomica-Heel as a new intervention model for the management of GERD. The Voting Consensus group was composed of 49 Italian Medical Doctors with different specializations: Gastroenterology, otolaryngology, geriatrics, and general medicine. A scientific committee analyzed the literature, determined areas that required investigation (in agreement with the multiple-choice questionnaire results), and identified two topics of interest: (1) GERD disease; and (2) GERD treatment. Statements for each of these topics were then formulated and validated. The Delphi process involved two rounds of questioning submitted to the panel experts using an online platform. RESULTS According to their routinary GERD practice and current clinical evidence, the panel members provided feedback to each questionnaire statement. The experts evaluated 15 statements and reached consensus on all 15. The statements regarding the GERD disease showed high levels of agreement, with consensus ranging from 70% to 92%. The statements regarding the GERD treatment also showed very high levels of agreement, with consensus ranging from 90% to 100%. This Delphi process was able to reach consensus among physicians in relevant aspects of GERD management, such as the adoption of a new approach to treat patients with GERD based on the overlapping between PPIs and Nux vomica-Heel. The consensus was unanimous among the physicians with different specializations, underlying the uniqueness of the agreement reached to identify in the overlapping approach between PPIs and Nux vomica-Heel a new intervention model for GERD management. The results support that an effective approach to deprescribe PPIs through a progressive decalage timetable (reducing PPIs administration to as-needed use), should be considered. CONCLUSION Nux vomica-Heel appears to be a valid opportunity for GERD treatment to favor the deprescription of PPIs and to maintain low disease activity together with the symptomatology remission.
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Affiliation(s)
- Edda Battaglia
- Gastroenterology Unit, ASLTO4, Ivrea 10015, Turin, Italy
| | | | - Marco Del Prete
- Specialist in Nephrology International Academy of Physiological Regulating Medicine, Milan 20100, Italy
| | - Marco Monzani
- Specialist in Endocrinology, Territorial Social and Health Authority of Brianza, Monza 20900, Italy
| | - Marco Astegiano
- Gastroenterology Specialist, Retired from Gastroenterology and Hepatology Unit, AOU Città della Salute e della Scienza, Turin 10123, Italy
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Zullo A, Annibale B, Dinis-Ribeiro M, Fanchellucci G, Esposito G, Hassan C. Gastric juice analysis in clinical practice: why, how, and when. The experience with EndoFaster. Eur J Gastroenterol Hepatol 2024; 36:264-270. [PMID: 38179876 DOI: 10.1097/meg.0000000000002704] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/06/2024]
Abstract
Gastric juice analysis may be useful for clinical purposes, including the detection of H. pylori infection and diffuse atrophic gastritis on gastric mucosa. EndoFaster is a novel device which performs real-time analysis of gastric juice revealing the infection and hypochlorhydria by measuring ammonium concentrations and pH levels. This review aimed to evaluate the clinical applications of such a tool. By considering data from overall 11 studies, the values of sensitivity, specificity, positive predictive value, negative predictive value, accuracy, positive likelihood ratio, and negative likelihood ratio were 90%, 86%, 67%, 96%, 87%, 8.5, and 0.13, respectively, for H. pylori diagnosis, and 83%, 92%, 58%, 97%, 91%, 9.9 and 0.2, respectively, for suspecting diffuse atrophic gastritis. The very high value of negative predictive values for both H. pylori and mucosal atrophy would allow avoiding to perform useless negative gastric biopsies when the results of the test are negative. Some promising data suggest that gastric juice analysis may be useful also to diagnose H. pylori infection in patients with chronic active gastritis without evidence of bacteria at histology, as well as in predicting persistent acid reflux in patients on proton pump inhibitor therapy for reflux disease.
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Affiliation(s)
- Angelo Zullo
- Gastroenterology Unit, 'Nuovo Regina Margherita' Hospital
| | - Bruno Annibale
- Department of Medical-Surgical Sciences and Translational Medicine, Sant'Andrea Hospital, University Sapienza, Rome, Italy
| | - Mario Dinis-Ribeiro
- Gastroenterology Department, Portuguese Oncology Institute of Porto, and Porto Comprehensive Cancer Center (Porto.CCC) & RISE@CI-IPOP (Health Research Network), Porto, Portugal
| | - Gianluca Fanchellucci
- Department of Biomedical Sciences, Humanitas University, Pieve Emanuele
- Endoscopy Unit, Humanitas Clinical and Research Center-IRCCS, Rozzano, Italy
| | - Gianluca Esposito
- Department of Medical-Surgical Sciences and Translational Medicine, Sant'Andrea Hospital, University Sapienza, Rome, Italy
| | - Cesare Hassan
- Department of Biomedical Sciences, Humanitas University, Pieve Emanuele
- Endoscopy Unit, Humanitas Clinical and Research Center-IRCCS, Rozzano, Italy
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19
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Provenza D, Gillette C, Peacock B, Rejeski J. Managing heartburn and reflux in primary care. JAAPA 2024; 37:24-29. [PMID: 38349081 DOI: 10.1097/01.jaa.0001005620.54669.f4] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/24/2024]
Abstract
ABSTRACT This article describes an algorithmic approach to caring for patients presenting with heartburn and reflux, including empiric treatment with acid-suppression therapy and a data-driven approach to diagnostic testing. This article also reviews the efficacy and safety profile of the widely available and commonly used proton pump inhibitors. Refining our approach to diagnostic testing can reduce time to diagnosis, better control patients' symptoms, and limit complications of longstanding disease.
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Affiliation(s)
- Delaney Provenza
- At Wake Forest University School of Medicine in Winston-Salem, N.C., Delaney Provenza is an assistant professor, Christopher Gillette is an associate professor and director of research and scholarship, Brian Peacock is an assistant professor and PA program director, and Jared Rejeski is an assistant professor of gastroenterology. The authors have disclosed no potential conflicts of interest, financial or otherwise
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20
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Lakananurak N, Pitisuttithum P, Susantitaphong P, Patcharatrakul T, Gonlachanvit S. The Efficacy of Dietary Interventions in Patients with Gastroesophageal Reflux Disease: A Systematic Review and Meta-Analysis of Intervention Studies. Nutrients 2024; 16:464. [PMID: 38337748 PMCID: PMC10857327 DOI: 10.3390/nu16030464] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/13/2023] [Revised: 02/01/2024] [Accepted: 02/02/2024] [Indexed: 02/12/2024] Open
Abstract
BACKGROUND International guidelines recommend dietary interventions as one of the most important treatments for patients with gastroesophageal reflux disease (GERD). Evidence to confirm the efficacy of these treatment modalities is lacking. The present study aims to evaluate the efficacy of dietary interventions on GERD-related outcomes evaluated in intervention studies on GERD patients. METHODS A systematic review and meta-analysis was performed according to PRISMA. The PubMed/MEDLINE, Web of Sciences, and Scopus databases were utilized for the literature search. Two independent researchers searched for relevant publications published up until June 2023. Intervention studies evaluating the efficacy of dietary interventions in patients with GERD were included. RESULTS A total of 577 articles were identified during the initial literature search. After reviewing, 21 studies with 16 different types of dietary interventions were included in the analysis. The interventions were divided into low-carbohydrate diets (3 studies), high-fat diets (2 studies), speed of eating studies (3 studies), low-FODMAP diets (2 studies), and other interventions (12 studies). A meta-analysis could be performed for low-carbohydrate diets and speed of eating interventions. Low-carbohydrate diets resulted in a significant reduction in esophageal acid exposure time (mean difference = -2.834%, 95% confidence interval (CI): -4.554 to -1.114), while a slow speed of eating did not lead to a lower percentage of reflux events compared to fast eating (risk ratio = 1.044, 95% CI: 0.543-2.004). Most other interventions showed positive effects in only a single study. CONCLUSION Low-carbohydrate diets showed a significant improvement in GERD-related outcomes, while a slow eating speed did not result in a reduction in reflux events. The overall evidence regarding dietary interventions in GERD remains scarce. High-quality, long-term RCTs are still required to confirm the effects of dietary interventions in GERD patients.
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Affiliation(s)
- Narisorn Lakananurak
- Division of Clinical Nutrition, Department of Medicine, Faculty of Medicine, King Chulalongkorn Memorial Hospital, Chulalongkorn University, The Thai Red Cross Society, Bangkok 10330, Thailand;
| | - Panyavee Pitisuttithum
- Division of General Internal Medicine, Department of Medicine, Faculty of Medicine, King Chulalongkorn Memorial Hospital, Chulalongkorn University, The Thai Red Cross Society, Bangkok 10330, Thailand
- Center of Excellence in Neurogastroenterology and Motility, Faculty of Medicine, Chulalongkorn University, Bangkok 10330, Thailand; (T.P.); (S.G.)
| | - Paweena Susantitaphong
- Division of Nephrology, Department of Medicine, Faculty of Medicine, King Chulalongkorn Memorial Hospital, Chulalongkorn University, The Thai Red Cross Society, Bangkok 10330, Thailand;
- Center of Excellence for Metabolic Bone Disease in CKD Patients, Faculty of Medicine, Chulalongkorn University, Bangkok 10330, Thailand
| | - Tanisa Patcharatrakul
- Center of Excellence in Neurogastroenterology and Motility, Faculty of Medicine, Chulalongkorn University, Bangkok 10330, Thailand; (T.P.); (S.G.)
