Poliprotect in the PPI Deprescription Phase of Endoscopy-Negative Heartburn and Epigastric Pain Syndrome Patients: An RCT Post Hoc Analysis.

BACKGROUND

Proton pump inhibitors (PPIs) are widely used for upper gastrointestinal symptoms but are frequently prescribed inappropriately and often continued without clear indications. Deprescribing PPIs can be challenging due to symptom recurrence or rebound acid hypersecretion. The mucosal protective agent Poliprotect, a natural formulation with barrier, antioxidant, and anti-inflammatory properties, has shown non-inferiority to omeprazole in non-erosive heartburn and epigastric pain syndrome (EPS) without affecting intestinal microbiota.

AIM: To evaluate the role of Poliprotect formulation (neoBianacid) in maintaining symptom control after PPI withdrawal in patients with endoscopy-negative heartburn (HRTB) and EPS.

METHODS

This post hoc analysis used data from a multicenter, double-blind RCT including 125 endoscopy-negative patients (80 with HRTB, 45 with EPS) treated with omeprazole 20 mg/day for 4 weeks, followed by 4 weeks of on-demand Poliprotect after PPI discontinuation. Outcomes included symptom severity (VAS), responder rate (≥ 50% VAS reduction), use of rescue medication, quality of life (GIQLI), gastrointestinal symptoms (GSRS), treatment satisfaction, and safety.

RESULTS

At the end of deprescription, mean VAS scores remained stable, and 69.5% of PPI responders (65.8%, HRTB, and 76.2%, EPS) maintained symptom control. Additionally, 31% of PPI non-responders (33.3%, HRTB, and 27.3%, EPS) became responders with Poliprotect. Rescue antacid use and quality of life scores were not significantly changed. No adverse events were reported during the deprescribing phase.

CONCLUSIONS

On-demand Poliprotect was associated with maintenance of symptom control after PPI withdrawal and outcome improvement in approximately one-third of PPI non-responders. Poliprotect appears to be a safe, well-tolerated, and promising strategy to support PPI discontinuation in endoscopy-negative heartburn and EPS patients.

TRIAL REGISTRATION: Clinicaltrial.gov (NCT03238534) and EudraCT Database (2015-005216-15).