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ValerieA.KremerRES100Dec.6,2016
ProgressiveResearchAssignmentPart1Aand1BQuestionIsthehomeopathicremedy,Arnicamontana,effectiveperioperativelyindecreasingecchymosisandedemapost-rhinoplastyinmenandwomenover16yearsold7?TargetPopulationMenandwomenovertheageof167whoareseekingtohaverhinoplastyforcosmeticorreconstructivepurposes.InterventionTheinterventionofinterestisthehomeopathicremedy,Arnicamontana,tobeusedperioperatively.Therandomcontrolledtrial9failedtomentionthedosebutstateditwastakenthreetimesadayforfourdays.Thestudyalsofailedtomentionatwhatpointduringthesurgicalprocesswhenthepatientsstartedtakingarnica.Comparativepopulation/treatmentThecomparativepopulation/treatmentwouldbeadultmenandwomenwhoreceivedaplacebopost-rhinoplastytodecreaseecchymosisandswelling.DefiningoutcomesOutcomeswouldbemeasuredbysubjectivedifferencesbythepatients,aswellasobjectivedifferencesmeasuredbytheplasticsurgeonforecchymosisandedema.Inaddition,postoperativephotographsforcolorchangesandpostoperativeecchymosisassessmentswouldbeused.Etiology,prevalenceandjustificationThisinterventionisofsignificantrelevancesinceecchymosisandedemaarethemostcommonsideeffectsduringtherecoveryperiodpost-rhinoplasty.Thecauseofecchymosis,accordingtoGolger,isduetoosteotomy,orbreakingofnasalbones,whichisoftenrequiredduringaclosedrhinoplasty(1).AccordingtotheCanadianSocietyofPlasticSurgeonswebsite,bruisingistypicallydiminishedafteraweek,however,swellingpost-surgerycanlastmultipleweeksormonths(8).ItisdifficulttodetecttheprevalenceofecchymosisandedemaresultingfromrhinoplastyinCanadasincethestatisticsarenon-existentbecauseplasticsurgeonsdonotmaintainstatisticsinCanada(8).Also,Canadaonlyhas575plasticsurgeons,only1.2%oftheworld’splasticsurgeons,accordingtotheInternationalSocietyforAestheticPlasticSurgerywebsite(3),sotheprevalenceofecchymosisandedemawithrhinoplastyislowerinCanadacomparedtocountrieslikeBrazilandtheUnitedStates3.
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Toshowtheprevalenceofecchymosisandedemapost-rhinoplastyonaglobalscale,therewere730,287rhinoplastysurgeriesperformedin2015,7.6%ofthetotalplasticsurgeriesperformedglobally(3).Further,“Womenhadmorethan18millionsurgicalandnon-surgicalproceduresperformedgloballyin2015,85.6%ofthetotal.Thetopfivesurgicalproceduresperformedonwomenin2015were:breastaugmentation,liposuction,eyelidsurgery,abdominoplastyandrhinoplasty.Menhadmorethan3millionsurgicalandnon-surgicalprocedures,14.4%ofthetotal.Thetopfivesurgicalproceduresperformedonmenwere:eyelidsurgery,liposuction,gynecomastiasurgery,rhinoplasty,fatgraftingandearsurgery”(2).Therefore,thenumbersofpatientsworld-widewithecchymosisandedemapost-rhinoplastyaresignificant.Thereareothereffectivealternativestoreducingecchymosisandedemapost-rhinoplasty,suchassteroiduseandplacebo.AstudydonebyTheCatholicUniversityofKorea,CollegeofMedicine,foundthatedemaandeyelidecchymosiswasreducedbyperioperativesteroiduseandmulti-dosesteroidusewasmoreeffectivethansingleuse(5).However,accordingtotheMayoClinic,therearemultiplesideeffectswithsteroids,suchasprednisoneandcorticosteroids.Someofthesideeffectsoforalsteroiduseinclude:“elevatedpressureintheeyes(glaucoma),fluidretention,causingswellinginyourlowerlegs,highbloodpressure,problemswithmood,memory,behaviorandotherpsychologicaleffects,andweightgain,withfatdepositsinyourabdomen,faceandthebackofyourneck”(6).Injectedsteroidsmaycausesideeffectssuchas“skinthinning,lossofcolorintheskin,facialflushing,insomniaandhighbloodsugar”(6).Althoughthereareawidevarietyofsideeffectsfromcorticosteroids,therearemanybenefitsaswellsuchasrelieving“inflammation,painanddiscomfortofmanydifferentdiseasesandconditions”(6).Thehealthcareproviderweighsthesafetyandriskanalysiswhenusingsteroids6.Inthecaseofplacebo,thereisnoriskinsafetybyallowingthebodytohealitselfpost-rhinoplasty.Often,coldpacksaresuggestedasawaytodecreaseedema,whichhaveminimalrisk.TherewouldbeasignificantvalueforpatientswhofindhomeopathicArnicamontanatoreducingswellingandecchymosispost-rhinoplasty,ifprovedtobetrue.IfArnicamontanadecreasedhealingandrecoverytimeforpatientsundergoingrhinoplastyorotherfacialreconstructionorcosmeticprocedures,therewouldbeanincreasedlevelofpatientsatisfactioninrecoveryoutcomes.Inaddition,therewouldalsobesatisfactionforthesurgeoninknowingthathispatientsarehealingquicklyandseeingtheresultsfasterasedemadecreases.IampersonallyinterestedinthistopicsinceIhavehadreconstructiverhinoplastyduetomynosebeingpreviouslybrokenandwasinstructedbymyplasticsurgeontotakethehomeopathicArnicamontanatoreduceedemaandbruising.Althoughitworkedverywellforme,Iwasnotabletofindanyresearchstudiesatthetimetobackmysurgeon’ssupportforthehomeopathicremedy.Also,Iaminterestedinworkingwithplasticsurgerypatientsinthefutureandhopetoreducetheirhealingtime.ByhavingresearchstudiestosharewithpatientsthatArnicamontanaisaneffectivetreatment,Iwillfeelsupportedingivingittothemandtheycanalsomakeadecisiontotakeitornot.However,Iamalsoopentostudiesthatshowitsineffectivenesstogetawell-roundedandunbiasedpictureofwhat
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hasbeendoneinresearchonthistopic.IwanttobecertainthatwhatIamtellingmypatientsistrueandbackedbyevidencewhenitcomestotheeffectivenessofarnica.Basedonavailableresearch,and,inparticular,thestudydonebyTheCatholicUniversityofKorea,CollegeofMedicine,therehasbeensuccessaswellwithusingsteroidsincontrasttothecontrolgrouptodecreaseupperandloweredemaandecchymosispost-rhinoplasty(5).Also,researchhassuccessfullyshowntheuseoficecoldswabsindecreasingedemapost-septoplastywithbetterpost-operativecosmeticresults(4).SearchesDatabase SearchTerms PubMedMeSH
termsorMeSHclassificationtree
LimitsSet Numberofarticlessearchreturned
PubMedArnica+
therapeuticuse"Arnica/therapeutic
use"
HumansEnglish10Years 4
PubMedArnicamontana+rhinoplasty
"Arnica/therapeuticuse"
HumansEnglish10Years 4
CochraneLibrary
Arnicamontana+rhinoplasty N/A None 2
PubMedRhinoplasty+
edema N/A
HumansEnglish10Years 73
IprimarilysearchedPubMedsinceitcoversawiderangeofdatabasesthatwouldotherwisetakealongeramountoftimetoresearchindividuallytofindthesamestudies.IalsowasabletofindasystematicreviewonPubMedfortheuseofhomeopathicArnicainreducingedemaandecchymosispost-rhinoplasty.IdidnotfindasmanysearchresultsintheCochraneLibrary—only2.Inordertogetalargerpictureofmytopic,Ihadtosearchfor‘ecchymosisandrhinoplasty’or‘edemaandrhinoplasty’tofindtheothertreatmentsandclinicaltrialsthatwereperformedtogetabetterunderstandingoftheeffectivenessandsafelyoftheothertreatments.Duringthesearches,IalsomadesuretosetlimitsononlyhumantrialssinceIwantedtogatherinformationonhowArnicaaffectedhumans,sincethisisthepopulationIwillwanttofocuson.Inaddition,ImadesurethelanguagewassettoEnglishsinceIamnotfluentinreadingstudiesinotherlanguages.Finally,Ionlysearchedforstudieson
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Arnicathatwere10yearsoldbecauseIwantedtohavethemostup-to-dateresearchstudies.Also,sincemillennialrhinoplastyandotherplasticsurgerieshavebeenontherisefrompreviousgenerations(8),Ifeltitwasimportanttogatherthisresearchfromthepast10years.
