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.
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.


OBJECTIVE
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).
Category Development Organisation, Reckitt Benckiser, Slough, UK.
E
E
Thomas
A
A
Wade
G
G
Crawford
B
B
Jenner
N
N
Levinson
J
J
Wilkinson
D000328:Adult; D000464:Alginates / Q000009:adverse effects / Q000627:therapeutic use*; D000536:Aluminum Hydroxide / Q000009:adverse effects / Q000627:therapeutic use*; D000863:Antacids / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D004415:Dyspepsia / Q000188:drug therapy; D005260:Female; D005764:Gastroesophageal Reflux / Q000188:drug therapy* / Q000503:physiopathology; D006356:Heartburn / Q000188:drug therapy / Q000209:etiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D012824:Silicic Acid / Q000009:adverse effects / Q000627:therapeutic use*; D017693:Sodium Bicarbonate / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D000464:Alginates; D000863:Antacids; D004338:Drug Combinations; D012824:Silicic Acid; D000536:Aluminum Hydroxide; C007829:alginate, aluminium hydroxide, magnesium trisilicate, sodium bicarbonate drug combination; D017693:Sodium Bicarbonate