Validation of the Leuven Epigastric Pain Syndrome Scale in Patients With Epigastric Pain

BACKGROUND: Functional dyspepsia (FD) is a highly prevalent disorder of gut-brain interaction (DGBI) characterized by symptoms of postprandial distress or epigastric pain/burning. To measure symptom severity in FD, recently the Leuven postprandial distress scale (LPDS) was validated for postprandial distress symptoms. However, validated questionnaires for epigastric pain and burning, the cardinal symptoms of the epigastric pain syndrome (EPS), are currently lacking. AIM: The aim of this study was to validate the Leuven Epigastric Pain Syndrome scale for epigastric pain and epigastric burning in FD. METHODS: We used baseline and therapy data from treatment studies in patients with FD from the University Hospital of UZ Leuven. Only patients fulfilling the Rome IV criteria for EPS or PDS-EPS overlap were selected. For the Leuven Epigastric Pain Syndrome (LEPS) scale, the mean of the epigastric burning and epigastric pain question of the diary (Likert scale, 0-4, absent to very severe) was used. The correlation of the difference in LEPS before and after treatment with validated anchor questionnaires, including Patient Assessment of Upper Gastrointestinal Disorders Symptoms Questionnaire (PAGI-SYM) total, PAGI-SYM upper abdominal pain, PAGI-SYM heartburn, overall symptom severity (OSS), and overall treatment evaluation (OTE), was evaluated. PAGI-SYM upper abdominal pain was used as an anchor to calculate the minimal clinically important difference (MCID) of the LEPS score. Data are shown as Pearson correlation coefficient with a significance level α = 0.05. RESULTS: The analysis used data from 27 patients with EPS and 38 with overlap EPS-PDS Delta LEPS correlated positively with delta PAGI-SYM total and with delta PAGI-SYM upper abdominal pain whereas no correlation was found for delta LEPS and delta PAGI-SYM heartburn, indicating good convergent validity. Known group validity was confirmed by higher scores in patients with high OSS scores compared with patients with low OSS scores. Analysis of steady state data showed good test-retest reliability of the LEPS score. The MCID of the LEPS score was established at -0.3 points on the LEPS scale. CONCLUSION: The LEPS questionnaire is a sensitive and reliable outcome measure to record epigastric pain and burning symptoms in FD/EPS.