Cisapride in functional dyspepsia in general practice. A placebo-controlled, randomized, double-blind study

Area of Science:

• Gastroenterology
• Clinical Pharmacology

Background:

• Functional dyspepsia (FD) is a prevalent gastrointestinal disorder encountered in primary care settings.
• Investigating effective treatments for FD is crucial for improving patient outcomes.

Purpose of the Study:

• To evaluate the efficacy and safety of cisapride compared to placebo for treating functional dyspepsia in a general practice population.
• To identify any specific symptoms associated with Helicobacter pylori (H. pylori) infection in FD patients.
• To assess cisapride's effectiveness in H. pylori-positive FD patients.

Main Methods:

• A placebo-controlled, double-blind study involving 121 patients with FD randomized to receive cisapride (10 mg TID) or placebo.
• Symptom and adverse effect evaluations were conducted by general practitioners at 2 and 4 weeks.
• H. pylori status was determined via gastric biopsies and culture; patients underwent further gastrointestinal assessments to exclude other pathologies.

Main Results:

• No statistically significant difference in symptom reduction was observed between the cisapride and placebo groups after 4 weeks.
• The overall response rate was 63% for cisapride versus 44% for placebo, a difference that did not reach statistical significance.
• No specific symptoms were identified in H. pylori-positive FD patients, and their response to cisapride did not differ from H. pylori-negative patients.

Conclusions:

• Cisapride demonstrated no significant therapeutic advantage over placebo for functional dyspepsia managed in general practice.
• Helicobacter pylori infection status did not correlate with specific FD symptoms or influence cisapride treatment response.