DOMPERIDONE PLUS MAGNESIUM-HYDROXIDE AND ALUMINUM HYDROXIDE - A VALIDTHERAPY IN CHILDREN WITH GASTROESOPHAGEAL REFLUX - A DOUBLE-BLIND RANDOMIZED STUDY VERSUS PLACEBO

To evaluate the efficacy of different drug combinations in treating se vere gastroesophageal reflux (GER), we studied 80 children with GER. T he patients were randomly divided into four groups: group A was treate d with domperidone plus magnesium hydroxide and aluminum hydroxide, gr oup B with domperidone plus alginate, group C with domperidone alone, and group D received placebo. At the time of diagnosis and 8 weeks aft er treatment the patients were clinically evaluated and underwent 24-h continuous esophageal pH monitoring. After treatment a complete regre ssion of symptoms was observed in 16 of 20 patients in group A, in 8 o f 20 in group B (A versus B, p < 0.018), in 9 of 20 in group C (A vers us C, p < 0.034), and in 7 of 20 in group D (A versus D, p < 0.001). M oreover, there was a statistically significant improvement in several pH-metric variables studied in all treatment groups; in addition, a co mparison of the pH-metric data of the four groups after treatment indi cated that reflux variables were significantly lower in group A than i n the other groups. We concluded that the domperidone plus magnesium h ydroxide and aluminum hydroxide combination was more effective than th e other drugs we used in treating GER and in modifying the objective p i-I-metric variables in pediatric patients.