CAPPart2
TheeffectsofthehomeopathicArnicamontanaonreducingecchymosisandedemapost-rhinoplastySystemsInvolved:IntegumentaryandmusculoskeletalsystemsTherapeuticModalityUsed:HomeopathyPaperTitle:ARandomized,ControlledComparisonbetweenArnicaandSteroidsintheManagementofPostrhinoplastyEcchymosisandEdemaAuthors:TotonchiA.andGuyuronB.Journal:PlasticandReconstructiveSurgeryPublication:2007JulyAim:TocomparetheeffectivenessbetweenthehomeopathicArnicamontanaandcorticosteroiduseinthedecreaseofecchymosisandedemapost-rhinoplasty.Design:Thestudyisarandomizedsingle-blindedplacebo-controlledtrial.Setting:Theresearchersdonotstatewheretheresearchtookplace.ThedataisfromtheDepartmentofPlasticSurgeryatCaseWesternReserveUniversity,Cleveland,Ohio.ItisunclearwhethertheresearchtookplaceatCaseWesternReserveUniversity.Participants:Therewere48patientswhotookpartinthestudy,11maleand37females(9).Allofthepatientshadrhinoplastywithosteotomy(9).Therewasnoexclusioncriterialistedinthestudy.Thestudydoesn’tstatefromwheretheparticipantswererecruited.Thestudystatesthatthe48patientswererandomizedintothreegroupsbutdoesnotgiveanyfurtherdetailsabouthowtherandomizationwasconductedorifthegroupswereequal.Intervention(s):Patientswererandomlydividedintothreegroups.Theresearchdidn’tstatehowmanyparticipantswereineachgroup.GroupP“received10mgofdexamethasone(intravenously)intraoperativelyfollowedbya6dayoraltaperingdoseofmethyl-prednisone”(9).Theresearchdoesnotdeterminehowmuchmethyl-prednisone.GroupAreceivedarnica“threetimesadayfor4days”(9).GroupC,thecontrol,didnotreceiveanything(9).
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Mainoutcomemeasure(s):Thestudywasmeasuringtheintensityofecchymosisandextentofedemapost-rhinoplasty.Thestudymeasuredecchymosisandedemainthefollowingtable(9):
Summaryofkeyfindings&results:
• Thecontrolgrouphadmoreedemaonday2aftersurgerythantheothertwogroupswhoreceivedarnicaandmethyl-prednisone.
• After8dayspost-surgery,thesteroidgrouphadonlyareductionof5%intheextentofecchymosis(2.73)9thanthecontrol(2.17)9(34%)andthearnicagroup(1.42)9(51%).
• Whenlookingatthedifferencebetweenday2andday8aftersurgery,thearnicagroupandcontrolgrouphadgreaterdecreasesofintensityofecchymosisthanthesteroidgroup(bothby55%).(9)
Fig.1:Thetablebelowshowsthemeanratingscoresfromthestudy:(9).
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• Arnicashowedthegreatestextentofreducingtheextentofecchymosisby51%.ThisfindingisofstatisticalsignificancebecausethisshowsthatthehomeopathicArnicamontanadecreasedecchymosismorethansteroidsorfromthepatienttakingnothing.However,theresearchersdidnotfindthe51%statisticallysignificantbecausethepvaluewas<0.05,whichindicatesthat5%couldhavebeencausedbychance.
• Theseverityinedemadecreasedthemostinthesteroidgroup(.94)(92%),followedbythecontrolgroup(1.71)(87%)followedbythearnicagroup(1.04)(47%)(9).ThisfindingshowsthatsteroidsweremoresuccessfulatdecreasingedemathanthehomeopathicArnicamontanaorfromtakingnothingatall.Thearnicagroupdid,however,decreaseby87%andtheresearchersdidfindthisstatisticallysignificant(withapvalueof<0.0001).
Theresearchersdonotnotetherelativeorabsoluteriskreduction,adversereactions,orparticipantretention.
