Efficacy And Safety of Adjuvant Sucralfate to Proton Pump Inhibitor in Gastroesophageal Reflux Disease: A Multicentric, Open Label, Randomized Clinical Trial

Ramakrishna BS, Shukla A, Mohapatra JR, Doraiswami BV, Srinivas V, Harindranath S, Satai M, Jayaraman GV, Saha M and Mitra M

Published on: 2023-07-05

Abstract

Background: Gastroesophageal reflux disease (GERD) is a chronic disorder with increasing prevalence in recent times owing to changing lifestyle. Overuse/misuse of proton pump inhibitors (PPIs) is common, often leading to adverse effects. Supplementation with a mucosal protective agent might be beneficial. Based on this, the current study was designed to investigate the efficacy and safety of combinatorial treatment with PPI and sucralfate and compare it to PPI monotherapy.

Methods: A total of 100 adult subjects aged 18-65 years diagnosed with GERD were screened and enrolled from three sites in India and randomized by 1:1 allocation to be treated for 28 days with either PPI or PPI + sucralfate (along with advice on lifestyle modifications and standard of care). Efficacy analysis was performed based on patient responses to selected parameters (heartburn, regurgitation, heartburn when lying, regurgitation when lying, feeling of discomfort inside chest, bitter/acid/sour taste in mouth, and retching) on the Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM). Safety was analyzed based on adverse events (AEs).

Results: Treatment with PPI and sucralfate for 28 days resulted in statistically significant improvement in scores of all selected parameters except retching. The percentage of change in scores and proportion of responders between day 14 and day 28 were higher in the PPI + Sucralfate group than the PPI group for all selected parameters except bitter/acid/sour taste in mouth. Only 10% subjects reported mild/moderate AEs in the PPI + Sucralfate group, all of which resolved completely.

Conclusion: Combinatorial treatment with PPI and sucralfate might be more beneficial for the relief of several GERD-associated symptoms compared to PPI monotherapy.