Comparison of PPIs and H2-receptor antagonists plus prokinetics for dysmotility-like dyspepsia

Abstract

Aim: To compare efficacy of proton pump inhibitors (PPIs) with H(2)-receptor antagonists (H(2)RAs) plus prokinetics (Proks) for dysmotility-like symptoms in functional dyspepsia (FD).

Methods: Subjects were randomized to receive open-label treatment with either rabeprazole 10 mg od (n = 57) or famotidine 10 mg bid plus mosapride 5 mg tid (n = 57) for 4 wk. The primary efficacy endpoint was change (%) from baseline in total dysmotility-like dyspepsia symptom score. The secondary efficacy endpoint was patient satisfaction with treatment.

Results: The improvement in dysmotility-like dyspepsia symptom score on day 28 was significantly greater in the rabeprazole group (22.5% ± 29.2% of baseline) than the famotidine + mosapride group (53.2% ± 58.6% of baseline, P < 0.0001). The superior benefit of rabeprazole treatment after 28 d was consistent regardless of Helicobacter pylori status. Significantly more subjects in the rabeprazole group were satisfied or very satisfied with treatment on day 28 than in the famotidine + mosapride group (87.7% vs 59.6%, P = 0.0012). Rabeprazole therapy was the only significant predictor of treatment response (P < 0.0001), defined as a total symptom score improvement ≥ 50%.

Conclusion: PPI monotherapy improves dysmotility-like symptoms significantly better than H(2)RAs plus Proks, and should be the treatment of first choice for Japanese FD.

Keywords: Dysmotility; Functional dyspepsia; H2-receptor antagonist; Prokinetics; Proton pump inhibitor.

Figure 1

Study flow chart. This study enrolled 146 subjects with functional dyspepsia and, after excluding 30 subjects for non-attendance and two for non-compliance, 57 subjects in each treatment group completed the study.

Figure 2

Change in dysmotility-like dyspepsia symptom score over time. Significantly greater improvement was seen in dysmotility-like dyspepsia symptom score on day 28 of treatment in the proton pump inhibitor (PPI) group than in the H₂-receptor antagonist (H₂RA) + prokinetic (Prok) group. No significant additional symptomatic improvement was seen after day 7 of H₂RA + Prok treatment, whereas further symptomatic improvements were seen over time in the PPI group. ^aP < 0.05, PPI vs H₂RA + Prok; ^cP < 0.05 vs pre-Rx in each group; ^eP < 0.05 vs 7 d Rx in each group.

Figure 3

Change in dysmotility-like dyspepsia symptom score over time according to Helicobacter pylori status. Significantly greater symptomatic improvement was seen in the proton pump inhibitor group than in the H₂-receptor antagonist (H₂RA) + prokinetic (Prok) group after 28 d of treatment, regardless of Helicobacter pylori (H. pylori) status. No additional significant symptomatic improvement was seen after day 7 of H₂RA + Prok treatment, regardless of H. pylori status. ^aP < 0.05, PPI vs H₂RA + Prok; ^cP < 0.05 vs pre-Rx in each group; ^eP < 0.05 vs 7 d Rx in each group.

Figure 4

Subject satisfaction after 14 d and 28 d of treatment. Subject satisfaction was significantly higher in the proton pump inhibitor (PPI) group than in the H₂-receptor antagonist (H₂RA) + prokinetic (Prok) group on day 28 of treatment. No significant increase in subject satisfaction was seen in the H₂RA + Prok group between days 14 and 28, whereas a significant increase was seen in the PPI group between days 14 and 28. ^aP < 0.05, PPI vs H₂RA + Prok; ^cP < 0.05 vs 14 d Rx.