Title:Intragastricballoonsforthetemporarymanagementofmorbidobesity
Agency:MedicalServicesAdvisoryCommittee(MSAC) MDP106
CommonwealthDepartmentofHealthandAgeing
GPOBox9849CanberraACT2601
Reference:MSAC1112Assessmentreport
First printedJuly2008
ISBN(Print)1-74186-630-8,ISBN(Online)1-74186-631-6
Aim:
To evaluatethe safety, effectiveness,and costconsiderationsassociatedwith intragastric balloons for thetemporarymanagementofmorbidobesityinadditionto conventional
therapies(diet±physicalactivity± behaviouraltherapy± drugtherapy)versus conventional therapiesalone;and usedpriortoobesitysurgery,versusobesitysurgeryalone.
ResultsandConclusions:
Safety:
Intragastricballoonsare lesssafethanconventionaltherapy.Seriouscomplicationssuchas
death,gastrointestinalobstruction,gastricperforation,oesophagealruptureandbiliary pancreatitisoccurredin lessthan1per centof patients.Minorcomplicationssuchasnausea andvomitingwerefrequentlyreported(32–100% of patients).Twopercentofpatients requiredearlyremovaloftheballoondueto intolerance.
Twostudiesprovidedlimitedevidencethatsuper-obesepatientshaveimprovedsafety outcomeswhentheyreceiveintragastricballoontherapypriorto obesitysurgery,relativeto surgeryalone.
Effectiveness:
Theevidenceconsistentlyshowedthatpatients,onaverage,lost weightwhileundergoing intragastricballoontherapy(with/withoutconventionaltherapies).However, thethreesmall randomisedcontrolledtrialsidentifiedwere inconclusiveastowhetherintragastricballoons areas,ormore, effectivethanconventionaltherapiesaloneat assistingweightloss. Intragastricballoonsmadenodifferencetolong term weightlosswhenpatientsalso underwentobesity surgery.
Costconsiderations:
Therewasinsufficientinformationonwhichto basea cost-effectivenessanalysis.Basedon
an estimated4,903–8,000intragastricballoonsbeing inserted/removedperyear, an additional$19,236,067–$30,535,600wouldpotentiallybeincurredper annumbythe Australian healthcaresystem.Thesecostswouldbe in additiontothecostsassociatedwith conventionalmanagementofobesity.
Recommendation:
TheMSAChasconsideredthe safety, andclinicaleffectivenessofintragastricballoonsfor thetemporarymanagementofmorbidobesityinadditionto conventionaltreatmentsuchas
diet, exerciseandbehaviourmodification.
TheMSACfindsthat intragastricballoonsusedforthe temporarymanagementofmorbid obesityposeadditionalrisksto patientswhencomparedtothestandardtreatmentfor morbid obesityandthattheydonot provideadditionalclinicalbenefitsover standardtreatment.
Theremay bearole forthe temporaryplacementofintragastricballoonsforthe management ofthesuper obesepatient priortobariatricsurgeryhowever,evidencetosupportthis approachislimited.
TheMSACfindsthatthe useofintragastricballoonsforthe temporarymanagementof morbidobesityislesscost-effectivethanstandardtreatmentformorbidobesity.
TheMSACrecommendsthatpublicfundingis not supportedforthis procedure.
The MinisterforHealthand Ageingendorsedthisrecommendationonthe20thMay2008.
Method:
Medline,Embase,TheCochraneLibrary,andseveralotherbiomedicaldatabases,HTAand
otherinternetsitesweresearched(1990-June2007).Specificjournalswerehandsearchedandreferencelists pearled.Studieswereassessedforinclusioninthe reviewusingpre-determinedPICOselectioncriteriaand reasonsforexclusionweredocumented.Studyqualitywasappraised,data extractedinastandardisedmanner,and findingssynthesisednarratively.
Prepared by AdelaideHealth Technology Assessment (AHTA) on behalf of the MSAC