title: Alginate controls heartburn in patients with erosive and nonerosive reflux disease.
abstract: OBJECTIVE
  To evaluate the effect of a novel alginate-based compound, Faringel, in modifying reflux characteristics and controlling symptoms.
  
  
  METHODS
  In this prospective, open-label study, 40 patients reporting heartburn and regurgitation with proven reflux disease (i.e., positive impedance-pH test/evidence of erosive esophagitis at upper endoscopy) underwent 2 h impedance-pH testing after eating a refluxogenic meal. They were studied for 1 h under basal conditions and 1 h after taking 10 mL Faringel. In both sessions, measurements were obtained in right lateral and supine decubitus positions. Patients also completed a validated questionnaire consisting of a 2-item 5-point (0-4) Likert scale and a 10-cm visual analogue scale (VAS) in order to evaluate the efficacy of Faringel in symptom relief. Tolerability of the treatment was assessed using a 6-point Likert scale ranging from very good (1) to very poor (6).
  
  
  RESULTS
  Faringel decreased significantly (P < 0.001), in both the right lateral and supine decubitus positions, esophageal acid exposure time [median 10 (25th-75th percentil 6-16) vs 5.8 (4-10) and 16 (11-19) vs 7.5 (5-11), respectively] and acid refluxes [5 (3-8) vs 1 (1-1) and 6 (4-8) vs 2 (1-2), respectively], but increased significantly (P < 0.01) the number of nonacid reflux events compared with baseline [2 (1-3) vs 3 (2-5) and 3 (2-4) vs 6 (3-8), respectively]. Percentage of proximal migration decreased in both decubitus positions (60% vs 32% and 64% vs 35%, respectively; P < 0.001). Faringel was significantly effective in controlling heartburn, based on both the Likert scale [3.1 (range 1-4) vs 0.9 (0-2); P < 0.001] and VAS score [7.1 (3-9.8) vs 2 (0.1-4.8); P < 0.001], but it had less success against regurgitation, based on both the Likert scale [2.6 (1-4) vs 2.2 (1-4); P = not significant (NS)] and VAS score [5.6 (2-9.6) vs 3.9 (1-8.8); P = NS]. Overall, the tolerability of Faringel was very good 5 (2-6), with only two patients reporting modest adverse events (i.e., nausea and bloating).
  
  
  CONCLUSIONS
  Our findings demonstrate that Faringel is well-tolerated and effective in reducing heartburn by modifying esophageal acid exposure time, number of acid refluxes and their proximal migration.
authors.affiliation: Division of Gastroenterology, Department of Internal Medicine, University of Genoa, 16126 Genoa, Italy. edoardo.savarino@gmail.com
authors.forename: Edoardo
authors.initials: E
authors.lastname: Savarino
authors.forename: Nicola
authors.initials: N
authors.lastname: de Bortoli
authors.forename: Patrizia
authors.initials: P
authors.lastname: Zentilin
authors.forename: Irene
authors.initials: I
authors.lastname: Martinucci
authors.forename: Luca
authors.initials: L
authors.lastname: Bruzzone
authors.forename: Manuele
authors.initials: M
authors.lastname: Furnari
authors.forename: Santino
authors.initials: S
authors.lastname: Marchi
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Savarino
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000464:Alginates / Q000009:adverse effects / Q000627:therapeutic use*; D000863:Antacids / Q000009:adverse effects / Q000627:therapeutic use*; D001688:Biological Products / Q000009:adverse effects / Q000627:therapeutic use; D017097:Electric Impedance; D050782:Esophageal pH Monitoring; D005260:Female; D005764:Gastroesophageal Reflux / Q000150:complications*; D020723:Glucuronic Acid / Q000009:adverse effects / Q000627:therapeutic use; D006356:Heartburn / Q000209:etiology* / Q000517:prevention & control*; D006603:Hexuronic Acids / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D008297:Male; D062407:Meals; D008875:Middle Aged; D011446:Prospective Studies; D012720:Severity of Illness Index; D017693:Sodium Bicarbonate / Q000009:adverse effects / Q000627:therapeutic use; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000464:Alginates; D000863:Antacids; D001688:Biological Products; D006603:Hexuronic Acids; C578753:faringel; D020723:Glucuronic Acid; D017693:Sodium Bicarbonate