Comparable efficacy of generic and original alginate for symptom control in PPI-refractory GERD

Gastroesophageal reflux disease (GERD) is a prevalent global condition, affecting 18.1-27.8% of North Americans and 6.3-18.3% of the Thai population. While proton pump inhibitors (PPIs) are the first-line treatment, only about one-third of patients achieve adequate symptom control. Alginate-based medications in combination with PPIs have shown promise, but the comparative effectiveness of generic versus original alginates remains unexplored. To compare the effectiveness of generic alginate (ONE GERD) versus original alginate (Gaviscon Dual Action Suspension) in combination with PPIs for treating GERD symptoms in patients who failed standard PPI therapy.This multicenter prospective randomized controlled non-inferiority trial included 48 patients who failed standard-dose PPI treatment. Patients were randomized to receive either generic or original alginate four times daily for 28 days. Treatment response was evaluated using the Reflux Disease Questionnaire (RDQ) at days 7 and 28. At day 7, both groups showed identical response rates of 45.83%. By day 28, response rates increased to 54.17% for generic alginate and 70.83% for original alginate (p = 0.23). Total RDQ scores and symptom-free rates showed no significant differences between groups at both time points. Adverse event rates were comparable (16.67% vs. 8.33%, p = 0.66). Analysis of specific symptoms (heartburn, chest pain, and regurgitation) revealed similar improvements in both groups throughout the study period. This study provides evidence supporting the therapeutic equivalence of the generic alginate (ONE GERD) to the original formulation (Gaviscon Dual Action Suspension) in treating symptoms for patients with GERD who have failed PPI therapy. Crucially, the comparable efficacy and safety, coupled with the inherent lower cost of generic medications, suggest significant economic benefits and the potential for wider patient access to effective GERD management. This makes generic alginate a viable and attractive alternative in clinical practice, particularly in resource-limited settings or for patients facing financial constraints, thereby contributing to more equitable healthcare solutions without compromising therapeutic outcomes.