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Randomized Controlled Trial
. 2024 Dec;56(1):2354683.
doi: 10.1080/07853890.2024.2354683. Epub 2024 May 16.

Effect of on-demand vs continuous prescription of proton pump inhibitors on symptom burden and quality of life: results of a real-world randomized controlled trial in primary care patients with gastroesophageal reflux disease

Anna Andreasson  1   2   3 , Lars Agréus  4 , Nikolaos Mastellos  5 , Grzegorz Bliźniuk  6 , Dorota Waśko-Czopnik  7 , Agapi Angelaki  8 , Eirini Theodosaki  8 , Christos Lionis  8 , Karin Hek  9 , Robert Verheij  9   10   11 , Ellen Wright  12 , Stevo Durbaba  12 , Jean Muris  13 , Piotr Bródka  14 , Stanislaw Saganowski  14 , Jean-Francois Ethiér  15 , Vasa Curcin  16 , Brendan Delaney  17
Affiliations
Randomized Controlled Trial

Effect of on-demand vs continuous prescription of proton pump inhibitors on symptom burden and quality of life: results of a real-world randomized controlled trial in primary care patients with gastroesophageal reflux disease

Anna Andreasson et al. Ann Med. 2024 Dec.

Abstract

Objectives: This study aimed to assess the impact of on-demand versus continuous prescribing of proton pump inhibitors (PPIs) on symptom burden and health-related quality of life in patients with gastroesophageal reflux disease (GERD) presenting to primary care.

Methods: Thirty-six primary care centres across Europe enrolled adult GERD patients from electronic health records. Participants were randomised to on-demand or continuous PPI prescriptions and were followed for 8 weeks. PPI intake, symptom burden, and quality of life were compared between the two groups using mixed-effect regression analyses. Spearman's correlation was used to assess the association between changes in PPI dose and patient-reported outcomes.

Results: A total of 488 patients (median age 51 years, 58% women) completed the initial visit, with 360 attending the follow-up visit. There was no significant difference in PPI use between the continuous and on-demand prescription groups (b=.57, 95%CI:0.40-1.53), although PPI use increased in both groups (b = 1.33, 95%CI:0.65 - 2.01). Advice on prescribing strategy did not significantly affect patient-reported outcomes. Both symptom burden (Reflux Disease Questionnaire, b=-0.61, 95%CI:-0.73 - -0.49) and quality of life (12-item Short Form Survey physical score b = 3.31, 95%CI:2.17 - 4.45) improved from baseline to follow-up in both groups. Increased PPI intake correlated with reduced reflux symptoms (n = 347, ρ=-0.12, p = 0.02) and improved quality of life (n = 217, ρ = 0.16, p = 0.02).

Conclusion: In real-world settings, both continuous and on-demand PPI prescriptions resulted in similar increases in PPI consumption with no difference in treatment effects. Achieving an adequate PPI dose to alleviate reflux symptom burden improves quality of life in GERD patients. EudraCT number 2014-001314-25.

Keywords: continuous use; gastroesophageal reflux disease; on-demand use; proton pump inhibitors; quality of life; randomized controlled trial; self-rated health.

Plain language summary

Continuous and on-demand prescription increase in proton pump inhibitor consumption equally in real-world settings and did not result in different outcomes.Reaching a sufficient dose of proton pump inhibitor to reduce reflux symptom burden improves quality of life in patients with gastroesophageal reflux disease.

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Figures

Figure 1.
Figure 1.
CONSORT flow chart.
Figure 2.
Figure 2.
PPI use (tablets per week) at baseline and follow up between treatment allocations. PPI = proton pump inhibitors.
Figure 3.
Figure 3.
Reflux symptom burden at baseline and follow-up between treatment allocations.
See this image and copyright information in PMC

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