Observational studies on homeopathy - HRI · 2018-01-11 · Observational studies on homeopathy ......
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Observational studies on homeopathy, November 2015 www.HRI-research.org | Page 1 Observational studies on homeopathy To healthcare providers, patients and clinicians, what matters most is not necessarily how well a treatment performs under the artificially controlled conditions on a randomised controlled trial (RCT), but the results seen in clinical practice. Evidence from ‘uncontrolled observational studies’ provides insight into changes in patients who have received treatment provided by homeopaths. These studies consistently show that patients improve clinically following homeopathic treatment (often from chronic, difficult to treat conditions); some also highlight areas of potential economic benefit for the NHS as a whole in terms of reduced prescribing of conventional drugs. United Kingdom Five published studies carried out from 1999 to the present day have tracked the outcome of patients being treated at NHS homeopathic hospitals: Liverpool (2001) An outcome survey carried out at the Liverpool department of homeopathic medicine over a 12 month period in 1999-2000 surveyed 1,100 patients 1 ; 76.6% reported an improvement in their condition since starting homeopathic treatment and 60.3% regarded their improvement as major. 814 patients were taking conventional treatment for their condition and 424 [52%] of these were able to reduce or stop conventional medication. The main conditions treated were osteoarthritis, eczema, chronic fatigue syndrome, asthma, anxiety, headaches, inflammatory arthritis and irritable bowel syndrome. Royal London Homeopathic Hospital (2003) A 500-patient survey at the RLHH showed that many patients were able to reduce or stop conventional medication following homeopathic treatment. 2 The extent of improvement varied between diagnoses e.g. 72% of patients with skin complaints reported being able to stop or reduce their conventional medication; for cancer patients there was no reduction. The study also showed that many patients seek homeopathy because of their concerns about the safety of conventional treatment. Bristol Homeopathic Hospital (2005) An observational study at Bristol Homeopathic Hospital included over 6,500 consecutive patients with over 23,000 attendances in a six-year period; 3 70% of follow-up patients reported improved health, 50% major improvement. The largest improvements were
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Observationalstudiesonhomeopathy,November2015www.HRI-research.org|Page1
Observationalstudiesonhomeopathy
Tohealthcareproviders,patientsandclinicians,whatmattersmostisnotnecessarilyhowwellatreatmentperformsundertheartificiallycontrolledconditionsonarandomisedcontrolledtrial(RCT),buttheresultsseeninclinicalpractice.Evidencefrom‘uncontrolledobservationalstudies’providesinsightintochangesinpatientswhohavereceivedtreatmentprovidedbyhomeopaths.Thesestudiesconsistentlyshowthatpatientsimproveclinicallyfollowinghomeopathictreatment(oftenfromchronic,difficulttotreatconditions);somealsohighlightareasofpotentialeconomicbenefitfortheNHSasawholeintermsofreducedprescribingofconventionaldrugs.
UnitedKingdomFivepublishedstudiescarriedoutfrom1999tothepresentdayhavetrackedtheoutcomeofpatientsbeingtreatedatNHShomeopathichospitals:Liverpool(2001)
AnoutcomesurveycarriedoutattheLiverpooldepartmentofhomeopathicmedicineovera12monthperiodin1999-2000surveyed1,100patients1;76.6%reportedanimprovementintheirconditionsincestartinghomeopathictreatmentand60.3%regardedtheirimprovementasmajor.814patientsweretakingconventionaltreatmentfortheirconditionand424[52%]ofthesewereabletoreduceorstopconventionalmedication.Themainconditionstreatedwereosteoarthritis,eczema,chronicfatiguesyndrome,asthma,anxiety,headaches,inflammatoryarthritisandirritablebowelsyndrome.
