Real-world study on efficacy and safety of pancreatin enteric-coated capsules in treatment of postprandial distress syndrome in older patients

Abstract Background: Functional dyspepsia is common among older adults, with postprandial distress syndrome (PDS) as the main subtype. Clinical guidelines recommend prokinetic agents as first-line treatment for symptom relief of PDS. However, concerns over side effects limit their application with older patients. We investigated the efficacy and safety of pancreatin in treating older PDS patients. Methods: In this multicenter, real-world study, 175 older patients (age ≥ 60 years) diagnosed with PDS were divided into three groups: itopride monotherapy (56 patients), pancreatin enteric-coated capsule (PECC) monotherapy (62 patients), and combination therapy with PECC and itopride (57 patients). We compared the efficacy and safety of the treatments over a 2-week period, with follow-up 2 weeks post-treatment. The primary outcome was symptom improvement, change in Leuven postprandial distress scale (LPDS) score. Secondary outcomes were percentage changes in patient anxiety (generalized anxiety disorder-7 [GAD-7]) and depression (patient health questionnaire-9 [PHQ-9]) scores and adverse event incidence. Results: Baseline characteristics were similar among groups ( P > 0.05). All groups experienced symptom relief from day 1 of treatment, with significant improvement through weeks 1 and 2 ( P < 0.05). Changes in LPDS scores were not significantly different between the treatment groups at any time point. Average PHQ-9 scores for all groups decreased during treatment and stabilized after discontinuation. GAD-7 scores also significantly decreased then remained stable, with no significant difference among groups. No treatment-related adverse events were observed. Conclusion: PECC monotherapy effectively and safely treats PDS, with efficacy comparable to itopride monotherapy and combination therapy with pancreatin and itopride.