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12/03/2019
1
Therolesofplaceboandempathy
intheclinicalencounter
Whenevidencemeetsexperience
@jeremyhowick
January24th,2019
12/03/2019
2
Whatyouwilllearn
• Abouttherela>onshipbetweenexper>seand
evidence
• Aboutashamclinicalconundrum
• Whyeveryhealthcareconsulta>onneedsa
doseofempathy
• Andwhytheseareallrelated
Evidenceversusexperience
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Sacke<onthe‘sins’ofexpertness
Expertscommittwosinsthatretardtheadvanceofscience…1. Addingourpres>getoour
opinionsgivesthelaJerfargreaterpersuasivepowerthantheydeserve…
2. Ongrantapplica>onsandmanuscriptsthatchallengethecurrentexpertconsensus,reviewersfacetheunavoidabletempta>ontoacceptorrejectnewevidence…ontheextenttowhichtheyagreeordisagreewiththepublicposi>onstakenbyexpertsonthesemaJers.(SackeJ,BMJ2000;320:1283)
Expertjudgmentwastakenas
authorita5vebeforeEBMNIHReport(1990)
Groupjudgmentmethodsareperhapsthemostwidelyusedmeansofassessmentofmedicaltechnologiesinmanycountries.Theconsensusdevelopmentconferenceisarela>velyinexpensiveandrapidmechanismfortheconsidera>onandevalua>onofdifferentaJributesofamedicaltechnologyincluding,forexample,safety,efficacy,andefficiency,amongmanyothers(GoodmanandBaratz1990,p.1).
Good
Old
Boys
Sat
Aroundthe
Table
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GOBSAT Arrogance at work
“… particularly in the UK, they felt,
‘Nothing good could come from the
colonies,’ … The other thing … was they
felt that in many places the
paediatricians were the people who were
discouraging use ... It was actually
paediatric versus obstetric issues” (Pat
Crowley).
EBM(JAMA,1992)
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Whatisevidence-basedmedicine?
Knowledge
Therapeu>c
Circumstances
Pa>entvalues
Exper>se
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ButwesUllneedevidence…
Whatistheevidenceforthe
effecUvenessofosteopathy?
Cochranereviewofosteopathy
• Cochranereview(Rubinsteinetal2011),whichis‘best’evidence.
• 26randomisedtrials(6070pa>ents)
• Concludes:“Insummary,SMTappearstobenobeJerorworsethanotherexis>ngtherapiesforpa>entswithchroniclow-backpain.”
• Ifthatwereanewdrug,itwouldbeconsideredaverygoodresult.
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EvidenceandOsteopathy(general)
• Systema>creviewssuggestthatforsome
ailments,especiallybackpain,
• BeJerthannotreatment
• Osteopathyhassimilarbenefitstoother
op>ons
• Similarbenefitstoshamosteopathy
Isthisaplacebo?
Licciardoneetal.2003.SPINEVolume28,Number13,pp1355–1362
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Shamosteopathy
• ROMac>vi>es
• Touch
• SimulatedROM
ac>vi>es
• …andpresumably:
communica<on
Whatyouwilllearn
• Abouttherela>onshipbetweenexper>seand
evidence
• Aboutashamclinicalconundrum
• Whyeveryhealthcareconsulta>onneedsa
doseofempathy
• Andwhytheseareallrelated
12/03/2019
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Conundrum:Isshamosteopathylike
aplacebopill?Orisitlikeexercise?
Prozac Placebo
_ =
Fluoxetine Fluoxetine
Placebo effects
(including
empathy)
Other factors (regression
to mean)
Fluoxetine
Placebo effects
(including
empathy)
Other factors (regression
to mean)
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Exercise Placebo?
_ =
1. Belief
2. Par>cipant/
inves>gator
interac>on
3.Psychological’ benefits
4.>metabolicrate
5.>body
temperature
6.>heartrate
7.>endorphinand
adrenalinelevels
?