- Division of Gastroenterology, Department of Medicine, Faculty of Medicine, King Chulalongkorn Memorial Hospital, Chulalongkorn University, The Thai Red Cross Society, Bangkok 10330, Thailand
| | - Sutep Gonlachanvit
- Center of Excellence in Neurogastroenterology and Motility, Faculty of Medicine, Chulalongkorn University, Bangkok 10330, Thailand; (T.P.); (S.G.)
- Division of Gastroenterology, Department of Medicine, Faculty of Medicine, King Chulalongkorn Memorial Hospital, Chulalongkorn University, The Thai Red Cross Society, Bangkok 10330, Thailand
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Joel A, Konjengbam A, Viswanath Y, Kourounis G, Hammond E, Frank H, Kuttuva S, Mbarushimana S, Hidayat H, Thulasiraman S. Endoscopic radiofrequency Stretta therapy reduces proton pump inhibitor dependency and the need for anti-reflux surgery for refractory gastroesophageal reflux disease. Clin Endosc 2024; 57:58-64. [PMID: 37157958 PMCID: PMC10834287 DOI: 10.5946/ce.2023.026] [Citation(s) in RCA: 2] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/14/2023] [Revised: 02/06/2023] [Accepted: 02/08/2023] [Indexed: 05/10/2023] Open
Abstract
BACKGROUND/AIMS Radiofrequency treatment of the gastroesophageal junction using the Stretta procedure for treating gastroesophageal reflux disease (GERD) is observed to improve the symptoms and proton pump inhibitor (PPI) dependence and reduce the need for anti-reflux operations. As one of the largest studies in Europe, we evaluated the clinical outcomes of Stretta in patients with medically refractory GERD. METHODS A tertiary UK center evaluated all patients with refractory GERD who underwent Stretta between 2014 and 2022. Patients and primary care professionals were contacted to obtain information regarding the initiation of PPI and reintervention after Stretta. RESULTS Of the 195 patients (median age, 55 years; 116 women [59.5%]) who underwent Stretta, PPI-free period (PFP) data were available for 144 (73.8%) patients. Overall, 66 patients (45.8%) did not receive PPI after a median follow-up of 55 months. Six patients (3.1%) underwent further interventions. The median PFP after Stretta was 41 months. There was a significant negative correlation between PFP and age (p=0.007), with no differences between sexes (p=0.96). Patients younger than 55 years of age had a longer PFP than their older counterparts (p=0.005). Younger males had a significantly longer PFP than older males (p=0.021). However, this was not observed in the female cohort (p=0.09) or between the younger men and women (p=0.66). CONCLUSION Our findings suggest that Stretta is a safe and feasible option for treating refractory GERD, especially in younger patients. It prevents further anti-reflux interventions in most patients and increases the lead-time to surgery in patients with refractory GERD.
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Affiliation(s)
- Abraham Joel
- Department of General and Upper Gastrointestinal Surgery, James Cook University Hospital, Cleveland, UK
| | - Alakh Konjengbam
- Department of General and Upper Gastrointestinal Surgery, James Cook University Hospital, Cleveland, UK
| | - Yirupaiahgari Viswanath
- Department of General and Upper Gastrointestinal Surgery, James Cook University Hospital, Cleveland, UK
| | - Georgios Kourounis
- Department of General and Upper Gastrointestinal Surgery, James Cook University Hospital, Cleveland, UK
| | - Emily Hammond
- Department of General and Upper Gastrointestinal Surgery, James Cook University Hospital, Cleveland, UK
| | - Helen Frank
- Department of General and Upper Gastrointestinal Surgery, James Cook University Hospital, Cleveland, UK
| | - Shivani Kuttuva
- Department of General and Upper Gastrointestinal Surgery, James Cook University Hospital, Cleveland, UK
| | - Simon Mbarushimana
- Department of General and Upper Gastrointestinal Surgery, James Cook University Hospital, Cleveland, UK
| | - Hena Hidayat
- Department of General and Upper Gastrointestinal Surgery, James Cook University Hospital, Cleveland, UK
| | - Srivishnu Thulasiraman
- Department of General and Upper Gastrointestinal Surgery, James Cook University Hospital, Cleveland, UK
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Upadhyay R, Soni NK, Kotamkar AA, Naseem A, Phadke A, Nayar S, Pallewar S, Shetty P, Mungantiwar A, Jaiswal S, Qamra A. High Dose Pantoprazole for Gastroesophageal Reflux Disease: Need, Evidence, Guidelines and Our Experience. Euroasian J Hepatogastroenterol 2024; 14:86-91. [PMID: 39022196 PMCID: PMC11249892 DOI: 10.5005/jp-journals-10018-1426] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/22/2024] [Accepted: 03/11/2024] [Indexed: 07/20/2024] Open
Abstract
Gastroesophageal reflux disease (GERD) has a pooled prevalence of 15.2% in India with varying presentation in different subset of patients. The approach towards the management of GERD includes use of monotherapy or a combination of OTCs like antacids and/or prescription drugs like H2 receptor antagonists and proton pump inhibitors (PPI). Better efficacy and safety profile of PPIs have contributed to its wide spread use as compared with other drugs for the same indication. Among PPIs, most of the healthcare professionals prefer to prescribe pantoprazole in India. Standard dose of Pantoprazole (40 mg) is unable to meet the needs in case of extraesophageal symptoms, partial responders, patients with concomitant use of non-steroidal anti-inflammatory drugs (NSAIDs), or severe presentation in cases of overweight/obese patients. Multiple guidelines recommend doubling the dose of PPI in such cases. Twice daily dosing of PPI may reduce compliance. Thus, there is a need for a higher dose of Pantoprazole (80 mg) to be prescribed once daily in these cases so that improved compliance leads to better outcomes. The use of dual release Pantoprazole 80 mg may help to improve compliance and also enhance the time for which acid suppression takes place. In this review, we discuss the use of higher dose PPI based on scientific evidence and experience of clinicians for the same. How to cite this article Upadhyay R, Soni NK, Kotamkar AA, et al. High Dose Pantoprazole for Gastroesophageal Reflux Disease: Need, Evidence, Guidelines and Our Experience. Euroasian J Hepato-Gastroenterol 2024;14(1):86-91.
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Affiliation(s)
- Rajesh Upadhyay
- Department of Gastroenterology, Max Super Speciality Hospital, Shalimar Bagh, New Delhi, India
| | - Navin K Soni
- Department of Internal Medicine, Yatharth Super Specialty Hospital, Greater Noida, India
| | - Ashwin A Kotamkar
- Department of Medical Affairs, Macleods Pharmaceuticals Ltd., Mumbai, Maharashtra, India
| | - Azra Naseem
- Department of Pharmacology, D.Y. Patil University – School of Medicine, Navi Mumbai, India
| | - Aaditi Phadke
- Department of Medical Affairs, Macleods Pharmaceuticals Ltd., Mumbai, Maharashtra, India
| | - Shreshth Nayar
- MS Ramaiah Medical College and Hospital, MSR Nagar, Mathikere, Bengaluru, India
| | - Shailesh Pallewar
- Department of Medical Affairs, Macleods Pharmaceuticals Ltd., Mumbai, Maharashtra, India
| | - Parvan Shetty
- Department of Medical Affairs, Macleods Pharmaceuticals Ltd., Mumbai, Maharashtra, India
| | - Ashish Mungantiwar
- Department of R&D and Clinical Trials, Macleods Pharmaceuticals Ltd., Mumbai, Maharashtra, India
| | - Sunil Jaiswal
- Department of Formulation and Development, Macleods Pharmaceuticals Ltd., Mumbai, Maharashtra, India
| | - Amit Qamra
- Department of Medical Affairs, Macleods Pharmaceuticals Ltd., Mumbai, Maharashtra, India
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Wang TN, Underhill J, Tamer R, Perry KA, Haisley KR. Endoscopic impedance planimetry versus high-resolution manometry (HRM) for pre-operative motility evaluation in anti-reflux surgery. Surg Endosc 2024; 38:377-383. [PMID: 37803186 DOI: 10.1007/s00464-023-10418-x] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/02/2023] [Accepted: 08/29/2023] [Indexed: 10/08/2023]
Abstract
INTRODUCTION Pre-operative evaluation of patients with gastroesophageal reflux disease (GERD) includes assessment of esophageal motility. High-resolution manometry (HRM) is the gold standard; endoscopic impedance planimetry (IP) with Endoflip 2.0 is increasingly utilized in esophageal disorders of motility. We hypothesized that normal IP motility would correlate with normal HRM motility and tested this in a prospective cohort study. METHODS Patients presenting for surgical evaluation of GERD between 9/2020 and 10/2021 were prospectively enrolled under an IRB-approved protocol. Patients with prior esophageal/gastric surgery, known motility disorders, or large paraesophageal hernias were excluded. All underwent HRM and IP, with normal motility defined by Chicago 3.0 classification for HRM and the presence of repetitive antegrade contractions for IP. Logistic regression and t test were used to analyze the data; p value < 0.05 was considered significant. RESULTS Of 63 patients enrolled, 48 completed both IP and HRM testing. The cohort was 50% male with a median age of 52.5 [42.0, 66.0] years, mostly ASA class 1-2 (75.1%, n = 36) and had an average BMI of 31.4 ± 6.3 kg/m2. Normal motility tracings were in 62.5% of IP and 75% of HRM tests. Using HRM as the gold standard, IP detected normal motility with a sensitivity of 65.8% and a specificity of 50% (positive predictive value 83.3%, negative predictive value 27.8%). Normal IP was not statistically significant in predicting normal HRM (OR 3.182, 95% CI 0.826-12.262, p = 0.0926). Tolerability of IP was significantly better than HRM with lower rates of discomfort (10.9% vs. 93.4%, p < 0.0001) and higher willingness to repeat testing (100% vs. 47.8%, p < 0.0001). CONCLUSION Esophageal motility testing with Endoflip 2.0 is well tolerated by patients. The low specificity (50%), poor negative predictive value (27.8%), and lack of statistically significant concordance between IP and HRM raises concern for the reliability of this test as a stand-alone replacement for HRM in the pre-operative evaluation for GERD.
