Gaviscon® vs. omeprazole in symptomatic treatment of moderate gastroesophageal reflux. a direct comparative randomised trial

Abstract

BackgroundMedical 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.MethodsA 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.Results278 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.ConclusionGaviscon® 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.Trial registrationISRCTN62203233.

Evidence-based clinical practice guidelines for gastroesophageal reflux disease 2015

“…Comment: The significant inhibition effect of sodium alginate for GER has been demonstrated [60][61][62], and the drug is effective for GERD symptoms [63][64][65][66]. However, to achieve effective results, it is necessary to use the drug more than four times a day.…”

“…PPIs are more cost-effective for the J Gastroenterol (2016) 51:751-767 757 treatment of GERD than H2RAs or step-up therapy starting from H2RA [72,73]. PPIs have a superior effect in terms of heartburn symptom relief over H2RAs or alginate for the treatment of GERD diagnosed by symptoms [66,74]. PPIs have a superior effect in terms of heartburn symptom relief than H2RAs or prokinetic drugs for the treatment of nonerosive GERD [75].…”

The Role of the Acid Pocket in Gastroesophageal Reflux Disease

“…However, the omeprazole group had significantly more heartburn-free days by the end of the first week and self-assessed pain relief was better. 55 There is a possible role for these medications in the treatment of refractory GERD. A prospective randomized clinical trial from Japan evaluated the symptomatic response to sodium alginate combined with omeprazole 20 mg daily compared with PPI alone.…”

Medical Therapy of Gastroesophageal Reflux Disease Beyond Proton Pump Inhibitors: Where Are We Heading

“…Another suggested option is the administration of alginates, an anionic polysaccharide occurring naturally in brown algae, which are only slightly inferior to omeprazole in less severe forms of GERD [22]. Theoretically, the acid pocket would be an ideal target for this compound since alginates accumulate just below the esophagogastric junction creating a foam layer above the gastric content.…”