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

Abstract

SummaryBackgroundSeveral studies have shown that patients with non‐erosive reflux disease (NERD) are less responsive to proton pump inhibitors (PPIs) than those with erosive disease as they belong to different subgroups, in whom factors other than acid can trigger symptoms.AimTo evaluate whether combined therapy (mucosal protection plus acid suppression) would improve symptom relief compared to PPI treatment alone.MethodsIn 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 PPIs 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.ResultsAt 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.ConclusionThe synergistic effect of Essox with PPI treatment suggests that mucosal protection added to acid suppression could improve symptoms and HRQL in NERD patients.

Medical devices that look like medicines: safety and regulatory concerns for children in Europe

“…HACSPol is promoted for mucosal repair and relief of GORD symptoms 17. Clinical documentation is poor and limited to adults treated for 2 weeks add-on to proton pump inhibitors (PPIs), mixing naïve and PPI-resistant patients, with Vaseline oil in water as placebo 48 49. There are no data comparing HACSPol with PPIs or the single ingredients (justifying the combination), nor data on use beyond 2 weeks.…”

Review of emerging therapy in refractory GERD- an evidence based approach

“…The main objective of the study was to confirm the effectiveness and safety profile of this medical device in combination with PPIs versus acid suppression alone in patient presented with positive NERD cases with Endoscopy negative reflux disease 16 The results have found that HA+CS combination along with PPI was able to relieve the symptoms with significant improvement in quality of life in comparison to administering PPI therapy alone. 18 In the nutshell, this study demonstrated that when NERD patients were given a combination of medication (mucosal protective agent + PPI), the outcome was much better in terms of relieving severity of the symptoms like heartburn & regurgitation when compared to only PPI therapy. Moreover almost 92% of the patient gave positive feedback on palatability & safety of the treatment, irrespective of the time of the dosage.…”

<p>Evaluation of Human Esophageal Epithelium Permeability in Presence of Different Formulations Containing Hyaluronic Acid and Chondroitin Sulphate</p>

“…13 More recently, a prospective double-blind placebo-controlled trial conducted in several Italian centres showed that the combination of a PPI + HA-CS in syrup was able to relieve symptoms and improve the quality of life more than a PPI alone. 14 A recent open-label uncontrolled study showed that administration of orodispersible tablets containing CS, aluminium hydroxide and HA improves non-erosive GERD clinical typical and atypical symptoms and gastric juice-related biochemical parameters (eg, neutrophil, lymphocyte, eosinophil, parietal cells, red blood cells and exudate protein counts). 15 Recently, 3D tissue models have been adopted in the field of medical devices for the evaluation of potential irritation and sensitization by medical device extracts on the skin.…”