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Randomized Controlled Trial Multicenter Study
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, Lars Agréus, Nikolaos Mastellos, Grzegorz Bliźniuk, Dorota Waśko-Czopnik, Agapi Angelaki, Eirini Theodosaki, Christos Lionis, Karin Hek, Robert Verheij, Ellen Wright, Stevo Durbaba, Jean Muris, Piotr Bródka, Stanislaw Saganowski, Jean-Francois Ethiér, Vasa Curcin, and Brendan Delaney.
- Division of Psychobiology and Epidemiology, Department of Psychology, Stockholm University, Stockholm, Sweden.
- Ann. Med. 2024 Dec 1; 56 (1): 23546832354683.
ObjectivesThis 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.MethodsThirty-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.ResultsA 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).ConclusionIn 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.
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