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Practice Guideline
. 2025 Sep;57(9):1730-1747.
doi: 10.1016/j.dld.2025.06.012. Epub 2025 Jul 8.

Italian guidelines for the diagnosis and treatment of functional dyspepsia - joint consensus from the Italian societies of gastroenterology and endoscopy (SIGE), Neurogastroenterology and motility (SINGEM), hospital gastroenterologists and endoscopists (AIGO), digestive endoscopy (SIED) and general medicine (SIMG)

Affiliations
Practice Guideline

Italian guidelines for the diagnosis and treatment of functional dyspepsia - joint consensus from the Italian societies of gastroenterology and endoscopy (SIGE), Neurogastroenterology and motility (SINGEM), hospital gastroenterologists and endoscopists (AIGO), digestive endoscopy (SIED) and general medicine (SIMG)

Giovanni Sarnelli et al. Dig Liver Dis. 2025 Sep.

Abstract

Functional dyspepsia (FD) is one of the most prevalent disorders of the upper gastrointestinal tract. Despite its broad prevalence, FD diagnosis and treatment are still not well standardized. The aim of this project was to outline an Italian Guideline to define a standardized approach in terms of diagnostic and therapeutic work-up to support both general practitioners and specialists in Gastroenterology. To address this issue, experts from 5 Italian Societies conducted a Delphi consensus process, which included a review of the current literature and voting process on 24 key statements. Recommendations and quality of evidence were evaluated using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) criteria. Consensus for each statement was defined as ≥ 80 % agreement. DIAGNOSTIC APPROACH: The panel reached consensus on defining FD and its main symptoms and dividing this entity into two different subgroups: the epigastric pain syndrome (EPS) and the post-prandial distress syndrome (PDS). Consensus was reached on defining FD as a diagnosis of exclusion and on the need of performing an esophagogastroduodenoscopy with biopsies to exclude organic causes in patients 45 or older, in presence of alarm symptoms and/or in case of refractoriness to treatment. It was agreed that all patients should be screened for H. pylori infection (by invasive or non-invasive means) and that all HP-positive patients should receive eradication therapy. Routine blood tests were recommended to exclude underlying systemic diseases that could present with dyspeptic symptoms. On the other hand, the panel recommended against the routine use of additional testing, including abdominal ultrasound, celiac disease screening and motility studies in FD patients. TREATMENT APPROACH: Consensus was not reached regarding the dietary regimen to adopt in FD patients. Healthy general lifestyle advice was deemed as reasonable to pursue in FD patients, while the use of exclusion diets was discouraged by the panel. The consensus supports a short course of PPIs at standard dose as a first line treatment in FD patients, regardless of the prevalent symptom pattern, while higher PPI doses should not be pursued as an effective strategy in improving patient's response. Consensus was not reached regarding the routine use of H2RA, antacids and alginate-containing products and/or mucosal protectants in the management of FD. The panel recommended against the use of prokinetics as first line treatment in FD patients and advised on preferentially using a short course of prokinetics in PDS-subtype patients. The panel recommends the use of tricyclic antidepressants to treat EPS and supports the use of mirtazapine for FD patients, particularly for those patients with weight loss, while no sufficient evidence was available to recommend SSRIs. The panel recommends the use of cognitive and behavioral therapy for dyspepsia patients who do not respond to medical therapies. Finally, although the panel recognizes the usefulness of complementary and alternative (CAM) treatments in the management of FD patients, no sufficient evidence was available to recommend its use in FD patients, owing to the poor methodology of most published studies involving CAM.

Keywords: Anti-depressants; CBT; Functional dyspepsia; Guidelines; PPI; Prokinetics.

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Conflict of interest statement

Declaration of competing interest Giovanni Sarnelli: has served as a speaker, consultant, and/or advisory board member for Aboca, Alfasigma, Bruschettini, Farmagens, Dr. Falk, Malesci, Recordati, Sanofi/Regeneron, Takeda. Marcella Pesce: speaker for Dr. Falk, Bruschettini. Giovanni Barbara: Consultancies, business interests or sources of honoraria payments from Aboca, AB Biotics, Agave, Alfa Sigma, AGPharma, Bayer, Biocodex, Boeringer, Bromatech, Cadigroup, Danone, Diadema, Falk Pharma, GE Healthcare, Giuliani, Mayoly, Malesci, Monteresearch, Sanofy, Sofar, Yakult. Nicola de Bortoli: has served as speaker for Alfasigma, Dr Falk, Malesci, Reckitt Benckiser, Sanofi/Regeneron; has served as consultant for Alfasigma, Dr. Falk, Sanofi/Regeneron, has received research support from Sanofi/Regeneron, Dr Falk. Giuseppe Esposito: none. Marzio Frazzoni: none. Giuseppe Galloro: none. Luigi Gatta: none. Matteo Ghisa: none. Claudio Londoni: none. Elisa Marabotto: none. Alberto Meggio: none. Antonio Pisani: none. Mentore Ribolsi: none. Paolo Usai Satta: none. Carmelo Scarpignato: has served as a speaker, consultant, and/or advisory board member for Alfasigma, Pfizer, Takeda, Reckitt Benckiser, and Shionogi, and has in the past received funding from Giuliani Pharmaceuticals and Pfizer. Vincenzo Savarino: has served as speaker for Malesci, Grunenthal, Takeda and Alfasigma. Vincenzo Stanghellini: none. Cesare Tosetti: has served as consultant for NAMED, SILA. Pierfrancesco Visaggi: none. Fabiana Zingone: FZ has served as a speaker for Werfen, EG Stada Group, Fresenius Kabi, Kedrion, Janssen, Pfizer, Takeda, Unifarco, Malesci, Galapagos; FZ has served as a consultant for Galapagos, Takeda, and Tillotts. Edoardo Vincenzo Savarino: has served as speaker for Abbvie, Abivax, Agave, AGPharma, Alfasigma, Apoteca, Biosline, CaDiGroup, Celltrion, Dr Falk, EG Stada Group, Fenix Pharma, Galapagos, Johnson&Johnson, JB Pharmaceuticals, Innovamedica/Adacyte, Eli Lilly, Malesci, Mayoly Biohealth, Montefarco, Novartis, Omega Pharma, Pfizer, Rafa, Reckitt Benckiser, Sandoz, Sanofi/Regeneron, SILA, Sofar, Takeda, Tillots, Unifarco; has served as consultant for Abbvie, Agave, Alfasigma, Biogen, Bristol-Myers Squibb, Celltrion, Dr. Falk, Eli Lilly, Fenix Pharma, Ferring, Giuliani, Grunenthal, Johnson&Johnson, JB Pharmaceuticals, Merck & Co, Nestlè, Pfizer, Reckitt Benckiser, Sanofi/Regeneron, SILA, Sofar, Takeda, Unifarco; he received research support from Bonollo, Difass, Pfizer, Reckitt Benckiser, Sanofi/Regeneron, SILA, Sofar, Unifarco, Zeta Farmaceutici. Brigida Barberio: has served as speaker for Abbvie, Agave, Alfasigma, AGpharma, Janssen, Eli Lilly, MSD, Pfizer, Sofar, Takeda, Unifarco; has served as consultant for Abbvie and Janssen.

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