Gaviscon® vs. Omeprazole in Symptomatic Treatment of Moderate Gastroesophageal Reflux

A Direct Comparative Randomised Trial

Denis Pouchain; Marc-André Bigard; François Liard; Marc Childs; Annick Decaudin; Donna McVey

Disclosures

BMC Gastroenterol. 2012;12(18) 

In This Article

Background

In Western countries, 20% to 40% of adults suffer from episodes of heartburn due to gastroesophageal reflux disease (GERD).[1] In France, a questionnaire study of 8,000 adults representative of the general population found a 31.3% prevalence of GERD symptoms. GERD was moderate (symptoms at least once a week) in 7.8% of cases (6% in under-50 year-olds, 10% in over-50s).[2] Most (86%) moderate GERD sufferers had consulted for their symptoms, but 26% had delayed for more than one year, usually because they were not worried and/or were self-medicating. Treatment was monotherapy in two-thirds of cases: proton pump inhibitors (PPI) in 45% of cases, and antacids or alginates in 46%. Treatment was judged satisfactory by two-thirds of patients.[2]

The efficacy of PPIs in symptomatic treatment of heartburn without esophagitis is well established.[3,4] The level of evidence is weaker for alginates (raft-forming oral suspensions/formulations), as the old comparative trials were on small samples: 286 patients overall in six trials vs. placebo.[5–9] Moreover, symptomatic efficacy is hard to assess for alginates, as formulae differ from country to country, with floating gel resistance varying by a factor of three.[10,11]

In case of GERD symptoms without esophagitis on endoscopy or where endoscopy is not considered necessary (esophagitis prevalence in the general population not exceeding 2%),[1] treatment aims at rapid relief of symptoms (heartburn, acid regurgitation).

There have been no studies with a modern scientific double-blind, double-dummy design directly comparing one alginate to a PPI with heartburn as the primary clinical endpoint. We therefore performed a trial called "Gaviscon® vs. Omeprazole in symptOmatic treatment of moDerate gastroesophageal reflux" (GOOD), the aim of which was to compare short-term symptomatic efficacy and safety between an alginate (Gaviscon®, 4 × 10 mL/day) and a PPI (omeprazole 20 mg/day) in moderate GERD in a general practice setting.

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