Randomised clinical trial: relief of upper gastrointestinal symptoms by an acid
pocket-targeting alginate-antacid (Gaviscon Double Action) - a double-blind,
placebo-controlled, pilot study in gastro-oesophageal reflux disease.
Author(s): Thomas E(1), Wade A, Crawford G, Jenner B, Levinson N, Wilkinson J.
Affiliation(s): Author information:
(1)Category Development Organisation, Reckitt Benckiser, Slough, UK.
Publication date & source: 2014, Aliment Pharmacol Ther. , 39(6):595-602
BACKGROUND: The alginate-antacid, Gaviscon Double Action (Gaviscon DA; Reckitt
Benckiser, Slough, UK) suppresses reflux after meals by creating a gel-like
barrier that caps and displaces the acid pocket distal to the oesophago-gastric
junction. The effect of Gaviscon DA on reflux and dyspepsia symptoms has not yet
been demonstrated with a modern trial design.
AIM: A pilot study to assess the efficacy and safety of Gaviscon DA compared with
matched placebo for decreasing upper gastrointestinal symptoms in symptomatic
gastro-oesophageal reflux disease (GERD) patients.
METHODS: A randomised, double-blind, parallel group study was performed in 110
patients with symptoms of GERD. Patients received Gaviscon DA or placebo tablets
for 7 consecutive days. The primary endpoint compared the change in overall
Reflux Disease Questionnaire (RDQ) symptom score (combined
heartburn/regurgitation/dyspepsia). Secondary endpoints assessed individual
dimensions, GERD dimension (heartburn and regurgitation) and overall treatment
evaluation (OTE).
RESULTS: There was a greater decrease in overall RDQ symptom score in the
Gaviscon DA group compared with the placebo group (Least Squares Mean difference
-0.55; P = 0.0033), and for each of the dimensions independently. Patients in the
Gaviscon DA group evaluated their overall treatment response higher than patients
in the placebo group [mean (standard deviation) OTE 4.1 (2.44) vs. 1.9 (3.34);
P = 0.0005]. No differences in the incidence of adverse events were observed
between treatment groups.
CONCLUSIONS: Gaviscon DA decreases reflux and dyspeptic symptoms in GERD patients
compared with matched placebo and has a favourable benefit-risk balance. Larger
scale clinical investigations of medications targeting the acid pocket are
warranted. (EudraCT, 2012-002188-84).
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