Short-course oral steroids alone for chronic rhinosinusitis

92 Pages·2016·1.11 MB·English

CochraneDatabaseofSystematicReviews
Short-course oral steroids alone for chronic rhinosinusitis
(Review)
HeadK,ChongLY,HopkinsC,PhilpottC,BurtonMJ,SchilderAGM
HeadK,ChongLY,HopkinsC,PhilpottC,BurtonMJ,SchilderAGM.
Short-courseoralsteroidsaloneforchronicrhinosinusitis.
CochraneDatabaseofSystematicReviews2016,Issue4.Art.No.:CD011991.
DOI:10.1002/14651858.CD011991.pub2.
www.cochranelibrary.com
Short-courseoralsteroidsaloneforchronicrhinosinusitis(Review)
Copyright©2016TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd.
TABLE OF CONTENTS
HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
PLAINLANGUAGESUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
SUMMARYOFFINDINGSFORTHEMAINCOMPARISON . . . . . . . . . . . . . . . . . . . 4
BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Figure1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Figure2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Figure3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Figure4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Figure5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
AUTHORS’CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
CHARACTERISTICSOFSTUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
DATAANDANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Analysis1.1.Comparison1Oralsteroidsversusnotreatment/placebo,Outcome1Disease-specifichealth-relatedquality
oflife-nopooling(2to3weeks). . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Analysis1.2.Comparison1Oralsteroidsversusnotreatment/placebo,Outcome2Disease-specifichealth-relatedquality
oflife-RQLQ(3to6months). . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Analysis1.3.Comparison1Oralsteroidsversusnotreatment/placebo,Outcome3Diseaseseverity(patient-reportedtotal
symptomscore). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Analysis1.4.Comparison1Oralsteroidsversusnotreatment/placebo,Outcome4Individualsymptoms:nasalobstruction
(finalvalue). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Analysis1.5.Comparison1Oralsteroidsversusnotreatment/placebo,Outcome5Individualsymptoms:nasalobstruction
(changefrombaseline). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Analysis1.6.Comparison1Oralsteroidsversusnotreatment/placebo,Outcome6Individualsymptoms:nasaldischarge
(finalvalue). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
Analysis1.7.Comparison1Oralsteroidsversusnotreatment/placebo,Outcome7Individualsymptoms:nasaldischarge
(changefrombaseline). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Analysis1.8.Comparison1Oralsteroidsversusnotreatment/placebo,Outcome8Individualsymptoms:facialpressure
(finalvalue). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Analysis1.9.Comparison1Oralsteroidsversusnotreatment/placebo,Outcome9Individualsymptoms:facialpressure
(changefrombaseline). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
Analysis1.10.Comparison1Oralsteroidsversusnotreatment/placebo,Outcome10Individualsymptoms:lossofsenseof
smell(finalvalue). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
Analysis1.11.Comparison1Oralsteroidsversusnotreatment/placebo,Outcome11Individualsymptoms:lossofsenseof
smell(changefrombaseline). . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Analysis1.12.Comparison1Oralsteroidsversusnotreatment/placebo,Outcome12Adverseevents-significantmood
disturbance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
Analysis1.13.Comparison1Oralsteroidsversusnotreatment/placebo,Outcome13Adverseevents-gastrointestinal
disturbance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
Analysis1.14.Comparison1Oralsteroidsversusnotreatment/placebo,Outcome14Adverseevents-insomnia. . . 75
Analysis1.15.Comparison1Oralsteroidsversusnotreatment/placebo,Outcome15Endoscopyscore-nasalpolyps(final
value). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Analysis1.16.Comparison1Oralsteroidsversusnotreatment/placebo,Outcome16Endoscopyscore-nasalpolypsscore
(changefrombaseline). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
ADDITIONALTABLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Short-courseoralsteroidsaloneforchronicrhinosinusitis(Review) i
Copyright©2016TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd.
APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
CONTRIBUTIONSOFAUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
DECLARATIONSOFINTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
SOURCESOFSUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
DIFFERENCESBETWEENPROTOCOLANDREVIEW . . . . . . . . . . . . . . . . . . . . . 88
INDEXTERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
Short-courseoralsteroidsaloneforchronicrhinosinusitis(Review) ii
Copyright©2016TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd.
[InterventionReview]
Short-course oral steroids alone for chronic rhinosinusitis
KarenHead1,LeeYeeChong1,ClaireHopkins2,CarlPhilpott3,MartinJBurton1,AnneGMSchilder4
1UKCochraneCentre,Oxford,UK.2ENTDepartment,Guy’sHospital,London,UK.3DepartmentofMedicine,NorwichMedical
School, University of East Anglia, Norwich, UK. 4evidENT, Ear Institute, Faculty of Brain Sciences, University College London,
London,UK
Contact address: Karen Head, UK Cochrane Centre, Summertown Pavilion, 18 - 24 Middle Way, Oxford, UK.
