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

OBJECTIVE: The aim of this study was to compare symptoms for patients with uninvestigated dyspepsia and a negative Helicobacter pylori serology who we re treated with cisapride or placebo. METHODS: Helicobacter pylori-seronegative patients with chronic dyspepsia w ere randomized to receive cisapride 10 mg t.i.d. or placebo t.i.d. for 30 d ays. 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 ind ividual symptom by two grades. RESULTS: A total of 60 patients were randomized; 56 completed the 1-month f ollow-up and 40 completed the 3-month follow-up interview. The mean score f or all patients at the time of entry was 11.0 and declined to 8.3 and 8.2 a t 1 and 3 months, respectively, after randomization. At 1 month and 3 month s after randomization, there was no significant difference in the number of patients meeting the "success" variable for patients receiving cisapride a s compared to placebo. The mean decline in symptom severity scores was not significantly different for patients receiving placebo or cisapride at 1 mo nth(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 symptom s was found for patients receiving cisapride as compared to placebo in the setting of uninvestigated dyspepsia and a negative Helicobacter pylori sero logy. (Am J Gastroenterol 2000;95:2212-2217. (C) 2000 by Am. Cell. of Gastr oenterology).