1-17-07-Rabago-nasal Irrigation Int Med Talk 2007 2

7/21/2019 1-17-07-Rabago-nasal Irrigation Int Med Talk 2007 2

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Nasal irrigation for recurrentNasal irrigation for recurrent

rhinosinusitis and chronic sinusrhinosinusitis and chronic sinuscomplaints: a 3-part multi-methodcomplaints: a 3-part multi-method

studystudy

UW Internal Medicine Primary Care ConferenceUW Internal Medicine Primary Care ConferenceDavid a!ago" MDDavid a!ago" MD

#-#$-%&&$#-#$-%&&$

http:''((()fammed)(isc)edu'research'pro*ects'nasalirrigationhttp:''((()fammed)(isc)edu'research'pro*ects'nasalirrigation

)html)html


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+!*ectives+!*ectives

evie( !asics of rhinosinusitisevie( !asics of rhinosinusitis

Introduce nasal irrigationIntroduce nasal irrigation

Descri!e 3 studiesDescri!e 3 studies

Discuss future directionsDiscuss future directions


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hinosinusitis: Why do (ehinosinusitis: Why do (e

care,care,+ne of #& most common am!ulatory D.s"+ne of #& most common am!ulatory D.s"%/)$ million office'0D visits annually%/)$ million office'0D visits annually

11ththleading cause of 2! #3 million 45%6leading cause of 2! #3 million 45%671-578 of d get 2!71-578 of d get 2!

91)7 !illion direct indirect costs91)7 !illion direct indirect costs

Patients care a!out ;Patients care a!out ;; often refractory to treatment; often refractory to treatment

Prevalence chronic ; #3


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2natomy2natomy


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2natomy2natomy


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PathophysiologyPathophysiology

Insult triggers inflammatory cascadeInsult triggers inflammatory cascade

involving cytokines, macrophages,involving cytokines, macrophages,

mediatorsmediators

Allergic response involves IgE, EosAllergic response involves IgE, Eos

Blood vessels dilateBlood vessels dilate

Capillary permeability increasesCapillary permeability increases

More mucus secretionMore mucus secretion

Coordinated ciliary action disrupted, slowCoordinated ciliary action disrupted, slow

Sinus ostia occludedSinus ostia occluded


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Pathologic

Sinus

Mucosal

Thickening/,

further blockage

Bacterial infection,

viral infection

Inflammation

Bacterial or viralgrowth

Ciliary damage

Secretions thicken,

pH changes

infectious/allergic/

irritant

Ostial occlusion


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Predisposing conditionsPredisposing conditions

URIsURIs

Allergic rhinitisAllergic rhinitis

TobaccoTobacco

PolypsPolyps

Dental infectionsDental infections

;(imming'diving;(imming'diving

Cocaine a!useCocaine a!use=oreign !ody=oreign !ody

;eptal deviation;eptal deviation

>ypertrophic tur!inates>ypertrophic tur!inates

2!nl ostiomeatal comple2!nl ostiomeatal compleCystic fi!rosisCystic fi!rosis

Dia!etesDia!etes

Immune deficienciesImmune deficiencies


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Nasal IrrigationNasal Irrigation

DefinitionDefinition ;aline in the nasal cavity;aline in the nasal cavity

;ynonyms;ynonyms ?ala Neti" Neti Pot @herapy" Nasal Aavage"?ala Neti" Neti Pot @herapy" Nasal Aavage"

>ypertonic ;aline Aavage>ypertonic ;aline Aavage

Irrigant'Concentration'Bolume: varia!leIrrigant'Concentration'Bolume: varia!le

BesselsBessels cupped hand" !ul! syringe" spray !ottle"cupped hand" !ul! syringe" spray !ottle"

Water Pic" NetiWater Pic" Netipot" ;inucleanse"pot" ;inucleanse"

hinomer" Naso Cuphinomer" Naso Cup


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Cultural andCultural and

Medical >istoryMedical >istory

Used for centuries as part of 2yurvedicUsed for centuries as part of 2yurvedic

tradition of Medicinetradition of Medicine

Medical eferences to nasal irrigation sinceMedical eferences to nasal irrigation since#75&.s#75&.s

Used as Post-+p ad*unctive care for nasalUsed as Post-+p ad*unctive care for nasal

surgerysurgery2necdotal evidence for efficacy in sinusitis)2necdotal evidence for efficacy in sinusitis)

