Efficacy and tolerability of peg-only laxative on faecal impaction and chronic constipation in children. A controlled double blind randomized study vs a standard peg-electrolyte laxative.docVIP

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Efficacy and tolerability of peg-only laxative on faecal impaction and chronic constipation in children. A controlled double blind randomized study vs a standard peg-electrolyte laxative.doc

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Efficacy and tolerability of peg-only laxative on faecal impaction and chronic constipation in children. A controlled double blind randomized study vs a standard peg-electrolyte laxative

Savinoetal.BMCPediatrics2012,12:178 /1471-2431/12/178 RESEARCH ARTICLE OpenAccess Efficacyandtolerabilityofpeg-onlylaxativeon faecalimpactionandchronicconstipationin children.Acontrolleddoubleblindrandomized studyvsastandardpeg-electrolytelaxative FrancescoSavino1*,SerenaViola1,MaiullariErasmo2,GiovanniDiNardo3,SalvatoreOliva3andSalvatoreCucchiara3 Abstract Background:PEG-basedlaxativesareconsideredtodaythegoldstandardforthetreatmentofconstipationin children.PEGformulationsdifferintermsofcompositionofinactiveingredientswhichmayhaveanimpacton acceptance,complianceandadherencetotreatment.Wethereforecomparedtheefficacy,tolerability,acceptance andcomplianceofanewPEG-onlyformulationcomparedtoareferencePEG-electrolyte(PEG-EL)formulationin resolvingfaecalimpactionandinthetreatmentofchronicconstipation. Methods:Childrenaged2–16yearswithfunctionalchronicconstipationforatleast2monthswererandomizedto receivePEG-only0.7g/kg/dayin2divideddosesor6.9gPEG-EL1–4sachetsaccordingtoagefor4weeks. ChildrenwithfaecalimpactionwererandomizedtoreceivePEG-only1.5/g/kgin2divideddosesuntilresolutionor for6daysorPEG-ELwithaninitialdoseof4sachetsandincreasing2sachetsadayuntilresolutionorfor7days. Results:Ninety-sixchildrenwererandomizedintothestudy.Fivepatientswithdrewconsentbeforestarting treatment.Threechildrendiscontinuedtreatmentforrefusalduetobadtasteoftheproduct(1PEG-only,2PEG-EL); 1(PEG-EL)foranadverseeffect(abdominalpain).Intent-to-treatanalysiswascarriedoutin49childreninthe PEG-onlygroupand42inthePEG-ELgroup. Nosignificantdifferenceswereobservedbetweenthetwotreatmentgroupsatbaseline. Adequatereliefofconstipationintermsofnormalizedfrequencyandpainlessdefecationofsoftstoolswas achievedinallpatientsinbothgroups.Thenumberofstools/weekwas9.2±3.2(mean±SD)inthePEG-only groupand7.8±2.4inthePEG-ELgroup(p=0.025);thenumberofdayswithstoolwas22.4±5.1inthePEG-only groupand19.6±7.2inthePEG-ELgroup(p=0.034). InthePEG-onlygroupfaecalomaresolutionwasobservedin5childrenontheseconddayandin2childrenonthe