Functional endoscopic balloon dilation of sinus ostia for chronic rhinosinusitis (Review) pdf

Functional endoscopic balloon dilation of sinus ostia for
chronic rhinosinusitis (Review)
Ahmed J, Pal S, Hopkins C, Jayaraj S
This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library
2011, Issue 7

Functional endoscopic balloo n dilation of sinus ostia for chronic rhinosinusitis (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wil ey & Sons, L td.
T A B L E O F C O N T E N T S
1HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8AUTHORS’ CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
9ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
9REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
11CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
14DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
14ADDITIONAL TABLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
14APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
15HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
15CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
15DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
16SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
16INDEX TERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
iFunctional endo s copic balloon dilation of sinus ostia for chronic rhi nosinusitis (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wil ey & Sons, L td.

[Intervention Review]
Functional endoscopic balloon dilation of sinus ostia for
chronic rhinosinusitis
Jahangir Ahmed
1
, Surojit Pal
1
, Claire Hopkins
2
, Samuel Jayaraj
1
1
ENT Department, Whipps Cross University Hospital, London, UK.
2
ENT Department, Guy’s Hospital, London, UK
Contact address: Jahangir Ahmed, ENT Department, Whipps Cross University Hospital, London, UK.

Editorial group: Cochrane Ear, Nose and Throat Disorders Group.
Publication status and date: New, published in Issue 7, 2011.
Review content assessed as up-to-date: 19 December 2010.
Citation: Ahmed J, Pal S, Hopkins C, Jayaraj S. Functional endoscopic balloon dilation of sinus ostia for chronic rhinosinusitis.
Cochrane Database of Systematic Reviews 2011, Issue 7. Art. No.: CD008515. DOI: 10.1002/14651858.CD008515.pub2.
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
A B S T R A C T
Background
Dilation of sinus ostia using a high-pressure balloon has been introduced as a treatment for chronic rhinosinusitis (CRS) refractory to
medical treatment. The efficacy of this technology, however, has not been systematically reviewed.
Objectives
To assess the effectiveness of balloon sinus ostial dilation as a treatment for patients suffering with CRS refractory to medical treatment.
Search methods

We searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register; CENTRAL; PubMed; EMBASE; CINAHL; Web
of Science; BIOSIS Previews; Cambridge Scientific Abstracts; ISRCTN and additional sources for published and unpublished trials.
The date of the most recent search was 20 December 2010.
Selection criteria
Randomised controlled trials in patients of any age with rhinosinusitis lasting longer than 12 weeks who have failed a prolonged course
of medical treatment. Studies compared either balloon sinus ostial dilation or a hybrid procedure (balloon dilation in conjunction with
functional e ndoscopic sinus surgery (FESS)) versus conventional surgery (e.g. FESS) or a waiting list control.
Data collection and analysis
Two authors independently selected studies for inclusion, extracted data and assessed risk of bias.
Main results
One study (34 patients) met our inclusion criteria although it was not yet a pe er reviewed publication. The study randomised patients
with chronic f r ontal sinusitis who had failed a prolonged course of medical treatment into two groups: balloon dilatation of the frontal
recess (plus conventional FESS of other involved sinuses) versus conventional FESS (Draf type 1/2a procedures on the frontal sinuses).
At 12 months follow up there was no statistically significant difference in radiological resolution of frontal sinuses between the two
groups. The percentages of directly observed patent frontal recesses at 12 months were 75% in the balloon dilation group versus 63%
in the FESS-only group. The authors state that this was statistically significant but details of the analysis were not presented. Indeed
the study as a whole suffers from a bias in the way its outcome measures were reported.
No major complications were reported. Three patients in the FESS-only group required fur ther revision frontal sinus surgery compared
to one in the balloon dilation group, although synechiae were more common in the latter.
1Functional endoscopic balloon dilation o f sinus ostia for chronic rhinosinusitis (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wil ey & Sons, L td.
Authors’ conclusions
At present th ere is no convincing evidence supporting th e use of endoscopic balloon sinus ostial dilation compared to conventional
surgical modalities in the management of CRS refractory to medical treatment. With the escalating use of balloon sinuplasty, there is
an urgent need for more randomised controlled trials to determine its efficacy over conventional surgical treatment modalities.
P L A I N L A N G U A G E S U M M A R Y
Balloon dilation of sinus openings for chronic rhinosinusitis
Chronic rhinosinusitis is one of the most common ailments in the world, affecting all age groups and causing significant suffering.
First-line management of this condition is medical, usually comprising a nasally applied steroid, supplemented with a combination of
antihistamines, antibiotics and/or oral steroids. Surgical intervention usually becomes necessary if there is failure of a prolonged course

