Randomized trial in postprandial functional dyspepsia: Reassurance and diagnostic explanation with or without traditional dietary advice.

Background: Almost 80% of individuals with functional dyspepsia experience meal-related symptoms and are diagnosed with postprandial distress syndrome (PDS). However, studies evaluating dietary modifications in PDS are sparse. We performed a single-center randomized trial comparing reassurance and diagnostic explanation (RADE) with or without traditional dietary advice (TDA) in PDS.

Methods: Following a normal upper gastrointestinal endoscopy, individuals with PDS were randomized to a leaflet providing RADE ± TDA; the latter recommending small, regular meals and reducing the intake of caffeine/alcohol/fizzy drinks and high-fat/processed/spicy foods. Questionnaires were completed over 4 weeks, including self-reported adequate relief of dyspeptic symptoms, and the validated Leuven Postprandial Distress Scale (LPDS), Gastrointestinal Symptom Rating Scale, and Nepean Dyspepsia Index for quality of life. The primary endpoint(s) to define clinical response were (i) ≥50% adequate relief of dyspeptic symptoms and (ii) >0.5-point reduction in the PDS subscale of the LPDS (calculated as the mean scores for early satiety, postprandial fullness, and upper abdominal bloating).

Key Results: Of the 53 patients with PDS, 27 were assigned RADE-alone and 26 to additional TDA. Baseline characteristics were similar between groups, with a mean age of 39 years, 70% female, 83% white British, and coexistent irritable bowel syndrome in 66%. The primary endpoints of (i) adequate relief of dyspeptic symptoms were met by 33% (n = 9) assigned RADE-alone versus 39% (n = 10) with TDA; p-value = 0.70, while (ii) a reduction of >0.5 points in the PDS subscale was met by 37% (n = 10) assigned RADE-alone versus 27% (n = 7) with TDA; p-value = 0.43. Response rates did not differ according to irritable bowel syndrome status. There were no significant between-group changes in the gastrointestinal symptom rating scale and dyspepsia quality of life.

Conclusions & Inferences: This study of predominantly white British patients with PDS found the addition of TDA did not lead to significantly greater symptom reduction compared with RADE alone. Alternate dietary strategies should be explored in this cohort.