Efficacy of adding sodium alginate to omeprazole in patients with nonerosive reflux disease: a randomized clinical trial

Abstract

Nonerosive reflux disease (NERD) is the most common form of gastroesophageal reflux disease. Patients with NERD have a lower response rate to proton pump inhibitors (PPIs) than patients with erosive esophagitis when gauged from relief of heartburn. Sodium alginate decreases the acidity of refluxate and protects the esophageal mucosa. However, whether the addition of sodium alginate to PPI therapy can improve NERD symptoms remains unknown. Accordingly, the aim of this study was to evaluate the efficacy of adding sodium alginate to basal PPI therapy for NERD. Patients who had experienced heartburn on at least 2 days per week during the 1-month period before entering the study and had no endoscopic mucosal breaks (grade M or N according to Hoshihara's modification of the Los Angeles classification) were randomized to one of two treatments for 4 weeks: omeprazole (20 mg once daily) plus sodium alginate (30 mL four times a day) (group A) or omeprazole (20 mg once daily) alone (group B). Eighty-seven patients were enrolled, and 76 patients were randomly assigned to group A (n = 36) or group B (n = 40). Complete resolution of heartburn for at least 7 consecutive days by the end of treatment was significantly more common in group A (56.7%) than in group B (25.7%). One patient from group A had mild drug-related diarrhea that was not clinically serious. In conclusion, omeprazole combined with sodium alginate was better than omeprazole alone in Japanese patients with NERD.

Diagnosis and management of patients with reflux symptoms refractory to proton pump inhibitors

“…For the time being, there are no data supporting the use of prokinetics as add-on therapy in patients with refractory reflux symptoms105 while adding alginates (spontaneously done by many patients) to omeprazole 20 mg has been recently shown to improve symptom control 106…”

Management of the patient with incomplete response to PPI therapy

“…These data suggest that alginates have potential to reduce PPI resistant reflux by targeting the acid pocket. Manabe et al randomly assigned 76 NERD patients to omeprazole 20 mg daily or omeprazole plus sodium alginate [62]. Complete resolution of heartburn for at least 7 consecutive days by the end of 4 weeks treatment was significantly better in the group receiving the combination (57%) compared to omeprazole alone (26%).…”

The Role of the Acid Pocket in Gastroesophageal Reflux Disease

“…They found significantly more patients experienced resolution of heartburn for at least 7 consecutive days when taking the combination therapy, and this group had 54.9% heartburn-free days compared with 35.9% in the PPI only group over the 4-week period. 56 Alginate-antacid medications are a therapeutic option in the treatment of GERD. They can be used alongside PPIs in patients with refractory symptoms.…”