HRI Submission to Decommissioning Homeopathy consultation ... · 8/14/2017 · decommissioning...

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DecommissioningHomeopathy

HomeopathyResearchInstituteSubmissiontotheBristol,NorthSomersetandSouthGloucestershireCCGsConsultation11August2017RachelRobertsBSc(Hons)MCHFSHomChiefExecutive,HomeopathyResearchInstitute(HRI)rachelroberts@hri-research.orgwww.hri-research.org

HRIisaninnovativeinternationalcharitycreatedtoaddresstheneedforhighqualityscientificresearchinhomeopathy.

Thefollowingtextiscopiedfromtheconsultationwebpage:https://www.bristolccg.nhs.uk/get-involved/nhs-service-proposals/decommissioning-homeopathy

Decommissioninghomeopathy

Bristol,NorthSomersetandSouthGloucestershireCCGsproposetodecommissionallNHSfundedhomeopathicoralternativetherapies.

Currently,accesstohomeopathytreatmentforpatientsatthePortlandCentreforIntegrativeMedicine(PCIM)issubjecttopriorapprovalviaanagreedsetofcriteria.SimonStevens,chiefexecutiveofNHSEngland,hasrecentlystatedhomeopathyshouldnotbefundedbytheNHS.

TheScienceandTechnologySelectCommitteeconcludedin2010thattheNHSshouldceasefundinghomeopathy,agreeingwiththegovernmentthatthereisnoevidencetoshowthathomeopathyisclinicallyeffective.Thatis,itdoesnotworkbeyondtheplaceboeffect.ThecommitteerecommendedthatplacebosshouldnotberoutinelyprescribedontheNHS;thatthefundingofhomeopathichospitalsshouldnotcontinue,andthatNHSdoctorsshouldnotreferpatientstohomeopaths.

Patientswhowishtoaccesshomeopathictreatmentwillcontinuetohavetheoptiontoself-fundtheirtreatmentorseekfundingfromtheIndividualFundingRequestPaneliftheycandemonstrateexceptionalcircumstances.

Wewouldliketohearyourviews.Thebriefsurveybelowwillbeopenfrom18Julyto15August2017.Feedbackwillbemadeavailableonthiswebsite.

Alternativelypleaseemailcontactus.bnssg@nhs.net

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Giveyourfeedbackonthisproposal

DoyouunderstandthereasonsforourproposaltostopNHSfundingforhomeopathytreatment?

• Yes

DoyouagreeordisagreewithourproposaltoceaseNHSfundingforhomeopathy?

• DisagreeWhydoyousaythat?

Thereasonsgivenfortheproposaltodecommissionhomeopathyareeasytounderstandinthesensethattheyhavebeenexplainedclearly;however,theyareimpossibletounderstandinthesensethattheydonotprovidejustificationforsuchadecisionintermsofethicsoreconomics–twocoreconceptsattheheartofsuchhealthcarecommissioningdecisions.

Thesituationissimple.Atpresent,homeopathyisbeingprovidedtopatientswhowantit,needitandreportclinicalbenefitfromit.

Thehomeopathyserviceisbeingprovidedbydoctorswhoareexperiencedintheuseofbothconventionalmedicineandhomeopathy,andhavemadetheclinicaljudgmentthathomeopathyisthemostappropriatetreatmentfortheseparticularpatients.

Itisalsoimportanttonotethatthepatientsreceivingthisservicearebeingreferredforhomeopathictreatmenteitherbecauseconventionalmedicinehasfailedtoprovidesufficientclinicalbenefit,orbecauseconventionalmedicineiscontraindicated.

Bearinginmindthepointsabove,itisessentialthatanydecisiontakentoremovesuchasuccessfulservicehastobefullyjustifiedtothepatientswhocurrentlyuseit,tothedoctorswhoprovideitandthegeneralpublicwhomaywishtousetheserviceinfuture.Credibleassuranceswouldbeneededthatdecommissioningwouldnotleadtopoorerpatientoutcomesorreducedqualityoflifeforthosepatientswhowouldnolongerhaveaccesstohomeopathictreatment.

Thenatureoftherequiredjustificationisstraightforward–Bristol,NorthSomersetandSouthGloucestershireCCGsmustexplainhowadecisiontodecommissionhomeopathyisethicallyandeconomicallysound.

• Itisonlyethicaltodecommissionhomeopathyifanalternativetreatmentoptionisprovidedwhichgivessimilarorsuperiorclinicalbenefits.

• Itisonlyeconomicallyjustifiedtodecommissionhomeopathyifthereplacementservicecoststhesameorlessthantheexistinghomeopathyservice.

