| Methods |
Randomised study
Double‐blind design was not feasible (see text for details). |
| Participants |
Age 2‐18 months
Chronic vomiting and GOR confirmed by 24h pH oesophageal monitoring (pH<4 for ≥5% of the recording period).
No neurological, respiratory, metabolic, GI disease, treatment with H2 antagonists, theophylline, anticholinergic drugs. |
| Interventions |
4 weeks of either:
cisapride p.o. 0.2 mg/kg qid (n=26)
Gaviscon 1/2 sachet to each 90 ml feed qid (n=24, 21 also had Carobel). |
| Outcomes |
Parental evaluation at 4 weeks of improvement (improved, not improved).
Investigator evaluation at 4 weeks of 24‐h pH (RE was defined as pH<4 for ≥15min). |
| Notes |
All 50 infants completed the study.
Other outcomes measured at 4 weeks: daily parental evaluation of severity of V: 0 (absent), 1(1‐4 episodes/day), 2 (>4 episodes/day), leading to a final symptoms score (range 0‐1); improvement in diary scores. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
Details not given. |
| Allocation concealment? |
Unclear risk |
Unclear |
| Blinding?
All outcomes |
High risk |
Double‐blind design was not feasible (see text of review for details). |
