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7/24/16
www.caleblack.com 1
Evalua5ngHealthClaimsinAlt-MedChapter10
Thereareinfacttwothings,scienceandopinion;theformerbegetsknowledge,thelaIerignorance.
HippocratesofKos
ABigChunkofChange
• IntheU.S.approximately$3trillionarespentonhealthcareeachyear,or$10,000perperson
• OthercountriesworldwideoTenspendupto10%oftheirGDPonhealthcare
• Weshouldknowifit’sbeingspentwiselyorpoorly
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Opera5onalDefini5ons
• Alterna5veandcomplementarymedicineare“healthcareapproachesdevelopedoutsideofmainstreamWestern,orconven5onal,medicine”
• Integra5vehealthcaredescribes“conven5onalandcomplementaryapproachestogetherinacoordinatedway”
(NCCIH,n.d.)
Opera5onalDefini5ons
• Evidence-basedprac5ceis– “…theconscien5ous,explicit,andjudicioususeofcurrentbestevidenceinmakingdecisionsaboutthecareofindividualpa5ents.”
– “…healthcareprac5cethatisbasedonintegra5ngknowledgegainedfromthebestavailableresearchevidence,clinicalexper5se,andpa5ents’valuesandcircumstances.”
(SackeIetal.,1996)(Dickersinetal.,2007)
Evidence-basedPrac5ce
• Usesthosemedicines,therapies,ordiagnos5cassessmentsthathavebeendemonstratedtobeeffec5veviawell-controlledtrials
• Anewtermwithalonghistory,includinglargeamountofpushbackfromphysiciansof5mespast(andevencurrently)
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EBPvs.CAM
• EBPisamethodofmakingdecisions,whileCAMreferstoatypeoftreatment
• EBPstartswiththepa5entandaskswhatisthebestevidencetoachieveanoutcome
• InEBP,thereisnot“alterna5ve”or“conven5onal”treatments,but…
LevelsofEvidence
• Evidence-basedtreatments
• Poorlystudiestreatments
• Non-evidence-basedtreatments
Evidence-BasedTreatments
• Thoseprocedures,medica5ons,andthelikewhichhavebeenreliablyshowntocauseimprovementinvarioussymptoms
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PoorlyStudiedTreatments
• Thoseprocedures,medica5ons,andthelikewhichhavenotbeenstudiedwellenoughtodeterminetheirimpactonvarioussymptoms,orforwhichthereisconflic5ngevidenceregardingtheireffec5veness
Non-Evidence-BasedTreatments
• Thoseprocedures,medica5ons,andthelikewhichhavebeenreliablyshownnottocauseimprovementinvarioussymptoms
NoPanaceas
• Notreatmentswillcurealldiseaseorillness
• ThesametreatmentcanbeEBTforoneproblem,butnon-EBTorPSTforanother
• E.g.,an5bio5csareEBTforbacterialinfec5ons,butnon-EBTsforviralones
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Non-Sta5cCategories
• Asinallscience,ourunderstandingofhealthtreatmentsisconstantlyevolving
• Thismeansthattreatmentscanmovefrom“mainstream”to“alterna5ve”andviceversa– Variousherbalsupplements– Deepbreathing
• OfficeofAlterna5veMedicine
1991
• Na5onalCenterforComplementaryandAlterna5veMedicine
1998 • Na5onalCenterforComplementaryandIntegra5veMedicine
2014
WhytheChange?
• “Truealterna5vemedicineisuncommon.Mostpeoplewhousenon-mainstreamapproachesusethemalongwithconven5onaltreatments.”
• ThenameshiTsseemdesignedtohelpobscuresomepoints,though
(NCCIH,n.d.)
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PurposefulConfusion?