AuthorsConclusion:Theauthorsofthestudycametotheconclusionthatbotharnicaandcorticosteroidsareeffectiveatreducingswellingpost-rhinoplastytwodayspost-surgery.However,theresearcherswereconcernedabouttheincreaseinbruisingwiththecorticosteroidgroup.Sincetherewasadelayinbruisereductionwiththecorticosteroids,theresearchersarenotcertainabouttheeffectivenessofcorticosteroidstodecreaseecchymosispost-rhinoplasty.Inaddition,theresearcherswereconcernedaboutthesideeffectofperioperativehypertensionfromthecorticosteroids,possiblyleadingtoanincreaseinbruisingpost-rhinoplasty.Qualityoftheevidence:TheevidenceinthisRCTisnotconsistentwiththreeotherRCTsmeasuringtheeffectofcorticosteroidsonreducingedemaandecchymosispost-rhinoplasty.Sincetheresearchmethodsareunclearandshowconflictingscientificevidence,thispaperreceivesaC(UnclearofConflictingScientificEvidence)accordingtoCAPguidelines.Conflictofinterest:Therewerenoconflictsofinterestorcommercialaffiliationfromanyoftheauthors.Costeffectiveness:Thecosteffectivenesswasnottakenintoconsiderationforthisstudy.However,sincehomeopathicremediesareinexpensive,around$10,andiftheyareabletohelppatientshealfasterfromsurgery,itwouldbecosteffectivetodotheresearch.However,theresearchersdidnotaddressthisinthestudy.Discussion:Strengthsoftheresearch:
• WhencomparedtootherRCTsabouttheeffectivenessofarnicainreducingedema,theresearchwasverysimilarinthattheyfoundthatarnicawasveryeffectiveinreducingedema(9,14).
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• ThiswasthefirstRCTofitskindtocomparetheuseofarnicaandcorticosteroidsin
thesamestudytoreduceecchymosisandswellingpost-rhinoplasty(9).Thisisastrengthbecausethisstudycombinesbothprotocols(arnicaandsteroids)andcomparestheirresults,whereasotherstudieshavenotdonethiscomparison.
• Theresearchersincludedotherstudiesshowingprosandconsabouttheeffectivenessofarnicainreducingbruisingandswellingpost-rhinoplasty,suchasErnstandPittler’smeta-analysisofeightstudiesthatstatedarnicaisineffectiveandnobetterthanaplacebo(9).Uponfurtherresearchintothemeta-analysis,itstatedthat‘mostofthestudieswereburdenedwithseveremethodologicalflaws’sothedataisnotcompletelyreliable(10).
• Thestudyhasveryhighinternalvalidityinthatitcompletedwhatitsetouttodoin
comparingtheefficacyofthehomeopathicArnicamontanaandsteroidspost-rhinoplasty.
• ComparingtheuseofArnicamontanaandsteroidsgavethisstudymoderatelyhigh
externalvaliditysincepost-rhinoplastypatientswillhavethesethreeoptionsopentothem(Arnica,steroids,ornothing).Thesearetypicaloptionsintherealworld.
Limitationsoftheresearch:
• Theauthorsdonotstatethedoseofarnicausedinthetrial.Eventhoughthearnicaprovedtobeeffective,itwouldhavebeenhelpfultoseewhatdosetheresearchersactuallyusedcomparedtoothersimilarstudiesthatusedarnica.TheChaietstudystatedallofthedosesandstrengthsofthehomeopathicArnicamontanathatwereusedintheirstudy.(13)ExcludingthedoseofarnicathatwasusedintheTotonchiandGuyuronstudy,hindersexternalvaliditysinceitisunclearatwhatdosepatientsshouldtakethehomeopathicArnicamontanaintherealworldpost-rhinoplastytodecreaseecchymosisandedema.Theinternalvaliditystillremainshighinthestudybecausetheresearchersdideffectivelycomparearnicaandsteroidsintheirbenefitspost-rhinoplasty.
• Thetimingofwhenthesteroidandarnicawastakenisunclear,whichmayhave
affectedthedata.GroupPwasgiventhesteroid,dexamethasone,intravenously(10mg)duringsurgeryandthenGroupPreceivedanoraldoseofmethyl-prednisonefor6days(9).Thestudyalsodoesnotstatethedoseofmethyl-prednisone.ThestudyalsosaysthatGroupAreceivedarnica“threetimesadayforfourdays”9butdoesnotstatewhenthepatientsstartedtakingarnica.Thisissignificantlimitationbecausewedonotknowifthesteroidstartedworkingquicklybyday2andstartedtodropoff.Also,ifarnicawastakenpre-operatively,couldithavepresentedamorestatisticalfinding?Itisunclearinthisstudy.Also,notincludingthedosesandtimetablesofthesteroidsandarnicadecreasestheexternalvalidityofthisstudysinceitwouldbedifficulttoreplicateandgetidenticalresults.
