Chronic functional dyspepsia: short- and medium-term outcome of a therapeutic trial with cisapride

In an open, multicenter trial, 329 patients (who attended gastroenterology practices or outpatient gastroenterology departments of hospitals) with a mean age of 47.3 years, received 5 mg of cisapride three times a day (TID) for at least 2 weeks for the treatment of persistent, recurring symptoms of functional dyspepsia. The patients' symptoms required investigation or were unresponsive to previous drug treatment. When necessary, the dose of cisapride was increased to 10 mg TID, in most patients after 1 week of treatment, and the duration of therapy was extended to 4 weeks. At the end of cisapride treatment, the most frequently reported symptoms of functional dyspepsia were significantly improved. At the onset of the trial, 72.3% of patients complained of a moderate-to-severe feeling of fullness; this decreased to 19.7% after 2 weeks of treatment and to 15.3% after 4 weeks. The symptoms of bloating, a feeling of heaviness in the stomach, and postprandial epigastric discomfort showed similar improvement. Overall, 43.6% of patients were symptom-free or almost symptom-free after 1 week of cisapride treatment, 69.6% after 2 weeks, and 71.5% after 4 weeks. Only 11% of patients needed the increased dose of cisapride. Six weeks after completion of the trial, 74 patients (22.5%) had recurrent symptoms of functional dyspepsia. Adverse experiences were noted in 74 patients (22.5%), most commonly loose stools (7.6% of all patients), fatigue (4.9%), and headaches (4.0%). In most cases, these adverse experiences were mild and transient in nature and led to premature discontinuation of treatment in 11 patients (3.3%).(ABSTRACT TRUNCATED AT 250 WORDS)