Inordertotakeadecisiontodecommissionhomeopathy,itwouldthereforebenecessaryfortheCCGstoprovidethepublicwiththefollowing:

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1.Specificdetailsofwhattreatmentoptionswillofferedtothesepatientsinplaceofthehomeopathyservice,especiallyincaseswhereconventionalmedicineisnotanoption.

2.Evidencethatthereplacementserviceswillleadtoaminimumclinicaloutcomeof“improvedhealth”in70%ofpatientsand“majorimprovement”in50%ofpatients1–theresultsachievedwithpatientsattendingtheformerNHSBristolHomeopathicHospital(whosecliniciansarenowworkingforthePortlandCentreforIntegrativeMedicine).

3.Evidenceofthecostsavingwhichwillbeachievedbyreplacinghomeopathywiththesenewservices,byprovidingtheactualcostsoftheexistinghomeopathyserviceandprojectedcostsofreplacementservices.

Ifthecriteriaoutlinedabovecannotbemet,homeopathycannotbedecommissionedandthedecisionmustbetakentocontinuewiththeexistingprovisionofhomeopathyforethicalandeconomicreasons.IsthereanythingelseyouwouldliketosayaboutourproposalnottoofferhomeopathytreatmentintheNHS?

OneofthestrategicaimsoftheHomeopathyResearchInstitute(HRI)istoprovideaccurateandobjectiveinformationabouttheevidenceonhomeopathy.

Havingreadthereasonsgivenforproposingtodecommissionhomeopathy,itappearsthatBristol,NorthSomersetandSouthGloucestershireCCGsarenotfullyawareofthefactssurroundingthe2010ScienceandTechnologySelectCommittee‘EvidenceCheck2:HomeopathyReport’2(EC2)–henceourparticularinterestinthisconsultation.

TheEC2reportisanunsuitableresourcetoinformdecision-making

AsthefindingsoftheEC2reportareinformingthisproposeddecommissioningdecision,thereliabilityandcredibilityofthereportneedtobecarefullyconsidered.Althoughdescribedbysomeasa‘comprehensivereview’oftheevidence,EC2isnotascientificdocument.Nosystematicscientificmethodwasapplied,itwasnotcarriedoutbyexpertacademicsinthefieldandthechoiceofevidenceincludedshowedadisturbingbias–bothintermsofwrittensubmissionsandthechoiceofwitnessespermittedtogiveoralevidence.

Suchfundamentalflawshavebeenwidelyacknowledged:whilst3outof4MPsvotedinfavourofthereport,onememberoftheSelectCommittee(IanStewartMP)abstained,dissentingfromthereportbecausehewasconcernedbythe“balanceofwitnesses”;70MPsexpressedtheirconcernbysigninganEarlyDayMotion(EDM908)andanindependentcritiquebyEarlBaldwinofBewdleyconcludedthatthereportwas“anunreliablesourceofevidenceabouthomeopathy”3.

EarlBaldwin’sopinionisofparticularinterest,asheservedontheHouseofLordsScienceandTechnologySub-Committeethatinquiredintocomplementaryandalternativemedicinein1999-2000andsowasfamiliarbothwithcorrectS&TCommitteeproceduresandthetopicinquestion.

Thesefactscanbeverifiedinmoredetailatwww.homeopathyevidencecheck.org.

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TheScienceandTechnologySelectCommittee’sconclusionshavebeenquotedcorrectlyi.e.thatthey,“…recommendedthatplacebosshouldnotberoutinelyprescribedontheNHS;thatthefundingofhomeopathichospitalsshouldnotcontinue,andthatNHSdoctorsshouldnotreferpatientstohomeopaths.”Howeverthefollowingstatementthatthecommitteewas,“agreeingwiththegovernmentthatthereisnoevidencetoshowthathomeopathyisclinicallyeffective.Thatis,itdoesnotworkbeyondtheplaceboeffect”isincorrect.

Clearlythecommitteedidnot“agreewiththegovernment”.InfactasEC2hasbeensoseverelycriticisedbyGovernment,iftheCCGsdecidetogoaheadandtellthepublicthatthisreportisthereasonwhyhomeopathyisbeingdecommissioned,thiscannotbedonewithanyclaimoffollowingGovernment’slead;insteadBristol,NorthSomersetandSouthGloucestershireCCGswillneedtoprovidetheirownjustificationforbasingacommissioningdecisiononanon-scientificreportcriticisedby70MembersofParliament,supportedbyonly3MembersofParliament,critiquedbyaMemberoftheHouseofLordwithdirectexperienceinsuchSelectCommitteeEvidenceCheckprocesses,andwhosefindingswerenotacceptedbytheDepartmentofHealth.