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• Itisunclearhowmanypeopleweredividedintothecontrolgroups.Ifthecontrolgroupswereseverelyuneven,itcouldhaveaffectedthedatareliability.Inparticular,iftherewereonly3peoplein1groupandtheyhadadifferentreactiontothesteroidorarnica,itcouldhavethrownofftheresults.
• Thestudydoesnotmentionhowmanysurgeonsdidtherhinoplasties.Having
multiplesurgeonsperformtherhinoplastiescouldhavebeenapossiblefactorintheedemaorecchymosis.SomecomparableRCTsmentionthattheyusedonesurgeonandanotherRCTused3surgeonsduringthestudy(11).Inaddition,iftherewasadifferentsurgeonpergroup,itcouldhaveaffectedtheinternalvalidityofthestudybecausehavingadifferentsurgeoncouldhaveaddedanothervariablewhenthestudywassetouttocomparesteroidsandarnicapost-rhinoplasty.
• Theresearchersdonotmentionwhatsurgicalinstrumentswereusedinthestudy.If
thereweredifferentsurgicalinstruments,thiscouldhavebeenanotherfactorthatcouldhavecontributedtothebruisingandswelling.TheKargistudystatesthat“thesamesurgicalinstruments”wereusedbyallofthesurgeons.
• Theresearchersdidnottakeabaselinereadingfortheextentandintensityof
ecchymosisandseverityofedema.Thedatacouldhavebeenmorereliableifthebaselinewasknown.
• Therewasnoinclusionorexclusioncriterialistedforthepatients.Itisunclearif
therewerepatientswhowereexcludedforanyreason.
• Theauthorsdidnotcalculatethenumberneededtotreatornumberneededtoharm.
• Theresearchdidnotindicatethattheparticipantswereblinded.Thiscouldbea
limitationofthestudybecauseifparticipantsknewtheywerenotreceivinganytreatment,theymaybelesslikelytocomplywiththestudy.Thereisadefinitelyapossibilitythattherewaslittlecompliancewiththecontrolgroup.Thestudyalsodidnotindicateiftheparticipantswereallowedtotakeanyibuprofenoranyotherpainrelieveraftersurgerythatcouldalsoactananti-inflammatory.Thiscouldhavebeenanothervariablethatwouldhavealteredthedata.
Howthestudy’sfindingsaddtothebodyofresearch:TheTotonchiandGuyuronstudyfoundthatbothcorticosteroidsandthehomeopathicArnicamontanawereeffectiveinreducingedemapost-rhinoplastywithin2dayspost-opandwithresolutionafter8days(9).Also,theyalsodiscoveredthatthegroupgivencorticosteroidsexhibitedandincreasedintensityofecchymosisthantheArnicaorcontrolgroups(9).Theresearchersattributethisfactortoperioperativehypertensionthatcouldhaveincreasedecchymosis(9).Also,theyfoundthatarnicadidnotsignificantlydecreasetheextentandintensityofecchymosispost-rhinoplasty.Thesefindingsaddtothefieldofresearchonthistopicsincesurgeonsmaynotwanttosuggestcorticosteroidstoreduceecchymosispost-rhinoplastyevenif
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corticosteroidshelptoreduceswelling.Also,ifpatientshavehypertension,theymayexhibittheundesiredeffectofincreasedbruisingpost-rhinoplasty.Theresearchisinalignmentwithsimilarstudiesandhavealsofoundthatarnicaisnotbeneficialindecreasingtheintensityandextentofecchymosispost-rhinoplasty(9,10).Applicationofresultstopatients:TheresearchfromtheRCTsabouttheeffectivenessofthehomeopathicArnicamontanashowsthatarnicaissafeandiseffectiveinaperioperativesetting(13).Inaddition,arnicaisaneffectivehomeopathictoreduceedemapost-rhinoplasty.Thisresultineffectivereductionofswellingpost-rhinoplastywilladdtopatientsatisfactionwiththeirrhinoplastyandhealingexperience.Furtherwork/researchneeded:InordertoaccuratelyfindthemosteffectiveamountofthehomeopathicArnicamontanatoreduceecchymosisandedema,moreresearchneedstobedone.SincetheRCTshavevaryingornodoseofArnicalisted,itisdifficulttofindwhatthemosteffectivedosewouldbetodecreasebruisingpost-rhinoplasty.Furtherresearchshouldbeconductedtofindoutthisinformation.
