UNDERSTANDING THE HOMEOPATHY DEBATE …€¦ · · 2017-10-22UNDERSTANDING THE HOMEOPATHY DEBATE...
Transcript of UNDERSTANDING THE HOMEOPATHY DEBATE …€¦ · · 2017-10-22UNDERSTANDING THE HOMEOPATHY DEBATE...
UNDERSTANDINGTHEHOMEOPATHYDEBATE Theevidencebaseforhomeopathyisacontroversialtopic,withscientistsonbothsidesofthedebatedrawingdifferentconclusionsfromtheexistingdata.
Itisoftenreportedthatthereisnoevidencehomeopathyworksorthatthecurrentevidencebaseshowsthathomeopathyisnobetterthanplacebo.Neitherstatementiscorrect.
Suchmisconceptionsstemlargelyfromtwodocuments–theUKHouseofCommonsScienceandTechnologyCommitteeEvidenceCheck2:Homeopathyreport(EC2)1andthemorerecentInformationPaperonHomeopathyproducedbytheAustralianNationalHealthandMedicalResearchCouncil(the“AustralianReport”)2.ReliabilityoftheEvidenceCheck2report
AstheEC2report,publishedin2010,continuestobewidelyreferredto,itsreliabilityneedstobeconsideredobjectively.Althoughdescribedbysomeasa‘comprehensivereview’oftheevidence,theEC2reportisnotascientificdocument–itisareportcompiledbyacommitteeof14MembersofParliament(MPs).Nosystematicscientificmethodwasapplied,itwasnotcarriedoutbyexpertacademicsinthefieldanditwasnotpeerreviewed.Assuchitcannotbeconsideredpartofthescientificliterature.
Furthermore,thechoiceofevidenceincludedinthisEvidenceCheckshowedadisturbingbias–bothintermsofwrittensubmissionsandthechoiceofwitnessespermittedtogiveoralevidence.TheEC2reportwascriticisedbyMPsanddismissedbyGovernment
ThemultipleflawsintheEC2reportweresignificantenoughtodrawwidespreadcriticismfromfellowpoliticianswhoarefamiliarwithhowsuchEvidenceChecksshouldbeconducted.
AnindependentcritiquebyEarlBaldwinofBewdleyconcludedthatthereportwas“anunreliablesourceofevidenceabouthomeopathy”3.EarlBaldwin’sopinionisofparticularinterestasheservedontheHouseofLordsScienceandTechnologySub-Committeethatinquiredintocomplementaryandalternativemedicinein1999-2000,givinghimfirst-handknowledgeofbothcorrectCommitteeprocedureandthetopicinquestion.
Fromthecommitteeof14MPs,only3MPsvotedtoendorsethefinalEC2reportandoneMember(IanStewartMP)votedagainstthereportduetohisconcernoverthe“balanceofwitnesses”.Afterpublication,70MPsopposedthereport,signinganEarlyDayMotion(EDM908)toformallycriticisetheapproachtakenandthereport’sconclusions.
Mostimportantly,theGovernment’sresponse4rejectedtherecommendationsofthereportandendorsedapatient’srighttocontinuetoaccesshomeopathyontheNHS.Thesefactscanbeverifiedinmoredetailatwww.homeopathyevidencecheck.org.
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TheEC2reportonlyconsideredafractionoftheevidencebase
TheEC2reportonlyconsideredclinicalevidence–itexcludedalllaboratorystudiestestinghomeopathyonplantsandanimalmodels,fundamentalresearchintopropertiesofhomeopathicmedicinesandveterinarystudies.
TheCommitteealsoexcludedallstudiestestingclinicaleffectivenessi.e.observationalstudiesandpragmaticrandomisedcontrolledtrialswhichtesthowhomeopathyperformsinrealworldclinicalsettings.
Theonlyevidenceconsideredwasontheefficacyofhomeopathyi.e.howhomeopathyperformsagainstplaceboundertightlycontrolledtrialconditions.Fivesystematicreviewsofrandomisedcontrolledtrials(RCTs)wereconsideredbythecommittee5,6,7,8,9.Fromthisevidence,thefourwhichreachedbroadlypositivefindingsinfavourofhomeopathyweredismissed,5,6,7,8basedentirelyonthetestimonyofProfEdzardErnst10whostatedthat,inhisopinion,threewereoutofdateandoneshouldactuallybeconsiderednegative.TheonlystudywhichErnstdidnotcriticiseatallwas‘TheLancetstudy’byShangetal.9whichhedescribedasreachinga“devastatinglynegativeoverallconclusion”.