AstheCCGshavenowbeenmadeawareofthemultiplereasonswhytheEC2reportcannotbereliedupontoinformdecision-making,ifthereportcontinuestobeusedtojustifyadecommissioningproposal,apoint-by-pointanswertoallissuesraisedinEDM908mustbeprovidedforpublicscrutiny.

EvidencecoveredbytheEC2report

Reliabilityaside,asecondpertinentissueisthatEC2onlyconsideredefficacyofhomeopathy,notrealworldeffectivenessassessingthe‘wholetreatmentpackage’asprovidedbyhomeopathsineverydaypractice.Theythereforeexcludedallobservationalstudiesandpragmaticrandomisedcontrolledtrialsandonlyconsideredfivecomprehensivemeta-analysesofrandomisedcontrolledtrials(RCTs)4,5,6,7,8.Fromthisevidencethefourmeta-analyseswhichfoundinfavourofhomeopathywereexcluded,4,5,6,7basedsolelyonthetestimonyofProfEdzardErnstthat,inhisopinion,theywereunreliable.Thisleftonlyonestudytoinformthereport’sconclusions–thecomprehensivecomparativemeta-analysisknownasTheLancetstudybyShangetal.publishedin20058.

MultipleconcernshavebeenraisedabouttheShangetal.study,particularlythefactthatitsconclusionswerebasedononly8trialsoutof110availableatthetimeandthatitfailsasensitivityanalysis9

i.e.ifyouremovejustoneofthe8trialsusedintheanalysis,theresultis

reversed,showingthathomeopathyworksbeyondplacebo.Furthermorenotoneofthe8trialsusedinvolvesindividualisedhomeopathictreatment–theformofhomeopathyconsideredtobe‘usualcare’,aspracticedbymosthomeopaths. ItisalsoessentialtonotethatShangatal.paper,conducted12yearsago,nolongerreflectstheentiretyoftoday’sevidencebase.

Thesixthandmostrecentcomprehensivemeta-analysisbyMathieetal.,publishedin2014,includes151placebo-controlledrandomisedtrials–41morethanShang’steamidentifiedin

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2005,butwhichwouldhavemettheirinclusioncriteriaifavailableatthetime.Thisstudyfoundthathomeopathicmedicines,whenprescribedduringindividualisedtreatment,are1.5to2.0timesmorelikelytohaveabeneficialeffectthanplacebo10.

ThisdemonstratestheextenttowhichShangetal.2005,whichnowcoversonly73%oftheeligibletrials,hasbeensupersededbyMathieetal.2014–evidenceofthehighestacademicqualitywhichdidnotevenexistatthetimeoftheHouseofCommonsEvidenceCheck.

Consideringonlyrelevantscientificevidence PCIMisprovidingindividualisedhomeopathictreatment(IHT),aformofhomeopathyinvolvinganin-depthconsultation,followedbyaprescription(usuallyasinglehomeopathicmedicine)basedonthespecificsymptomsofthepatient.IHTisgenerallyconsideredtobethe‘goldstandard’ofhomeopathictreatmentandinresearchtermsis‘usualcare’.Thisisnottobeconfusedwithnon-individualisedhomeopathywhereasingleproduct,containingmultiplehomeopathicmedicines,isprescribedtoallpatientsbasedonclinicaldiagnosisalonee.g.over-the-counterhomeopathicmedicines.

Therefore,onlyresearchassessingIHTisrelevanttothiscommissioningdecision.IftheCCGswishtoconsiderevidenceofefficacy,theMathie2014paperisthemostrelevant,rigorousandrecentscientificevidenceavailable:asthisreviewofallplacebo-controlledtrialsonIHTfoundthatthisformofhomeopathy,asdeliveredbyPCIM,hasagreaterclinicaleffectthanplacebo,itisclearthatcurrentbestevidencesupportsthedecisiontocontinueprovisionoftheexistingNHShomeopathyservice.

AstheEC2reportbaseditsconclusionsonlyontheShangetal.paper,whichinturnbaseditsconclusionsonlyontrialsofnon-individualisedhomeopathy,neitherdocumentisactuallyrelevanttothisdiscussion.