@en C@s@en C@s


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Nasal Irrigation cupNasal Irrigation cup


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Where does the solution go,Where does the solution go,


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Where does theWhere does thesolutionsolutiongogo,,

before irrigation after irrigation


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Eiological ationaleEiological ationale


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@hree studies@hree studies

Phase #:Phase #: fastidiousfastidiousC@ in the short termC@ in the short term

Phase %:Phase %: pragmaticpragmaticprospective long-termprospective long-termcase seriescase series

Phase 3:Phase 3: FualitativeFualitativestudystudy


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Phase #: +!*ective'DesignPhase #: +!*ective'Design

Does daily NI improve sinus symptoms andDoes daily NI improve sinus symptoms and

Fuality of life" and decrease medication useFuality of life" and decrease medication use

in adults (ith chronic sinus complaints and ain adults (ith chronic sinus complaints and ahistory of sinusitis compared to 4standard ofhistory of sinusitis compared to 4standard of

care.,care.,

andomiGed Controlled @rial" Intention toandomiGed Controlled @rial" Intention to

@reat" Primary Care and ;pecialty Clinics@reat" Primary Care and ;pecialty Clinics


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Subject Participation in Phases 1, 2 and3

76 subjects consented & randomized

H!I

n " #$

+pt out:n H #%

tandard o% are

n " $'

;ingle >;NI use group:n H 1istoriesPersonal >istories

0ducation0ducationConsent'andomiGationConsent'andomiGation 1% 0perimental 2rm1% 0perimental 2rm %< Control 2rm%< Control 2rm

=ilm'Demonstration'Practice=ilm'Demonstration'Practice


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InterventionsInterventions

ontrolontrol: outine care for sinus c'o: outine care for sinus c'o

./perimental./perimental: outine care for sinus c'o: outine care for sinus c'o

plus daily nasal irrigation / monthsplus daily nasal irrigation / months

Concentration: J % K normal salineConcentration: J % K normal saline

p>:J7)& !uffered (ith !aLing sodap>:J7)& !uffered (ith !aLing soda

Bolume: #31 ml per nostrilBolume: #31 ml per nostril


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Primary +utcomesPrimary +utcomes::uality of Aife Measuresuality of Aife Measures

M+;-;hort =orm-#% &-#&&6M+;-;hort =orm-#% &-#&&6

hinosinusitis Disa!ility Inde &-#&&6hinosinusitis Disa!ility Inde &-#&&6

;ingle Item 2ssessment #-$6;ingle Item 2ssessment #-$6 Please evaluate the overall severity of yourPlease evaluate the overall severity of your

sinus symptoms since you enrolled in the studysinus symptoms since you enrolled in the study

0ach assessed at !aseline"#)1" 3" and / mos0ach assessed at !aseline"#)1" 3" and / mos

eminder callseminder calls


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;econdary +utcomes;econdary +utcomes

Daily adherence logDaily adherence log

Ei-(eeLly symptom and medication logEi-(eeLly symptom and medication log

;ide 0ffects;ide 0ffects

;atisfaction;atisfaction


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esults: andomiGation"esults: andomiGation"

Compliance"Completion ateCompliance"Completion ate

0ffective randomiGation0ffective randomiGation

/5'$/ 5&)$86 su!*ects completed/5'$/ 5&)$86 su!*ects completed

studystudy

2dherence to daily use 7$82dherence to daily use 7$8

5/8 Fuestionnaire completion rate5/8 Fuestionnaire completion rate


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Clinical elevance: Num!erClinical elevance: Num!er

Needed @o @reatNeeded @o @reat

;I2 and ;DI: What 8 of su!*ects achieved;I2 and ;DI: What 8 of su!*ects achieved

J #18 improvement,J #18 improvement, ;ymptoms: What 8 of su!*ects reported;ymptoms: What 8 of su!*ects reported

symptoms or med use O 1&8 of %-(Lsymptoms or med use O 1&8 of %-(L

periods,periods,

Meds: What 8 of su!*ects reportedMeds: What 8 of su!*ects reported

medication use %18 of %-(eeL !locLs,medication use %18 of %-(eeL !locLs,


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NN@ for hinosinusitis IndeNN@ for hinosinusitis Inde

and ;ingle-Item and ;ingle-Item


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NN@ for ;ymptomsNN@ for ;ymptoms

and Medications at / monthsand Medications at / months


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;atisfaction and ;ide 0ffects;atisfaction and ;ide 0ffects