AstheEC2report’sconclusionwaseffectivelybasedsolelyontheShangetal.study,onceagainthequalityandreliabilityofthisevidencebecomesofparamountimportance.
MultipleconcernshavebeenraisedabouttheShangetal.study,particularlythefactthatitsconclusionswerebasedononly8trialsoutofthe110availabletotheauthorsatthetimeandthatitfailsa‘sensitivityanalysis’11i.e.ifyouchangejustoneofthe8trialstheychosetoincludeintheiranalysis,theresultisreversed,showingthathomeopathyworksbeyondplacebo.Thiscompletelyunderminesthepaper’sfindings.ItishighlysurprisingthatProfErnstdidnotmaketheCommitteeawareofthisfundamentalflawwiththepaper.TheEC2reportisnowwoefullyoutofdate
AlthoughtheEvidenceCheckwaspublishedin2010,thereportbaseditsconclusionsonsystematicreviewspublishedupto2005.ProfErnstalsostatesinhissubmissionthathisarguments(againsthomeopathy)werebasedonevidencepublishedupto200512.Thatmeansthattheevidencediscussedin2010wasalreadyatleastfiveyearsold.
Aswetakeafreshlookattheevidencebaseforhomeopathyin2017,itisclearthatthefieldofhomeopathyresearchhasprogressedsignificantlysincetheEvidenceCheck2,includingpublicationofmorerecentsystematicreviews.
Forexample,areviewbyMathieetal.publishedin2014foundthathomeopathicmedicines,whenprescribedduringindividualisedtreatment,are1.5to2.0timesmorelikelytohaveabeneficialeffectthanplacebo.13Thisstudyincludes151placebo-controlledrandomisedtrials–41morethanShang’steamidentified,butwhichwouldhavemettheirinclusioncriteriaiftheyhadbeenavailableatthetime.
Thisdemonstratestheextenttowhichthenow-12year-oldShangetal.paper,whichcoversonly73%ofeligibletrials,hasbeensupersededbytheMathieetal.2014paper–evidenceofthehighestacademicqualitywhichdidnotevenexistatthetimeoftheEvidenceCheck2.
Anevenmorerecentsystematicreview(Mathieetal.2017)included75doubleblind,randomisedplacebocontrolledclinicaltrialsofnon-individualisedhomeopathictreatment
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forabroadrangeofconditions.Mathieetal.foundasmallbeneficialeffectfornon-individualisedhomeopathictreatmentthatwasstatisticallysignificantlydifferentfromplacebo.However,thispooledoverallresultonlypartiallywithstoodrigoroussensitivityanalysis,wheremeta-analyseswereperformedon18differentsub-groupsoftrialsincludingsamplesize,potency,acute/chronicconditionsetc.Theoverallqualityoftheevidencepreventeddecisiveconclusions,whiletheresults’positivetrendindicatestheneedformoreandhigher-qualitytrials.Reliabilityofthe2015AustralianReportonHomeopathy
InMarch2015,theAustralianNationalHealthandMedicalResearchCouncil(NHMRC)publishedanInformationPaperonhomeopathy,commonlyreferredtoas‘TheAustralianReport’2.Thisdocumentconcludesthat“…therearenohealthconditionsforwhichthereisreliableevidencethathomeopathyiseffective”.
ThisreporttriggeredheadlinesaroundtheworldsuggestingNHMRChadfoundthathomeopathydoesn’tworkforanycondition14.AnextensivedetailedinvestigationbytheAustralianHomeopathicAssociation(AHA)intoNHMRC’sconduct,combinedwithanin-depthscientificanalysisofthereportbyHRI,revealedevidenceofseriousproceduralandscientificmisconduct,drasticallyreducingthecredibilityandreliabilityofthisreport.
ThesefailuresincludeNHMRChidingthefactthattheycarriedoutthehomeopathyreviewtwice.Sincetheexistenceofafirstreviewwasdiscovered,NHMRChavecontinuedtorefusetoreleasethisdocumentintothepublicdomain.
ThesecondtimetheNHMRCdidthereviewtheyusedanarbitrarymethodtoassesstheevidenceonhomeopathythathasneverbeenusedinanyotherreview,beforeorsince.NHMRCdecidedthatfortrialstobe‘reliable’theyhadtohaveatleast150participantsandreachanunusuallyhighthresholdforquality.
