Alginates: From the ocean to gastroesophageal reflux disease treatment

Reckitt Benckiser Turke

Trimebutine maleate monotherapy for functional dyspepsia: A multicenter, randomized, double-blind placebo controlled prospective trial

Background and Objectives:Functional dyspepsia (FD) is one of the most common functional gastrointestinal disorders; it has a great impact on patient quality of life and is difficult to treat satisfactorily. This study evaluates the efficacy and safety of trimebutine maleate (TM) in patients with FD.Materials and Methods: A multicenter, randomized, double-blind, placebo controlled, prospective study was conducted, including 211 patients with FD. Participants were randomized to receive TM 300 mg twice per day (BID, 108 patients) or placebo BID (103 patients) for 4 weeks. The Glasgow Dyspepsia Severity Score (GDSS) was used to evaluate the relief of dyspepsia symptoms. Moreover, as a pilot secondary endpoint, a substudy (eight participants on TM and eight on placebo) was conducted in to evaluate gastric emptying (GE), estimated using a 99mTc-Tin Colloid Semi Solid Meal Scintigraphy test.Results: Of the 211 patients enrolled, 185 (87.7%) (97 (52.4%) in the TM group and 88 (47.6%) in the placebo group) completed the study and were analyzed. The groups did not differ in their demographic and medical history data. Regarding symptom relief, being the primary endpoint, a statistically significant reduction in GDSS for the TM group was revealed between the first (2-week) and final (4-week) visit (p-value = 0.02). The 99 mTc-Tin Colloid Semi Solid Meal Scintigraphy testing showed that TM significantly accelerated GE obtained at 50 min (median emptying 75.5% in the TM group vs. 66.6% in the placebo group,p= 0.036). Adverse effects of low to moderate severity were reported in 12.3% of the patients on TM.Conclusion: TM monotherapy appears to be an effective and safe approach to treating FD, although the findings presented here warrant further confirmation.Galenica A.E. Pharmaceutical Compan

Post COVID-19 irritable bowel syndrome

Objectives: The long-term consequences of COVID-19 infection on the gastrointestinal tract remain unclear. Here, we aimed to evaluate the prevalence of gastrointestinal symptoms and post-COVID-19 disorders of gut-brain interaction after hospitalisation for SARS-CoV-2 infection. Design: GI-COVID-19 is a prospective, multicentre, controlled study. Patients with and without COVID-19 diagnosis were evaluated on hospital admission and after 1, 6 and 12 months post hospitalisation. Gastrointestinal symptoms, anxiety and depression were assessed using validated questionnaires. Results: The study included 2183 hospitalised patients. The primary analysis included a total of 883 patients (614 patients with COVID-19 and 269 controls) due to the exclusion of patients with pre-existing gastrointestinal symptoms and/or surgery. At enrolment, gastrointestinal symptoms were more frequent among patients with COVID-19 than in the control group (59.3% vs 39.7%, p<0.001). At the 12-month follow-up, constipation and hard stools were significantly more prevalent in controls than in patients with COVID-19 (16% vs 9.6%, p=0.019 and 17.7% vs 10.9%, p=0.011, respectively). Compared with controls, patients with COVID-19 reported higher rates of irritable bowel syndrome (IBS) according to Rome IV criteria: 0.5% versus 3.2%, p=0.045. Factors significantly associated with IBS diagnosis included history of allergies, chronic intake of proton pump inhibitors and presence of dyspnoea. At the 6-month follow-up, the rate of patients with COVID-19 fulfilling the criteria for depression was higher than among controls. Conclusion: Compared with controls, hospitalised patients with COVID-19 had fewer problems of constipation and hard stools at 12 months after acute infection. Patients with COVID-19 had significantly higher rates of IBS than controls. Trial registration number: NCT04691895

How to select patients for anti-reflux surgery? The ICARUS guidelines (International Consensus regarding preoperative examinations and clinical characteristics assessment to select adult patients for AntiReflUx Surgery)

