Effectiveness of a Multicomponent Formulation: A Prospective Observational Study in Patients with Gastroesophageal Reflux Symptoms

Giulia Fiorini; Luigi Gatta; Matteo Pavoni; Gabriella Massarenti; Beatrice Rosa; Cristina Marchesani; Giulia Collatuzzo; Raffaele Manta; Luciano Potena; Attilio Varricchio; Arrigo Francesco Giuseppe Cicero; Federica Fogacci; Claudio Borghi; Giovanni Barbara; Dino Vaira

doi:10.3390/ph19060866

Effectiveness of a Multicomponent Formulation: A Prospective Observational Study in Patients with Gastroesophageal Reflux Symptoms

Pharmaceuticals (Basel). 2026 May 30;19(6):866. doi: 10.3390/ph19060866.

Authors

Giulia Fiorini^{1

2}, Luigi Gatta³, Matteo Pavoni², Gabriella Massarenti², Beatrice Rosa², Cristina Marchesani², Giulia Collatuzzo⁴, Raffaele Manta⁵, Luciano Potena^{1

2}, Attilio Varricchio⁶, Arrigo Francesco Giuseppe Cicero^{1

2}, Federica Fogacci², Claudio Borghi^{1

2}, Giovanni Barbara², Dino Vaira^{1

2}

Affiliations

¹ Cardiovascular Medicine Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, 40138 Bologna, Italy.
² Department of Medical and Surgical Sciences, University of Bologna, 40126 Bologna, Italy.
³ Management Staff Department Area of Organizational Innovation Complex Operational Unit for Outpatient and Diagnostic Demand Management, Tuscany North West Local Health Authority, 56121 Pisa, Italy.
⁴ Department of Biomedical and Clinical Sciences, University of Milan, 20157 Milan, Italy.
⁵ Gastroenterology and Digestive Endoscopy, "Riuniti" Hospital, Azienda USL Toscana Nord Ovest, 57124 Livorno, Italy.
⁶ Department of Otolaryngology, University of Molise, 86100 Campobasso, Italy.

Abstract

Background: Gastroesophageal reflux symptoms (GERSs) represent the most prevalent phenotype of gastroesophageal reflux disease and frequently overlap with the symptoms of functional dyspepsia, posing diagnostic and therapeutic challenges. Limitations of long-term acid suppression have prompted interest in alternative mucosa-protective approaches. This study was conducted to evaluate the effectiveness of a novel multicomponent formulation (Tamacid-Pro^®) in patients with reflux-like symptoms and negative endoscopy. Methods: In this prospective observational study, consecutive adult patients undergoing upper gastrointestinal endoscopy at a tertiary centre between January 2025 and February 2026 were screened. Patients with upper gastrointestinal symptoms lasting ≥2 months, negative endoscopy, and no evidence of Helicobacter pylori infection were enrolled. Participants received Tamacid-Pro^® three times daily for 3 months. Symptom frequency and intensity were assessed at baseline and after treatment using the Reflux Disease Questionnaire (RDQ). Changes over time were analyzed using paired t-tests, and multivariable linear regression was performed to identify response predictors. Results: A total of 1035 patients were included. After 3 months of treatment, all RDQ items showed a statistically significant improvement in both frequency and intensity (p < 0.0001). Significant reductions were observed in the GERD composite score, as well as in heartburn, regurgitation, and dyspepsia dimensions (all p < 0.0001). In a multivariable analysis, female sex was independently associated with greater improvement across multiple symptom domains, whereas alcohol consumption was negatively associated with improvement in the heartburn dimension. Conclusions: In this large real-world cohort of endoscopy-negative patients, treatment with Tamacid-Pro^® was associated with significant improvement in both typical reflux and dyspeptic symptoms. These findings support the role of multicomponent, mucosa-protective formulations as a valuable therapeutic option in patients with GERSs and overlapping functional gastrointestinal disorders.

Keywords: Tamacid-Pro®; dyspepsia; gastroesophageal reflux disease (GERD).