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Affiliation(s)
- Theresa N Wang
- Department of Surgery, Center for Minimally Invasive Surgery, The Ohio State University, Columbus, OH, USA.
| | - Jennifer Underhill
- Department of Surgery, Center for Minimally Invasive Surgery, The Ohio State University, Columbus, OH, USA
| | - Robert Tamer
- Department of Surgery, Center for Surgical Health Assessment, Research and Policy, The Ohio State University, Columbus, OH, USA
| | - Kyle A Perry
- Department of Surgery, Center for Minimally Invasive Surgery, The Ohio State University, Columbus, OH, USA
| | - Kelly R Haisley
- Department of Surgery, Center for Minimally Invasive Surgery, The Ohio State University, Columbus, OH, USA
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Harper S, Kartha M, Mealing S, Borbély YM, Zehetner J. Cost-effectiveness of the RefluxStop device for management of refractory gastroesophageal reflux disease in Switzerland. J Med Econ 2024; 27:805-815. [PMID: 38820006 DOI: 10.1080/13696998.2024.2362564] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/03/2024] [Accepted: 05/29/2024] [Indexed: 06/02/2024]
Abstract
BACKGROUND One of the most prevalent conditions in Western societies is gastroesophageal reflux disease (GERD). In Switzerland, the standard treatment for GERD is proton pump inhibitor (PPI)-based medical management, but surgical options such as Nissen fundoplication and magnetic sphincter augmentation (MSA) are available. RefluxStop is a novel device that offers an alternative solution. The purpose of this report is to evaluate the cost-effectiveness of RefluxStop compared to PPIs and existing surgical treatments. METHODS A model (Markov) was developed using the Swiss healthcare payer perspective with a lifetime horizon, 1-month cycle length, and a 3% annual discount rate for costs and benefits. Adverse events specific to treatment arms were incorporated, and benefits were measured in quality-adjusted life-years (QALYs). Clinical efficacy data for RefluxStop was obtained from its CE mark study, and comparator treatments were based on published literature. Deterministic and probabilistic sensitivity analyses were used to explore uncertainty. Since there are no head-to-head studies between RefluxStop and PPI therapy, Nissen fundoplication, or MSA, a limitation of this study is the use of naïve, indirect comparison of clinical effectiveness between the studied treatment options. RESULTS Higher QALYs and lower costs were provided by RefluxStop compared to Nissen fundoplication and the MSA system. The incremental cost-effectiveness ratio (ICER) for RefluxStop was CHF 2,116 in comparison to PPI-based medical management. At a cost-effectiveness threshold of CHF 100,000 per QALY gained, the probability of RefluxStop being cost-effective was high, with probabilities of 100%, 97%, and 100% against PPI-based medical management, Nissen fundoplication, and MSA, respectively. The robustness of the analysis was provided by deterministic and probabilistic sensitivity analyses. CONCLUSION This cost-effectiveness analysis demonstrates that there is a high likelihood of RefluxStop being a cost-effective treatment modality in adults with GERD when compared with other treatment options available in Switzerland.
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Affiliation(s)
- Sam Harper
- York Health Economics Consortium, York, UK
| | | | | | - Yves M Borbély
- Department of Visceral Surgery and Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
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25
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Alshammari SA, Almutairi MN, Alomar MO, Alsherif ZM, Alsubaie FH, Almezaini AI. Overlap Between Gastroesophageal Reflux Disease and Irritable Bowel Syndrome and Its Impact on Quality of Life. Cureus 2023; 15:e50840. [PMID: 38249262 PMCID: PMC10798282 DOI: 10.7759/cureus.50840] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 12/20/2023] [Indexed: 01/23/2024] Open
Abstract
Background Gastroesophageal reflux disease (GERD) and irritable bowel syndrome (IBS) are common gastrointestinal disorders that can negatively affect quality of life and healthcare costs. The co-occurrence of these conditions can lead to more complex symptomatology and therapeutic challenges. Therefore, understanding the extent of overlap between GERD and IBS is paramount. This study aims to estimate the overlap between GERD and IBS in Saudi Arabia and its impact on quality of life. Methods Patients with GERD at primary care clinics at King Khalid University Hospital in Riyadh, Saudi Arabia, were the subjects of cross-sectional research. The patients were selected using a simple random sampling technique, and an electronic questionnaire was utilized to collect data. Symptoms of IBS were assessed based on Rome IV criteria, and quality of life was evaluated using the GERD quality of life tool. Results Of the 293 GERD patients, the prevalence of co-occurrence of IBS among GERD patients was 35.8%. The GERD health-related quality of life (GERD- HRQL) scores ranged from 0 to 50, with a median and interquartile range (IQR) of 14 (8.5-20). Those with GERD and IBS had a significantly higher GERD-HRQL score than the patients with GERD alone (11 vs. 9, p-value: 0.049). Furthermore, patients with GERD and IBS had a significantly higher GERD-HRQL score than the patients with IBS alone (15 vs. 11, p-value: 0.001). Of the total participants, 29.4% reported having abdominal pain in the last three months. The majority of the participants (55.6%) reported experiencing abdominal pain one to two times per week, while 22.2% reported experiencing it two to three days per month. Conclusion The high prevalence of IBS co-existence among GERD patients highlights the importance of considering both diseases in clinical practice to improve patient outcomes. The study also found that patients with both GERD and IBS had a significantly lower quality of life than those with GERD or IBS alone.
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Affiliation(s)
- Sulaiman A Alshammari
- Family and Community Medicine, King Saud University College of Medicine, Riyadh, SAU
| | - Mohsen N Almutairi
- Family and Community Medicine, King Saud University College of Medicine, Riyadh, SAU
| | - Mohammad O Alomar
- Family and Community Medicine, King Saud University College of Medicine, Riyadh, SAU
| | - Ziyad M Alsherif
- Family and Community Medicine, King Saud University College of Medicine, Riyadh, SAU
| | - Faisal H Alsubaie
- Family and Community Medicine, King Saud University College of Medicine, Riyadh, SAU
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26
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Alshareefy Y, Alshareefy A. Oesophageal pH capsule retention: case report and proposed endoscopic management. Int J Surg Case Rep 2023; 111:108917. [PMID: 37797524 PMCID: PMC10558307 DOI: 10.1016/j.ijscr.2023.108917] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/28/2023] [Revised: 09/28/2023] [Accepted: 09/30/2023] [Indexed: 10/07/2023] Open
Abstract
INTRODUCTION AND IMPORTANCE Gastro-oesophageal reflux disease (GORD) is a common chronic condition affecting up to 20 %. Proton pump inhibitor (PPI) is considered 1st line therapy however 10-40 % of patients do not respond adequately subsequently requiring further investigations. One of these investigations includes oesophageal pH testing via a wireless capsule placed into the oesophagus, which may remain there for up to 96 h before being self-displaced. Our report describes a rare case of oesophageal pH capsule retention and proposes a pragmatic approach to its management including endoscopic removal. CASE PRESENTATION A 33 year-old male attended our out-patient clinic with ongoing reflux symptoms and intermittent dysphagia. His response to first line therapy including lifestyle modifications and with PPIs was unsatisfactory thus a plan for an oesophageal Ph capsule study was agreed and performed. On day 4 post-procedure he reported severe dysphagia to solid foods. A Chest X-ray was performed which confirmed the presence of the capsule 7 days post-procedure. On day 12 post-procedure, gastroscopy and retrieval of the capsule was performed successfully. CLINICAL DISCUSSION We recommend gastroenterologists use submucosal elevation in combination with manual traction in order to detach the capsule from the underlying mucosa, followed by retrieval using forceps to grab the thread-end of the capsule. CONCLUSION We hope our report raises awareness for this rare complication as well as providing education to practicing gastroenterologists on a formal manoeuvre for successful endoscopic management of a retained oesophageal pH capsule.
