Background: Functional dyspepsia is a major diagnostic and therapeutic challenge for the clinician. Several systems for the identification of 'high-risk' patients and classifications of dyspepsia subtypes and treatment schemes have been proposed in the past with limited experimental evidence to support the claims made. The present trial was designed to compare two different treatment modalities in a group of functional dyspepsia patients selected on the basis of a standardized diagnostic procedure as 'non-risk' for organic disease and to assess the result in the major symptom sub-groups of functional dyspepsia as a means of identifying the potential for improving treatment outcome.
Methods: The efficacy of the prokinetic drug cisapride (5 mg four times daily) and of the histamine H2-receptor antagonist cimetidine (200 mg four times daily) were evaluated after 1 month of treatment and after a further follow-up of 1 month. Patients were randomized to the trial if they fulfilled the following criteria: 1) 'low-risk' symptoms or negative endoscopy findings, and 2) 2 weeks of single-blind antacid treatment did not provide satisfactory relief. For analysis patients were stratified into dyspepsia subtypes.
Results: One hundred and sixty-one patients entered the run-in period, and 137 patients were randomized to the study. At the end of 4 weeks' treatment a small but significant difference in favour of cisapride was found; this difference can mainly be accounted for by the significant difference found in the dysmotility-like subtype (83% improved with cisapride versus 59% with cimetidine). No significant differences could be detected between drugs in the other dyspepsia subtypes at the end of the treatment-or follow-up period.
Conclusions: The study confirms the classification into dyspepsia-subtypes as a useful tool in selecting the most appropriate drug therapy.