Clinical Trial
Comparative Study
Journal Article
Randomized Controlled Trial
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Treatment of childhood peptic esophagitis: a double-blind placebo-controlled trial of nizatidine.

BACKGROUND: Nizatidine is an H2 histaminic receptor blocker, which acts on the oxintic cells in the stomach. The efficacy of nizatidine on acid gastric secretion has been widely studied in adults with erosive and ulcerative esophagitis, but not in children. The aim of the present study was to evaluate the therapeutic efficacy of nizatidine in children with reflux esophagitis.

METHODS: Twenty-six patients were studied; all of them underwent endoscopy with multiple esophageal biopsies and 24-h intraesophageal pH monitoring. The diagnosis of esophagitis was based on histologic features. Patients were randomly assigned to double-blind treatment with either nizatidine or a placebo (10 mg/kg/day in two doses) for 8 weeks. A symptomatic score assessment was evaluated during the study.

RESULTS: Twenty-four patients completed the 8-week protocol. After therapy, 9/13 (69%) patients on nizatidine and 2/13 (15%) patients on the placebo were healed (p < 0.007 by Fisher's exact test). Histological findings were improved in two other (16.7%) patients and unchanged in the last (8.3%) patient on nizatidine. In the placebo group there was histological improvement in three (25%) patients, no variation in six (50%), and worsening in one (8.3%). After therapy, determination of esophageal pH showed a statistically significant decrease of the total acid exposure time (p < 0.01) only in the nizatidine group. The clinical score analysis showed an improvement of symptoms only in the nizatidine group (p < 0.01), except for vomiting, which was reduced in both groups.

CONCLUSIONS: Our results show that nizatidine is effective in treating children with reflux esophagitis. The children included in this study did not have severe esophagitis, and the conclusion must be limited to those with mild to moderate degrees of disease.

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