Progressive Research Assignment Part3:Findingfurtherevidence:Itwaslearnedinpart2thatthehomeopathicArnicamontanaiseffectiveindecreasingedemapost-rhinoplasty.However,itwasfoundthatarnicaisnotsignificantlyeffectiveindecreasingtheextentandintensityofecchymosisafterrhinoplasty.Sincearnicahastraditionallybeenusedtodecreasebruisingandmanysurgeonssuggestitsusetodecreaseecchymosispost-rhinoplasty,Ibelieveitwouldbebeneficialtofindfurtherevidencetosupportthisclaim.Inaddition,Iwouldbeinterestedtoseethestudies,includingthedoseandtimetable,thathavebeendonebyAlpinePharmaceuticalstosupporttheirclaimthatarnicadecreasesbruisingaftersurgery.Iwouldlookfordouble-blindRCTstofindfurtherevidencethatstatethedoseandtimeintervalthatarnicawasused.Itwouldbebeneficialtoseeifarnicaneedstobetakenoneweekpriortosurgeryinordertodecreasebruising.Perhapsthereisaspecificwindow,aswellaseffectivedose,beforeandafterforarnicatobetakentobeeffectiveindecreasingbruisingafterrhinoplasty.Iwouldbeinterestedinfurtherresearchthatshowsthis.Applicationofresultstopatientmanagement:IntheTotonchiandGuyuronstudy,theresearchersfoundbothcorticosteroidsandthehomeopathicArnicamontanawereeffectiveinreducingedemapost-rhinoplasty9,aspreviouslystatedinsection2.Theydidnotindicatethatarnicaorcorticosteroidswereeffectiveinreducingtheintensityandextentofecchymosispost-rhinoplasty.However,althoughtheydidusethehomeopathicArnicamontanaformulationSinEcchbyAlpinePharmaceuticals,SanRaphael,Calif.,thepatientdoseandtimeschedulewerenotstated(17).Thepackagehasspecificdosinginstructionsandstatesthattheproducthas500mgofArnicamontana1Mand500mgofArnicamontana12Cbutitisnotcleariftheresearchershadthepatientsfollowtheinstructionsonthepackage.Becauseofthislackofdetail,itmakesitdifficulttotranslatethisstudytopatientmanagement.Withoutproperdosageoratimeframe,itisunclearhowArnicamontanawouldbeusedtodecreaseedemaeffectively,likethestudysuggests.More
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researchisrequiredtofindaneffectivedosingandtime-tabletotakearnicaorallytobeabletodecreaseedemaafterrhinoplasty.Fig.2:PackagingfromSinEcch(AlpinePharmaceuticals,San Raphael, Calif. (17)
WhetherornottheinformationgatheredinPart2assistsinansweringthequestionidentifiedinpart1:Theinformationgatheredinpart2assistsinansweringonlyhalfoftheoriginalquestioninpart1aboutthehomeopathicremedy,Arnicamontana,beingeffectiveperioperativelyindecreasingecchymosisandedemapost-rhinoplastyinmenandwomenover16yearsold.Theinformationinpart2findsthatarnicaiseffectiveindecreasingedemapost-rhinoplastybutdoesnotfinditeffectiveindecreasingecchymosis.Moreresearchisneededtoanswerthesecondhalfofthequestionwithregardstoalleviatingecchymosispost-rhinoplasty.OtherresearchthatsupportsorcontradictstheevidenceobtainedinPart2:TheChaietandMarcusstudy(2016)contradictstheTotonchiandGuyuron(2005)studyinitsfindings.TheChaietandMarcusstudyfindsthatthehomeopathicArnicamontanaiseffectiveindecreasingtheextentandtheintensityofecchymosisafterosteotomiesinrhinoplastysurgery,whichmaydramaticallyaffectpatientsatisfaction(13).Itis
