| Methods |
Three trials:
I open trial (n=69)
II (Van Eygen 1989a) randomised, double‐blind, placebo‐controlled trial (n=23)
III (Van Eygen 1989b) dose‐response trial (n=50). |
| Participants |
Age 5 days ‐ 12 months
Excessive R or V at least twice a day in all children.
In trial II: GOR at radiology or pH monitoring in all children.
In trial III: GOR at radiology, endoscopy or pH monitoring in 16 children.
Non‐pharmacologic measures (e.g. positioning, food thickening) had failed to improve the reflux. |
| Interventions |
4 weeks of either
Trial II: cisapride oral suspension 0.15 mg/kg tid (n=12)
placebo oral suspension (n=11).
Trial III: cisapride 0.1 mg/kg tid (n=14) (not used in the analysis)
cisapride 0.2 mg/kg tid (n=14)
placebo tid (n=17). |
| Outcomes |
Assessed at 2 and 4 weeks by the investigator: AE, global therapeutic result (poor=no change, fair=distinct but slight improvement, good=marked reduction in R, excellent=virtually complete symptomatic cure). |
| Notes |
In trial III: analysis based on 45 of 50 participants. There were 4 early drop‐outs and 1 protocol violation and a further 10 drop‐outs (4 in the cisapride 0.2 mg/kg group and 6 in the placebo group.
Other outcomes assessed at 2 and 4 weeks by investigator: severity of R (severe=the major part of the meal is R, moderate=effortless R of a mouthful of feeding, slight=R of rather excessive saliva only, no R); frequency of R (after each meal, at least twice a day, once a day or several times a week, never). |
| 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 |
"under double‐blind conditions, the medications being identical in appearance and taste" p670. Further details not given. |