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Phase # ConclusionsPhase # Conclusions

In aIn a controlledcontrolledsetting" daily nasal irrigation:setting" daily nasal irrigation: Improved Fuality of lifeImproved Fuality of life Decreased sinus symptomsDecreased sinus symptoms Decreased anti!iotic useDecreased anti!iotic use Decreased nasal spray useDecreased nasal spray use Well-toleratedWell-tolerated >igh satisfaction>igh satisfaction


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Phase %: +!*ectivePhase %: +!*ective

@o assess nasal irrigation use-@o assess nasal irrigation use-

patterns adherence" efficacy" side-patterns adherence" efficacy" side-

effects" and satisfactioneffects" and satisfaction in a long-termin a long-term#% mos6 standard clinical setting#% mos6 standard clinical setting


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Subject Participation in Phases 1, 2 and 3

$/ su!*ects consented randomiGed

>;NIn H 1%

*pt out)n " ($

;tandard of Caren H %;NI in Phases # %:n H //

ualitative ;tudy :%7 ualitative Intervie(s

Phase 3: ualitativestudy

Phase $) 0ollo12

up study +($ mos,-

Phase #: +riginalC@ / mos)6


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Ph % Inclusion Criteria'InterventionPh % Inclusion Criteria'Intervention

2ll $/ su!*ects from Phase I invited to2ll $/ su!*ects from Phase I invited to

participateparticipate

1< $#86 consented1< $#86 consented

=ormer control su!*ects trained in nasal=ormer control su!*ects trained in nasal

irrigationirrigation

Eoth groups used nasal irrigation asEoth groups used nasal irrigation asdesireddesired


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Ph % Primary +utcomes:Ph % Primary +utcomes:

uality of Aife Measuresuality of Aife Measures

hinosinusitis Disa!ility Inde &-#&&6hinosinusitis Disa!ility Inde &-#&&6;ingle Item 2ssessment #-$6;ingle Item 2ssessment #-$6

;ino-Nasal +utcomes @est ;N+@-%&6;ino-Nasal +utcomes @est ;N+@-%&6

0ach assessed at / and#7 mos0ach assessed at / and#7 mos


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Ph % ;econdary +utcomesPh % ;econdary +utcomes

=reFuency and Pattern of Nasal=reFuency and Pattern of NasalIrrigation UseIrrigation Use

;inus ;ymptom ;everity and;inus ;ymptom ;everity and=reFuency=reFuency

;ide 0ffects;ide 0ffects;atisfaction;atisfaction

l lt


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esults:esults:;imilar Easeline Characteristics;imilar Easeline Characteristics

2ge2ge

oA ;coresoA ;coresQenderQender

ace'0thnicityace'0thnicity

0ducation0ducation

2llergy >2llergy >

Nasal ;urgicalNasal ;urgical>>

ICD-5 CodeICD-5 Code

Clinic @ypeClinic @ype


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esults: Compliance andesults: Compliance and

Completion atesCompletion ates

1


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esults:esults:

Primary +utcomesPrimary +utcomesIInterventionntervention

;DI: Improved;DI: Improved

;I2: Improved;I2: Improved

;N+@-%&: ;ta!le;N+@-%&: ;ta!le

ControlControl

;DI: Improved %%)18;DI: Improved %%)18

;I2: Improved 378;I2: Improved 378

;N+@-%&:Improved 3/8;N+@-%&:Improved 3/8


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ltesults:


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esults:esults:

;econdary +utcomes;econdary +utcomes=reFuency=reFuency %)< irrigations'(eeL%)< irrigations'(eeL

PatternPattern

318 ;cheduled318 ;cheduled /18 When ;ymptomatic/18 When ;ymptomatic 18 Not at all18 Not at all

ltesults:


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esults:esults:

;econdary +utcomes;econdary +utcomes;ide effects: 58 nasal irritation;ide effects: 58 nasal irritation

and !urning6and !urning6;atisfaction: 5/8 overall (ill;atisfaction: 5/8 overall (ill

continue to use and recommendcontinue to use and recommend


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Phase %: +verall resultsPhase %: +verall results

