valerie a. kremer res 100 dec. 6, 2016 - wordpress.com a. kremer res 100 dec. 6, 2016 progressive...

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Valerie A. Kremer RES 100 Dec. 6, 2016 Progressive Research Assignment Part 1A and 1B Question Is the homeopathic remedy, Arnica montana, effective perioperatively in decreasing ecchymosis and edema post-rhinoplasty in men and women over 16 years old 7 ? Target Population Men and women over the age of 16 7 who are seeking to have rhinoplasty for cosmetic or reconstructive purposes. Intervention The intervention of interest is the homeopathic remedy, Arnica montana, to be used perioperatively. The random controlled trial 9 failed to mention the dose but stated it was taken three times a day for four days. The study also failed to mention at what point during the surgical process when the patients started taking arnica. Comparative population/treatment The comparative population/treatment would be adult men and women who received a placebo post-rhinoplasty to decrease ecchymosis and swelling. Defining outcomes Outcomes would be measured by subjective differences by the patients, as well as objective differences measured by the plastic surgeon for ecchymosis and edema. In addition, postoperative photographs for color changes and postoperative ecchymosis assessments would be used. Etiology, prevalence and justification This intervention is of significant relevance since ecchymosis and edema are the most common side effects during the recovery period post-rhinoplasty. The cause of ecchymosis, according to Golger, is due to osteotomy, or breaking of nasal bones, which is often required during a closed rhinoplasty (1). According to the Canadian Society of Plastic Surgeons website, bruising is typically diminished after a week, however, swelling post- surgery can last multiple weeks or months (8). It is difficult to detect the prevalence of ecchymosis and edema resulting from rhinoplasty in Canada since the statistics are non-existent because plastic surgeons do not maintain statistics in Canada (8). Also, Canada only has 575 plastic surgeons, only 1.2% of the world’s plastic surgeons, according to the International Society for Aesthetic Plastic Surgery website (3), so the prevalence of ecchymosis and edema with rhinoplasty is lower in Canada compared to countries like Brazil and the United States 3 .

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Page 1: Valerie A. Kremer RES 100 Dec. 6, 2016 - WordPress.com A. Kremer RES 100 Dec. 6, 2016 Progressive Research Assignment Part 1A and 1B Question Is the homeopathic remedy, Arnica montana,

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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12.GurlekA,FarizA,AydoganH,Ersoz-OzturkA,ErenA.EffectsofDifferentCorticosteroidsonEdemaandEcchymosisinOpenRhinoplasty.AestheticPlasticSurgery.2006.30,150-154.13.ChaietS,MarcusB.PerioperativeArnicamontanaforReductionofEcchymosisinRhinoplastySurgery.AnnalsofPlasticSurgery.2016May.Volume76,Number5,477-482.14.HatefD,EllsworthW,AllenJ,BullocksJ,HollierL,StalS.PerioperativeSteroidsforMinimizingEdemaandEcchymosisAfterRhinoplasty:AMeta-Analysis.AestheticSurgeryJournal.2011Aug.Volume31,Number6,648–657.15.HoD,JagdeoJ,WaldorfH.IsThereaRoleforArnicaandBromelaininPreventionofPost-ProcedureEcchymosisorEdema?ASystematicReviewoftheLiterature.TheAmericanSocietyforDertmatologicSurgery.2016Apr.Volume42,Number4,445-63.16.SeeleyB,DentonA,AhnM,MaasC.EffectofHomeopathicArnicamontanaonBruisinginFace-lifts:ResultsofaRandomized,Double-blind,Placebo-ControlledClinicalTrial.ArchivesofFacialPlasticSurgery.2006Jan./Feb.Volume8,54-59.17.SinEcch[packageinsert].SanRaphael,Calif.:AlpinePharmaceuticals.