Background/Aims: This multi-center study in Japan aimed to clarify whether any significant differences in clinical characteristics and symptoms exist between patients with functional dyspepsia (FD) and those with refractory FD, that is, FD with pancreatic enzyme abnormalities (FDP), and determine the severity of the pancreatic enzyme abnormalities affecting FD symptoms or exocrine pancreatic dysfunction by comparing relevant factors.
Methods: In total, 111 consecutive patients who presented with FD (n＝46) or FD-P (n＝42) based on Rome III classification and 23 controls were recruited from four institutions in Japan. Their clinical characteristics and clinical symptoms were assessed using questionnaires. We measured the levels of five pancreatic enzymes (amylase, lipase, trypsin, phospholipase A2, and elastase-1) in the sera of the patients with FD and FD-P. Pancreatic exocrine function was analyzed using N-benzoyl-L-tyrosyl-p-aminobenzoic acid (BT-PABA). Patients with FD-P (n＝19) consented and underwent endosonography (Olympus EUS-UCT 260 convex scanning endosonography).
Results: No significant differences were noted in age, sex or body mass index (BMI) between patients with FD and FD-P. An abnormal trypsin level was the most prevalent change in the pancreatic enzymes of patients with FD-P. Severe pancreatic enzyme abnormalities in more than four of the tested pancreatic enzymes were observed in approximately 13％ of patients with FD-P. The triglyceride concentration was higher in patients with FD-P than in those with FD. Conversely, no significant association was detected among the presence of exocrine pancreatic dysfunction, pancreatic enzyme abnormalties, and clinical symptoms in patients with FD-P.
Conclusions: Trypsin level is a useful marker for distinguishing FD from FD-P. Further studies are warranted to clarify whether the severity of pancreatic enzyme abnormalities and exocrine pancreatic dysfunction affect the pathophysiology of patients with FD-P.