| Methods |
Randomised, double‐blind, placebo‐controlled trial |
| Participants |
Age 6 weeks ‐ 2 years
Daily R or V during a 1 week baseline period
AND ≥1 episode of GOR (pH<4 for >20min) at 18‐h pH monitoring.
Exclusion criteria: not meeting the inclusion criteria, premature, previous GI surgery (excluding for appendicitis), illnesses and drugs that could interfere with cisapride, reflux due to known anatomic abnormalities, underlying disease, infection of the GI tract; parents who couldn't express concern, comply with study, complete diaries. |
| Interventions |
6 weeks of positioning and thickened feeds (where appropriate) and either:
cisapride suspension (1mg/ml) 0.2 mg/kg qid (n=23) or
placebo suspension (n=26). |
| Outcomes |
Assessed at 2, 4, 6 weeks by parent and investigator: global evaluation of condition on VAS 0‐100 mm (0=the worst it's ever been, 100=completely recovered); any AE, specific AE.
Assessed at 6 weeks by parent and investigator: global evaluation of overall treatment (deterioration=symptoms worse, poor=no improvement, fair=slight improvement, persistence of some symptoms, good=improvement, occasional symptoms, excellent=complete relief of symptoms).
Assessed at 6 weeks by investigator: 24‐h pH, LOS pressure, oesophagitis at biopsy. |
| Notes |
45 participants (21 cisapride, 24 placebo) were evaluated (4 were non‐compliant or had violated protocol).
Other outcomes: various at 24‐h pH, swallow pressure, daily diary recording of each episode (none, mild, moderate, severe), score for R and V. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
"randomisation code for the allocation of patients to cisapride or placebo suspension was generated by computer" (p501). |
| Allocation concealment? |
Low risk |
Adequate |
| Blinding?
All outcomes |
Unclear risk |
"matching suspension of placebo" p500. "The double‐blind code was to be broken only in the event of an emergency." p501. Further details not given. |
