Treatment of uninvestigated dyspepsia with cisapride for patients with negative Helicobacter pylori serologies

Abstract

OBJECTIVE: The aim of this study was to compare symptoms for patients with uninvestigated dyspepsia and a negative Helicobacter pylori serology who were treated with cisapride or placebo. METHODS: Helicobacter pylori-seronegative patients with chronic dyspepsia were randomized to receive cisapride 10 mg t.i.d. or placebo t.i.d. for 30 days. Symptom scores were performed 1 month and 3 months after randomization. Outcomes measured were dyspepsia symptom scores and a treatment “success” variable defined as absence of symptoms or decrease in the most severe individual symptom by two grades. RESULTS: A total of 60 patients were randomized; 56 completed the 1-month follow-up and 40 completed the 3-month follow-up interview. The mean score for all patients at the time of entry was 11.0 and declined to 8.3 and 8.2 at 1 and 3 months, respectively, after randomization. At 1 month and 3 months after randomization, there was no significant difference in the number of patients meeting the “success” variable for patients receiving cisapride as compared to placebo. The mean decline in symptom severity scores was not significantly different for patients receiving placebo or cisapride at 1 month (mean, −2.8 vs −3.1; difference = 0.3, p = 0.74) or 3 months (−3.1 vs −2.6, difference = −0.5, p = 0.58) after randomization. CONCLUSIONS: No significant difference in the severity of dyspeptic symptoms was found for patients receiving cisapride as compared to placebo in the setting of uninvestigated dyspepsia and a negative Helicobacter pylori serology.