Objective: Anti-reflux surgery can be proposed in patients with gastro-esophageal reflux disease, especially when proton pump inhibitor use leads to incomplete symptom improvement. However, to date, international consensus guidelines on the clinical criteria and additional technical examinations used in patient selection for anti-reflux surgery are lacking. We aimed at generating key recommendations in the selection of patients for anti-reflux surgery. Design: We included 35 international experts (gastroenterologists, surgeons and physiologists) in a Delphi process and developed 37 statements that were revised by the Consensus Group, to start the Delphi process. Three voting rounds followed where each statement was presented with the evidence summary. The panel indicated the degree of agreement for the statement. When 80% of the Consensus Group agreed (A+/A) with a statement, this was defined as consensus. All votes were mutually anonymous.Results: Patients with heartburn with a satisfactory response to PPIs, patients with a hiatal hernia (HH), patients with esophagitis LA grade B or higher and patients with Barrett’s esophagus are good candidates for anti-reflux surgery. An endoscopy prior to anti-reflux surgery is mandatory and a barium swallow should be performed in patients with suspicion of a HH or short esophagus. Esophageal manometry is mandatory to rule out major motility disorders. Finally, esophageal pH (+/- impedance) monitoring off PPI is mandatory to select patients for anti-reflux surgery, if endoscopy is negative for unequivocal reflux esophagitis. Conclusion: With the ICARUS guidelines, we generated key recommendations for selection of patients for anti-reflux surgery

Computer-Based Intelligent Solutions for the Diagnosis of Gastroesophageal Reflux Disease Phenotypes and Chicago Classification 3.0

Gastroesophageal reflux disease (GERD) is a multidisciplinary disease; therefore, when treating GERD, a large amount of data needs to be monitored and managed.The aim of our study was to develop a novel automation and decision support system for GERD, primarily to automatically determine GERD and its Chicago Classification 3.0 (CC 3.0) phenotypes. However, phenotyping is prone to errors and is not a strategy widely known by physicians, yet it is very important in patient treatment. In our study, the GERD phenotype algorithm was tested on a dataset with 2052 patients and the CC 3.0 algorithm was tested on a dataset with 133 patients. Based on these two algorithms, a system was developed with an artificial intelligence model for distinguishing four phenotypes per patient. When a physician makes a wrong phenotyping decision, the system warns them and provides the correct phenotype. An accuracy of 100% was obtained for both GERD phenotyping and CC 3.0 in these tests. Finally, since the transition to using this developed system in 2017, the annual number of cured patients, around 400 before, has increased to 800. Automatic phenotyping provides convenience in patient care, diagnosis, and treatment management. Thus, the developed system can substantially improve the performance of physicians

The additive effect of ethanol and extract of cigarette smoke on rabbit esophagus epithelium

WOS: 000262671000026PubMed ID: 19032455The combination of alcohol and smoking takes a place in the epidemiology and pathogenesis of gastroesophageal reflux disease and squamous cancers of the esophagus. Therefore, a study was designed to assess the impact of these agents alone or in combination on the structure and function of squamous epithelium of rabbit esophagus. Rabbit esophageal epithelium was mounted in Ussing Chambers, exposed luminally for ethanol (1-10%), extract of cigarette smoke (EOCS) and combinations or sequential application of these agents. An in-vivo model was also used to mimic conditions more representative of human alcohol consumption. Ethanol (1-10%) dose dependently decreased tissue resistance. Extract of cigarette smoke caused a reduction on transepithelial potential difference (PD), short circuit current. Combinations of EOCS, ethanol (5-10% EtOH and EOCS 1-2) showed a more pronounced decrease than agents alone, mainly the result of EOCS. In vivo studies showed that EOCS administration dropped PD dose dependently. In-vivo 10% EtOH, EOCS-2 dropped PD (55%) similar to in-vitro 5% EtOH, EOCS-1. The effect was clearly additive; boluses of 10% ethanol (36%) and EOCS-2 (17%) decreased PD and combination of agents resulted in a 55% drop on PD which is a very similar decrease compared to the sum of the separate effects of agents (53%). Ethanol affected the barrier and cigarette smoke altered ion transport on rabbit esophageal epithelium under conditions reflecting human consumption. Results were consistent with in vivo and in vitro conditions except higher concentrations were needed in vivo. When applied, these agents showed an additive effect. Ethanol predisposed the tissue to the effect of EOCS