Abstract
Most infants with gastroesophageal reflux (GER) disease (GERD) are successfully treated only by conservative care. To assess whether pharmacologic therapy is needed in GERD with RE, 32 patients(pts) were randomized to either Cimetidine(C) (17)(30 mg/kg/d) or place-bo(P)(15), in addition to intensive postural therapy, in a 12 week double-blind trial. Mean(±SD) age(months) was 21.7±37.6 (C) and 29.03±39.7 (P). GER was diagnosed by prolonged pH test, RE by endroscopy and histology and graded by a scoring system. Based on clinical, pHmetric and histological data, 12 Cpts (70.6%) and 3 Ppts ( 20%) healed (X2:5.6,p<0.01), 4 Cpts (23.5%) and 3 Ppts (20%) improved (N.S.), 4 Cpts (23.5%) and 9 Ppts (60%) worsened (X2:4.7,p<0.0 1). The RE score (mean±SD) significantly decreased only in Cpts ( pre:6.3±2.4, post:1.6±2.4, p<0.01), not in Ppts(pre:6.2±2.7, post:5.4±3.8, N.S.). Histological improvement was seen in all (100%) of C-pts with moderate RE vs 42.9% of Ppts (X2 :6.8,p<0.01) and in 87.5% of Cpts with severe RE vs 37.5% of Ppts (X2 :4.9, p<0.01). In conclusion, although GERD in infancy has a naturally self limited course with conservative care, extensive pharmacologic therapy is needed in presence of RE.
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Cucchiara, S., Gobio Casali, L., Balli, F. et al. 55. A DOUBLE-BLIND CONTROLLED STUDY OF CIMETIDINE IN REFLUX ESOPHAGITIS (RE). Pediatr Res 22, 105 (1987). https://doi.org/10.1203/00006450-198707000-00076
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DOI: https://doi.org/10.1203/00006450-198707000-00076