title: Gaviscon® vs. omeprazole in symptomatic treatment of moderate gastroesophageal reflux. a direct comparative randomised trial.
abstract: BACKGROUND
  Medical management of GERD mainly uses proton pump inhibitors. Alginates also have proven efficacy. The aim of this trial was to compare short-term efficacy of an alginate (Gaviscon®, 4 × 10 mL/day) and omeprazole (20 mg/day) on GERD symptoms in general practice.
  
  
  METHODS
  A 14-day multicentre randomised double-blind double-dummy non-inferiority trial compared Gaviscon® (4 × 10 mL/day) and omeprazole (20 mg/day) in patients with 2-6 day heartburn episodes weekly without alarm signals. The primary outcome was the mean time to onset of the first 24-h heartburn-free period after initial dosing. Secondary outcomes were the proportion of patients without heartburn by D7, pain relief by D7, and reduction in pain intensity by D7 and D14.
  
  
  RESULTS
  278 patients were recruited; 120 were included in the Gaviscon® group and 121 in the omeprazole group for the per protocol non-inferiority analysis. The mean time to onset of the first 24-h heartburn-free period after initial dosing was 2.0 (± 2.2) days for Gaviscon® and 2.0 (± 2.3) days for omeprazole (p = 0.93); mean intergroup difference was 0.01 ± 1.55 days (95% CI = -0.41 to 0.43): i.e., less than the lower limit of the 95% CI of -0.5 days predetermined to demonstrate non-inferiority. The mean number of heartburn-free days by D7 was significantly greater in the omeprazole group: 3.7 ± 2.3 days vs. 3.1 ± 2.1 (p = 0.02). On D7, overall quality of pain relief was slightly in favour of omeprazole (p = 0.049). There was no significant difference in the reduction in pain intensity between groups by D7 (p = 0.11) or D14 (p = 0.08). Tolerance and safety were good and comparable in both groups.
  
  
  CONCLUSIONS
  Gaviscon® was non-inferior to omeprazole in achieving a 24-h heartburn-free period in moderate episodic heartburn, and is a relevant effective alternative treatment in moderate GERD in primary care.
  
  
  BACKGROUND
  ISRCTN62203233.
authors.affiliation: Département de Médecine Générale, Université François Rabelais, Faculté de Médecine, 10 Boulevard Tonnellé, BP 3223, 6 Rue du Docteur Lebel 94300, Vincennes 37032, Tours Cedex 1, France. denis.pouchain@univ-tours.fr
authors.forename: Denis
authors.initials: D
authors.lastname: Pouchain
authors.forename: Marc-André
authors.initials: MA
authors.lastname: Bigard
authors.forename: François
authors.initials: F
authors.lastname: Liard
authors.forename: Marc
authors.initials: M
authors.lastname: Childs
authors.forename: Annick
authors.initials: A
authors.lastname: Decaudin
authors.forename: Donna
authors.initials: D
authors.lastname: McVey
mesh_terms: D000293:Adolescent; D000328:Adult; D000464:Alginates / Q000009:adverse effects / Q000627:therapeutic use*; D000536:Aluminum Hydroxide / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005764:Gastroesophageal Reflux / Q000188:drug therapy* / Q000517:prevention & control; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000009:adverse effects / Q000627:therapeutic use*; D054328:Proton Pump Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D012720:Severity of Illness Index; D012824:Silicic Acid / Q000009:adverse effects / Q000627:therapeutic use*; D017693:Sodium Bicarbonate / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000464:Alginates; D004338:Drug Combinations; D054328:Proton Pump Inhibitors; D012824:Silicic Acid; D000536:Aluminum Hydroxide; C007829:alginate, aluminium hydroxide, magnesium trisilicate, sodium bicarbonate drug combination; D017693:Sodium Bicarbonate; D009853:Omeprazole