Comparative Study of a Proton Pump Inhibitor with a Histamine H₂ Receptor Antagonist in Japanese Patients with Functional Dyspepsia

Abstract

: The present study sought to compare the effectiveness of a proton pump inhibitor PPI with that of a histamine H 2 receptor antagonist H2RA for treating functional dyspepsia FD in a real-world setting. A multicenter, open-label, randomized trial was conducted. FD patients were randomly assigned to receive either 20 mg, q.d., omeprazole OPZ ; a PPI or 150 mg, b.i.d., ranitidine hydrochloride RAN ; an H2RA for 4 weeks. Any change in the total Gastrointestinal Symptom Rating Scale GSRS score delta at week 4 was the primary outcome measure. Secondary outcome measures were reductions in scores for individual items on the GSRS at week 4. As a subanalysis, patients were strati ed according to Helicobacter pylori serology and the analyses were repeated. The mean SD deltas in total GSRS score for the OPZ and RAN groups were 0.8 0.7 and 0.6 0.6, respectively P 0.098 ; however, the delta in re ux score between the OPZ and RAN groups differed signi cantly 1.1 0.7 vs. 0.5 0.5, respectively ; P 0.001 . There were no significant differences between the two groups in any other scores for individual items on the GSRS. The results of the subanalysis were like those of the main analysis. The PPI and H2RA produced a comparable improvement in symptoms of FD in our patient cohort, thus we propose no advantage would be gained in using a PPI rather than an H2RA.