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

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.