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Aliment Pharmacol Ther. 2017 Jun;45(12):1524-1533. doi: 10.1111/apt.14064. Epub 2017 May 2.

Randomised clinical trial: addition of alginate-antacid (Gaviscon Double Action) to proton pump inhibitor therapy in patients with breakthrough symptoms.

Author information

1
RB, Slough, Berkshire, UK.
2
CPS Research, Glasgow, UK.
3
Zealand University Hospital, University of Copenhagen, Copenhagen, Denmark.

Erratum in

Abstract

BACKGROUND:

Symptomatic breakthrough in proton pump inhibitor (PPI)-treated gastro-oesophageal reflux disease (GERD) patients is a common problem with a range of underlying causes. The nonsystemic, raft-forming action of alginates may help resolve symptoms.

AIM:

To assess alginate-antacid (Gaviscon Double Action, RB, Slough, UK) as add-on therapy to once-daily PPI for suppression of breakthrough reflux symptoms.

METHODS:

In two randomised, double-blind studies (exploratory, n=52; confirmatory, n=262), patients taking standard-dose PPI who had breakthrough symptoms, assessed by Heartburn Reflux Dyspepsia Questionnaire (HRDQ), were randomised to add-on Gaviscon or placebo (20 mL after meals and bedtime). The exploratory study endpoint was change in HRDQ score during treatment vs run-in. The confirmatory study endpoint was "response" defined as ≥3 days reduction in the number of "bad" days (HRDQ [heartburn/regurgitation] >0.70) during treatment vs run-in.

RESULTS:

In the exploratory study, significantly greater reductions in HRDQ scores (heartburn/regurgitation) were observed in the Gaviscon vs placebo (least squares mean difference [95% CI] -2.10 [-3.71 to -0.48]; P=.012). Post hoc "responder" analysis of the exploratory study also revealed significantly more Gaviscon patients (75%) achieved ≥3 days reduction in "bad" days vs placebo patients (36%), P=.005. In the confirmatory study, symptomatic improvement was observed with add-on Gaviscon (51%) but there was no significant difference in response vs placebo (48%) (OR (95% CI) 1.15 (0.69-1.91), P=.5939).

CONCLUSIONS:

Adding Gaviscon to PPI reduced breakthrough GERD symptoms but a nearly equal response was observed for placebo. Response to intervention may vary according to whether symptoms are functional in origin.

PMID:
28464343
DOI:
10.1111/apt.14064
[Indexed for MEDLINE]
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