| Methods |
Randomised, double‐blind, placebo‐controlled study |
| Participants |
Age 6 months ‐ 4 years (mean age 14.4 months)
Minimum 3 months of symptomatic GOR with failure to respond to at least 6 weeks of non‐surgical treatment other than cisapride. |
| Interventions |
3‐8 weeks of either cisapride 0.6 mg/kg/day or placebo. |
| Outcomes |
Data on QTc retained in 4 (68 participants) of 7 study centres (134 participants in total) in the trial. 19/68 excluded as ECGs recorded after 8 weeks of treatment. Mean QTc reported at 3‐8 weeks of treatment and mean difference in QTc from baseline. |
| Notes |
Data on symptoms of GOR not published "because efficacy results did not reach statistical significance". |
| 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 |
"blindly assigned to receive either placebo or cisapride" p459. Further details not given. |