Initial Control ;u!s: Matched gains !yInitial Control ;u!s: Matched gains !y

initial nasal irrigation usersinitial nasal irrigation users

Initial 0perimental ;u!s: ContinuedInitial 0perimental ;u!s: Continuedsta!le improvementsta!le improvement

Eoth groups sta!le use %-3 per (eeLEoth groups sta!le use %-3 per (eeL

Continued satisfactionContinued satisfaction


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Phase 3: +!*ectivePhase 3: +!*ective

ualitatively assess attitudes andualitatively assess attitudes and

practices regarding use of salinepractices regarding use of saline

nasal irrigationnasal irrigation >o( did they do it,6>o( did they do it,6 >o( can (e help our pts do it,6>o( can (e help our pts do it,6

;u!*ect Participation in Phases # % and 3


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;u!*ect Participation in Phases #" % and 3

$/ su!*ects consented randomiGed

>;NIn H 1%

+pt out:n H #%

;tandard of Caren H %;NI use group:n H 1o( did NI fit into daily life,


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esults: ;ample similar toesults: ;ample similar to

Phase # % NI usersPhase # % NI users

2ge2ge

Easeline ;coresEaseline ;cores

Past Medical >istoryPast Medical >istory ;easonal 2llergies;easonal 2llergies 2sthma2sthma Nasal ;urgeryNasal ;urgery Nasal PolypsNasal Polyps Deviated ;eptumDeviated ;eptum

0nd Phase % scores0nd Phase % scores


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esults: @hemesesults: @hemes

0mpo(erment0mpo(erment

uality of Aifeuality of Aife

Earriers to use of >;NIEarriers to use of >;NI

;trategies for overcoming !arriers;trategies for overcoming !arriers


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esults: 0mpo(ermentesults: 0mpo(erment

I.ve learned that I can taLe care of a lot ofI.ve learned that I can taLe care of a lot of

this !y myself" so I do)this !y myself" so I do)

It.struly (onderful maLes me feelIt.struly (onderful maLes me feel

more in control of my o(n health and mymore in control of my o(n health and my

o(n sinus condition)o(n sinus condition)


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esults: uality of lifeesults: uality of life

almost instant relief of thealmost instant relief of the

congestioncongestion

When you suffer from a chronic illness forWhen you suffer from a chronic illness for

so long and then you don.tit.s such a !igso long and then you don.tit.s such a !ig

relief"such a !ig change (hen you canrelief"such a !ig change (hen you can

en*oy things that RotherS people taLe foren*oy things that RotherS people taLe forgranted)granted)


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esults: Earriers to NI useesults: Earriers to NI use

It (as RinitiallyS uncomforta!le and it LindIt (as RinitiallyS uncomforta!le and it Lind

of !urned) felt a !it liLe dro(ning)of !urned) felt a !it liLe dro(ning)

Pure and simple: it (as gross) It tooL aPure and simple: it (as gross) It tooL a

(hile to get used to it) It felt really funLy)(hile to get used to it) It felt really funLy)

@he hardest part (as creating a ha!it of@he hardest part (as creating a ha!it of

doing it and doing it all the time)doing it and doing it all the time)


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+vercoming !arriers+vercoming !arriers

It helped to hear that there (ere otherIt helped to hear that there (ere otherpeople going through thisI didn.t realiGepeople going through thisI didn.t realiGe

that I (as feeling isolated until I met somethat I (as feeling isolated until I met some

of the other people)of the other people)@eaching" teaching teaching@eaching" teaching teaching

@he actual instruction (hen (e (ent to@he actual instruction (hen (e (ent to

the RsinLS and you sho(ing us directly ho(the RsinLS and you sho(ing us directly ho(to use it made all the difference in theto use it made all the difference in the

(orld)(orld)

maLing it part of my daily routine)maLing it part of my daily routine)


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Conclusions: Ph 3Conclusions: Ph 3

Confirmed positive results from t(o prior studies)Confirmed positive results from t(o prior studies)

0ffective" safe" (ell-tolerated" inepensive therapy0ffective" safe" (ell-tolerated" inepensive therapy

Patients (ith freFuent ; and chronic sinusPatients (ith freFuent ; and chronic sinus

symptoms can learn in the office and use at homesymptoms can learn in the office and use at homeClinical success >;NI (ill liLely !e improved !yClinical success >;NI (ill liLely !e improved !y