RoyalLondonHomeopathicHospital(2003)
A500-patientsurveyattheRLHHshowedthatmanypatientswereabletoreduceorstopconventionalmedicationfollowinghomeopathictreatment.2Theextentofimprovementvariedbetweendiagnosese.g.72%ofpatientswithskincomplaintsreportedbeingabletostoporreducetheirconventionalmedication;forcancerpatientstherewasnoreduction.Thestudyalsoshowedthatmanypatientsseekhomeopathybecauseoftheirconcernsaboutthesafetyofconventionaltreatment.BristolHomeopathicHospital(2005)
AnobservationalstudyatBristolHomeopathicHospitalincludedover6,500consecutivepatientswithover23,000attendancesinasix-yearperiod;370%offollow-uppatientsreportedimprovedhealth,50%majorimprovement.Thelargestimprovementswere
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reportedinchildhoodeczemaorasthma,andininflammatoryboweldisease,irritablebowelsyndrome,menopausalproblemsandmigraine.Bristol,Glasgow,Liverpool,LondonandTunbridgeWells(2008)Inthispilotstudy,datafrom1602follow-uppatientappointmentsatallfiveNHShomeopathichospitalswerecollectedtogetheroveraone-monthperiod.4Attheirsecondhomeopathicappointment,34%offollow-uppatientsoverallreportedanimprovementthataffectedtheirdailyliving.Forpatientsattheirsixthappointment,thecorrespondingimprovementratewas59%.Eczema,chronicfatiguesyndrome,menopausaldisorder,osteoarthritisanddepressionwerethe"topfive"mostreferredconditions.
PatientsreferredtoNHShomeopathichospitalstypicallyhavechronicconditionsforwhichavailableconventionaltreatmentshavenotbeensufficientlyeffective.Intotal,thestudyidentified235separatemedicalcomplaintstreatedatthehospitalsduringonemonth.Manypatientshadmultiplepathologies.Thestudyshowedthatreportedhealthbenefitsmayoccurmorequicklyinsomemedicalconditionsthaninothers.ThepilotfindingsareinformingaprogrammeofstandardsettingfortreatmentoutcomesintheNHShomeopathichospitals.BristolHomeopathicHospital(2016)Confirmingtheresultsofthe2005study,thisrecentauditofjustunder200patientsperformedatBristolHomeopathicHospitaldemonstratedthatpatientswithlong-termconditionswhocomeunderhomeopathiccareexperiencestatisticallysignificantimprovementsintheirpresentingsymptomsandwellbeing.5Atotalof198patientswereassessedover1to5consultationsusingapatient-reportedoutcomemeasure(MYMOP2).Themostcommonconditionsseenwereneoplasms,psychologicalandgenitourinarycomplaintswhilethemostcommonlyreportedsymptomswerepain,mentalsymptomsandtiredness/fatigue.Intention-to-treatanalysisshowedthatameanMYMOP2scorechangeof1.24fromthefirsttolastconsultationwasachieved,withimprovementsbeingstatisticallysignificantforbothcompletersandnon-completers(p<0.001).France'EPI3’Project(2008-2012)
HomeopathyiswidelyusedinFranceandamajorstudyfollowing8559patientsattendingGPpracticeswasusedtoassesstheeffectivenessofhomeopathictreatment.This’EPI3
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study’6ismanagedbyLA-SERaUK-basedcompanyspecialisedinscientificevidenceformedicineandhealthtechnologies(http://www.la-ser.com/).Theprojectteamincludesindividualsfromhigh-profileinstitutionssuchastheInstitutPasteurinParis,UniversityofBordeauxandMcGillUniversity,Montreal;LucienAbenhaimistheFrenchGeneralDirectorofHealth(SurgeonGeneral).KeyfindingsoftheEPI3project:
• Upperrespiratorytractinfections(URTIs)
PatientstreatedbyGPstrainedinhomeopathydidaswellclinicallyasthosetreatedwithconventionalmedicine,butusedfewerconventionaldrugs.7Thisstudyinvestigatedtheuseofantibioticsandantipyretic/anti-inflammatorydrugsuseforthetreatmentofupperrespiratorytractinfections(URTIs).518adultsandchildrenwithURTIswereincluded.PatientswhoconsultedwithGPscertifiedinhomeopathyshowedsignificantlylowerconsumptionofantibiotics(OR=0.43,CI:0.27–0.68)andantipyretic/anti-inflammatorydrugs(OR=0.54,95%CI:0.38–0.76),withsimilarevolutioninrelatedsymptoms.