of medical treatment. In adults, functional endoscopic sinus surgery (FESS) has become established as the main surgical strategy in
these circumstances. Recently a new technology, balloon dilation of sinus ostia (sinus opening), has been introduced. This is designed
to open up the drainage pathways of the sinuses by the inflation of a high-pressure balloon in the sinus opening. We sought evidence in
the literature evaluating the effectiveness of balloon dilation of sinus ostia compared to conventional surgical methods in the surgical
management of patients of all ages suffering with ch r onic rhinosinusitis.
One unpublished trial met our inclusion criteria. This randomised 34 patients with chronic frontal sinusitis into two groups: in one
group balloon dilation was used to open up the drainage pathways of the frontal sinuses; in the other group conventional endoscopic
sinus surgery was used to do the same. For both groups all other sinuses were treated using conventional functional endoscopic sinus
surgery. Balloon dilation did not show an improvement in the resolution of frontal sinusitis as demonstrated by imaging studies,
however the technique was associated with an increased likelihood that someone observing a frontal sinus opening would find this
open. However, it is not clear whether this was a statistically significant result. The study report appeared to be biased in the way it
reported its outcome measures. At present, therefore, we cannot recommend the use of balloon dilation of sinus ostia over conventional
surgical treatment modalities in this setting.
B A C K G R O U N D
Description of the condition
Rhinosinusitis is defined as inflammation of the nose and paranasal
sinuses. Chronic rhinosinusitis (CRS) is one of the most prevalent
chronic ailments in the Western world, affecting up to 16% of
the adult population (
Adams 1999 ; Blackwell 2002). Although
benign it poses significant personal and societal pressures; impact-
ing on quality of life, schooling and work and leading to immense
economic costs. Indeed in the US A, CRS has been estimated to
generate annual health-related costs of more than $5 billion (
Gross
2001
).
The pseudostratified, ciliated, columnar epithelial mucosa of the
nasal cavities and paranasal sinuses are contiguous through the si-
nus ostia. Cilia beat the overlying mucus, which traps foreign ma-

terial and microbes, carrying them out of the sinuses through these
narrow openings onto the lateral nasal wall and from there into the
nasopharynx. Mucociliary clearance follows well-defined pathways
in healthy individuals. A key anatomical area in this mechanism
is the ’osteomeatal complex’, a common confluent drainage out-
flow tract for the frontal, maxillary and anterior ethmoid sinuses.
Anatomically it comprises the uncinate process which guards the
laterally placed three-dimensional ethmoid infundibulum, into
which the majority of these sinuses drain.
According to the European Position Paper on Rhinosinusitis and
Nasal Polyposis (EPOS) (
Fokkens 2007), rhinosinusitis is clini-
cally defined by two or more symptoms, one of which must be nasal
blockage/obstruction/congestion or nasal discharge (anterior/pos-
terior nasal drip). Accompanying cardinal symptoms may include
facial pressure/pain and alteration in smell. Chronicity is differen-
tiated by the duration of symptoms. Acute symptoms last less than
12 weeks with complete resolution; chronic symptoms persist for
more than 12 weeks. Symptoms should be supplemented by either
endoscopic or computed tomographic (CT) evidence of sinusitis.
The pathogenesis of CRS remains unclear, but is likely to be the
result of an interplay of multiple factors th at may be broadly cate-
2Functional endoscopic balloon dilation o f sinus ostia for chronic rhinosinusitis (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wil ey & Sons, L td.
gorised into infection (e.g. bacterial, including biofilms; viral and
fungal), intrinsic mucosal inflammation (e.g. aller gy, a predisposi-
tion to an eosinophilic inflammatory response) and impaired mu-
cociliary clearance (
Sturgess 1979; Zacharek 2003). In an attempt
to rationalise the pleth ora of data on aetiology, Timperley et al pro-

posed an “educational” model of CRS whereby this tr iad of factors
interact with and, importantly, propagate each other, culminating
in a positive feedback spiral of mucosal inflammation (
Timperley
2010
). Contrary to traditional concepts, it is now widely acknowl-
edged that the underlying anatomy of the sinus drainage path-
ways at best only plays an exacerbating role in CRS and that long-
term reduction in mucosal inflammation is the key to success-
ful resolution (
Timperley 2010). Thus, first-line management of
CRS is medical and usually involves a prolonged course of topi-
cal nasal steroids. Other medical options could include a combi-
nation of antibiotics, antihistamines and systemic steroids. There
is evidence of benefit from prolonged courses of macrolide an-
tibiotics (
Ragab 2004) and saline nasal irrigation (Harvey 2007).
In addition, leukotriene receptor antagonists may have a role in
the management of patients with an allergic aetiology (
Grainger
2006
). Indeed for the majority of patients with CRS, first-line
optimal medical therapy appears to be as eff ective as endoscopic
sinus surgery (
Fokkens 2007; Khalil 2006). The latter is therefore
usually reserved for failed medical treatment.
Functional endoscopic sinus surgery (FESS) opens up the si-
nus drainage pathways, enhancing mucosal clearance. The word
’functional’ emphasises the preservation of normal mucosal clear-
ance via the natural anatomic drainage pathways (

