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Cimetidine treatment of reflux esophagitis in children: an Italian multicentric study
S Cucchiara1, L Gobio-Casali, F Balli
1Department of Pediatrics, Universities of Naples, Italy.
Insights
Cimetidine effectively treats pediatric reflux esophagitis. This study found significant healing in children receiving cimetidine compared to placebo, highlighting its role in managing severe cases.
Area of Science:
- Pediatric Gastroenterology
- Pharmacology
- Clinical Trial Research
Background:
- Gastroesophageal reflux disease (GERD) in children can lead to esophagitis.
- Esophagitis management often requires pharmacologic intervention beyond conservative care.
- The efficacy of cimetidine in treating pediatric reflux esophagitis has been a subject of investigation.
Purpose of the Study:
- To evaluate the effectiveness of cimetidine in treating pediatric patients with gastroesophageal reflux disease complicated by esophagitis.
- To compare the outcomes of cimetidine treatment with placebo in children diagnosed with reflux esophagitis.
- To assess the impact of cimetidine on clinical and endoscopic measures of esophagitis severity.
Main Methods:
- A 12-week, randomized, double-blind trial involving 32 children with endoscopically diagnosed esophagitis.
- Patients received either cimetidine (30-40 mg/kg/day) or a placebo, alongside intensive postural therapy.
- Esophagitis severity was assessed using clinical, endoscopic, and histologic data.
Main Results:
- Significantly higher healing rates were observed in the cimetidine group (12/17) compared to the placebo group (3/15) (p < 0.01).
- Clinical and esophagitis scores decreased significantly in the cimetidine group versus the placebo group.
- Cimetidine demonstrated high efficacy in improving mild, moderate, and severe esophagitis, with notable differences compared to placebo (p < 0.01).
Conclusions:
- Cimetidine is an effective therapeutic agent for treating reflux esophagitis in children.
- Pharmacologic therapy, including cimetidine, is necessary for managing esophagitis in pediatric GERD.
- The study supports the use of cimetidine in children experiencing esophagitis due to GERD.
Abstract:
The effectiveness of cimetidine (30-40 mg/kg/day) was evaluated in 32 children with gastroesophageal reflux disease complicated by esophagitis who entered a random double-blind trial for 12 weeks. Esophagitis was diagnosed in all patients by endoscopy with biopsy. Seventeen patients (age, mean +/- SD: 21.7 +/- 37.65 months) received cimetidine (c-pts), and 15 (age, mean +/- SD: 29.03 +/- 39.73 months) received a placebo (p-pts). All patients received intensive postural therapy. Based on clinical and endoscopic (and histologic) data, 12 c-pts and three p-pts were healed (p less than 0.01), the condition of four c-pts and three p-pts had improved (not statistically significant), and the condition of one c-pt and nine p-pts had worsened (p less than 0.01). Both clinical and esophagitis scores significantly decreased only in the c-pt group, as compared with p-pts. Improvement of esophagitis was seen in all (100%) of c-pts with mild or moderate esophagitis versus 57.14% of p-pts (p less than 0.01) and in 87.5% of c-pts with severe esophagitis as compared with 25% of the p-pt group (p less than 0.01). We conclude that cimetidine is an effective agent for treatment of reflux esophagitis in children. Although gastroesophageal reflux disease in infancy has a naturally self-limited course with conservative care (thickened feedings and posture adjustment), extensive pharmacologic therapy is needed in the presence of esophagitis.