• Thereareincreasinglynega5veconnota5onsfortheterm“alterna5vemed”amongmany
• TheNCCIHalsodescribesnumeroustreatmentsthatarenon-EBTasbeingeitherEBTorPST– Homeopathy,acupuncture
PurposefulConfusion?• Currently,theNCCIHputsCAMintothreegroups
1. Naturalproducts– Herbs,vitamins,minerals,probio5cs,andother
dietarysupplements2. Mindandbodyprac5ces– Yoga,chiroprac5cmanipula5on,massage,
medita5on,acupuncture,relaxa5on,hypnotherapy,movementtherapies
3. Othercomplementaryhealthapproaches– Naturopathy,homeopathy,tradi5onalChinese
medicine,Ayurvedicmedicine,andanythingelsethatdoesn’tfitintheabovetwocategories
PurposefulConfusion?
• ThisgroupingobscuresthateachcategorycontainsamixtureoftreatmentswithverydifferingLoE
• Well-supportedEBTs(relaxa5on)aremixedwithnon-EBTs(acupuncture)andPSTs(probio5cs)
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By definition (I begin),alternative medicine (I continue) has either not been proved to work or been proved not to work.
Do you know what they call alternative medicine that's been proved to work?
Medicine.
Tim Minchin, “Storm”
GlobalUseofCAM
• Steadyrisegloballyinuseacrossthelast40years
• Mostcommonlyusedarechiroprac5c,homeopathy,herbalmedicine,andacupuncture 0
5
10
15
20
25
30
35
UseofCAM
1970s
2010s
GlobalCostsofCAM
0
5
10
15
20
25
30
35
40
UnitedStates UnitedKingdom Australia SouthAfrica
(inbillionsofUSD)
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Whywouldpeoplespendsomuchmoneyonthingsthatdon’twork?
Wouldn’ttheyrealizethesetreatmentswere
ineffectualandturntosomethingelseforhelp?
Theansweris“Becausetheydowork,justnotforthereasonspeoplethinktheydo.”
ImportanceofResearch
• HealthcareproviderswhouseEBTrelyheavilyonvalidandreliableresearchstudies
• Suchresearchiscri5calbecauseofa) howeasilybiascancreepintooureveryday
decisionmakingb) howinfluencedwearebypowerfulsocialforces,
suchasadver5singc) thestrengthoftheplaceboeffect
ThePlaceboEffect
• People’sbeliefshaveapowerfulimpactnotonlyonhowtheyprocessinforma5on,butalsoontheirbody
• Aplaceboisanytypeofshamorinac5vemedicaltreatmentorprocedure– Sugarpills– Fakeinfusions– Fakesurgeries
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ThePlaceboEffect
• “…themeasurable,observable,orfeltimprovementinhealthorbehaviornotaIributabletoamedica5onorinvasivetreatmentthathasbeenadministered.”
• Inotherwords,someonegetsaplaceboandthenshowsimprovement,evenwithnoac1vetreatment
(Carroll,2015)
“Iwillplease”
• Decadesofresearchhaveshownhowpowerfultheplaceboeffectcanbe
• BeIerinsubjec5ve,asopposedtoobjec5ve,tests– PeoplewithasthmareportfeelingbeIerwithshaminhalers,eventhoughthereisnotameasurablechangeinlungfunc5oning
Biology&thePlacebo
• Takingaplacebocancause– Produc5onofcannabinoidsandopiods
– Releaseofdopamine– Increasedprefrontalcortexac5va5on
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Psychology&thePlacebo
• Expecta5onscolorourpercep5onofbothhowwefeelandhowwebehave
• Evenwhengivennon-alcoholicbeer,peoplefeelandactasiftheyareintoxicated,aslongastheyweretolditwasalcoholic
NoceboEffect
• Whensomethingnega5vehappensoryoufeelworseaTerreceivingashamtreatmentbecauseyouexpecttofeelworse
HowtoMakeaPlaceboStronger
• Befriendly,comfor5ng,andinterested
• Injec5onworksbeIerthanacapsule,whichworksbeIerthanapill
• Bemoreexpensiveandinfancypackaging
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RegressiontotheMean
• RTMisamajorissuewefaceinhealthcareresearch
• Whenyoumeasuresomethingwhichhasmovedinanextremedirec5on,itwillmostlikelymoveback(regress)towardsnormal(themean)acrossrepeatedmeasurements
RTMExample1. Youbegintodevelopaheadache
2. Itstartssmall(notfarfromthe“noheadache”mean)
3. Itbuildsover5me,becomingunbearable(anextremevaluefromthemean)
4. Youtakeanaspirin
5. Soon,yourheadacheisdecreased(RTM)
RTMExample
• Threepossiblereasonswhyyourheadachewentaway– Aspirintrulyworkedtodecreasepain– Aspirinhadaplaceboeffect– Painmayhavedecreasednaturallyregardlessofwhatyoudid(RTM)
• Eachispossibleandplausible,whichiswhyweneedwell-controlledresearchtosortitout
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“Doesthistreatmentwork?”