Giveaway:Idon’tknowtheanswerto
theconundrum
HoweverIdoknowthatone
componentofosteopathy:empathy,
hasbenefits
AndIcansolvetheconundrum
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Whatyouwilllearn
• Abouttherela>onshipbetweenexper>seand
evidence
• Aboutashamclinicalconundrum
• WhyeveryhealthcareconsultaUonneedsa
doseofempathy
• Andwhytheseareallrelated
12/03/2019
12
12/03/2019
13
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Typesoftrials
EmpathyintervenUontrials:Thosethatrandomized
par>cipantstoenhancedprac>>onerempathy.
ExpectaUonintervenUontrials:Thosethat
randomizedpar>cipantstoenhancedposi>ve
messagesaimedatpromo>ngposi>veexpecta>ons.
Controlgroupwasalwaysusualcare.
Tominimizetheriskofbias,weonlyincluded
properlyrandomisedtrials.
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EmpathyStudyExample
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PosiUvemessagesstudyexample
ExampleexpectaUonsstudysummary
methods
• 124pa>entsscheduledforcoronaryarterybypassgrak(CABG)randomizedto:
• Interven>ontoop>mizeoutcomeexpecta>ons(EXPECT);or
• apsychologicalcontrolinterven>on(SUPPORT);or
• tostandardmedicalcare(SMC).
• Primaryoutcome:disability6monthsakersurgery(usingpaindisabilityscore,0-70);andinterleukin6,8.
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Howempathyworks
• Empathicprac>>onerscanreducestress.
• Empathicprac>>onerscanmakemore
accuratediagnoses.
• Andmoreappropriate,personalised
treatments.
HowexpectaUonswork
• Ac>vatethebrain'srewardmechanisms
(increaseddopamineac>vityinthenucleus
accumbens),andtheendogenousopioid
system.
• Reducestress,whichinturnappearsto
reducepain,anxiety,depression,anda
varietyofothercondi>ons.
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LimitaUons
• Hardtoisolatethesetypesofstudies.
• Heterogeneity.
• Lackofblinding.
• Insufficientdataaboutempathytraining.
• Didnotreportpoten>alharmsto
prac>>oners,forexampleduetoaddi>onal
emo>onaldemands.
LimitaUonsII
Smalleffectsize(about1or2pointsona10-point
visualanalogscale)
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ResponsetolimitaUons
• Costeffec>venessnotknownbutmarginal
costapproaches0
• Globalbenefits
• Asgoodasdrugs
Whataboutseriousillness
• Thereviewonlycontainstrialstrea>ngvery
commoncondi>ons.
• Insomecasestheprognosisisverybad,and
neitherempathynorexpecta>onswillcure.
• Thereisnohopeofanyrecovery.
• Whatdowedointhesesitua>ons?
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Inshort:empathicposiUve
communicaUon‘works’
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Outline
• Anoteaboutevidenceandexper>se
• Ashamclinicalconundrum
• Solvingtheconundrum
Backtotheconundrum
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Prozac Placebo
_ =
Fluoxetine Fluoxetine
Placebo effects
(including
empathy)
Other factors (regression
to mean)
Fluoxetine
Placebo effects
(including
empathy)
Other factors (regression
to mean)
Exercise Placebo?
_ =
1. Belief
2. Par>cipant/
inves>gator
interac>on
3.Psychological’ benefits
4.>metabolicrate
5.>body
temperature
6.>heartrate
7.>endorphinand
adrenalinelevels
?
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QuesUonsaboutosteopathysham
• WasthesimulatedROMactuallysimulated?
• Whatisthedifferencebetweensimulatedand
realROM?
• Wasthecommunica>onthesameinboth
groups?
Idon’tknow
Conclusion:Highquality,well-designed,
researchthatalignswithinterna>onal
bestprac>ceisgreatlyneededtobuilda
pragma>cevidencebaseforOMT
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Whatyouwilllearn
• Abouttherela>onshipbetweenexper>seand
evidence
• Aboutashamclinicalconundrum
• Whyeveryhealthcareconsulta>onneedsa
doseofempathy
• Andwhytheseareallrelated
12/03/2019
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Takeaways
• Evidenceandexper>searebothpartof
evidence-basedmedicine
• Expertcommunica<onisanevidence-based
interven>on
• Combineyourexper>setoavoidshamsand
docompara>veeffec>venessstudies
Wheretofindoutmore
• @jeremyhowick
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Thankyou
@jeremyhowick
