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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