[email protected].
Editorialgroup:CochraneENTGroup.
Publicationstatusanddate:New,publishedinIssue4,2016.
Reviewcontentassessedasup-to-date: 11August2015.
Citation: Head K, Chong LY, Hopkins C, Philpott C, Burton MJ, Schilder AGM. Short-course oral steroids alone for chronic
rhinosinusitis.CochraneDatabaseofSystematicReviews2016,Issue4.Art.No.:CD011991.DOI:10.1002/14651858.CD011991.pub2.
Copyright©2016TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd.
ABSTRACT
Background
ThisreviewisoneofasuiteofsixCochranereviewslookingattheprimarymedicalmanagementoptionsforpatientswithchronic
rhinosinusitis.
Chronicrhinosinusitisisacommonconditioninvolvinginflammationoftheliningofthenoseandparanasalsinuses.Itischaracterised
bynasalblockageandnasaldischarge,facialpressure/painandlossofsenseofsmell.Theconditioncanoccurwithorwithoutnasal
polyps.Oralcorticosteroidsareusedtocontroltheinflammatoryresponseandimprovesymptoms.
Objectives
Toassesstheeffectsoforalcorticosteroidscomparedwithplacebo/nointerventionorotherpharmacologicalinterventions(intranasal
corticosteroids,antibiotics,antifungals)forchronicrhinosinusitis.
Searchmethods
TheCochraneENTInformationSpecialistsearchedtheENTTrialsRegister;CentralRegisterofControlledTrials(CENTRAL2015,
Issue7);MEDLINE;EMBASE;ClinicalTrials.gov;ICTRPandadditionalsourcesforpublishedandunpublishedtrials.Thedateof
thesearchwas11August2015.
Selectioncriteria
Randomisedcontrolledtrials(RCTs)comparingashortcourse(upto21days)oforalcorticosteroidswithplaceboornotreatmentor
comparedwithotherpharmacologicalinterventions.
Datacollectionandanalysis
WeusedthestandardmethodologicalproceduresexpectedbyCochrane.Ourprimaryoutcomesweredisease-specifichealth-related
quality of life (HRQL), patient-reported disease severity, and the adverse event of mood or behavioural disturbances. Secondary
outcomesincludedgeneralHRQL,endoscopicnasalpolypscore,computerisedtomography(CT)scanscoreandtheadverseeventsof
insomnia,gastrointestinaldisturbancesandosteoporosis.WeusedGRADEtoassessthequalityoftheevidenceforeachoutcome;this
isindicatedinitalics.
Short-courseoralsteroidsaloneforchronicrhinosinusitis(Review) 1
Copyright©2016TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd.
Mainresults
WeincludedeightRCTs(474randomisedparticipants),whichcomparedoralcorticosteroidswithplaceboornointervention.Alltrials
onlyrecruitedadultswithchronicrhinosinusitiswithnasalpolyps.Alltrialsreportedoutcomesattwotothreeweeks,attheendof
theshort-courseoralsteroidtreatmentperiod.Threetrialsadditionallyreportedoutcomesatthreetosixmonths.Twoofthesestudies
prescribedintranasalsteroidstopatientsinbotharmsofthetrialattheendoftheoralsteroidtreatmentperiod.
Oralsteroidsversusplaceboornointervention
Disease-specifichealth-relatedqualityoflifewasreportedbyonestudy.Thisstudyreportedimprovedqualityoflifeaftertreatment
(twotothreeweeks)inthegroupreceivingoralsteroidscomparedwiththegroupwhoreceivedplacebo(standardisedmeandifference
(SMD)-1.24,95%confidenceinterval(CI)-1.92to-0.56,40participants,modifiedRSOM-31),whichcorrespondstoalargeeffect
size.Weassessedtheevidencetobelowquality(weareuncertainabouttheeffectestimate;thetrueeffectmaybesubstantiallydifferent
fromtheestimateoftheeffect).
Diseaseseverityasmeasuredbypatient-reportedsymptomscoreswasreportedbytwostudies,whichallowedthefourkeysymptoms
usedtodefinechronicrhinosinusitis(nasalblockage,nasaldischarge,facialpressure,hyposmia)tobecombinedintoonescore.The
resultsattheendoftreatment(twotothreeweeks)showedanimprovementinpatientsreceivingoralsteroidscomparedtoplacebo,
bothwhenpresentedasameanfinalvalue(SMD-2.84,95%CI-4.09to-1.59,22participants)andasachangefrombaseline(SMD
-2.28,95%CI-2.76to-1.80,114participants).Thesecorrespondtolargeeffectsizesbutweassessedtheevidencetobelowquality.