Kennedy 1985;
Stammberger 1986). Nowhere is this principle more impor-
tant than in the frontal recess. Here, preservation of mucosa is
paramount to prevent restenosis (recurrence of narrowing) and
consequent complex and potentially hazardous revision proce-
dures.
The outcome of sinus surgery will be affected by multiple fac-
tors. These may broadly be divided into patient factors (including
age, anatomy and comorbidity), factors related to disease (pres-
ence of polyposis, extent of inflammation, previous surgery) and
surgeon experience (
Fokkens 2007; Hopkins 2006; Stankiewicz
1989
). The Royal College of Surgeons of England conducted a
prospective national audit of sinus surgery performed in the UK
in 2000 (
Hopkins 2006). This included 3128 patients from 87
National Health Service (NHS) hospitals in England and Wales
undergoing FESS. Major complications, such as orbital penetra-
tion and cerebrospinal fluid leak, occurred in 0.4% whereas minor
ones, mostly excessive perioperative blee ding (but also postoper-
ative infection, stenosis and adhesions), occurred in 6.6%. Com-
plication risk was related to disease and patient characteristics as
opposed to techniques used or surgeon experience.
Description of the i nter vention
The concept of dilating an ostium via a high-pressure balloon
was originally developed and promoted in the fields of cardiology,
vascular surgery and urology. It has recently been applied to sinus
surgery and termed “balloon sinuplasty”
T M

(Acclarent Inc., CA,
USA). As in these specialties, the Seldinger technique (whereby a
catheter is advanced and positioned over a guidewire) is used for
balloon placement (
Brown 2006). Basic equipment requirements
include a sinus guidewire (a stainless steel coated wire with a ’soft’
non-penetrating tip), a sinus delivery catheter; a sinus balloon
and an inflation device. The delivery catheter, which is specifically
designed with regard to its length and angulation for each sinus, is
endoscopically positioned at the entrance of the relevant ostium.
The guidewire is passed through the catheter into the sinus and the
balloon advanced over it, positioned to straddle the ostium. It is
then transiently inflated to a high pressure (up to 12 atmospheres).
Rather than excising inflamed tissue and adjacent bone, the bal-
loon compresses the mucosa and causes microfracture of the un-
derlying circumferential bone. The aim of this technology is there-
fore to restore the natural sinus drainage pathways in a minimally
invasive way; with the hope of preventing the scarring associated
with mucosal stripping.
Early devices required fluoroscopic confirmation of correct place-
ment in the sinus, exposing the patient and surgeon to ionising
radiation. To avoid this, a guidewire, which houses an optical fibre
allowing a high power light to be e mitted from the tip has been
recently developed. The guidewire position is confirmed by trans-
sinus illumination when correctly positioned in the frontal and
maxillary sinuses.
Why it is im portant to do this review
The published literature on efficacy has to date predominantly
been limited to feasibility and safety profiling (
Bolger 2007; Kuhn

2008
; Levine 2008; Weiss 2008). The ’CLinical Evaluation to
confirm sAfety and efficacy of sinuplasty in the paRanasal sinuses’
(CLEAR) study, a multi-centred prospective cohort, included 115
patients (358 sinuses) with CRS that were treated either by balloon
sinus ostial dilation alone or a hybrid procedure (
Bolger 2007).
Ninety-seven percent of the sinuses were successfully cannulated.
Endoscopic patency at six months was reported at 80.5%, with
a similar figure (85.1%) in those followed up to one year (
Kuhn
2008
). In the latter study the figure rose to 91.6% if patency was
implied by radiological improvement. Parallel sustained improve-
ments in SNOT(sinonasal outcome test)-20 scores over the same
time period were also reported.
In Levine et al’s retrospective review of 1036 patients treated at
different centres (Levine 2008), 95.5% of patients reported an
improvement at initial follow up that was maintained in 73.8%
at a mean follow-up period of 40.2 weeks. Impressively for such a
large cohort, there were no major complications.
Friedman et al performed a retrospective chart review of a co-
hort of patients who were given a choice of having either func-
3Functional endoscopic balloon dilation o f sinus ostia for chronic rhinosinusitis (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wil ey & Sons, L td.
tional endoscopic dilation of sinus ostia (FEDS) or conventional
FESS (
Friedman 2008). They compared pre and postintervention
SNOT-20 scores in two groups. There were 35 patients in each
arm. Preoperatively, the SN OT-20 scores were similar (2.8 versus