• Insteadofthat,wehavetoaskboth:
1. “DoesthistreatmentworkbeIerthanaplacebo?”
2. “Wouldthiscondi5onnaturallyimproveover5me,evenwithnointerven5on?”
TheBlindResearchingtheBlind
• Thebestwaytoconductresearchontreatmentoutcomesisthroughtheuseofrandomized,placebo-controlled,double-blindprocedures(RPCDB)
• Thesetypesofhighqualityclinicaltrialsarewhatneedtobereliedon,inordertodetermineifsomethingisanEBT
RPCDBinAc5on
1. Dividetheen5regroupofpeopleinthestudyrandomlyintothetreatmentandcontrolarms
2. Comparethetreatmenttoamatchedtypeofplacebo,ratherthannothing
3. Par5cipantsshouldnotknowwhattreatmentarmtheyarein(beingblinded)
4. Theresearchersshouldalsonotknowwhatarmapar5cipantis(beingdouble-blinded)
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TheGoldStandard
• Thistypeoftrialiscri5cal,asitcontrolsforbiasandplacebos
• Studiesthatdon’tmeetthesecriteriacanshowtreatmentstowork,whentheyactuallydon’t
WhyisCAMSoPopular?
• HugenumbersofpeoplespendhugeamountsofmoneyeachyearonCAM,eventhoughmostisnon-EBT
• Exactreasonsdifferbasedontheindividual,butherearesomeofthemostcommonlyseenreasons
WhyisCAMSoPopular?
• Nosurgery,no“drugs”
• Theyareseenas“natural”
• Manyarecheaperandeasiertoaccess
• Reac5ontothefailingsofconven5onalmed
(Carroll,2003)
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WhyisCAMSoPopular?
• Poli5callobbyingandtheairofapprovalviastatelicensure
• Misunderstandingofhowscienceself-correctsacross5me
• Itworks,thankstoplaceboeffects!
(Carroll,2003)
TipsforAvoidingNon-EBT
• Theproductisadver5sedasaquickandeffec5vecure-allforawiderangeofailments
• Thepromotersusewordslikescien5ficbreakthrough,miraculouscure,exclusiveproduct,secretingredient,orancientremedy
• ThetextiswriIenin"medicalese”
(FTC,1999)
TipsforAvoidingNon-EBT
• Thepromoterclaimsthegovernment,themedicalprofession,orresearchscien5stshaveconspiredtosuppresstheproduct.
• Theadver5sementincludesundocumentedcasehistoriesclaimingamazingresults.
• Theproductisadver5sedasavailablefromonlyonesource.
(FTC,1999)
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TypicalCAMUser
• Middle-aged,female,andofhigherthanaverageeduca5onandincome
• Likelytohavemul5plemedicalcondi5ons,especiallyonesconven5onalmedicineoTenfailsattrea5ng
• Desperateforhelpandrelief,willingtotryanything