Comparison of the efficacy and safety of a new aluminium-free paediatric alginate preparation and placebo in infants with recurrent gastro-oesophageal reflux.

The aim of the present study was to compare the efficacy and safety of a new aluminium-free formulation of alginate with placebo in infants with recurrent gastro-oesophageal reflux. This was a double-blind, randomised, parallel-group study conducted at 25 centres in the UK. Of the 90 paediatric patients recruited in a general practice setting, 42 were randomised to receive alginate and 48 to receive placebo. Infants were assessed before treatment and again after seven and 14 days of treatment. Analyses were based on the last, valid, non-missing observation for each variable for the intent-to-treat (ITT) population of 42 alginate and 46 placebo patients. For the primary efficacy measure (number of vomitting/regurgitation episodes), alginate was significantly superior to placebo (p = 0.009). For the secondary efficacy measure (severity of vomiting), a trend in favour of alginate was observed (p = 0.061). Patients receiving alginate achieved superior assessments of treatment outcome by both investigators (p = 0.008) and parent/guardians (p = 0.002) alike. In addition, alginate achieved a significantly greater reduction in the mean severity of vomiting episodes recorded in a daily diary compared with placebo (p = 0.027) and resulted in more patients having at least 10% symptom-free days (p = 0.027). For none of the variables measured did placebo have a superior effect. More than one-half of all patients experienced some adverse event, although no statistically significant differences were observed between the two treatment groups (p > 0.1), and adverse events accounted for withdrawal in only 12.5% of the patients (alginate, n = 4; placebo, n = 7). Aluminium-free alginate demonstrated superior efficacy over placebo in treating recurrent gastro-oesophageal reflux in paediatric patients. The safety profile of alginate was similar to that of placebo.