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Cisapride for gastro-oesophageal reflux and peptic oesophagitis
Insights
Cisapride effectively treated reflux esophagitis in infants, improving clinical symptoms and healing esophageal inflammation. This prokinetic agent demonstrated significant benefits over placebo in a double-blind trial.
Area of Science:
- Pediatric Gastroenterology
- Clinical Pharmacology
Background:
- Gastro-oesophageal reflux and associated oesophagitis are common in infants.
- Current treatments may have limitations, necessitating novel therapeutic agents.
Purpose of the Study:
- To evaluate the efficacy of Cisapride, a novel prokinetic agent, in treating reflux oesophagitis in children.
- To compare the effects of Cisapride versus placebo on clinical symptoms, esophageal pH, and histological findings.
Main Methods:
- A randomized, double-blind, placebo-controlled trial involving 20 children with reflux oesophagitis.
- Diagnosis and assessment involved intraluminal esophageal pH monitoring, manometry, and endoscopy with biopsies.
- Treatment duration was followed by repeat diagnostic assessments.
Main Results:
- Cisapride significantly improved mean total clinical scores and reduced post-prandial reflux time compared to placebo.
- Histological examination showed significant improvement in oesophagitis scores only in the Cisapride group.
- Placebo treatment did not yield significant improvements in clinical or histological outcomes.
Conclusions:
- Cisapride is an effective therapeutic agent for managing symptoms of gastro-oesophageal reflux in infants.
- Cisapride promotes the healing of peptic oesophagitis in pediatric patients.
- The prokinetic properties of Cisapride offer a valuable treatment option for this condition.
Abstract:
Twenty children (age range 75 days-47 months) with reflux oesophagitis entered a random double blind trial in which they received either Cisapride (Janssen Pharmaceutical Ltd), a new prokinetic agent, or an identical placebo syrup. Diagnosis of gastro-oesophageal reflux was made by measurement of intraluminal oesophageal pH combined with manometry. Oesophagitis was assessed in all patients by histological examination of mucosal specimens taken during oesophagogastroduodenoscopy. Manometry, pH test, and endoscopy with biopsy examination were repeated at the end of the treatment period. Seventeen patients completed the trial, eight of whom were taking the drug and nine the placebo. Mean total clinical score and post-prandial reflux time (% of reflux) significantly improved in patients in the group given Cisapride but not in the group given placebo. Furthermore, there was a significant improvement of the histological oesophagitis score only in the children in the group given Cisapride, whereas placebo was ineffective. It is concluded that Cisapride is a useful agent both for the relief of symptoms of gastro-oesophageal reflux and for the healing of peptic oesophagitis in infancy.