| Methods |
Randomised, double‐blind, placebo‐controlled study |
| Participants |
Age 3 months ‐ 5 yrs
V and R present
GOR at oesophageal pH monitoring (RI <3.5% considered normal).
No organic pathology to justify the reflux. |
| Interventions |
4 weeks of either:
cisapride 0.2 mg/kg (n=15)
placebo (n=15). |
| Outcomes |
Assessment at 2 and 4 weeks (probably by parents) of digestive symptoms: severe (R and/or V after each meal of an important part of the meal), moderate (R of a small quantity more than once a day), mild (R of a very small quantity once a day or sometime during the week), absent.
Investigator assessment at 4 weeks: 24‐h oesophageal pH, AE, complications. |
| Notes |
1 drop‐out in the cisapride group ('lack of motivation').
Other outcomes measured: radiological image, endoscopy, respiratory symptoms improvement (nil, slight, good, excellent). |
| 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 |
Unclear risk |
Details not given. |