!rief patient education" >;NI demonstration" in-!rief patient education" >;NI demonstration" in-

person coaching" and the a!ility to tailor >;NI useperson coaching" and the a!ility to tailor >;NI use

to individual needs)to individual needs)


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Aimitations of 3 studiesAimitations of 3 studies

;mall;mall

;pecific population;pecific population

Use'participation !ias in second and thirdUse'participation !ias in second and third

phasesphases

;elf-report" recall !ias;elf-report" recall !ias

;hould you !e recommending;hould you !e recommending


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;hould you !e recommending;hould you !e recommending

Nasal Irrigation,Nasal Irrigation,

@hose (ho meet criteria of these studies and are@hose (ho meet criteria of these studies and arereceptivereceptive

Pts (ith less dG (ho are more proactivePts (ith less dG (ho are more proactive

Pts (ho (ant a 4natural. therapyPts (ho (ant a 4natural. therapy

;pecial populations;pecial populations Pregnant (omen (ith sinus complaintsPregnant (omen (ith sinus complaints

Pts (ith multiple 2! allergies'intolerancesPts (ith multiple 2! allergies'intolerances

Ee aggressive" suggest 4full trial. min F day #Ee aggressive" suggest 4full trial. min F day #monthmonth

,2llergic rhinitis" ,UI-triggered asthma,2llergic rhinitis" ,UI-triggered asthma


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=uture WorL=uture WorL

;ystematic evie(s'Practice Quidelines;ystematic evie(s'Practice Quidelines Clinical revie(" Cochrane revie(Clinical revie(" Cochrane revie(

@eaching paper@eaching paper

Eigger" !etter study,Eigger" !etter study,

Clinic integration studyClinic integration study


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Pu!licationsPu!lications

abago !, "gierska, A, Mundt, M#, Barrett, B, Bobula $,abago !, "gierska, A, Mundt, M#, Barrett, B, Bobula $,

Maberry % Efficacy of daily hypertonic saline nasal irrigationMaberry % Efficacy of daily hypertonic saline nasal irrigationamong patients with sinusitis& A randomi'ed controlled trial%among patients with sinusitis& A randomi'ed controlled trial%Journal of Family PracticeJournal of Family Practice())(*+-(.&)/01)++%())(*+-(.&)/01)++%

abago !, #asic 2, "gierska A, Mundt M, Barrett B, Maberryabago !, #asic 2, "gierska A, Mundt M, Barrett B, Maberry% 2he efficacy of hypertonic saline nasal irrigation for chronic% 2he efficacy of hypertonic saline nasal irrigation for chronicsinonasal symptoms%sinonasal symptoms% Otolaryngology: Head and Neck SurgeryOtolaryngology: Head and Neck Surgery())+ 33-.&314%())+ 33-.&314%

abago !, Barrett B, Marchand 5, Maberry , Mundt M%abago !, Barrett B, Marchand 5, Maberry , Mundt M%6ualitative6ualitative aspects of nasal irrigation use by patients withaspects of nasal irrigation use by patients with

chronic sinus disease in a multi1method studychronic sinus disease in a multi1method study Annals of FamilyAnnals of FamilyMedicineMedicine())7* /& (0+13)%())7* /& (0+13)%

8uerard E, abago !, Bukstein !* 9asal irrigation for chronic8uerard E, abago !, Bukstein !* 9asal irrigation for chronicsinus symptoms in patients with asthma, allergic rhinitis, andsinus symptoms in patients with asthma, allergic rhinitis, andnasal polyposis& a pilot study*nasal polyposis& a pilot study*In preparationIn preparation


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@hanLsT@hanLsT

Co-authorsCo-authors Eruce Earrett" 0mily Querard" o!Eruce Earrett" 0mily Querard" o!

Ma!erry" Au Marchand" Marlon MundtMa!erry" Au Marchand" Marlon Mundt

@om Pasic" 2leLsandra giersLa@om Pasic" 2leLsandra giersLa

MentorsMentors

MiLe =leming" ?im Eo!ulaMiLe =leming" ?im Eo!ulaUW-D=M" 22=P" NI>-NCC2MUW-D=M" 22=P" NI>-NCC2M


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1-17-07-Rabago-nasal Irrigation Int Med Talk 2007 2

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