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Affiliation(s)
- Yasir Alshareefy
- School of Medicine, Trinity College Dublin, The University of Dublin, Ireland.
| | - Ali Alshareefy
- Department of Gastroenterology, Medcare Hospital, Dubai, United Arab Emirates
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27
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Haseeb M, Thompson CC. Endoscopic therapy for gastroesophageal reflux disease: where are we, where are we going? Curr Opin Gastroenterol 2023; 39:381-389. [PMID: 37523156 PMCID: PMC10629818 DOI: 10.1097/mog.0000000000000968] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 08/01/2023]
Abstract
PURPOSE OF REVIEW Gastroesophageal reflux disease (GERD) is the most common chronic condition with increasing prevalence in the Western world. Despite medical therapy, a considerable proportion of patients continue to experience symptoms, thus fueling the demand for minimally invasive GERD treatment options. This review will assess the currently available endoscopic approaches by analyzing their outcomes data, indication for use and limitations. RECENT FINDINGS With increasing evidence of the safety and efficacy of endoscopic therapies, recent guidelines and consensus society documents have updated their recommendations for the endoscopic treatment of GERD. In this review, we have comprehensively assessed the current landscape of endoscopic approaches for the treatment of GERD and provided insight into future directions. SUMMARY Endoscopic therapies for GERD show promise as new treatments emerge and existing therapies evolve into safer and more reproducible options. They are well positioned to cater to a large subset of the population suffering from chronic condition of GERD.
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Affiliation(s)
- Muhammad Haseeb
- Division of Gastroenterology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA
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28
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Herdiana Y. Chitosan Nanoparticles for Gastroesophageal Reflux Disease Treatment. Polymers (Basel) 2023; 15:3485. [PMID: 37631542 PMCID: PMC10460071 DOI: 10.3390/polym15163485] [Citation(s) in RCA: 7] [Impact Index Per Article: 3.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/18/2023] [Revised: 08/14/2023] [Accepted: 08/18/2023] [Indexed: 08/27/2023] Open
Abstract
Gastroesophageal Reflux Disease (GERD) is a chronic ailment that results from the backward flow of stomach acid into the esophagus, causing heartburn and acid regurgitation. This review explores nanotechnology as a novel treatment approach for GERD. Chitosan nanoparticles (CSNPs) offer several advantages, including biocompatibility, biodegradability, and targeted drug delivery capabilities. CSNPs have been extensively studied due to their ability to encapsulate and release medications in a controlled manner. Different nanoparticle (NP) delivery systems, including gels, microspheres, and coatings, have been developed to enhance drug retention, drug targeting, and controlled release in the esophagus. These nanoparticles can target specific molecular pathways associated with acid regulation, esophageal tissue protection, and inflammation modulation. However, the optimization of nanoparticle formulations faces challenges, including ensuring stability, scalability, and regulatory compliance. The future may see CSNPs combined with other treatments like proton pump inhibitors (PPIs) or mucosal protectants for a synergistic therapeutic approach. Thus, CSNPs provide exciting opportunities for novel GERD treatment strategies.
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Affiliation(s)
- Yedi Herdiana
- Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, Universitas Padjadjaran, Sumedang 45363, Indonesia
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29
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Herdiana Y. Functional Food in Relation to Gastroesophageal Reflux Disease (GERD). Nutrients 2023; 15:3583. [PMID: 37630773 PMCID: PMC10458865 DOI: 10.3390/nu15163583] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/23/2023] [Revised: 08/01/2023] [Accepted: 08/04/2023] [Indexed: 08/27/2023] Open
Abstract
Gastroesophageal reflux disease (GERD) is a common esophageal disorder characterized by troublesome symptoms associated with increased esophageal acid exposure. The cornerstones of therapy in this regard include treatment with acid-suppressive agents, lifestyle modifications, and dietary therapy, although the latter has not been well defined. As concerns regarding long-term proton pump inhibitor (PPI) use continue to be explored, patients and healthcare providers are becoming increasingly interested in the role of diet in disease management. However, dietary interventions lack evidence of the synthesis effect of functional foods. The following is a review of dietary therapy for GERD, emphasizing food components' impact on GERD pathophysiology and management. Although the sequential dietary elimination of food groups is a common practice, the literature supports broader intervention, including reduced overall sugar intake, increased dietary fiber, and changes in overall eating practices. While the primary concern of food companies is to provide safe products, the caloric, nutritional, and functional composition of foods is also generating interest in the food industry due to consumers' concerns.
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Affiliation(s)
- Yedi Herdiana
- Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, Universitas Padjadjaran, Sumedang 45363, Indonesia
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30
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Sultan W, Naik S, Kondapally K, Johnston L. A Rare Case of Chylothorax Following a Redo Laparoscopic Nissen Fundoplication. Cureus 2023; 15:e41419. [PMID: 37546033 PMCID: PMC10403242 DOI: 10.7759/cureus.41419] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 07/03/2023] [Indexed: 08/08/2023] Open
Abstract
Gastroesophageal reflux disease (GERD) is a highly prevalent disease. Mechanical etiology, including hiatal hernia, can be resistant to empiric proton pump inhibitor (PPI) trials; Nissen fundoplication is commonly used to treat mechanical GERD. Chylothorax is a rare complication of abdominal surgeries, including anti-reflux procedures. In this case report, a 75-year-old female presented with shortness of breath following a redo laparoscopic Nissen fundoplication. Chest CT pulmonary angiography (CTPA) showed bilateral large pleural effusions that were managed by fluid restriction, repeated thoracocentesis, and chest tube insertion; the pleural fluid analysis was significant for fluid triglycerides high at 232 mg/dL which was diagnostic for chylothorax. The patient was treated conservatively. Appropriate management of chylothorax is crucial to avoid subsequent respiratory failure, immunodeficiency, and malnutrition. Chylomicrons and triglycerides in the pleural fluid can be diagnostic for chylothorax. Treatment of chylothorax includes three main approaches: controlling the cause, conservative treatment, and surgical interventions.
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Affiliation(s)
- Waleed Sultan
- Family Medicine, Conemaugh Memorial Medical Center, Johnstown, USA
| | - Sarvesh Naik
- Family Medicine, Conemaugh Memorial Medical Center, Johnstown, USA
| | | | - Lynn Johnston
- Family Medicine, Conemaugh Memorial Medical Center, Johnstown, USA
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31
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Hu Z, Wu J, Wang Z, Bai X, Lan Y, Lai K, Kelimu A, Ji F, Ji Z, Huang D, Hu Z, Hou X, Hao J, Fan Z, Chen X, Chen D, Chen S, Li J, Li J, Li L, Li P, Li Z, Lin L, Liu B, Liu DG, Lu Y, Lü B, Lü Q, Qiu M, Qiu Z, Shen H, Tai J, Tang Y, Tian W, Wang Z, Wang B, Wang JA, Wang J, Wang Q, Wang S, Wang W, Wang Z, Wei W, Wu Z, Wu W, Wu Y, Wu Y, Wu J, Xiao Y, Xu W, Xu X, Yang F, Yang H, Yang Y, Yao Q, Yu C, Zhang P, Zhang X, Zhou T, Zou D. Chinese consensus on multidisciplinary diagnosis and treatment of gastroesophageal reflux disease 2022. GASTROENTEROLOGY & ENDOSCOPY 2023; 1:33-86. [DOI: 10.1016/j.gande.2023.01.001] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 01/05/2025]
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Ugliono E, Rebecchi F, Mantova S, Osella G, Mansour AMFMH, Morino M. Laparoscopic antireflux surgery for refractory gastroesophageal reflux disease: long-term clinical outcomes. Updates Surg 2023:10.1007/s13304-023-01483-x. [PMID: 36862352 DOI: 10.1007/s13304-023-01483-x] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/17/2022] [Accepted: 02/23/2023] [Indexed: 03/03/2023]
Abstract
Persistent symptoms despite adequate Proton Pump Inhibitors (PPI) treatment are described in up to 40% of patients with Gastroesophageal Reflux Disease (GERD). The efficacy of Laparoscopic Antireflux Surgery (LARS) in PPI non-responder patients is still unclear. This observational study aims to report the long-term clinical outcomes and predictors of dissatisfaction in a cohort of refractory GERD patients submitted to LARS. Patients with preoperative refractory symptoms and objective GERD evidence submitted to LARS between 2008 and 2016 were included in the study. Primary endpoint was overall satisfaction with the procedure, secondary endpoints were long-term GERD symptom relief and endoscopic findings. Univariate and multivariate analyses were performed to compare satisfied and dissatisfied patients, in order to identify preoperative predictors of dissatisfaction. A total of 73 refractory GERD patients who underwent LARS were included in the study. At a mean follow-up of 91.2 ± 30.5 months, the satisfaction rate was 86.3%, with a statistically significant reduction in typical and atypical GERD symptoms. Causes of dissatisfaction were severe heartburn (6.8%), gas bloat syndrome (2.8%), and persistent dysphagia (4.1%). Multivariate analysis showed that a number of Total Distal Reflux Episodes (TDRE) > 75 was a predictive factor of long-term dissatisfaction after LARS while a partial response to PPI was a protective factor against dissatisfaction. LARS guarantees a high level of long-term satisfaction for selected refractory GERD patients. An abnormal TDRE at 24 h-multichannel intraluminal impedance-pH monitoring and the lack of response to preoperative PPI were predictors of long-term dissatisfaction.
