PLACEBO-CONTROLLED TRIAL OF CISAPRIDE AND NIZATIDINE IN UNSELECTED PATIENTS WITH FUNCTIONAL DYSPEPSIA

Objective: Patients in most trials of pharmacotherapy for nonorganic d yspepsia have been groups referred selectively for endoscopy, which co uld have led to a selection bias of nonresponders, explaining the nega tive outcome of most controlled treatment trials in nonorganic dyspeps ia, The aim of this study was to evaluate the effects of cisapride and nizatidine in patients with nonorganic dyspepsia who were recruited d irectly from primary care settings, and to evaluate the therapeutic im plications of dyspepsia subgrouping. Methods: A consecutive series of patients who consulted their general practitioner with dyspepsia were invited to an interview and endoscopy, Before endoscopy, symptoms were classified as reflux-like, dysmotility-like, ulcer-like, or unclassif iable. A total of 330 patients with either minor or no abnormalities a t endoscopy were randomized to double blind treatment with cisapride 1 0 mg t.i.d., nizatidine 300 mg at night, or placebo for 2 wk, Results: A symptomatic response was found in 62% of patients on cisapride (the rapeutic gain cisapride vs placebo: 0.1% [95% confidence interval -14% to 14%]) and in 54% of patients on nizatidine (therapeutic gain nizat idine vs placebo: -8% [95% confidence interval -22% to 7%]). Response to treatment was independent of symptom classification. Conclusions: T he effects of a 2-wk course of cisapride or nizatidine in unselected p atients with dyspepsia recruited from primary care were not superior t o those of placebo. Symptom subgrouping was not predictive of response to therapy. (C) 1998 by Am. Coil. of Gastroenterology.