2.7 respectively), but at three months postoperatively the FEDS
group had a significantly lower score (0.78 versus 1.29, P = 0.006).
Ramadan and Terrell reported a non-randomised study compar-
ing balloon sinus ostial dil ation and sinus irrigation (with ade-
noidectomy if enlarged) versus adenoidectomy alone for th e sur-
gical management of children aged below 12 with CRS who had
failed a prolonged course of medical treatment (Ramadan 2010).
Thirty out of 49 children had a balloon sinus dilation procedure.
At an average of one-year follow up, 80% of the balloon dilation
group, in comparison to 52.6% of the adenoidectomy-only group,
reported an improvement in symptoms using the SN-5 scale (
Kay
2003
). Interestingly 87% (48 of the 55) dilated sinus ostia in the
balloon dilation group were maxillary. The author in a different
study with a similar patient cohort had reported an 87.5% im-
provement in patient outcome scores if adenoidectomy was per-
formed in conjunction with maxillary sinus washout mediated by
endoscopic insertion of a needle through the natural ostium. This
compared favourably to a 60.7% improvement in the adenoidec-
tomy-alone group (
Ramadan 2008). It is therefore unclear whether
in addition to adenoidectomy, balloon sinus ostial dilation adds
any advantage over draining the maxillary sinuses by more simpler
means in children with CRS.
The United States Food and Drug Administration (FDA) provided
clearance for the use of “balloon sinuplasty”
T M
in 2005 (US FDA
2005

). The UK followed suit in 2008, when the National Institute
of Clinical Excellence (NICE) approved use of balloon dilation of
paranasal sinus ostia based on the above and other short-term effi-
cacy and safety profiles (
NICE 2008). Specific mention was made,
however, of the possibility of a revision to their recommendation
in the light of longer-term follow-up studies.
Despite these encouraging preliminary data, the use of balloon
sinus ostial dilation has generated much debate. First, there is
doubt about the theoretical premise of its action, i.e. opening the
ostia by mucosal and bony compression, as opposed to removing
these diseased entities. Indeed in addition to inflamed mucosa,
underlying osteitis may occur in up to 53% of surgical candidates
(Lee 2006). Concern has thus been expressed that foci of retained
pathological mucosa and bone may restimulate inflammation (
Lanza 2006). Proponents of the procedure, however, would argue
that to achieve a positive clinical response, it is not necessary nor
indeed practical to remove every piece of osteitic bone, which
conventional FESS does not do e ith er (
Melroy 2008).
The high-pressure compression injury inflicted on the respiratory
mucosal epithelium should recover due to the brief nature of the
application, nevertheless there is a lack of published basic scientific
research confirming this or indeed whether the mucociliary action
of the draining sinus is functionally restored. Little is also known
about the consequences of crushing the underlying bone, especially
that surrounding the frontal sinus. Kieff et al report a case series
where repneumatisation and bony regrowth of concha bollosae (an
enlarged air-filled middle turbinate) occurred following a crushing
procedure to alleviate middle meatal obstruction; in some cases up

to 15 years after the original procedure (
Kieff 2009). The authors
relate this observation to balloon dilation of the frontal recess area
where the agger nasi and other air cells in th e vicinity will inevitably
be crushed. It is postulated that there may be similar regrowth and
thus restenosis perhaps many years later in this region (
Kieff 2009)
In the context of recent insights into the underlying, complex ae-
tiology of CRS, the traditional idea that surgery for CRS works by
relieving ostial obstruction and thus enhancing ventilation may
only be a part of the story. Indeed up to 24% to 28% of patients
may still be symptomatic in terms of quality of life outcome mea-
sures following FESS (
Smith 2010). Where successful, FESS may
be so for different reasons. Thus an overall reduction of the total
inflammatory mucosal surface area and removal of osteitic bone
may create new cavities that are more efficient in mass-transport-
ing the mucous blanket (
Timperley 2010). Further more, access of
topical agents to the sinus mucosa post-surgery may be the key fac-
tor in breaking the positive feedback of inflammation. Harvey et
al have demonstrated that conventional FESS certainly improves
nasal sinus irrigation in a cadaveric model (Harvey 2008). A sim-
ilar effect has yet to be demonstrated in ostial balloon dilation as
a sole procedure.
Prominent rhinologists also argue that indications for this technol-
ogy at present are relatively sparse (
Jones 2006). Clearly it cannot
be used as a sole procedure in nasal polyposis or indeed in fungal
sinusitis and neoplasm where pathological clearance is vital. Pos-

sible other indications for this procedure may include recurrent
acute sinusitis, patient preference or in ’at-risk’ surgical candidates
(e.g. from comorbidities or a bleeding predisposition).
Most studies have used balloon dilation of sinus ostia as an adjunct
to FESS; its use being pertinent to anatomical areas deemed at
relatively high risk of iatrogenic stenosis or major complications,
the frontal recess for example. It will therefore be difficult, using
standardised outcome tools, to separate the additional benefits of
balloon dilation (and justify its relatively high additional monetary
cost) in comparison studies of FESS versus hybrid procedures.
Directly visualising the patency of individual sinuses will help in
this regard, but may not necessarily reflect patient well-being.
As balloon dilation of sinus ostia is a relatively novel technology,
there are likely to be few, high-level comparative studies in the
literature. This fact needs to be highlighted with the aim of stim-
ulating research of high methodological quality.
O B J E C T I V E S
To assess the effectiveness of balloon sinuplasty in the treatment
of chronic rhinosinusitis.
4Functional endoscopic balloon dilation o f sinus ostia for chronic rhinosinusitis (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wil ey & Sons, L td.
M E T H O D S
Criteria for consideri ng studies for this review
Types of studies
Prospective randomised controlled trials.
Types of participants
We applied no age restriction.
Inclusion criteria
Patients with a diagnosis of chronic rhinosinusitis as defined by
the EPOS 2007 criteria, i.e. two or more symptoms one of which

