DOUBLE-BLIND PLACEBO-CONTROLLED STUDY OF CISAPRIDE IN PATIENTS WITH NONSPECIFIC ESOPHAGEAL MOTILITY DISORDER ACCOMPANIED BY DELAYED ESOPHAGEAL TRANSIT

Background: Nonspecific esophageal motility disorder (NEMD) represents a difficult therapeutic of cisapride on the esophageal symptoms and e sophageal motor function in a group of patients with NEMD showing dela yed esophageal transit. Methods: Seventy eligible patients were entere d into a 4-week, double-blind randomized comparison of 10 mg of cisapr ide or placebo, four times daily. Symptom assessment, esophageal manom etry after wet swallows, and esophageal scintigraphy after intake of a liquid and solid bolus were performed in each patient before and afte r treatment. Results: After 4 weeks of treatment cisapride significant ly increased the prevalence of esophageal peristaltic contractions (pe rcentage of total contractions, P < 0.05 versus base line and placebo) and significantly improved esophageal emptying of the solid bolus (P < 0.05 versus placebo) but not of the liquid bolus. Placebo did nor ha ve any significant effects versus base line on these variables. Both p lacebo and cisapride improved the distal esophageal amplitude versus b ase line (no significant intergroup differences). Symptom scores were significantly reduced after 4 weeks of treatment versus base line in b oth groups (no significant intergroup differences except for heartburn and regurgitation, P < 0.05). On global evaluation of treatment, sign ificantly more patients in the cisapride group were rated as markedly or moderately improved, when compared with placebo. Conclusions: The r esults of the present study showed that cisapride is effective and wel l tolerated in patients with NEMD accompanied by delayed esophageal tr ansit. Symptomatic improvement may possibly be related to its benefici al action on the esophageal body by increasing the number of peristalt ic contractions and esophageal emptying of solids.