Clinical Trial: Treatment of Functional Dyspepsia According to Subtype Compared With Empirical Proton Pump Inhibitor

ABSTRACT Background International guidelines recommend contrasting initial treatment strategies for functional dyspepsia (FD). Aims To evaluate the efficacy and safety of treatment according to subtypes, compared with empirical proton pump inhibitor (PPI), in the initial treatment of FD. Methods We performed a single‐blinded, randomised controlled trial of adults with FD. In the intervention group (treatment according to subtype), patients were categorised into epigastric pain syndrome (treatment esomeprazole); postprandial distress syndrome (PDS; treatment itopride) and overlap (treatment itopride, maintain, add/or switch to esomeprazole at week 4). The control group received esomeprazole only. The primary efficacy outcome was the assessment of global symptom improvement (primary end point: best two points from the 7‐point Likert scale) over 8 weeks. Secondary outcomes included assessment of the change in nine individual upper gastrointestinal symptoms, quality of life (Short‐Form Nepean Dyspepsia Index) and adverse events. Results We randomised 180 patients (median age: 50; 68.7% female 56.7% PDS) 1:1 into intervention and control arms. The percentage of patients achieving the primary efficacy outcome were 74.4% and 72.2%, respectively ( p = 0.74). The improvement of individual symptoms in both groups were similar. The SF‐NDI improved after treatment in both groups ( p < 0.001) but there was no significant difference in the degree of change between groups. Rates of adverse events between groups were similar at week 8. Conclusion Initial treatment of FD according to subtype was not more effective than empirical PPI alone for up to 8 weeks. Further multicentre studies, with a larger sample size, are recommended to validate these findings. Trial Registration: ClinicalTrials.gov identifier: NCT04918017