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Affiliation(s)
- Elettra Ugliono
- Department of Surgical Sciences, University of Turin, Corso A.M. Dogliotti 14, 10126, Turin, Italy. .,Department of Mechanical and Aerospacial Engineering, Politecnico of Turin, Corso Duca Degli Abruzzi 24, 10129, Turin, Italy.
| | - Fabrizio Rebecchi
- Department of Surgical Sciences, University of Turin, Corso A.M. Dogliotti 14, 10126, Turin, Italy
| | - Serena Mantova
- Department of Surgical Sciences, University of Turin, Corso A.M. Dogliotti 14, 10126, Turin, Italy
| | - Giulia Osella
- Department of Surgical Sciences, University of Turin, Corso A.M. Dogliotti 14, 10126, Turin, Italy
| | - Ahmed Mohammed Farid Mahmoud Hamdy Mansour
- Department of Surgical Sciences, University of Turin, Corso A.M. Dogliotti 14, 10126, Turin, Italy.,Department of Mechanical and Aerospacial Engineering, Politecnico of Turin, Corso Duca Degli Abruzzi 24, 10129, Turin, Italy
| | - Mario Morino
- Department of Surgical Sciences, University of Turin, Corso A.M. Dogliotti 14, 10126, Turin, Italy
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Kendrick K, Kothari SN. Updates on Surgical Treatment for Gastroesophageal Reflux Disease. Am Surg 2023:31348231157414. [PMID: 36789472 DOI: 10.1177/00031348231157414] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/16/2023]
Abstract
Gastroesophageal reflux disease (GERD) is a common condition that is on the rise. Obesity is one risk factor that has increased in parallel with the rise of GERD. Typical symptoms include heartburn, regurgitation, dysphagia, cough, and chest pain. Patients with typical symptoms are empirically treated with proton pump inhibitors (PPIs). If the diagnosis is not clear, further evaluation is performed with endoscopy, pH monitoring, and esophageal manometry. Untreated GERD increases the risk of esophagitis, esophageal stricture, Barrett's esophagus, and esophageal adenocarcinoma. Treatment begins with lifestyle modification and medical therapy. If these fail, surgical and endoscopic surgical techniques are available, to provide treatment, symptom relief, and reduce long-term PPI use.
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Affiliation(s)
- Katherine Kendrick
- Department of Gastroenterology and Hepatology, 3626Prisma Health Upstate-Greenville Memorial Hospital, Greenville, SC, USA
| | - Shanu N Kothari
- University of South Carolina School of Medicine Greenville, 3626Prisma Health Upstate, Greenville, SC, USA
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34
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Frazzoni L, Fuccio L, Zagari RM. Management of gastro-esophageal reflux disease: Practice-oriented answers to clinical questions. World J Gastroenterol 2023; 29:773-779. [PMID: 36816619 PMCID: PMC9932426 DOI: 10.3748/wjg.v29.i5.773] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/14/2022] [Revised: 12/01/2022] [Accepted: 01/09/2023] [Indexed: 02/06/2023] Open
Abstract
Gastro-esophageal reflux disease (GERD) is a condition which is frequently faced by primary care physicians and gastroenterologists. Improving management of GERD is crucial to maximise both patient care and resource utilization. In fact, the management of patients with GERD is complex and poses several questions to the clinician who faces them in clinical practice. For instance, many aspects should be considered, including the appropriateness of indication to endoscopy, the quality of the endoscopic examination, the use and interpretation of ambulatory reflux testing, and the choice and management of anti-reflux treatments, i.e., proton-pump inhibitors and surgery. Aim of the present review was to provide a comprehensive update on the clinical management of patients with GERD, through a literature review on the diagnosis and management of patients with GER symptoms. In details, we provide practice-oriented concise answers to clinical questions, with the aim of optimising patient management and healthcare resource use.
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Affiliation(s)
- Leonardo Frazzoni
- Department of Digestive Diseases, IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico S Orsola, Bologna 40138, Italy
| | - Lorenzo Fuccio
- Department of Digestive Diseases, IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico S Orsola, Bologna 40138, Italy
- Department of Medical and Surgical Sciences, University of Bologna, Bologna 40138, Italy
| | - Rocco Maurizio Zagari
- Department of Digestive Diseases, IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico S Orsola, Bologna 40138, Italy
- Department of Medical and Surgical Sciences, University of Bologna, Bologna 40138, Italy
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Rettura F, Lambiase C, Grosso A, Rossi A, Tedeschi R, Ceccarelli L, Bellini M. Role of Low-FODMAP diet in functional dyspepsia: "Why", "When", and "to Whom". Best Pract Res Clin Gastroenterol 2023; 62-63:101831. [PMID: 37094910 DOI: 10.1016/j.bpg.2023.101831] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/26/2023] [Accepted: 03/30/2023] [Indexed: 04/26/2023]
Abstract
Functional dyspepsia (FD) is a frequent disorder of gut-brain interaction, affecting 5-7% of people globally, with significant impairment in quality of life. The management of FD is challenging due to the lack of specific therapeutic approaches. Although food seems to play a role in symptom production, its pathophysiologic role in patients with FD is not fully understood. Most FD patients report that their symptoms are triggered by food, especially in the post-prandial distress syndrome (PDS) group, although evidence to support the use of dietary interventions are limited. FODMAPs can increase production of gas in the intestinal lumen, through fermentation by intestinal bacteria, can exert osmotic effects by increasing water volume and can cause an excessive production of short-chain fatty acids (propionate, butyrate, and acetate). Emerging scientific evidence, confirmed by recent clinical trials, suggest that FODMAPs could be involved in the pathogenesis of FD. Given the consolidated approach of the Low-FODMAP Diet (LFD) in irritable bowel syndrome (IBS) management and emerging scientific evidence regarding the LFD in FD, a therapeutic role of this diet may be hypothesized also in FD, either alone or in combination with other therapies.
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Affiliation(s)
- Francesco Rettura
- Gastrointestinal Unit, Department of Translational Sciences and New Technologies in Medicine and Surgery, University of Pisa, 56010, Pisa, Italy
| | - Christian Lambiase
- Gastrointestinal Unit, Department of Translational Sciences and New Technologies in Medicine and Surgery, University of Pisa, 56010, Pisa, Italy.
| | - Antonio Grosso
- Gastrointestinal Unit, Department of Translational Sciences and New Technologies in Medicine and Surgery, University of Pisa, 56010, Pisa, Italy
| | - Alessandra Rossi
- Clinical and Experimental Medicine-Rheumatology Unit, University of Pisa, 56100, Pisa, Italy
| | - Riccardo Tedeschi
- Gastrointestinal Unit, Department of Translational Sciences and New Technologies in Medicine and Surgery, University of Pisa, 56010, Pisa, Italy
| | - Linda Ceccarelli
- Gastrointestinal Unit, Department of Translational Sciences and New Technologies in Medicine and Surgery, University of Pisa, 56010, Pisa, Italy
| | - Massimo Bellini
- Gastrointestinal Unit, Department of Translational Sciences and New Technologies in Medicine and Surgery, University of Pisa, 56010, Pisa, Italy
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Arabpour E, Khoshdel S, Akhgarzad A, Abdi M, Tabatabaie N, Alijanzadeh D, Abdehagh M. Baclofen as a therapeutic option for gastroesophageal reflux disease: A systematic review of clinical trials. Front Med (Lausanne) 2023; 10:997440. [PMID: 36873860 PMCID: PMC9981648 DOI: 10.3389/fmed.2023.997440] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/18/2022] [Accepted: 02/03/2023] [Indexed: 02/19/2023] Open
Abstract
Background The main components of gastroesophageal reflux disease (GERD) management include a combination of medications and lifestyle modifications; Nevertheless, based on the severity of symptoms and their response to medications, other treatments could be considered. Baclofen has been demonstrated in studies to relieve GERD symptoms. The current study aimed to precisely address the effects of baclofen on the treatment of GERD and its characteristics. Methods A systematic search was carried out in Pubmed/Medline, Cochrane CENTRAL, Scopus, Google Scholar, Web of Science, and clinicaltrials.gov up to December 10, 2021. The search terms included baclofen, GABA agonists, GERD, and reflux. Results We selected 26 papers that matched the inclusion criteria after examining 727 records. Studies were classified into four categories based on the study population and reported outcomes: (1) adults, (2) children, (3) patients with gastroesophageal reflux-induced chronic cough, (4) hiatal hernia patients. The results revealed that baclofen can significantly improve reflux symptoms and pH-monitoring and manometry findings to different degrees in all four mentioned categories; although its effect on pH-monitoring parameters seems less significant than the other parameters. Mild neurological and mental status deterioration were the most reported side effects. However, side effects occurred in a portion of less than 5% of short-term users and nearly 20% of long-term users. Conclusion In PPI-resistant patients, a trial of adding baclofen to the PPI may be helpful. Baclofen therapies may be more beneficial for symptomatic GERD patients who also report concurrent conditions including alcohol use disorder, non-acid reflux, or obesity. Systematic review registration https://clinicaltrials.gov/.