• Musculoskeletaldisorders(MSDs)
Patientstreatedwithhomeopathydidaswellclinicallyasthosetreatedwithconventionalmedicine,butusedonlyhalftheamountofnon-steroidalanti-inflammatorydrugs(NSAIDs)andhadfewerNSAID-relatedsideeffects.8
1153patientswithwhoconsultedGPscertifiedinhomeopathywerefollowed,comparinggroupswhoreceivedhomeopathyorconventionalmedicine(CM),oramixedapproachinvolvingbothapproaches.PatientsdidnotdifferbetweengroupsexceptforchronicityofMSDs,whichwashigherinthehomeopathygroup(62.1%)thaninboththeCM(48.6%)andmixed(50.3%)groups.Thetwelve-monthdevelopmentofspecificfunctionalscoreswasidenticalforallgroups(p > 0.05).Afteradjustingforpropensityscores,NSAIDuseover12monthswasalmosthalfinthehomeopathygroup(OR,0.54;95%CI,0.38-0.78)ascomparedtotheCMgroup;nostatisticallysignificantdifferencewasfoundinthemixedgroup(OR,0.81;95%CI:0.59-1.15).MSDpatientsseenbyhomeopathicphysiciansshowedasimilarclinicalprogressionwhenlessexposedtoNSAIDincomparisontopatientsseeninCMpractice,withfewerNSAID-relatedadverseeventsandnolossoftherapeuticopportunity.
• Sleep,anxietyanddepressivedisorders(SADD)
Patientstreatedbycertifiedhomeopathicphysicianswerelesslikelytobeprescribedpsychotropicdrugs.9TheEPI3study‘SADD’studyinvolved1572patientsdiagnosedwithsleep,anxietyanddepressivedisordersseekingtreatmentfromphysiciansingeneralpractice(GPs),withthreedifferentpracticepreferences:strictlyconventionalmedicine
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(GP-CM),mixedcomplementaryandconventionalmedicine(GP-Mx)andcertifiedhomeopathicphysicians(GP-Ho).PsychotropicdrugsweremorelikelytobeprescribedbyGP-CM(64%)thanGP-Mx(55.4%)andGP-Ho(31.2%).ThethreegroupsofpatientssharedsimilarSADDseverityintermsofcomorbiditiesandqualityoflife.
GermanyComparinghomeopathyandconventionalcare(2005)
AstudycommissionedbyaGermanhealthinsurancecompanytodeterminewhethertocontinuecoveringhomeopathictreatmentassessedthevalueofhomeopathyintreatingchronicconditionscommonlyseeningeneralpractice.10493patients(315adults,178children)treatedbygeneralpractitionersreceivedeitherconventionalmedicineorhomeopathy.Patientsinthehomeopathygroupreportedgreaterimprovementthantheconventionalmedicinegroup(p=0.002)withnosignificantdifferenceincost.
Thephysicians’assessmentsshowedthatchildrenwhoreceivedhomeopathyhadabetterclinicalresponsethanthosewhoreceivedconventionalmedicine(p<0.001).Conditionstreatedincludedheadache,lowbackpain,depression,insomniaandsinusitisinadults,andatopicdermatitis,allergicrhinitisandasthmainchildren.Followingthisstudy,InnungskrankenkasseHamburgdecidedtocontinuetocoverhomeopathictreatment.Eight-yearfollowupofchronicallyillpatientstreatedwithhomeopathy(2008)
Thisstudywhichfollowedover3500adultsandchildrenreceivingroutinehomeopathiccarefromGPs,11foundthat"patientswhoseekhomeopathictreatmentarelikelytoimproveconsiderably".Atthestart,97%ofparticipantswerediagnosedwithachroniccomplaint,with95%declaringpriorconventionaltreatmentfortheircondition.Diseaseseveritydecreasedsignificantly(p<0.001)betweenthestartofthestudy,after2yearsandafter8yearsofhomeopathictreatment.Notably,after8years,figureswerealmostidenticalto2-yearfollow-up,indicatingsteadylong-termhealthbenefits.
