Title:Hyperbaricoxygentherapy(HBOT)forthetreatmentof non- healing wounds in non-diabetic patientsand refractorysofttissue radiation injuries, May2003

Agency:MedicalServicesAdvisoryCommittee(MSAC) MailDropPoint107

AustralianGovernmentDepartmentofHealthandAgeing

GPOBox9848CanberraACT2601Australia.

Reference:MSAC application 1054,Assessmentreport,ISBN 0624825629, ISSN 1443-7120,

Aim

To assessthesafety,effectivenessand cost-effectivenessof HBOTfor thetreatmentof non- healing woundsin non-diabeticpatientsand refractorysofttissueradiation injuriesand under whatcircumstancespublicfundingshould besupported.

Conclusionsand Results

SafetyMost adverseeventsassociatedwithHBOTare self-limitingand resolvewith termination of therapy.Themostcommonadverseeventsreported were myopia, barotrauma, claustrophobiaand oxygentoxicity.Seriouslife- threateningeventsand fatalitieswererare.

EffectivenessFor theindication,non-healing woundsin non-diabeticpatients,evidencefrom a randomised controlledtrial (RCT)showedthatHBOTresultedin a decreasein woundarea, whilea studyusinghistorical controls reported a trendtoward preventionof woundbreakdown and infectionand a reductionin lengthof hospitalisation. Evidencewasavailable from RCTsof theeffectivenessof HBOTfor various sub-indicationsrelatingtoradiation

therapy.Theuseof HBOTfor cognitiveimpairment followingbrain irradiation showeda non-significantimprovementin neuropsychologicalfunction.In patientswithradiation-inducedbrachial plexopathy,therewereno significant differencesin sensorythresholdsor qualityof lifebetweenthosereceiving HBOTcompared tocontrols.In patientsathigh riskfor thedevelopmentof osteoradionecrosis,HBOTwasfound toincreasethelikelihood of healing toothsocketwoundsfollowingextractioncompared totheadministration of penicillin.In patientswho had undergoneradiation therapy,HBOTreducedthe likelihood of major woundinfection,major

wounddehiscence,and delayedwoundhealing in myocutaneousgrafts.

Cost-effectivenessTheclinicalevidencewasinadequatetosubstantiateclaimsthatHBOTwas cost-effectivein thetreatmentof refractorysofttissueradiation injuriesor non-diabeticrefractorywounds.

Recommendations

The clinical evidence was inadequate to substantiate claims that hyperbaric oxygen therapy (HBOT) was cost-effective in the treatment of refractory soft tissue radiation injuries or non- diabetic refractory wounds. However, MSACrecommended that, as there are no effective alternative therapies andin viewof the progress of local datacollections and an international trial, funding for HBOT continue for MBS listedindications at currentlyeligible sites, for a further threeyears.

Method

MSAC conducteda systematicreviewof medicalliteraturepublishedbetween1966and 2002 identifiedvia severaldatabasesincludingtheCochrane Library, Medline,PreMedline,Current Contents,BiologicalAbstracts,CINAHL,CancerLit,EMBASE, and HBO Evidence. Assessmentof clinicaleffectivenessreliedon 21primary studies,includingcaseseriesas supportiveevidence.