Background and objectives Gastroesophageal reflux disease (GERD) is a common gastrointestinal disorder characterized by troublesome symptoms affecting the quality of life. Sodium alginate antacid suspension provides quick and prolonged relief of symptoms due to its unique mechanism of action. The primary objective of this study was to evaluate improvement in GERD symptoms by assessing changes in symptom scores at the end of one week and to evaluate the responder rate. The secondary objective was to evaluate patient tolerability using the frequency and severity of adverse events and physician-reported outcomes. Methods This was a retrospective, observational data collection study that reviewed medical records of GERD patients who received sodium alginate antacid suspension (10-20 ml, 3-4 times daily) for one week. Data were retrieved, analyzed, translated into symptom scores (GERD Health-Related Quality of Life score), and classified based on disease severity. Primary outcomes were improvement in symptom scores (heartburn, regurgitation, swallowing difficulties, and bloating) and total scores at the end of treatment. The responder rates, physician-reported outcomes, and tolerability were also analyzed. Results Medical records for 10,000 patients treated with sodium alginate antacid suspension were reviewed. Out of these, data for 6,246 patients was further analyzed. Treatment with sodium alginate antacid suspension resulted in significant reductions in heartburn, regurgitation, swallowing difficulties, and bloating scores (p<0.001) in patients with moderate to severe GERD. The mean total GERD symptom score also decreased significantly from baseline (p<0.001). The responder rate, i.e., a reduction of ≥50% in the total symptom score from baseline to the end of one week, was 74%. Almost 90% of patients reported symptom improvement, but 2.22% of patients experienced adverse events. As per physicians, this suspension was effective in 96.64% of patients. Conclusion This real-world evidence study highlights rapid symptomatic relief in GERD patients with sodium alginate antacid suspension.
Keywords: alginates; gastroesophageal reflux disease; heartburn; real-world setting; regurgitation; sodium alginate antacid.
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