Thismulti-centre8-yearlongitudinalcohortstudyconcentratedonpatientsinroutinecaretreatedbyGPswithadditionalqualificationsinhomeopathy.Thestudyincluded3,709patients,73%ofwhichcontributeddatatothe8-yearfollow-upi.e.2,722adults(72.8%female,ageatbaseline41.0±12.3)and819children(48.4%female,age6.5±4.0).Themostfrequentdiagnoseswereallergicrhinitisandheadacheinadults,andatopicdermatitisandmultiplerecurrentinfectionsinchildren.
Mainoutcomemeasures,utilisingconventionalmedicalresearchinstruments,includedqualityoflife(QoL)andnumericalseverityscaleassessments.Oneintwopatientsexperiencedreductionsof50%insymptomseverityafter8years,withcorresponding
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changesinQoLmeasures.Ofadults,almost50%ofresponders(67.4%totalstudypopulation)experienced"clinicallyrelevanttreatmentsuccess"(complaintseverityreduced2pointsormoreona10-pointscale);inchildrenthefigurewas80%.Youngerage,femalegenderandmoreseverediseaseatbaselinewerefactorspredictiveofbettertherapeuticsuccess.References1. RichardsonWR.Patientbenefitsurvey:LiverpoolRegionalDepartmentofHomoeopathic Medicine.BrHomeopathJ,2001;90:158-162.2. SharplesF,vanHaselenR,FisherP.NHSpatients'perspectiveoncomplementarymedicine. ComplementTherMed,2003;11:243-248.3. SpenceD,ThompsonEA,BarronSJ.Homeopathictreatmentforchronicdisease:a6-year university-hospitaloutpatientobservationalstudy.JAlternComplementMed,2005;5:793-798.4. ThompsonEA,MathieRT,BaitsonES,BarronSJ,BerkovitzSR,BrandsM,FisherP,KirbyTM, LeckridgeRW,MercerSW,NielsenHJ,RatseyDHK,ReillyD,RonigerH,WhitmarshTE. Towardsstandardsettingforpatient-reportedoutcomesintheNHShomeopathichospitals. Homeopathy,2008;97:114-121.5. ThompsonE,ViksveenP,BarronS.Apatientreportedoutcomemeasureinhomeopathicclinicalpracticeforlongtermconditions.Homeopathy,2016;105(4):309-3176. Grimaldi-Bensouda,L.etal.Benchmarkingtheburdenof100diseases:resultsofanationwide representativesurveywithingeneralpractices.BMJOpen,2011;1:e000215.7. Grimaldi-Bensouda,L.etal.Managementofupperrespiratorytractinfectionsbydifferent medicalpractices,includinghomeopathy,andconsumptionofantibioticsinprimarycare:the EPI3cohortstudyinFrance2007-2008.PloSOne,2014;9,e89990.8. Rossignol,M.etal.Impactofphysicianpreferencesforhomeopathicorconventionalmedicines onpatientswithmusculoskeletaldisorders:resultsfromtheEPI3-MSDcohort. Pharmacoepidemiol.DrugSaf.2012;21:1093–1101.9. Grimaldi-Bensouda,L.etal.Whoseeksprimarycareforsleep,anxietyanddepressivedisorders fromphysiciansprescribinghomeopathicandothercomplementarymedicine?Resultsfromthe EPI3populationsurvey.BMJOpen2012;2.10. WittC,KeilT,SelimD,etal.Outcomeandcostsofhomeopathicandconventional treatmentstrategies:acomparativecohortstudyinpatientswithchronicdisorders. ComplementTherMed,2005;13:79-86.11. Witt,C.M.,Lüdtke,R.,Mengler,N.&Willich,S.N.Howhealthyarechronicallyillpatientsafter eightyearsofhomeopathictreatment?--Resultsfromalongtermobservationalstudy.BMC PublicHealth,2008;8,413.
