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The present study sought to compare the effectiveness of a proton pump inhibitor (PPI) with that of a histamine H2 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.

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Comparative Study of a Proton Pump Inhibitor with a Histamine H&lt;sub&gt;2&lt;/sub&gt; Receptor Antagonist in Japanese Patients with Functional Dyspepsia