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interestingtonotethatintheChaietandMarcusstudy,thepatientsweregiventhesameformulationofthehomeopathicArnicamontanabySinEcch17thatwasusedintheTotonchiandGuyuronstudy,whichcontains12capsulesof(SinEcch01)500mgofA.montana1Mand(SinEcch02)500mgofA.montana12C13.However,thepatientsintheChaietandMarcusstudywere‘givenV500mgofA.montana1Mpreoperativelyonthemorningofsurgeryand2morelaterthatdayaftersurgery,and500mgofA.montana12Cwasgivenorally3timesdailyforthenext3days,where‘‘C’’indicatesa100-foldserialdilution;andM,a1000-foldserialdilution’(13).Sincethepatients’doseandscheduleintheTotonchiandGuyuronstudyareunclear,itisstillinterestingtonotethatthesameformulationwasusedinbothstudies.Furthermore,byincreasingthedosepost-operativelybyhavingthepatienttake2V500mgofA.montana1M,andthenhavingthepatienttakethe12Cformulationfor3timesadayforthenext3days13,adifferencewasseeninthereductionoftheintensityandextentofecchymosis. Next,theSeeleyandcolleaguesstudy16,alsofoundinintheHoandcolleaguessystematicreview15,discoveredthatthesameSinEcch17formulareducedtheextentbutnotintensityecchymosispost-rhytidectomywhengiven1Mpreoperativelyonthemorningofsurgeryandcontinuedevery8hoursfor4days15.Thestudydoesnotindicateatwhatpointthepatientsbegantotakethe12Cformulaandstoppedthe1MA.montana. BoththeHoandcolleaguesandErnstandPittlersystematicreviewsfoundthatarnicamontanaisinsufficientwhencomparedtoplacebopost-procedureforecchymosisandedema(10,15).However,intheErnstandPittlerreview,itisinterestingtonotethattheystated:“Theexistingstudiescouldbeseverelyflawedandthereforeproduceamisleadingresult.Thetrialscertainlyareburdenedwithamultitudeofmethodologicallimitations.Smallsamplesizeandlackofteststatisticsarefrequentandobviousones.However,suchdrawbackswouldbelikelytocreatefalse-positiveratherthanfalse-negativeresult.Arnicacouldhavebeenappliedwrongly.” Overall,thereisbothsupportiveandconflictinginformationwithregardstotheuseofthehomeopathicA.montanatoreduceecchymosisandedemapost-rhinoplasty.Itisclearthatmoreresearchneedstobedonetodetectthemosteffectivedoseandtimescheduleforpatientstotakeit.ItisinterestingtonotethatmanyofthestudiesdidworktobuildoneachotherbyusingthesameSinEcch17formula.Howtheinformationgatheredinparts1-3canbeappliedinaclinicalsetting:Theinformationfromparts1-3canbeappliedinaclinicalsettingbyhavingpatientstaketheSinEcchA.montanaformulapost-rhinoplastyatthelevelseenintheChaietandMarcusstudysinceitwasproventodecreaseecchymosisandedemapost-rhinoplasty.Also,otherstudiesIhavementionedinparts1and2,showitseffectivenessaswell.Inaddition,theresearchfromtheRCTsabouttheeffectivenessofthehomeopathicArnicamontanashowsthatarnicaissafeandiseffectiveinaperioperativesetting(13).Sinceitissafeandeffective,itshouldbesuggestedforpatientstodecreaseecchymosisandedemapost-rhinoplasty.Withregardstotheuseofsteroidsfordecreasingecchymosisandedemaafterrhinoplasty,Iwouldnotrecommendsteroidsduetotheincreaseinecchymosis,asseenintheTotonchiandGuyuron.Althoughthisstudyseemstobeanoutliercomparetotheothersanalyzingsteroidsforpost-operativeuse.TheGurlekstudy,alsofounda“decreaseinedemaandecchymosis,butnotatastatisticallysignificantlevel”(12).Overall,Iwould
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suggestthehomeopathicarnicamontanatodecreasebruisingandswellingpost-rhinoplastyinaclinicalsetting.Istheregoodevidenceavailabletomakeaclinicaldecision:Yes,fromtheevidenceprovidedinparts1-3,thereisgoodevidencetomakeaclinicaldecisionsupportingtheuseofA.montanapost-rhinoplastytodecreaseecchymosisandedema.Eventhoughsomecontrastingevidencewaspresented,whentakingacloserlookatthecontrastingevidence,itseemsthatsomeofthestudieswerepoorlydoneandtheamountofarnicausedwasveryloworthepotencywasnotlistedatall.Justificationforalteringthequestionfrompart1Thequestionfrompartonewasnotaltered.
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