Table 2

Characteristics of included studies and risk of bias

StudyYearNoAgeRacecaodotril regimen1Control agent1ContextRisk of bias
RandomisationAllocation ConcealmentBlindingIncomplete outcomesSelective reportingOther
Cézard et al2520011723 months–4 years1.5 mg/kg administered orally 3 times dailyPlaceboInpatient, 13 separate French hospitalsStated randomised but not method givenNot mentionedDouble blindedLow riskAll appropriate outcome dataInvolvement with pharma not clear, many recruited patients did not meet inclusion
Gutiérrez-Castrellón et al2620102801 month–2 years1.5 mg/kg administered orally 3 times dailyPlaceboInpatient, MexicoComputer generatedCentral allocationDouble blindedLow riskAll appropriate outcome dataAuthors confirm no drug company involvement
Gutiérrez-Castrellón et al 2620101841 month–2 years1.5 mg/kg administered orally 3 times dailyPlaceboOutpatient, MexicoComputer generatedCentral allocationDouble blindedLow riskAll appropriate outcome dataAuthors confirm no drug company involvement
Salazar Lindo et al2720001353–35 months1.5 mg/kg administered orally 3 times dailyPlaceboInpatient, PeruStated randomised but not method givenNot mentionedDouble blindedLow riskAll appropriate outcome dataAuthors confirm no drug company involvement
Santos et al2820091893–36 months1.5 mg/kg administered orally 3 times dailyPlaceboOutpatient, single centre, SpainComputer generatedNot successfully concealedOpen labelOne patient's details missingAll appropriate outcome dataAuthors confirm no drug company involvement, except in initial design
Melendez Garcia et al292007503–71 monthsNot specifiedKaolin/pectinOutpatient, GuatemalaStated randomised but not method givenNot mentionedUnclear how blindedNot completeNo side effect dataNone apparent
Turck et al3019991022–10 years1.5 mg/kg administered orally 3 times daily0.03 mg/kg loperamideOutpatient, multiple French centresStated randomised but not method givenNot mentionedDouble blindedLow riskAll appropriate outcome dataNone apparent