Randomised clinical trial: the use of alginates during preinvestigation proton pump inhibitor wash-out and their impact on compliance and symptom burden

Abstract

Background/aimsInvestigation of gastro-oesophageal reflux disease is usually performed off proton pump inhibitors (PPIs). This can exacerbate symptoms, potentially impacting investigation accuracy if patients circumvent the preinvestigation instructions. There are no standard recommendations on how to manage PPI withdrawal. We aimed to assess the impact of structured alginate use on symptom burden.MethodsParticipants were already established on ≥4 weeks of PPI therapy and being referred for manometry and 24-hour pH/impedance testing. Preinvestigation instructions involved stopping PPIs and H2 receptor antagonists for 1 week, but antacids and alginates were allowed until the night before. Participants were randomised to follow these standard instructions (control group), or the same instructions with the provision of Gaviscon Advance to be taken four times daily (treatment group). The primary outcome assessed change in Gastro-Oesophageal Reflux Disease Health-Related Quality of Life Score.Key resultsData for 48 patients were available for primary outcome assessment. While patients in the control group had a significant increase in symptoms (median difference 6.5, 95% CI (1 to 7), p=0.04), no change occurred in the treatment arm (median difference -1.5, 95% CI (-2, 3.5), p=0.54). There were no serious adverse events.ConclusionsStructured alginate use prevents symptom exacerbation during preinvestigation PPI wash-out. These findings are limited to the 1-week wash-out period but can benefit thousands of patients undergoing investigation for gastro-oesophageal reflux each year. Further research is required to assess this effect in other settings, such as sustained PPI deprescription. The trial was funded by Reckitt Benckiser.Trial registration numberEudraCT registration 2019-004561-41

Optimising reflux symptom burden and patient compliance during PPI washout periods for oesophageal pH monitoring studies: should we be more proactive with alginate use?

“… 1 These findings suggest that a proactive introduction of alginates during preinvestigation PPI washout periods can be successful in alleviating patient reflux symptoms. 1 …”

“…1 Interestingly, while those who were assigned to a control group experienced a significant exacerbation of symptoms after stopping PPI therapy, those who received four daily doses of Gaviscon Advance (treatment group) had no significant increase in symptoms. 1 These findings suggest that a proactive introduction of alginates during preinvestigation PPI washout periods can be successful in alleviating patient reflux symptoms. 1 The main limitation of this trial is that the baseline Gastroesophageal Reflux Disease-Health Related Quality of Life scores were different in the two groups, with a higher symptom severity and reflux burden in those that were in the structured alginate (treatment) group.…”

“…In this edition of BMJ Open Gastroenterology, an important randomised clinical trial by Vales et al has investigated the structured use of alginates during preinvestigation proton pump inhibitor (PPI) washout to aid compliance and alleviate symptom burden. 1 …”

“…Importantly, as alginates do not affect production of acid, they can be ingested up to the night before the test. 1 In the Vales et al clinical trial, 60 participants were investigated with oesophageal 24-hour pH/impedance testing having been established on PPI medication for 4 weeks or more. PPIs and H2 receptor antagonists were stopped a week prior to the investigation; however, antacids and alginates could be used up to the night before.…”

“…In this edition of BMJ Open Gastroenterology, an important randomised clinical trial by Vales et al has investigated the structured use of alginates during preinvestigation proton pump inhibitor (PPI) washout to aid compliance and alleviate symptom burden. 1 Under normal circumstances, 24-hour oesophageal pH/impedance monitoring requires patients to stop taking their PPI at least a week prior to the investigation in order to accurately measure their normal acid levels. 2 Unfortunately, it is often difficult for patients to abstain from PPIs for fear of exacerbating their reflux symptoms, which is known to occur due to rebound acid hypersecretion after PPI withdrawal.…”