Whendecidingwhetherornottodecommissionhomeopathy,Bristol,NorthSomersetandSouthGloucestershireCCGswillofcoursebeconsideringhowwellNHSHomeopathyserviceshaveperformedtodate.Itisthereforehighlysurprisingtofindthatnoinformationhasbeenprovidedonyour‘Decommissioninghomeopathy’11pageaboutresearchwhichhasbeenconductedspecificallytoassesstheperformanceofNHSHomeopathyservices.Asthisprimaryresearchevidencerelatesdirectlytothedecisionbeingtaken,itsabsencefromtheconsultationisaseriouscauseforconcern.

Fourpublishedstudiescarriedoutfrom1999to2008trackedtheoutcomeofpatientsbeingtreatedatNHShomeopathichospitals:Liverpool(2001)AnoutcomesurveycarriedoutattheLiverpooldepartmentofhomeopathicmedicineovera12monthperiodin1999-2000surveyed1,100patients12;76.6%reportedanimprovementintheirconditionsincestartinghomeopathictreatmentand60.3%regardedtheirimprovementasmajor.814patientsweretakingconventionaltreatmentfortheirconditionand424[52%]ofthesewereabletoreduceorstopconventionalmedication.The

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mainconditionstreatedwereosteoarthritis,eczema,chronicfatiguesyndrome,asthma,anxiety,headaches,inflammatoryarthritisandirritablebowelsyndrome.

RoyalLondonHomeopathicHospital(2003)A500-patientsurveyattheRLHHshowedthatmanypatientswereabletoreduceorstopconventionalmedicationfollowinghomeopathictreatment13.

Theextentofimprovement

variedbetweendiagnosese.g.72%ofpatientswithskincomplaintsreportedbeingabletostoporreducetheirconventionalmedication;forcancerpatientstherewasnoreduction.Thestudyalsoshowedthatmanypatientsseekhomeopathybecauseoftheirconcernsaboutthesafetyofconventionaltreatment.BristolHomeopathicHospital(2005)AnobservationalstudyatBristolHomeopathicHospitalincludedover6,500consecutivepatientswithover23,000attendancesinasix-yearperiod1;70%offollow-uppatientsreportedimprovedhealth,50%majorimprovement.Thelargestimprovementswerereportedinchildhoodeczemaorasthma,andininflammatoryboweldisease,irritablebowelsyndrome,menopausalproblemsandmigraine.

Bristol,Glasgow,Liverpool,LondonandTunbridgeWells(2008)Inthispilotstudy,datafrom1602follow-uppatientappointmentsatallfiveNHShomeopathichospitalswerecollectedtogetheroveraone-monthperiod14.

Attheirsecond

homeopathicappointment,34%offollow-uppatientsoverallreportedanimprovementthataffectedtheirdailyliving.Forpatientsattheirsixthappointment,thecorrespondingimprovementratewas59%.Eczema,chronicfatiguesyndrome,menopausaldisorder,osteoarthritisanddepressionwerethe"topfive"mostreferredconditions.Wehaveprovidedstrongevidencethatindividualisedhomeopathyhasaclinicaleffectbeyondplacebo,andcompellinglyconsistentevidencethatwhendeliveredwithinanNHSsetting,homeopathyleadstoclinicalbenefitandreducedconventionaldruguse.Astheonlyevidencementionedontheconsultationwebsiteisthe2010EC2report,onehastoassumethattheCCGswereunawareofthisscientificevidencewhichclearlysupportscontinuationoftheexistinghomeopathyservice.ThefactthatthisevidencecannowbetakenintoconsiderationdemonstratesthevalueofthisconsultationinprovidingCCGswiththeopportunitytoreceiveandconsidernewdatabeforecomingtoadecision.

However,weacknowledgethatcommissioningdecisionsarenotbasedonresearchevidencealone.AssuchBristol,NorthSomersetandSouthGloucestershireCCGsmayprefertobasetheirdecision-makingprimarilyontheethicalandeconomicissuesoutlinedabove.Thus,unlessamoreclinicallyeffectiveandcost-effectivetreatmentoptioncanbeprovidedforthepatientswhocurrentlyusethisservice,homeopathyshouldnotbedecommissionedandthestatusquoshouldbemaintained.

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Pleasetelluswhetheryouare: MemberofthepubliclivinginBristol MemberofthepubliclivinginNorthSomerset MemberofthepubliclivinginSouthGloucestershire ABristol/NorthSomerset/SouthGloucestershireGP AnNHSprovider Asocialcareprovider Aprivateprovider Arepresentativefromthevoluntarysector Other(pleasespecify)

AreyouregisteredwithaGPin: Bristol NorthSomerset SouthGloucestershire IamnotregisteredwithaGPmit

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