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Affiliation(s)
- Erfan Arabpour
- Department of Gastroenterology and Hepatology, Imam Hossein Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran
| | - Sina Khoshdel
- Department of Internal Medicine, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran
| | - Ali Akhgarzad
- Department of Internal Medicine, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran
| | - Mohammadamin Abdi
- School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran
| | - Negin Tabatabaie
- Department of Internal Medicine, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran
| | - Dorsa Alijanzadeh
- School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran
| | - Mohammad Abdehagh
- Department of Gastroenterology and Hepatology, Imam Hossein Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran
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Lata T, Trautman J, Townend P, Wilson RB. Current management of gastro-oesophageal reflux disease-treatment costs, safety profile, and effectiveness: a narrative review. Gastroenterol Rep (Oxf) 2023; 11:goad008. [PMID: 37082451 PMCID: PMC10112961 DOI: 10.1093/gastro/goad008] [Citation(s) in RCA: 4] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/16/2022] [Revised: 12/09/2022] [Accepted: 02/01/2023] [Indexed: 04/22/2023] Open
Abstract
Background The purpose of this study was to review the current management of gastro-oesophageal reflux disease (GORD), including treatment costs, safety profile and effectiveness. Methods A literature review was performed of randomized-controlled trials, systematic reviews, Cochrane reports and National/Societal guidelines of the medical, endoscopic and surgical management of GORD. Proton pump inhibitor (PPI) prescribing patterns and expenditure were reviewed in different countries, including Australia, Canada, New Zealand, UK and USA. Results Proton pump inhibitors (PPIs) are primarily indicated for control of GORD, Helicobacter pylori eradication (combined with antibiotics), preventing NSAID-induced gastrointestinal bleeding and treating peptic ulcer disease. There is widespread overprescribing of PPIs in Western and Eastern nations in terms of indication and duration, with substantial expense for national health providers. Despite a favourable short-term safety profile, there are observational associations of adverse effects with long-term PPIs. These include nutrient malabsorption, enteric infections and cardiovascular events. The prevalence of PPI use makes their long-term safety profile clinically relevant. Cost-benefit, symptom control and quality-of-life outcomes favour laparoscopic fundoplication rather than chronic PPI treatment. Laparoscopic fundoplication in long-term management of PPI-responsive GORD is supported by SAGES, NICE and ACG, and PPI-refractory GORD by AGA and SAGES guidelines. The importance of establishing a definitive diagnosis prior to invasive management is emphasized, especially in PPI-refractory heartburn. Conclusions We examined evidence-based guidelines for PPI prescribing and deprescribing in primary care and hospital settings and the need for PPI stewardship and education of health professionals. This narrative review presents the advantages and disadvantages of surgical, endoscopic and medical management of GORD, which may assist in shared decision making and treatment choice in individual patients.This paper was presented (GS020) at the 88th RACS Annual Scientific Conference, 6-10 May, 2019.
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Affiliation(s)
- Tahmina Lata
- Corresponding author. Faculty of Medicine and Health, University of Sydney, City Road, Camperdown, NSW 2006, Australia. Tel: +0061-2-93512222.
| | - Jodie Trautman
- General Surgery Department, Wollongong Hospital, Wollongong, NSW, Australia
| | - Philip Townend
- General Surgery Department, Gold Coast University Hospital, Southport, QLD, Australia
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Study on the Effect of Different Endoscopic Auxiliary Treatment of Gastric Mucosal Microtumor. EVIDENCE-BASED COMPLEMENTARY AND ALTERNATIVE MEDICINE 2022; 2022:2557952. [PMID: 36267085 PMCID: PMC9578834 DOI: 10.1155/2022/2557952] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Subscribe] [Scholar Register] [Received: 07/08/2022] [Revised: 08/04/2022] [Accepted: 08/10/2022] [Indexed: 11/17/2022]
Abstract
Objective To explore the effect of endoscopy in the treatment of gastric mucosal microtumors. Methods A total of 229 patients with gastric mucosal microtumors were treated in our hospital from January 2016 to December 2021. All patients were divided into three groups group A, group B, and group C. Group A was treated with a transparent cap combined with circle-assisted endoscopic resection, group B with ligator combined with circle-assisted endoscopic resection, and group C with endoscopic mucosal tumor resection. The effects of the three groups were observed. Results There were 47 patients in group A, 17 males, and 30 females, aged 36-69 years, with an average age of 55.6 ± 9.2 years. There were 54 patients in group B, 18 males, and 36 females, aged 38-72 years, with an average age of 57.6 ± 7.7 years. There were 128 patients in group C, 29 males, and 99 females, aged 33-78 years, with an average age of 55.6 ± 8.4 years. There is no significant difference in age and sex between group A, group B, and group C (P > 0.05). The incidence of postoperative complications in group B (66.7%) was significantly higher than that in group A (57.4%) and group C (53.9%) (all P < 0.05). The incidence of postoperative complications in group A (57.4%) was higher than that in group C (53.9%), and the difference was statistically significant (P < 0.05). Conclusion Endoscopic mucosal resection and ligation combined with circle-assisted endoscopic resection are effective and safe in the treatment of gastric mucosal microtumors, but it needs to be combined with targeted nursing measures. The transparent cap combined with ring-assisted endoscopic resection has a significant effect on the treatment of gastric mucosal micromasses, reducing operative complications.
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Maev IV, Andreev DN, Kucheryavyy YA, Lobanova EG, Shefer DI. Efficacy of an esophageal mucosal protectant in the treatment of patients with gastroesophageal reflux disease: a systematic review. MEDITSINSKIY SOVET = MEDICAL COUNCIL 2022:20-26. [DOI: 10.21518/2079-701x-2022-16-15-20-26] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 07/28/2024]
Abstract
Gastroesophageal reflux disease (GERD) is one of the most widespread gastrointestinal pathologies and the most common reason for seeking medical care at the level of a primary link of public health services in many countries around the world. The classic clinical presentations of GERD are heartburn, belching, and regurgitation (spitting up), but the overall spectrum of GERD symptoms is broader and more heterogeneous in scope, including extraesophageal symptoms. Clinical and/or endoscopic refractoriness of some patients to the standard proton pump inhibitors (PPIs) therapy remains a global challenge in the management of patients with GERD at the current stage of clinical medicine development. A medicinal product of a fundamentally new class was developed to optimize the treatment of patients with GERD – an esophageal mucosal protectant, which consists of a fixed combination of hyaluronic acid and chondroitin sulfate dissolved in a bioadhesive carrier (polymerase 407). This review is primarily aimed at systematizing data on the efficacy of the esophageal mucosal protectant in the treatment of patients with GERD. The systematic review that summarized the results of 10 studies involving 1090 patients with GERD showed that adding this esophageal mucosal protectant to the PPI therapy increased the efficacy of GERD therapy, as well as improved the frequency of symptomatic, endoscopic and morphological response to the treatment. Such combination therapy contributes to the optimization of the treatment of patients with various disease phenotypes, regress of both esophageal and extraesophageal symptoms, and potentiation of repair of the esophageal mucosa. To increase the efficacy of treatment and improve the prognosis of the disease, this approach should be implemented at the early stages of therapy in real clinical practice.
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Affiliation(s)
- I. V. Maev
- Yevdokimov Moscow State University of Medicine and Dentistry
| | - D. N. Andreev
- Yevdokimov Moscow State University of Medicine and Dentistry
| | | | - E. G. Lobanova
- Yevdokimov Moscow State University of Medicine and Dentistry
| | - D. I. Shefer
- Yevdokimov Moscow State University of Medicine and Dentistry
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Morozov S, Sentsova T. Local inflammatory response to gastroesophageal reflux: Association of gene expression of inflammatory cytokines with esophageal multichannel intraluminal impedance-pH data. World J Clin Cases 2022; 10:9254-9263. [PMID: 36159432 PMCID: PMC9477692 DOI: 10.12998/wjcc.v10.i26.9254] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/16/2022] [Revised: 04/21/2022] [Accepted: 08/16/2022] [Indexed: 02/05/2023] Open
Abstract
BACKGROUND Gene expression of inflammatory cytokines may take part in the pathophysiology of different forms of gastroesophageal reflux disease (GERD).
AIM To explore gene expression of inflammatory cytokines in esophageal mucosa in patients with erosive esophagitis (EE) and non-erosive forms of GERD (NERD) and its association with data of esophageal multichannel intraluminal impedance-pH (MII-pH) measurements.
METHODS This was a single-center prospective study. Esophageal mucosa samples were taken from the lower part of the esophagus during endoscopy. Expression of interleukin (IL)-1β, IL-10, IL-18, tumor necrosis factor α (TNFA), toll-like receptor 4 (TLR4), GATA binding protein 3 (GATA3), differentiation cluster 68 (CD68) and β-2 microglobulin genes in esophageal mucosa was assessed with ImmunoQuantex assays. MII-pH measurements were performed on all the participants. Diagnosis of GERD was confirmed by the results of the MII-pH data. Based on the endoscopy, patients were allocated to the groups of EE and NERD. The control group consisted of non-symptomatic subjects with normal endoscopy and MII-pH results. We used nonparametric statistics to compare the differences between the groups. Association of expression of the mentioned genes with the results of the MII-pH data was assessed with Spearman’s rank method.