InAugust2016asubmissionofcomplaintwasmadetotheCommonwealthOmbudsman,whoiscurrentlyinvestigatingNHMRC’sconductinproducingtheirreportonHomeopathy.
Formoredetailedinformationvisitwww.hri-research.org/Australian-ReportMovingbeyondthedebate
HavingidentifiedthereasonswhytheEC2reportandAustralianReportcannotbeusedbydecision-makers,itisusefultoconsiderwhatevidencecanandshouldbeusedtoidentifythepotentialclinicalbenefitsofhomeopathyandinformhealthcarepolicy.
Researchinhomeopathyisacomplexandrapidlyevolvingfield.AtHRIwewouldencouragethosewishingtotrulyunderstandthescientificbasisofhomeopathytoconsidertheentireevidencebaseobjectively–fromlaboratorystudiestoobservationalstudiesandrandomisedcontrolledtrials–solongasthestudiesareofhighqualityandrelatedirectlytothequestioninhand.
Informationonsuchstudiescanbefoundatwww.hri-research.org.Shortsummariesofthemostfrequentlyrequestedevidencecanbefoundunderthefollowingsections:
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EssentialEvidence https://www.hri-research.org/resources/essentialevidence/HomeopathyFAQs https://www.hri-research.org/resources/homeopathy-faqs/Researchtogo https://www.hri-research.org/resources/research-to-go/
TheCORE-Homdatabasecontaininginformationon1015clinicaltrialsonhomeopathycanalsobeaccessedfreeofchargehere:
https://www.hri-research.org/resources/research-databases/core-hom/
Theseresourcesdemonstrateclearlythatthereisgoodqualityscientificevidencedemonstratingthathomeopathicmedicinesarenot‘justwater’andthathomeopathictreatmentcanhaveaneffectbeyondplacebo.However,tomoveusbeyondthecurrentsituationofintensedebate,morehighqualityresearchisessential,toprovidemoredefinitiveanswerstothekeyquestions–howdohomeopathicmedicinesworkandwhatcantheytreat?
References 1. House of Commons Science and Technology Committee - Evidence Check 2: Homeopathy, Fourth Report of Session 2009-10 (February, 2010) 2. NHMRC Information Paper: Evidence on the effectiveness of homeopathy for treating health conditions, March 2015 3. Earl Baldwin of Bewdley, June 2010: Observations on the report Evidence Check 2: Homeopathy by the House of Commons Science and Technology Committee, February 2010
4. http://www.parliament.uk/edm/2009-10/908 5. Kleijnen, J., Knipschild, P. & ter Riet, G. Trials of homeopathy. BMJ 302, 960 (1991). 6. Linde, K. et al. Are the clinical effects of homeopathy placebo effects? A meta-analysis of placebo-controlled trials. Lancet 350, 834–843 (1997). 7. Linde, K. et al. Impact of study quality on outcome in placebo-controlled trials of homeopathy. J. Clin. Epidemiol. 52, 631–636 (1999). 8. Cucherat, M., Haugh, M. C., Gooch, M. & Boissel, J. P. Evidence of clinical efficacy of homeopathy. A meta-analysis of clinical trials. HMRAG. Homeopathic Medicines Research Advisory Group. Eur. J. Clin. Pharmacol. 56, 27–33 (2000). 9. Shang A, Huwiler-Muntener K, Nartey L, et al. Are the clinical effects of homoeopathy placebo effects? Comparative study of placebo-controlled trials of homoeopathy and allopathy. Lancet, 2005; 366: 726–32 10. House of Commons Science and Technology Committee - Evidence Check 2: Homeopathy, Fourth Report of Session 2009-10. (February, 2010) Page 18, Point 65 to 69 (p.22 of PDF
11. Lüdtke, R. & Rutten, A. L. B. The conclusions on the effectiveness of homeopathy highly depend on the set of analyzed trials. J. Clin. Epidemiol. 61, 1197–1204 (2008). 12. House of Commons Science and Technology Committee - Evidence Check 2: Homeopathy, Fourth Report of Session 2009-10. (February, 2010) Memorandum submitted by Professor Edzard Ernst (HO 16), Evidence Ev 26 (p.85 of PDF)
13. Mathie RT, et al. Randomised placebo-controlled trials of individualised homeopathic treatment: systematic review and meta-analysis. Systematic Reviews, 2014; 3:142. 14. Homeopathy is bunk, study says. The Guardian, 8 April 2014