Orenstein 2000.

Methods	Multicentre, randomised controlled trial
Participants	96 children > 2 months old with biopsy‐proven oesophagitis.
Interventions	1. cisapride 0.2 mg/kg qid and placebo 2. cimetidine 10 mg/kg qid and placebo 3. cisapride + cimetidine 4. placebo + placebo.
Outcomes	Measured at 2, 6 and 12 months. Initial findings reported for 2 months. 1.Symptoms measured by parents using the Infant Gastroesophageal Reflux Questionnaire 2. Vomiting 3. Crying 4. Biopsy measuring histological parameters of papillary height and basal layer thickness
Notes	Trial finished but only published as an abstract. Personal communication provided by Dr SR Orenstein, Academic Hospital of Pittsburgh, USA (Orenstein 2009). Cisapride versus no cisapride: symptom questionnaire showed 86% with cisapride were well or better at 2 months compared with 70% for no cisapride groups (if 3 lost to follow up in cisapride group and 8 given no cisapride were assumed to have worse symptoms). No significant improvement in vomiting (frequency or volume). This paper was never published in article form as cisapride was taken off the market in the US amid concerns about its toxicity. 100 infants were enrolled, and nearly all of them completed the 12 months of the protocol, although follow up was discontinued for the last few infants in concordance with the wishes of the FDA and the company.
Risk of bias
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	"randomised, double‐blind in blocks of 8" pA20. Further details not given.
Allocation concealment?	Unclear risk	Unclear ‐ details not given
Blinding? All outcomes	Unclear risk	"blindly assigned to 1 of 4 arms", "At any visit with both Sx & Bx unimproved, infants were rescued to un‐masked Cm‐Cs, without un‐masking prior Rx." P0791. Further details not given.