RESULTS Data from 60 patients with GERD and 10 subjects of the control group were available for the analysis. Higher expression of IL-18 (5.89 ± 0.4 vs 5.28 ± 1.1, P = 0.04) and GATA3 (2.92 ± 0.86 vs 2.23 ± 0.96, P = 0.03) was found in the EE group compared to NERD. Expression of IL-1β, IL-18, TNFA, and TLR4 was lower (P < 0.05) in the control group compared to EE and NERD. Esophageal acid exposure correlated with the expression of IL-1β (Spearman’s rank r = 0.29), IL-18 (r = 0.31), TNFA (r = 0.35), GATA3 (r = 0.34), TLR4 (r = 0.29), and CD68 (r = 0.37). Mean esophageal рН correlated inversely with the expression of IL-18, TNFA, GATA3, TLR4, and CD68. No association of gene expression with the number of gastroesophageal refluxes was found.
CONCLUSION In patients with EE, local expression of IL-18 and GATA3 was higher compared to subjects with NERD. Esophageal acid exposure correlated directly with expression of IL-1β, IL-18, TNFA, TLR4, CD68, and β-2 microglobulin genes. Inverse correlation was revealed between expression of IL-18, TNFA, GATA3, TLR4, and CD68 and mean esophageal pH.
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Affiliation(s)
- Sergey Morozov
- Department of Gastroenterology, Hepatology and Nutrition, Federal Research Center of Nutrition, Biotechnology and Food Safety, Moscow 115446, Russia
| | - Tatyana Sentsova
- Department of Hospital Pediatrics No. 2, Russian National Research Medical University named after N.I. Pirogov, Moscow 117997, Russia
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Zhou W, Chen X, Fan Q, Yu H, Jiang W. Using proton pump inhibitors increases the risk of hepato-biliary-pancreatic cancer. A systematic review and meta-analysis. Front Pharmacol 2022; 13:979215. [PMID: 36188583 PMCID: PMC9515471 DOI: 10.3389/fphar.2022.979215] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/01/2022] [Accepted: 08/15/2022] [Indexed: 11/13/2022] Open
Abstract
Background: More and more studies are focusing on the adverse effects and damage caused by PPI abuse, we carried out a systematic review and meta-analysis for assessing whether the proton pump inhibitor (PPI) leads to hepato-biliary-pancreatic cancer. Methods: PubMed, EMBASE and Web of Science were searched until 1 July 2022, 25 studies (17 case-control and 8 cohort studies; 2741853 individuals) included in this study. Pooled Odd Ratios (ORs) were used for random effect models. Sensitivity analysis and dose-response analysis, subgroup analysis were all conducted. Results: The aggregate OR of the meta-analysis was 1.69 (95% confidence interval (CI): 1.42–2.01, p = 0.01) and heterogeneity (I2 = 98.9%, p < 0.001) was substantial. According to stratified subgroup analyses, the incidence of hepato-biliary-pancreatic cancer was associated, expect for study design, study quality and region. Risk of hepato-biliary-pancreatic cancer is highest when people is treated with normal doses of PPI. The risks decrease and become insignificant when the cumulative defined daily dose (cDDD) increases. Conclusion: The use of PPI may be associated with an increased risk of hepato-biliary-pancreatic cancer. Hence, caution is needed when using PPIs among patients with a high risk of hepato-biliary-pancreatic cancer.
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Affiliation(s)
- Wence Zhou
- First Clinical Medical College, Lanzhou University, Lanzhou, Gansu, China
- Department of General Surgery, Second Hospital of Lanzhou University, Lanzhou, Gansu, China
- *Correspondence: Wence Zhou,
| | - Xinlong Chen
- First Clinical Medical College, Lanzhou University, Lanzhou, Gansu, China
- Department of General Surgery, First Hospital of Lanzhou University, Lanzhou, Gansu, China
| | - Qigang Fan
- First Clinical Medical College, Lanzhou University, Lanzhou, Gansu, China
| | - Haichuan Yu
- First Clinical Medical College, Lanzhou University, Lanzhou, Gansu, China
| | - Wenkai Jiang
- First Clinical Medical College, Lanzhou University, Lanzhou, Gansu, China
- Department of General Surgery, First Hospital of Lanzhou University, Lanzhou, Gansu, China
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Qi M, Zhou Y, Zhou YX, Fang SQ. Progress in research of pathogenesis of refractory gastroesophageal reflux disease. Shijie Huaren Xiaohua Zazhi 2022; 30:769-774. [DOI: 10.11569/wcjd.v30.i17.769] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/07/2023] Open
Abstract
Refractory gastroesophageal reflux disease (rGERD) is a common clinical disease with many pathogenic factors, complex mechanisms, and increasing incidence. At present, scholars believe that the pathogenesis of rGERD is closely related to intra- and extra-esophageal factors. Elucidating the mechanism of rGERD can contribute to the diagnosis and treatment of the disease. This paper summarizes the current progress in the research of the pathogenesis of rGERD, and puts forward our own thoughts and prospects for the disease, in order to provide ideas for the in-depth study of the pathogenesis of rGERD.
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Affiliation(s)
- Mei Qi
- Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200080, China
| | - Yue Zhou
- Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200080, China
| | - Yu-Xuan Zhou
- Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200080, China
| | - Sheng-Quan Fang
- Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200080, China
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Leowattana W, Leowattana T. Potassium-competitive acid blockers and gastroesophageal reflux disease. World J Gastroenterol 2022; 28:3608-3619. [PMID: 36161043 PMCID: PMC9372813 DOI: 10.3748/wjg.v28.i28.3608] [Citation(s) in RCA: 14] [Impact Index Per Article: 4.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/16/2022] [Revised: 04/24/2022] [Accepted: 06/26/2022] [Indexed: 02/06/2023] Open
Abstract
Proton pump inhibitors (PPIs), the most commonly used antisecretory medi-cations in the management of reflux illness, virtually eliminate elective surgery for ulcer disease, and relegate anti-reflux surgery to patients with gastroesophageal reflux disease (GERD) who are inadequately managed by medical therapy. However, PPI medications still leave some therapeutic demands of GERD unmet. Furthermore, up to 40%-55% of daily PPI users have chronic symptoms, due to PPI refractoriness. Potassium-competitive acid blockers (P-CABs) transcend many of the problems and limits of PPIs, delivering quick, powerful, and extended acid suppression and allowing for treatment of numerous unmet needs. Recently, it has become clear that compromised mucosal integrity plays a role in the etiology of GERD. As a result, esophageal mucosal protection has emerged as a novel and potential treatment approach. An increasing body of research demonstrates that when P-CABs are used as primary drugs or add-on drugs (to regular treatment), they provide a considerable extra benefit, particularly in alleviating symptoms that do not respond to PPI therapy.
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Affiliation(s)
- Wattana Leowattana
- Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University, Bangkok 10400, Thailand
| | - Tawithep Leowattana
- Department of Medicine, Faculty of Medicine, Srinakharinwirot University, Bangkok 10110, Thailand
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Tsukanov VV, Cherepnin MA, Vasyutin AV, Tonkikh JL, Kasparov EV, Maslennikova NA, Pavlova NV. Efficacy of rabeprazole (Razo®) in the treatment of various clinical variants of GERD: results from the GERBERA study. MEDITSINSKIY SOVET = MEDICAL COUNCIL 2022:28-35. [DOI: 10.21518/2079-701x-2022-16-7-28-35] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 08/12/2024]
Abstract
Introduction. Gastroesophageal reflux disease (GERD) is extremely common in the structure of gastroenterological diseases. Aim. To conduct a prospective observational post-marketing study of rabeprazole (Razo®) 20 mg taking once daily in patients with non-erosive reflux disease (NERD) after 2 and 4 weeks of therapy and esophagitis stage A and B after 4 weeks of therapy (GERBERA).Materials and methods. 75 patients with GERD were included in the study (36 men and 39 women, mean age 41.7 ± 1.5 years). Clinical examination with the completion of standard questionnaires, assessment of the quality of life of patients were performed at three visits: before the start of the treatment, after 2 and 4 weeks of therapy. Fibroesophagogastroduodenoscopy was performed in all patients before treatment and in patients with esophagitis after 4 weeks of therapy. All patients received rabeprazole (Razo®) at a dose of 20 mg once a day for the treatment of GERD. The diagnosis of heartburn and sour eructation was carried out according to the recommendations of the Montreal Consensus, the diagnosis of esophagitis was performed based on the Los Angeles classification.Results and discussion. Among patients with NERD, 74.1% of patients responded to Razo® therapy after 2 weeks of treatment, after 4 weeks the proportion of responders increased to 94.4% (p = 0.008). Healing of erosions after 4 weeks was observed in 90.5% of patients with esophagitis. Razo® therapy was accompanied by a pronounced improvement in GERD patients in all parameters of quality of life and patient satisfaction with the results of Razo® treatment.Conclusion. Based on the results of our study, we obtained high efficacy of Razo® at a dose of 20 mg once a day for the treatment of patients with NERD and erosive esophagitis.