Onestudy(114participants)followedpatientsfor10weeksafterthetwo-weektreatmentperiod.Allpatientsinbotharmsreceived
intranasalsteroidsattheendoftheoralsteroidtreatmentperiod.Theresultsshowedthattheinitialresultsaftertreatmentwerenot
sustained(SMD-0.22,95%CI-0.59to0.15,114participants,percentageimprovementfrombaseline).Thiscorrespondstoasmall
effectsizeandweassessedtheevidencetobelowquality.
There was an increase in adverse events in peoplereceiving orals steroids compared with placebo for gastrointestinal disturbances
(riskratio(RR)3.45,95%CI1.11to10.78;187participants;threestudies)andinsomnia (RR3.63,95%CI1.10to11.95;187
participants;threestudies).Therewasnosignificantimpactoforalsteroidsonmooddisturbancesatthedosageusedintheincluded
study(riskratio(RR)2.50,95%CI0.55to11.41;40participants;onestudy).Weassessedtheevidencetobelowqualityduetothe
lackofdefinitionsoftheadverseeventsandthesmallnumberofeventsorsamplesize,orboth).
Othercomparisons
Nostudiesthatcomparedshort-courseoralsteroidswithothertreatmentforchronicrhinosinusitismettheinclusioncriteria.
Authors’conclusions
Attheendofthetreatmentcourse(twotothreeweeks)thereisanimprovementinhealth-relatedqualityoflifeandsymptomseverity
inpatientswithchronicrhinosinusitiswithnasalpolypstakingoralcorticosteroidscomparedwithplaceboornotreatment.Thequality
oftheevidencesupportingthisfindingislow.Atthreetosixmonthsaftertheendoftheoralsteroidtreatmentperiod,thereislittle
ornoimprovementinhealth-relatedqualityoflifeorsymptomseverityforpatientstakinganinitialcourseoforalsteroidscompared
withplaceboornotreatment.
Thedataontheadverseeffectsassociatedwithshortcoursesoforalcorticosteroidsindicatethattheremaybeanincreaseininsomnia
andgastrointestinaldisturbancesbutitisnotclearwhetherthereisanincreaseinmooddisturbances.Alloftheadverseeventsresults
arebasedonlowqualityevidence.
More research in this area, particularly research evaluating patients with chronic rhinosinusitis without nasal polyps, longer-term
outcomesandadverseeffects,isrequired.
Thereisnoevidencefororalsteroidscomparedwithothertreatments.
PLAIN LANGUAGE SUMMARY
Short-termoralcorticosteroidscomparedwithnotreatmentorothertreatmentsforchronicrhinosinusitis
Reviewquestion
Short-courseoralsteroidsaloneforchronicrhinosinusitis(Review) 2
Copyright©2016TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd.
Wereviewedtheevidenceforthebenefitsandharmsofashortcourse(typicallyupto21days)ofcorticosteroidgivenbymouthto
peoplewithchronicrhinosinusitiscomparedwithgivingaplaceboornotreatment,oranothertypeoftreatment.
Background
Chronicrhinosinusitisisacommonconditionthatisdefinedasinflammationofthenoseandparanasalsinuses(agroupofair-filled
spacesbehindthenose,eyesandcheeks).Patientswithchronicrhinosinusitisexperienceatleasttwoormoreofthefollowingsymptoms
foratleast12weeks:blockednose,dischargefromtheirnoseorrunnynose,painorpressureintheirfaceand/orareducedsenseof
smell(hyposmia).Somepeoplewillalsohavenasalpolyps,whicharegrape-likeswellingsofthenormalnasallininginsidethenasal
passageandsinuses.
Shortcoursesoforalcorticosteroidsareawidelyusedtreatmentforchronicrhinosinusitis.Theyworkbycontrollingtheinflammatory
responseandwhenpolypsarepresenttheyrapidlyreducethesizeofthepolypstoimprovesymptoms.Theadverseeffectsofcorticos-
teroidscanincludeinsomnia,moodchangesandgastrointestinalchanges(suchasstomachpain,heartburn,diarrhoea,constipation,
nauseaandvomiting).Whengivenoverthelongerterm,orthroughmanyrepeatedshortcourses,itisalsopossibletodeveloposteo-
porosis(fragilebones).
