Poliprotect may improve heartburn symptoms among patients with normal upper GI endoscopy

A recent study published in The American Journal of Gastroenterology by Enrico Stefano Corazziari and team of researchers has demonstrated that Poliprotect, a mucosal protective agent, is noninferior to omeprazole in relieving heartburn and epigastric pain or burning in patients with normal upper gastrointestinal (GI) endoscopy findings. This finding is significant as alternative treatment options are needed for patients who do not respond well to proton-pump inhibitors (PPIs) or who are unable to take PPIs due to factors such as pregnancy or infancy.

The randomized controlled trial involved 275 outpatients with endoscopy-negative findings who were randomly assigned to receive a 4-week treatment of either omeprazole (20 mg once daily) or Poliprotect (administered five times a day for the initial two weeks and on-demand thereafter). Following this, there was an open-label 4-week treatment period during which all participants received Poliprotect on-demand. The efficacy and safety of both treatments were assessed, along with changes in gut microbiota.

● Results showed that the 2-week treatment with Poliprotect was noninferior to omeprazole in terms of symptom relief.

● The between-group difference in the change in visual analog scale symptom score was -5.4 (95% confidence interval: -9.9 to -0.1) in the intention-to-treat population and -6.2 (95% confidence interval: -10.8 to -1.6) in the per-protocol population.

● Poliprotect's benefit remained consistent even when shifted to on-demand intake, and no significant changes were observed in the gut microbiota.

● Omeprazole initially provided symptom relief, it was associated with higher usage of rescue medicine sachets compared to Poliprotect.

● Omeprazole use was linked to an increased abundance of oral cavity genera in the intestinal microbiota.

● No relevant adverse events were reported in either treatment arm.

The findings suggest that Poliprotect is a viable alternative to standard-dose omeprazole for patients experiencing heartburn and epigastric burning without erosive esophagitis and gastroduodenal lesions. Furthermore, Poliprotect treatment did not adversely affect gut microbiota, which is an important consideration in maintaining a healthy balance of intestinal flora.

These promising results highlight the potential of Poliprotect as an effective and safe mucosal protective agent for the relief of heartburn and epigastric pain. Further research and larger-scale studies are warranted to confirm these findings and explore the long-term efficacy and safety of Poliprotect in a broader population.

Reference:

Corazziari, E. S., Gasbarrini, A., D’Alba, L., D’Ovidio, V., Riggio, O., Passaretti, S., Annibale, B., Cicala, M., Repici, A., Bassotti, G., Ciacci, C., Di Sabatino, A., Neri, M., Bragazzi, M. C., Ribichini, E., Radocchia, G., Iovino, P., Marazzato, M., Schippa, S., & Badiali, D. (2023). Poliprotect vs omeprazole in the relief of heartburn, epigastric pain, and burning in patients without erosive esophagitis and gastroduodenal lesions: A randomized, controlled trial. The American Journal of Gastroenterology. https://doi.org/10.14309/ajg.0000000000002360