| Methods |
Randomised, double‐blind, placebo‐controlled trial |
| Participants |
Age 75 days ‐ 47 months
Reflux oesophagitis in all (endoscopy and biopsy).
Diagnosis of GOR made by oesophageal pH (pH<4 for ≥20min) and manometry.
Exclusion criteria: infections, neurologic, metabolic, renal disorders, abnormalities of the GI tract. |
| Interventions |
8 weeks of either:
cisapride syrup (1mg/ml) 0.3 mg/kg tid or
placebo syrup. |
| Outcomes |
Assessed at 8 weeks by investigator:
24‐h pH
LOS pressure
oesophagitis at biopsy.
Improvement at end of treatment: cured (clinical, pH‐metric and histological variables normalised), improved (at least one of the three variables had improved), unchanged, worsened. |
| Notes |
3 participants were withdrawn: 2 febrile URTI, 1 failed to take drug continuously.
Other outcomes measured: peristalsis amplitude, clinical score. |
| 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 |
"placebo syrup, which was identical to cisapride in taste and appearance" p454. Further details not given. |
