Therapy of Upper Gastrointestinal Symptoms: Experience with a Medical Device Made of Natural Substances

Abstract

Purpose of review Medical devices made of substances are widely used in clinical practice, but they are considered to have less therapeutic efficacy than pharmacological agents. In this narrative review, we report a recent RCT experience of a medical device made of natural substances (Poliprotect) that proved as effective as the standard reference treatment. The RCT addressed three questions: (1) Is Poliprotect useful in the initial treatment of heartburn and epigastric pain/burning as an alternative to the reference standard therapy with PPI, (2) is Poliprotect useful in the medium-term treatment of heartburn and epigastric pain/burning, and (3) is Poliprotect useful in the deprescribing phase of PPI? Recent findings Firstly, Poliprotect proved non-inferior to omeprazole for symptom relief in confirmed upper endoscopic negativity; secondly, the benefit remained unaltered after shifting to on-demand intake, with no gut microbiota variation; and thirdly, Poliprotect can be used to deprescribe the PPI treatment, avoiding the symptomatic worsening that accompanies the hyper secretive gastric acid rebound effect. Summary A medical device made of natural substances can be as effective as a pharmacological agent in the therapy of upper gastrointestinal symptoms in endoscopy-negative patients. Poliprotect effect started from the first day of treatment to improve in the following 2 weeks and to be maintained unaltered in the following 4 weeks with on-demand regimen. Finally, this medical device of natural substances showed high safety without affecting the gut microbiota.