title: Fixed combination of hyaluronic acid and chondroitin-sulphate oral formulation in a randomized double blind, placebo controlled study for the treatment of symptoms in patients with non-erosive gastroesophageal reflux.
abstract: BACKGROUND
  Proton pump inhibitors (PPIs) are a major breakthrough in the medical management of gastroesophageal reflux disease (GERD). In several patients with non erosive reflux disease symptoms (NERD) the response to PPIs is partial or limited and symptoms relief needs the administration of additional medications.
  
  
  OBJECTIVE
  The aim of this study was to evaluate the effect of a new medical device, based on an oral fixed combination of hyaluronic acid and chondroitin-sulphate (HA+CS), in a bioadhesive carrier, in adults with symptoms of non erosive gastroesophageal reflux and with a low response to PPIs.
  
  
  METHODS
  Twenty patients who had experienced heartburn and/or acid regurgitation for at least 3 days during a 7 day run-in period, without endoscopic mucosal breaks, were randomized in a double blind crossover study to receive four daily doses of a fixed oral combination of HA+CS and placebo for 14 days. Relief of cardinal symptoms of GERD was evaluated at the end of each period.
  
  
  RESULTS
  A significant greater Sum of Symptoms Intensity Difference, compared to placebo, was observed after HA+CS treatment (-2.7 vs 0.5 - p < 0.01), being both heartburn (-1.6 vs 0.5 - p < 0.03) and acid regurgitation (-1.1 vs 0.1 - p < 0.03) significantly improved by the medical device. A speed of action ≤ 30 min was significantly more frequently reported by patients during HA+CS administration than with placebo (60% vs 30% - p = 0.05). Total disappearance of symptoms was observed in 50% of the patients compared to 10% during placebo administration (p = 0.01 between group comparison).
  
  
  CONCLUSIONS
  A fixed combination of HA+CS has demonstrated to be effective in gastroesophageal reflux control, with a rapid onset of action.
authors.affiliation: Department of Surgery, School of Medicine, University of Modena, Modena, Italy. palmieri@unimo.it.
authors.forename: B
authors.initials: B
authors.lastname: Palmieri
authors.forename: A
authors.initials: A
authors.lastname: Merighi
authors.forename: D
authors.initials: D
authors.lastname: Corbascio
authors.forename: V
authors.initials: V
authors.lastname: Rottigni
authors.forename: G
authors.initials: G
authors.lastname: Fistetto
authors.forename: A
authors.initials: A
authors.lastname: Esposito
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D016009:Chi-Square Distribution; D002809:Chondroitin Sulfates / Q000008:administration & dosage*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004338:Drug Combinations; D004359:Drug Therapy, Combination; D005260:Female; D005764:Gastroesophageal Reflux / Q000175:diagnosis / Q000188:drug therapy*; D005765:Gastrointestinal Agents / Q000008:administration & dosage*; D006635:Histamine H2 Antagonists / Q000008:administration & dosage; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage*; D007558:Italy; D008297:Male; D008875:Middle Aged; D054328:Proton Pump Inhibitors / Q000008:administration & dosage; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D004338:Drug Combinations; D005765:Gastrointestinal Agents; D006635:Histamine H2 Antagonists; D054328:Proton Pump Inhibitors; C501944:chondroitin sulfate, sodium hyaluronate drug combination; D006820:Hyaluronic Acid; D002809:Chondroitin Sulfates