must be blocked nose or nasal discharge, lasting for longer than 12
weeks with accompanying endoscopic signs and/or CT changes.
Patients should have failed a prolonged course of medical treat-
ment and thus be e ligible for surgical intervention.
Exclusion criteria
We excluded patients with granulomatous disease, sinonasal ma-
lignancy or who have undergone revision surgery.
Types of interventions
Studies that include patients who have received balloon sinus os-
tial dilation either solely or as part of a hybrid (balloon dilation/
FESS) procedure after failure of an appropriate course of medical
treatment, versus a control group. The latter could be a waiting
list control group or a conventional FESS group.
Types of outcome measures
Primary outcomes
• A nasal-specific or quality of life symptom scoring system.
Secondary outcomes
• Changes in nasal endoscopic view and/or CT images (these
will be a primary outcome measures in studies comparing hybrid
procedures).
• Documented adverse effects and complications.
• A reduction in subsequent maintenance/rescue medication.
• The need for subsequent revision procedures.
Search methods for identification of studies
We conducted systematic searches for randomised controlled tri-
als. There were no language, publication year or publication status
restrictions. The date of the last search was 20 December 2010.
Electronic searches
We searched the following databases f rom their inception for pub-
lished, unpublished and ongoing trials: the Cochrane Ear, Nose

and Throat Disorders Group Trials Register; the Cochrane Cen-
tral Register of Controlled Trials (CENTRAL) (The Cochrane Li-
brary 2010, Issue 4); PubMed; EMBASE; CINAHL; LILACS;
KoreaMed; IndMed; PakMediNet; CAB Abstracts; Web of Sci-
ence; BIOSIS Previews; CNKI; ISRCTN; ClinicalTrials.gov; IC-
TRP (International Clinical Trials Registry Platform) and Google.
We modelled subject strategies for databases on the search strategy
designed for CENTRAL. Where appropriate, we combined sub-
ject strategies with adaptations of the highly sensitive search strat-
egy designed by the Cochrane Collaboration for identifying ran-
domised controlled trials and controlled clinical trials (as described
in the Cochrane Handbook for Systematic Reviews of Interventions
Version 5.0.2, Box 6.4.b. (
Handbook 2011)). Search strategies for
major databases including CENTRAL are provided in Appendix
1
.
Searching other resources
We scanned the reference lists of identified publications for addi-
tional trials and contacted trial authors where necessary. In addi-
tion, we searched PubMed, TRIPdatabase, NHS Evidence - ENT
& Audiology, and Google to retrieve existing systematic reviews
relevant to this systematic review, so that we could scan their ref-
erence lists for additional trials.
Data collect ion and analysis
Selection of studies
Two authors (JA and SP) independently assessed a ll potential stud-
ies as identified by the search strategy f or eligibility, defined above.
We obtained full-text articles if th e relevant information to enable
inclusion/exclusion was not apparent from the title or abstract.

Disagreements were settl ed by discussion with all authors.
Data extraction and management
JA and SP independently extracted data onto a standardised pro-
forma. We attempted contact with the corresponding author in
trials where data were missing or ambiguous.
5Functional endoscopic balloon dilation o f sinus ostia for chronic rhinosinusitis (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wil ey & Sons, L td.
Assessment of risk of bias in included studies
JA and SP individually assessed the risk of bias for each poten-
tially suitable study. We utilised the tool recommended by The
Cochrane Collaboration (
Handbook 2011). In summary this in-
volved assessing each study with respect to six domains, namely: se-
quence generation, allocation concealment, blinding, incomplete
data, selective outcome reporting and ’other’ issues. For each of
these domains we documented a) a description (verbatim if possi-
ble) of the relevant event and b) an overall judgement of the risk
of bias (low, high or unclear risk of bias). Thus, we obtained a six
by two table for each study. As more studies e merge in future, we
may use RevMan 5.1 to generate an overall ’Risk of bias’ graph
and summary figure (Higgins 2011; RevMan 2011).
Data synthesis
We aimed to calculate risk ratio (RR) for studies reporting binary
outcomes and standardised mean difference (SMD) for those re-
porting continuous outcomes. The latter takes into account the
use of different outcome scales between studies.
Subgroup analysis and investigation of heterogeneity
In subsequent updates we will assess the impact of heterogene-
ity on any meta-analyses we perform using the I
2

statistic. As de-
scribed in the current Cochrane Handbook for Systematic Reviews of
Interventions (
Handbook 2011), we will use a fixed-effect model
in the absence of significant heterogeneity. Should there be sig-
nificant heterogeneity, this will be explored and if necessary we
will reconsider pooling the data and simply report individual trial
outcomes.
Where possible, we will pe rform subgroup analysis, in the first
instance based on the following patient characteristics: chronic
rhinosinusitis with or without nasal polyposis.
R E S U L T S
Description of studies
See: Characteristics of included studies; Characteristics of e xcluded
studies.
See
Characteristics of included studies and Characteristics of
excluded studies
.
Results of the search
We retrieved a total of 75 references f r om the electronic searches:
40 of these were removed at first-level screening (i.e. duplicates
and clearly irrelevant items), leaving 35 references for furthe r con-
sideration. Eleven published references were deemed to be rele-
vant and we retrieved full-text versions of these. Following exam-
ination of the ful l text, we excluded all 11 studies (see
Excluded
studies
). We also identified one as yet unpublished trial which was
presented as a poster at the American Academy of Otolaryngology,