Studycharacteristics
Thisreviewincludesevidenceupto11August2015.Weincludedeightrandomisedcontrolledtrialswithatotalof474participants.
Allofthepatientswereadultswhohadchronicrhinosinusitiswithnasalpolyps.Allofthestudiesfollowedpatientsuntiltheendof
treatment(twotothreeweeks)andthreestudies(210participants)followeduppeopleforthreetosixmonthsaftertheinitialtreatment
hadended.Fiveoftheeightreportsmentionedhowthetrialwasfunded.Noneofthefundingsourceswerepharmaceuticalcompanies.
Keyresults
Attheendofatwo-orthree-weektreatmentcourse,peoplewhotookoralsteroidsmayhavehadabetterqualityoflife,lesssevere
symptomsandsmallernasalpolypsthanpeoplewhohadplaceboordidnotreceiveanytreatment.Afterthreetosixmonths,therewas
littleornodifferenceinqualityoflife,symptomseverityornasalpolypsbetweenthepeoplewhohadoralsteroidsandthepeoplewho
hadplaceboornointervention.
Thepeoplewhotookoralsteroidsmayhavehadmoregastrointestinaldisturbancesandinsomniathanthepeoplewhohadplaceboor
nointervention.Itisnotclearifthepeoplewhotookoralsteroidshadmoremooddisturbancesthanthepeoplewhohadplaceboor
nointervention.
Qualityoftheevidence
Wejudgedthequalityoftheevidencefororalsteroidsplusintranasalsteroidsforadultswithnasalpolypstobelow(furtherresearch
isverylikelytohaveanimportantimpactonourconfidenceintheeffectestimateandislikelytochangetheestimate),asthesomeof
theresultsareonlyfromoneortwostudies,whichdonothavealotofparticipants.Mostofthetrialsdonothaveahighriskofbias,
butonlypeoplewithnasalpolypswereincludedinthereview.
Short-courseoralsteroidsaloneforchronicrhinosinusitis(Review) 3
Copyright©2016TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd.
Copyright©Short-cours SUMMARY OF FINDINGS FOR THE MAIN COMPARISON [Explanation]
20eo Short-courseoralcorticosteroidscomparedwithplacebo/notreatmentforchronicrhinosinusitis
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heCocteroids PInatteirevnetnotriopno:psuhloartti-ocno:ucrhseroonriaclrchoinrtoiscionsutseirtoisidwsithnasalpolyps
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ranelone Comparison:placebo/notreatment
Cfo
ollarch Outcomes Relativeeffect Anticipatedabsoluteeffects∗(95%CI) Quality Whathappens
boro ofparticipants (95%CI)
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ation.icrhin (studies) Withoutoralsteroids Withoralsteroids Difference
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blishedinusitis Dheisaeltahs-ere-slapteecdifqicualityof - Notestimable - Tspheecifimcehaenalthd-irseelaatseed- ⊕LO⊕W(cid:13)1(cid:13) Acateloswreerduscceodreimpinadiri--
by(Re lifemeasuredby quality of life in the in- ment. Treatment ef-
Johvie severityscoreofRSOM- terventiongroupwas1. fect in favour of short-
nw
W) 31(unclearrange) 24 standard deviations courseoralsteroids
ile Follow-up:2weeks lower (1.92 lower to 0. • ASMDof 1.24is
y
& of participants:40 56lower) consideredalarge
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on (1RCT) effectsize.
s
,
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td
. Disease severity, as - - - • Themeanfinal ⊕⊕(cid:13)(cid:13) Alowerscoreindicates
measuredbypatient-re- symptom score2inthe LOW3 milder symptoms in
portedsymptom score, interventiongroupat ⊕⊕(cid:13)(cid:13) favour of short-course
measured by combin- 17dayswas2.84 LOW9 oralsteroids
ing 4 individual symp- standarddeviations ⊕⊕(cid:13)(cid:13) • SMDsof 2.84and
toms lower(4.00lowerto1. LOW10 2.28areconsideredto
• 59lower) belargeeffectsizes.
of participants:22(1 • Thechangefrom Patientstreatedwith
RCT) baselineinsymptom oralsteroidsprobably
• score7inthe hadmuchmilder
of participants:114 interventiongroupat2 symptomsat2to3
(1RCT) weekswas2.28 weeks.
• standarddeviations • ASMDof 0.22is
of participants:114 lower(2.76lowerto1. consideredtobea
(1RCT) 80lower) smalleffectsize.
