Randomised clinical trial: the effectiveness of Gaviscon Advance vs non-alginate antacid in suppression of acid pocket and post-prandial reflux in obese individuals after late-night supper

Aliment Pharmacol Ther. 2020 Jun;51(11):1014-1021. doi: 10.1111/apt.15746. Epub 2020 Apr 28.

Abstract

Background: Late-night supper increases the risk of postprandial reflux from the acid pocket especially in obesity. An alginate-based, raft-forming medication may be useful for obese patients with GERD.

Aims: To compare the efficacy of Gaviscon Advance (Reckitt Benckiser, UK) and a non-alginate antacid in post-supper suppression of the acid pocket and post-prandial reflux among obese participants.

Methods: Participants underwent 48 h wireless and probe-based pH-metry recording of the acid pocket and lower oesophagus, respectively, and were randomised to single post-supper (10 pm) dose of either Gaviscon Advance or a non-alginate antacid on the second night. Primary outcomes were suppression of median pH of acid pocket and lower oesophagus, measured every 10-minutes post-supper for 1 h. Secondary outcomes were suppression of % time pH < 4 at lower oesophagus and improvement in frequency and visual analogue score (VAS) of regurgitation.

Results: Of the 81 screened participants, 55 were excluded and 26 (mean age 33.5 years, males 77.8% and BMI 32.8 kg/m2 ) were randomised to Gaviscon Advance (n = 13) or antacid (n = 13). Median pH of the acid pocket but not the lower oesophagus was suppressed with Gaviscon Advance vs antacid (all P < 0.04) Gaviscon Advance but not antacid significantly reduced in % time pH < 4, symptom frequency and VAS on day 2 vs day 1 (all P < 0.05).

Conclusions: Among obese individuals, Gaviscon Advance was superior to a non-alginate antacid in post-supper suppression of the acid pocket. (Clinical trial registration unique identifier: NCT03516188).

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Alginates / therapeutic use*
  • Aluminum Hydroxide / therapeutic use*
  • Antacids / therapeutic use*
  • Anti-Ulcer Agents / therapeutic use
  • Drug Combinations
  • Female
  • Gastric Acid / metabolism
  • Gastroesophageal Reflux / drug therapy*
  • Humans
  • Hydrogen-Ion Concentration
  • Malaysia
  • Male
  • Meals* / drug effects
  • Middle Aged
  • Obesity
  • Postprandial Period / drug effects
  • Silicic Acid / therapeutic use*
  • Sodium Bicarbonate / therapeutic use*
  • Time Factors
  • Treatment Outcome
  • Young Adult

Substances

  • Alginates
  • Antacids
  • Anti-Ulcer Agents
  • Drug Combinations
  • Silicic Acid
  • Aluminum Hydroxide
  • alginate, aluminium hydroxide, magnesium trisilicate, sodium bicarbonate drug combination
  • Sodium Bicarbonate

Associated data

  • ClinicalTrials.gov/NCT03516188