Head and Neck Surgery annual meeting, Boston, September 2010
(
Plaza 2010). The corresponding author kindly provided us with
a manuscript detailing the study, but not the raw data. This study
met the inclusion criteria for the review.
Included studies
The study by Plaza et al was a prospective randomised controlled
trial that aimed to evaluate the eff ectiveness and safety of balloon
dilation of the frontal recess in the management of CRS of the
frontal sinuses. Patients were aged over 18, had CRS including
nasal polyposis as dictated by EPOS criteria (
Fokkens 2007) with
radiological involvement of their frontal sinuses and had failed an
eight-week course of medical th erapy. They were randomly allo-
cated to the following surgical treatment arms: 1) balloon dilation
of the frontal recess with conventional FESS for the remaining
paranasal sinuses as required (i.e. a hybrid procedure); or 2) con-
ventional FESS for frontal and other paranasal sinuses as required.
In the latter arm, dissection was performed until the surgeon was
able to completely visualise the frontal sinus ostium, which in all
cases was achieved with Draf type 1 or 2a procedures (see
Table
1
for the Draf classification). Postoperative care was the same for
both groups and patients were followed up for 12 months. Pa-
tients were excluded if pregnant or lactating, if they had concur-
rent asthma, severe systemic illness (e.g. diabetes) or had previous
nasal surgery. Smokers who smoked more than 20 cigarettes per
day were also excluded.
The primary outcome measures were radiological grading of the

frontal sinuses using the Lund-Mackay staging system and office
endoscopic assessment of the patency of the frontal recesses. They
also recorded a pre and postoperative score on non-validated visual
analogue scale s of common rhinosinusitis symptoms as well as
corresponding scores on a Spanish adaptation of the Rhinosinusitis
Disability Index (RSDI). Thir ty-four patients were randomised,
resulting in 17 in each group.
Excluded studies
All 11 of the retrieved published studies were excluded (see sections
Characteristics of excluded studies table and Why it is important
to do this review
for further details).
Inadults, all published studies that collected clinical or radiological
outcome data prospectively were limited to uncontrolled, non-
randomised case series (
Bolger 2007; Brown 2006; Catalano 2009;
Friedman 2008; Levine 2008; Luong 2008; Weiss 2008). The
CLEAR study, reported over the course of three papers is the most
6Functional endoscopic balloon dilation o f sinus ostia for chronic rhinosinusitis (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wil ey & Sons, L td.
cited of these. It followed a cohort of 115 patients from multiple
centres. In the face of a 43% loss to follow up (50 of 115 patients),
stable improvements in ostial patency and SNOT 20 scores were
maintained at two years of follow up (
Weiss 2008; see also section:
Why it is important to do this review). Catalano et al (Catalano
2009
) focused on specifically treating different severities of frontal
sinus disease with balloon dilation of the frontal recess, using CT
changes as the primary outcome measure. This study was also

excluded for not having a control group but, in addition, 13 of 20
patients had previously had prior endoscopic sinus surger y.
We excluded Levine et al’s mul ticentre review of 1036 patients as
it was a retrospective uncontrolled review (
Levine 2008)
The only published comparative study in adults was that of Fried-
man et al (
Friedman 2008). We excluded this study because it was
a retrospective char t review, in which selected patients were given
a choice of interventions and were thus not randomised. Simi-
larly in ch ildren, the comparative study by Ramadan and Terrell
(Ramadan 2010), although carried out prospectively, lacked ran-
domisation and was thus also excluded.
Risk of bias in included studies
See the ’Risk of bias’ table in
Characteristics of included studies.
The included study (
Plaza 2010) was a prospective, randomised
controlled trial. Randomisation was by a computer-generated se-
quence of numbers. However, from the manuscript provided, it
was unclear whether patient allocation was adequately concealed,
i.e. whether the allocator used a pre-drawn list of random num-
bers. The patient and the outcome assessor were blinded to the
intervention arm.
No formal calculation was made to determine the sample size to
adequately power the study, although the authors state: “sample
size was estimated considering previous papers on sinuplasty”. A
type II statistical error therefore remains a possibility. One patient
from e ach group was lost to follow up. Statistical analysis was based
on intention-to-treat.

