Title:Carbon-labelledureabreathtestsfordiagnosisof Helicobacter pylori infection
February/March2006(printedJuly 2006) Agency:MedicareServicesAdvisoryCommittee(MSAC)
CommonwealthDepartmentof HealthandAgedCare
GPOBox9848CanberraACT2601Australia
Reference:MSAC application1085,Assessmentreport,ISBN 1741860164, ISSN 1443-7120,
Aim
To assessthesafety,effectivenessand cost-effectivenessof carbon-labelled ureabreath tests (C-UBTs)for diagnosis ofHelicobacterpylori infectionand under whatcircumstancespublic fundingshould besupportedfor theprocedure.
Conclusionsand results
SafetyThepotentialriskfor patientsundergoing C-UBTsfor diagnosis ofH.pylori infectionare minimal duetothenon-invasivenatureof theprocedure.Data from four caseseriesindicatedthattheprocedurewaswelltoleratedbypatientsand that systemic,gastrointestinaland allergic-typeeventsare extremelyrare.
EffectivenessTwelvecross-sectionalstudiesreportingthediagnosticcharacteristicsof UBTs againstthereferenceof endoscopyand testingof biopsy samplesasa firstline diagnostictestwereincluded.Acrossstudies,sensitivityranged from 90-100%, specificityfrom 86-100%,and positiveand negativelikelihood ratios from 6.8-
66.7and 0.0-0.1,respectively.ThesediagnosticcharacteristicsindicatethatUBTs are themostaccuratenon-invasivetestsfor diagnosingH.pyloriinfection.
FourprospectiveRCTscomparing healthoutcomesof dyspepticpatients undergoing UBTsasa firstlinediagnostictestforH.pyloriinfectionand subsequentmanagementwiththoseofpatientsreceivingendoscopyand subsequentmanagementor empirical treatmentwereincluded.Resultssuggest improved outcomesfor peopleundergoing theUBTfollowedbymanagement compared toempirical treatment,and similar outcomescomparedtoendoscopy and subsequentmanagement.
Cost-effectivenessResultsof a cost-effectivenessanalysisofUBTasa firstlinediagnostictestin the managementof uncomplicateddyspepsiacomparedtoserology,empirical antisecretorytreatmentand endoscopysuggestedthat,under baseline assumptions,serologyand UBTweresimilar withrespecttototalcost,total QALYsand timelivingwithoutdyspepsiaover a one-yeartimeframe.Theresults of an analysisof thefinancial implicationsof substitutingUBTinto current clinical practicesuggestthattheremaybefinancial costsavingsof more than $15 million per annum.
Recommendations
Publicfundingshould besupportedfor theuseof carbon-labelled ureabreathtestingasa first lineprocedurefor thediagnosis ofHelicobacterpyloriinfection.
Method
MSAC conducteda systematicreviewof literaturevia Medline,Embase,theCochrane Library, CINAHL, BiologicalAbstractsand theAustralasian MedicalIndex from 1966toMay 2005.