4
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by(Re of participants:40 100per1000 250per1000 150moreper1000 events intheoral corti-
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iley Health-related quality Thisoutcomewasnotreportedinanyof thestudies
&
of life, using generic
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. Adverse RR3.45 Studypopulation ⊕⊕(cid:13)(cid:13) There were more
events:gastrointestinal (1.11to10.78) LOW5 gastrointestinal distur-
disturbance bance adverse events
Follow-up:3months in the oral corticos-
of participants:187 47per1000 160per1000 114moreper1000 teroidsgroup
(3RCTs) (52to501) (5moreto455more)
Adverseevents:insom- RR3.63 Studypopulation ⊕⊕(cid:13)(cid:13) There were more in-
nia (1.10to11.95) LOW6 somnia adverseevents
Follow-up:3months in the oral corticos-
of participants:187 23per1000 84per1000 61moreper1000 teroidsgroup
(3RCTs) (26to278) (2moreto255more)
5
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opyright©hort-cours *Theriskintheinterventiongroup(andits95%confidenceinterval)isbasedontheassumedriskinthecomparisongroupandtherelativeeffectof theintervention(andits
20eo 95%CI).
16ral
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heCocteroids CI:confidenceinterval;OR:oddsratio;RCT:randomisedcontrolledtrial;RR:riskratio;RSOM-31:RhinosinusitisOutcomeMeasures-31;SMD:standardmeandifference
hranealone GHRigAhDqEuWaloitryk:iWngeGarroeuvpergyracdoensfidoefnetvtihdaetntcheetrueeffectliesclosetothatof theestimateof theeffect
Cofor Moderate quality:We are moderately confident in the effect estimate:The true effect is likely to be close to the estimate of the effect,but there is a possibility that it is
llabchr substantiallydifferent
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ration.nicrhin LVoewryqlouwaliqtyu:aOlituyr:cWonefhidaevnecveeirnytlhitetleefcfoencftidesetnicmeaitnetihseliemfifteecdt:eTshteimtrautee:eTfhfeecttrumeaeyfbfeecstuisbslitkaenltyiatollybdeifsfuebresntatnfrtoiamllythdeiffeesrteimntaftreomoftthheeeesftfiemctateof effect
Po
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blishedinusitis 1DoRwSnOgMra-3d1edwtaoslouwseqdu(aulintykndouwentovalilmidiittaytioofnsthiinssstuubdsycmaleethaonddotlohgeyraanngdeimopfrseccoisrieosn.isOnulnyctlehaerd).isOenaesesmseavlelrsittyudsyca(lne=of4t0h)e,
by(Re whichlackedinformationaboutthemethodof randomisationandallocationconcealment.Thereisaalsoconcernthatthe
Johvie magnitude of improvement is not sustained;one study that used a non-validated instrument reported smaller benefit at
nWw) threetosixmonthsthanattwotothreeweeksforhealth-relatedqualityof life.
ile 2Theindividualsymptomsmeasuredwere:nasalobstruction,nasaldischarge,senseof smellandpressureoverthesinuses.
y
& Scoresfortheindividualsymptoms(0to10visualanaloguescale(VAS))weresummedtofindthetotalscore.Theeffectsize
So couldbeunderestimatedwiththismethod.
n
s, 3Downgraded to low quality due to imprecision. Results are from one very small study (n = 22) and the results were only
L
td measured at the end of treatment (17 days). There is a concern that the magnitude of improvement is not sustained. The
.
outcomewasnotmeasuredusingavalidatedtool.
4Downgradedtolow qualityduetolimitations instudymethodologyandimprecision.Onesmallstudy(n=40),whichlacked
information about the method of randomisation and allocation concealment. The definition of ’mood disturbance’ is not
providedinthepaper.Theresultshavelargeconfidenceintervals.
5Downgraded to low quality due to inconsistency and imprecision. The terminology between the papers for this outcome
differed from ‘‘diarrhoea/GI disturbance’’to ‘‘gastrointestinal disturbance’’to ‘‘reflux and/or gastric pain’’. A low number of
eventswerereportedresultinginlargeconfidenceintervals.
6Downgradedtolow qualityduetoinconsistencyandimprecision.Thedefinitionof ’insomnia’is not providedinthepapers.
Alow numberof eventswerereportedresultinginlargeconfidenceintervals.
7The individual symptoms measured were: blocked nose, rhinorrhoea, hyposmia and sinonasal pain. The results were
measuredasindividualsymptomsonaseven-pointLikertscale(0=nosymptoms)andpresentedaspercentagechangefrom
baselineforeachsymptom,whichwas averagedacrossthefoursymptoms tocreateanaveragechangefrom baseline.The
effectsizecouldbeunderestimatedwiththismethod.
8All patients in both groups received intranasal steroids at the end of the treatment period until the end of follow-up (12
weeks).
6
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