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Affiliation(s)
- V. V. Tsukanov
- Federal Research Center “Krasnoyarsk Science Center” of the Siberian Branch of the Russian Academy of Sciences, Separate Subdivision “Scientific Research Institute of medical problems of the North”
| | - M. A. Cherepnin
- Federal Research Center “Krasnoyarsk Science Center” of the Siberian Branch of the Russian Academy of Sciences, Separate Subdivision “Scientific Research Institute of medical problems of the North”
| | - A. V. Vasyutin
- Federal Research Center “Krasnoyarsk Science Center” of the Siberian Branch of the Russian Academy of Sciences, Separate Subdivision “Scientific Research Institute of medical problems of the North”
| | - J. L. Tonkikh
- Federal Research Center “Krasnoyarsk Science Center” of the Siberian Branch of the Russian Academy of Sciences, Separate Subdivision “Scientific Research Institute of medical problems of the North”
| | - E. V. Kasparov
- Federal Research Center “Krasnoyarsk Science Center” of the Siberian Branch of the Russian Academy of Sciences, Separate Subdivision “Scientific Research Institute of medical problems of the North”
| | - N. A. Maslennikova
- Krasnoyarsk State Medical University named after Professor V.F. Voino-Yasenetsky
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Gronich N, lavi I, Lejbkowicz F, Pinchev M, Rennert G. Association of CYP2C19 polymorphism with proton pump inhibitors effectiveness and with fractures in real‐life: retrospective cohort study. Clin Pharmacol Ther 2022; 111:1084-1092. [PMID: 35124810 PMCID: PMC9311419 DOI: 10.1002/cpt.2552] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/04/2021] [Accepted: 02/01/2022] [Indexed: 11/08/2022]
Abstract
Symptom refractoriness of patients treated with proton pump inhibitors (PPIs) might be explained by polymorphism in CYP2C19. This is a retrospective cohort study in which we used the computerized database of Clalit Health Services to compose a cohort from cancer case‐control studies’ participants that had been genotyped, and that have been dispensed PPI (January 1, 2002 to November 10, 2020). We retrieved demographic and clinical variables on date of PPI initiation (cohort entry), and studies’ questionnaires‐reported consumption of foods/beverages known to increase peptic‐related symptoms. Primary outcome was an abdominal pain diagnosis; secondary outcome was a composite of abdominal pain, visit to a gastroenterology clinic, change to another PPI, PPI dose increase, or metoclopramide prescription, reflecting symptoms persistence/recurrence; in a 2‐year follow‐up. We also evaluated the association between genetic groups and hip/wrist/spine fractures, in a long‐term follow‐up. Of 3,326 PPI initiators, there were 66 (2.0%), 739 (22.2%), 1394 (41.9%), 947 (28.5%), and 180 (5.4%) CYP2C19 poor, intermediate, normal, rapid, and ultra‐rapid metabolizers, respectively. Being a poor metabolizer was associated with lower risk for the primary outcome, hazard ratio (HR) = 0.50 (95% confidence interval (CI) 0.27–0.91), HR = 0.52 (95% CI 0.28–0.94); and for the secondary outcome, HR = 0.57 (95% CI 0.38–0.86), HR = 0.58 (95% CI 0.39–0.87), in univariate and multivariable cox regression analyses, respectively. In long‐term follow‐up with 20,142 person‐years of follow‐up: 7.6% (5 cases) within the poor metabolizers group, and 11.6%, 12.9%, 12.8%, and 11.1% in the normal, intermediate, rapid, and ultra‐rapid metabolizers groups, respectively, had a new fracture (nonsignificant). We conclude that CYP2C19 poor metabolizer status is associated with higher effectiveness of PPIs, and is not associated with higher risk for fractures.
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Affiliation(s)
- Naomi Gronich
- Department of Community Medicine and Epidemiology Lady Davis Carmel Medical Center Haifa Israel
- Ruth and Bruce Rappaport Faculty of Medicine Technion–Israel Institute of Technology Haifa Israel
| | - Idit lavi
- Department of Community Medicine and Epidemiology Lady Davis Carmel Medical Center Haifa Israel
| | - Flavio Lejbkowicz
- Department of Community Medicine and Epidemiology Lady Davis Carmel Medical Center Haifa Israel
| | - Mila Pinchev
- Department of Community Medicine and Epidemiology Lady Davis Carmel Medical Center Haifa Israel
| | - Gad Rennert
- Department of Community Medicine and Epidemiology Lady Davis Carmel Medical Center Haifa Israel
- Ruth and Bruce Rappaport Faculty of Medicine Technion–Israel Institute of Technology Haifa Israel
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Visaggi P, Mariani L, Svizzero FB, Tarducci L, Sostilio A, Frazzoni M, Tolone S, Penagini R, Frazzoni L, Ceccarelli L, Savarino V, Bellini M, Gyawali PC, Savarino EV, de Bortoli N. Clinical use of mean nocturnal baseline impedance and post-reflux swallow-induced peristaltic wave index for the diagnosis of gastro-esophageal reflux disease. Esophagus 2022; 19:525-534. [PMID: 35768671 PMCID: PMC9436885 DOI: 10.1007/s10388-022-00933-6] [Citation(s) in RCA: 9] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/23/2022] [Accepted: 06/07/2022] [Indexed: 02/03/2023]
Abstract
The clinical diagnosis of gastro-esophageal reflux disease (GERD) is based on the presence of typical esophageal troublesome symptoms. In clinical practice, heartburn relief following a proton pump inhibitor (PPI) trial or endoscopy can confirm a diagnosis of GERD. In cases of diagnostic uncertainty or before anti-reflux interventions, combined impedance-pH monitoring (MII-pH) provides a comprehensive assessment of both physical and chemical properties of the refluxate, allowing to achieve a conclusive diagnosis of GERD. Recently, the Lyon Consensus proposed the use of mean nocturnal baseline impedance (MNBI) and post-reflux swallow-induced peristaltic wave index (PSPW-I) as novel MII-pH metrics to support the diagnosis of GERD. The calculation of MNBI and PSPW-I currently needs to be performed manually, but artificial intelligence systems for the automated analysis of MII-pH tracings are being developed. Several studies demonstrated the increased diagnostic yield MNBI and PSPW-I for the categorization of patients with GERD at both on- and off-PPI MII-pH monitoring. Accordingly, we performed a narrative review on the clinical use and diagnostic yield of MNBI and PSPW-I when the diagnosis of GERD is uncertain. Based on currently available evidence, we strongly support the evaluation of PSPW-I and MNBI as part of the standard assessment of MII-pH tracings for the evaluation of GERD, especially in patients with endoscopy-negative heartburn.
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Affiliation(s)
- Pierfrancesco Visaggi
- Division of Gastroenterology, Department of Translational Research and New Technologies in Medicine and Surgery, School of Medicine, University of Pisa, Pisa, Italy
| | - Lucia Mariani
- Division of Gastroenterology, Department of Translational Research and New Technologies in Medicine and Surgery, School of Medicine, University of Pisa, Pisa, Italy
| | - Federica Baiano Svizzero
- Division of Gastroenterology, Department of Translational Research and New Technologies in Medicine and Surgery, School of Medicine, University of Pisa, Pisa, Italy
| | - Luca Tarducci
- Division of Gastroenterology, Department of Translational Research and New Technologies in Medicine and Surgery, School of Medicine, University of Pisa, Pisa, Italy
| | - Andrea Sostilio
- Division of Gastroenterology, Department of Translational Research and New Technologies in Medicine and Surgery, School of Medicine, University of Pisa, Pisa, Italy
| | - Marzio Frazzoni
- Digestive Pathophysiology Unit, Baggiovara Hospital, Modena, Italy
| | - Salvatore Tolone
- General and Bariatric Surgery Unit, Department of Surgery, University of Caserta Luigi Vanvitelli, Caserta, Italy
| | - Roberto Penagini
- Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy
- Gastroenterology and Endoscopy Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy
| | - Leonardo Frazzoni
- Gastroenterology Unit, Department of Medical and Surgical Sciences, Sant'Orsola Hospital, University of Bologna, Bologna, Italy
| | - Linda Ceccarelli
- Division of Gastroenterology, Department of Translational Research and New Technologies in Medicine and Surgery, School of Medicine, University of Pisa, Pisa, Italy
| | - Vincenzo Savarino
- Gastroenterology Unit, Department of Internal Medicine "DiMI", University of Genoa, Genoa, Italy
| | - Massimo Bellini
- Division of Gastroenterology, Department of Translational Research and New Technologies in Medicine and Surgery, School of Medicine, University of Pisa, Pisa, Italy
| | - Prakash C Gyawali
- Division of Gastroenterology, Washington University School of Medicine, St. Louis, USA
| | - Edoardo V Savarino
- Division of Gastroenterology, Department of Surgical, Oncological and Gastroenterological Sciences, University of Padua, Padua, Italy
| | - Nicola de Bortoli
- Division of Gastroenterology, Department of Translational Research and New Technologies in Medicine and Surgery, School of Medicine, University of Pisa, Pisa, Italy.
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