In the poster and manuscript provided, the authors state an im-
provement in visual analogue scale (VAS) and Rhinosinusitis Dis-
ability Index (RSDI) scores at 12 months f ollow up compared
to preoperatively, although no confirmatory statistics were docu-
mented. Furthermore, a comparison between the two treatment
groups in this regard was not made. Despite these being secondary
outcome measures, the poster (and manuscript in its current un-
published f orm) therefore suffers from a ’selective reporting’ bias.
Indeed, although there was mention of significance or non-sig-
nificance at P < 0.05 with reference to comparison of the main
outcome variables, the exact figures including confidence intervals
were not disclosed (see
Effects of interventions). Unfortunately
the authors did not provide us with the raw data to enable us to
perform further analysis. We appreciate that these documents may
not reflect the final version and any changes will be highlighted in
the next update of this review.
Effects of in terventions
On the basis of the only included study (
Plaza 2010), we may only
comment in this regard on balloon dilation of the frontal recess.
Thirty-four patients were randomised to the treatment groups:
hybrid versus functional endoscopic sinus surgery (FESS)-only
(Draf I/2a), resulting in 17 patients in each group. The overall
median age of enrolled patients was 41.25 (range 20 to 65). The
corresponding age figures were not available per group.
Primary outcome measures
Nasal-specific or qu ality of life symptom scoring system
The authors state that there were no significant differences in vi-
sual analogue scale (VAS)/Rhinosinusitis Disability Index (RSDI)

scores, measured olfactory thresholds or severity of nasal polyposis
between the groups but no figures were provided. Sixteen patients
in each group were available for follow up at 12 months.
Changes in nasal e ndoscopic view and/or computed
tomography (CT) images in studies comparing hybrid
procedures
As this study effectively compared a hybrid procedure with con-
ventional FESS, Plaza et al’s main outcome measures were radi-
ological and endoscopic appearance of sinus ostia in the follow-
up clinic. To this effect, Lund-Mackay scores of the frontal si-
nuses fell from a preoperative mean of 1.9 to 0.5 at 12 months
in the hybrid group, with similar figures in the FESS-only group
(2 to 0.4). These falls in scores were statistically significant, with
P quoted as < 0.05, but exact figures or confidence intervals were
not documented. A between-group frontal Lund-Mackay score
analysis was not performed, although the authors state that the
percentage CT resolution of frontal sinus disease at 12 months
(80.95% in the hybrid procedure versus 75% in the FESS-only
group) was not statistically significant. Endoscopic patency at 12
months was quoted as “statistically more frequent after balloon
treatment (75% versus 63%; P < 0.05)”. Unfortunately no other
data or analysis were provided. Due to lack of raw data, no sub-
group analysis was possible.
Secondary outcome measures
Documented adverse effects and complications
No major complications were reported. Synechiae were reportedly
more common in the hybrid group but “not statistically”. No
further details of complications were available.
7Functional endoscopic balloon dilation o f sinus ostia for chronic rhinosinusitis (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wil ey & Sons, L td.

A reduction in subsequent maintenance/rescue medication
The study made no reference to this outcome.
The need for subsequent revision procedures
Three patients in the FESS-only group required further revision
frontal sinus surgery compared to one in the hybrid group.
D I S C U S S I O N
Summary of main results
We felt that although the study by Plaza et al (Plaza 2010) is
yet to be peer reviewed and published and despite the lack of
available raw data it was important to include it in this review.
This is the first prospective, double-blind, randomised controlled
trial assessing the efficacy of balloon sinus ostial dilation, in this
case for the management of chronic frontal sinusitis refractory to
medical therapy.
With regard to the FESS-only treatment arm, the philosophy of
their approach in dealing with this difficult anatomical area is a
widely accepted one, i.e. to perform the l east invasive procedure
that enables restoration of physiological drainage (
Kuhn 2006),
with more complex procedures reserved for failure of simpler ones
(
Kuhn 2006; Lee 2010). In some large case series over 80% of
patients have been successfully managed by endoscopic frontal si-
nusotomy (equivalent to Draf type 1/2 procedures) as the primary
surgical intervention, although th ey were performed in ter tiary re-
ferral centres with a high level of expertise (
Chan 2009; Chandra
2004
; Philpott 2010). Indeed in one series of 717 frontal sinus
procedures, 92% of patients were effectively managed by a Draf

2a procedure (
Hahn 2009). By comparison, in the CLEAR study
(
Kuhn 2008) the patency of frontal sinuses treated by balloon di-
lation was 85% (63/74) at a follow-up period of one y ear.
The strengths of the current study are independence from cor-
porate sponsorship, a high-quality methodology, a relatively long
follow up and a low attrition rate. In terms of radiological reso-
lution of frontal sinusitis at 12 months postoperatively, there was
no significant difference between a hybrid pr ocedure as compared
to conventional FESS. There was a stated significant difference in
endoscopic patency at this time interval, but the treatment effect
appears to be relatively small (75% versus 63%).
However, the overall quality of the trial does suffer, mainly due to
a ’selective reporting’ bias, with a conspicuous absence of compar-
isons of symptom scores between the groups and a lack of much of
the numerical data and statistical analysis. Furthermore, the group
sizes were possibly not large enough to detect a true difference in
frontal sinus radiological scores (i.e. the trial was not adequately
powered). Pre-trial sample size calculations should always be per-
formed where relevant statistical data are available from the litera-
ture. A minimum effect size or ’minimum clinically important dif-
ference (MCID)’ will need to be defined and the study adequately
powered (usually at 80%) to detect this minimum difference. With
regards to quality of l ife outcome scores, validation across many
quality of life instr uments consistently appears to place the MCID
at 0.5 times the standard de viation (SD); assuming normality of
the distribution of the measured outcome parameter (
Norman
2003

