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Summary   Background  Several studies have shown that patients with non‐erosive reflux disease ( NERD ) are less responsive to proton pump inhibitors ( PPI s) than those with erosive disease as they belong to different subgroups, in whom factors other than acid can trigger symptoms.    Aim  To evaluate whether combined therapy (mucosal protection plus acid suppression) would improve symptom relief compared to  PPI  treatment alone.    Methods  In a multicenter, randomised, double‐blind trial, 154 patients with  NERD  were randomised to receive Esoxx (Alfa Wassermann, Bologna, Italy), a hyaluronic acid‐chondroitin sulphate based bioadhesive formulation, or placebo, in addition to acid suppression with standard dose  PPI s for 2 weeks. Symptoms (heartburn, acid regurgitation, retrosternal pain and acid taste in the mouth) and health‐related quality of life ( HRQL ) were evaluated before and after treatment. The primary endpoint was the proportion of patients with at least a 3‐point reduction in the total symptom score.    Results  At the end of treatment, the primary endpoint was reached by 52.6% of patients taking Esoxx compared to 32.1% of those given placebo ( P  < 0.01). The same was true also for  HRQL , evaluated by means of the Short Form‐36 questionnaire, which improved with both treatments, but some items were significantly better after Esoxx plus  PPI  therapy.    Conclusion  The synergistic effect of Essox with PPI treatment suggests that mucosal protection added to acid suppression could improve symptoms and HRQL in NERD patients.

alimentary pharmacology and therapeutics

Randomised clinical trial: mucosal protection combined with acid suppression in the treatment of non‐erosive reflux disease – efficacy of Esoxx, a hyaluronic acid–chondroitin sulphate based bioadhesive formulation