PT - JOURNAL ARTICLE AU - Andres Vales AU - Cathal Coyle AU - Kate Plehhova AU - Anthony Hobson AU - Philip Woodland TI - Randomised clinical trial: the use of alginates during preinvestigation proton pump inhibitor wash-out and their impact on compliance and symptom burden AID - 10.1136/bmjgast-2022-001026 DP - 2023 Jan 01 TA - BMJ Open Gastroenterology PG - e001026 VI - 10 IP - 1 4099 - http://bmjopengastro.bmj.com//content/10/1/e001026.short 4100 - http://bmjopengastro.bmj.com//content/10/1/e001026.full SO - BMJ Open Gastro2023 Jan 01; 10 AB - Background/aims Investigation 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.Methods Participants 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 results Data 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.Conclusions Structured 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 number EudraCT registration 2019-004561-41Data are available on reasonable request. Deidentified participant data are available in spreadsheet format on reasonable request. The study proposal has also been made available. Requests can be made to the first author—andres@thefunctionalgutclinic.com—Orcid ID 0000-0001-7774-310X. Reuse is permitted once the authors have approved and ensured any obligations (eg, Ethics committee guidelines etc) have been met and that the study is cited as the original source of the data.