Gaviscon and Carobel compared with cisapride in gastro-oesophageal reflux.

We compared the efficacy of the prokinetic agent cisapride with that of Gaviscon (an alginate/alkaline compound) plus Carobel (carob seed flour) in the treatment of gastrooesophageal reflux (GOR). Fifty infants with confirmed GOR received either oral cisapride (0.8 mg/kg/day) or Gaviscon plus Carobel for one month in a randomised, parallel group study. Parental evaluations, diary scores, and 24 hour lower oesophageal pH recordings before and at the end of each treatment were compared. In the cisapride group 14/26 (53%) were considered better by their parents compared with 19/24 (79%) of those who received Gaviscon plus Carobel. Diary scores, range (0.00-1.00), improved in both groups with the median change being greater in the Gaviscon plus Carobel group (-0.21) than the cisapride group (-0.15). Five of 17 pH variables had significantly improved from baseline in infants who had received cisapride compared with 11/17 in those receiving Gaviscon plus Carobel. However, unpaired analysis of diary and pH data showed no significant differences between the two groups. We conclude that first line treatment of GOR with cisapride is no more effective than conventional treatment with Gaviscon plus Carobel.

Variations in results of simultaneous ambulatory esophageal pH monitoring.

Twenty-four-hour esophageal pH monitoring is regarded as the gold standard investigation for gastroesophageal reflux (GER) (1) and the possibility of an "incorrect" answer, false positive or false negative, is only rarely considered (2). However, when a group of infants in this hospital had such pH studies performed on two consecutive days, considerable differences in the results were found (3). This also had been reported from other centers (4-6). It seems likely that most of the differences were due to true "biological" variability in the amount of GER from day to day, but it remains possible that variation in the accuracy of the equipment in detecting acid reflux was also involved.

Gastro-oesophageal reflux and respiratory function in infants with respiratory symptoms.

This study aimed to define the incidence and severity of gastro-oesophageal reflux (GOR), as measured using 24 hour oesophageal pH monitoring, in 38 infants with recurrent respiratory symptoms and to relate these findings to measures of respiratory function. Twenty one infants had a pH under 4 for more than 5% of the time (one definition of abnormal GOR) and nine had GOR exceeding age related normal values. Maximum expiratory flow at functional residual capacity was reduced in 37 infants, airways resistance was raised in 19 infants, and thoracic gas volume was abnormal in 11 infants. There was no association between indices of GOR and measures of lung function whether assessed by correlation or by chi 2 analysis for normal versus abnormal values. However, individual infants appeared to have respiratory symptoms produced by GOR. This suggests that host responsiveness to GOR may be of greater relevance than the amount of GOR.

Reproducibility of 24 hour oesophageal pH studies in infants.

Thirteen infants who had undergone 24 hour oesophageal pH monitoring to diagnose gastro-oesophageal reflux had a second study carried out to see if the results were reproducible. The studies were done without restricting the babies' activities. Appreciable differences were found, the percentage of the total time during which the pH was less than 4 varying by up to 3.7-fold between the two tests. The differences were largely the result of biological rather than technical variability. From these results estimates were made of the reliability of a single diagnostic study and the size of changes that would be necessary to show the effect of treatment. These findings have a considerable impact on the diagnosis of abnormal gastro-oesophageal reflux and its response to treatment whether using 24 hour pH monitoring or any other method of measurement.