). As an example, in one multicentred cohort of patients with
chronic rhinosinusitis (CRS), the standard deviation (SD) of the
RSDI scores in untreated patients was 20.7, giving a MCID of
10.35 (0.5 x 20.7) (
Smith 2010; Soler 2010). A total of 128 pa-
tients (64 in each arm) will be required in a study with a power
of 80% to detect an MCID of 0.5 times the SD of the measured
outcome parameter (calculated using one of the many statistical
packages freely available on the internet (
Dupont 1990)). This
number is relatively large and may require co-operation between
multiple ce ntres to achieve.
The distribution of the ’total’ Lund-Mackay scores of patients with
CRS is al so normally distributed and can thus be described with
a mean and SD score. In the UK National Comparative Audit of
Surger y for Nasal Polyposis and Chronic Rhinosinusitis (
Hopkins
2007) the mean and SD of pre-operative Lund-Mackay scores of
1840 patients were 11 and 6.5. The MCID for radiological scoring
has not been validated and quality of life symptom scores only
weakly correlate with radiology (
Hopkins 2007), neverthel ess 0.5
x SD is a statistically acknowledged ’moderate’ size effect that is a
useful guide in designing an adequately powered study.
All other prospective studies in adults lacked a control arm and
thus by their very nature can only confirm safety and feasibility.
The only other comparative study in adults was retrospective and
non-randomised. Likewise in the paediatric population, a study
comparing adenoidectomy with or without balloon sinuplasty suf-
fered from being non-randomised.

A U T H O R S ’ C O N C L U S I O N S
Implications for practice
The only completed randomised controlled trial to date which
has assessed the efficacy of balloon dilation of sinus ostia was the
study by Plaza et al (
Plaza 2010). The study revealed no significant
difference in radiological resolution of a balloon dilation/hybrid
(with FESS) procedure compared to conventional functional en-
doscopic sinus surgery (FESS-only) in the management of chronic
frontal sinusitis refractory to medical treatment. The authors do
report a statistically significant improvement in endoscopic pa-
tency, but as mentioned the study in its currently presented form
suffers from a significant risk of bias, particularly in the reporting
of outcome measures and statistical analyses. Bearing in mind that
8Functional endoscopic balloon dilation o f sinus ostia for chronic rhinosinusitis (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wil ey & Sons, L td.
the raw data were not made available and the potential limitation
in sample size and thus power of the study, it is difficult to draw
firm conclusions. Therefore, at present, there is no evidence to
support the use of endoscopic balloon dil ation of sinus ostia over
and above conventional surgical modalities in the management of
CRS refractor y to medical treatment.
Surgical management of children with CRS has been primarily
with adenoidectomy due to its technical simplicity and safety. In
failures, additional drainage and washout of maxillary and other
sinuses has been advocated by either needle drainage or FESS. It
should be noted, however, that the vast majority of children with
CRS do improve with medical management. Again there is no
evidence to support the use of balloon dilation of sinus ostia in
children with CRS over the use of conventional surgical treatment.

Implications for research
With the escalating use of balloon sinus ostial dilation, there is
an urgent need for randomised controlled trials to determine its
efficacy over conventional surgical treatment methods. In order to
reduce heterogenous outcome data and thus enable meta-analyses,
trials should ideally utilise outcome measures similar to those that
formed the basis of this review.
A C K N O W L E D G E M E N T S
We would like to thank Jenny Bellorini, Gemma Sandberg and
the review panel of the Cochrane Ear, Nose and Throat Disorders
Group for their helpful comments.
R E F E R E N C E S
References t o studies included in this review
Plaza 2010 {unpublished data only}
Plaza G, E isenberg G, Montojo J, Onrubia T, Urbasos M.
Balloon dilatation of the frontal recess: a randomised study.
American Academy of Otolaryngology, Head and Neck
Surgery annual meeting, Boston, 26-29 September 2010.
2010:Poster SP503.
References t o studies excluded from this review
Bolger 2007 {published data only}
Bolger WE, Brown CL, Church CA, Goldberg AN,
Karanfilov B, Kuhn FA, et al.Safety and outcomes of balloon
catheter sinusotomy: a multicenter 24-week analysis in 115
patients. Otolaryngology - Head and Neck Surgery 2007;137
(1):10–20.
Brown 2006 {published data only}
Brown CL, Bolger WE. Safety and feasibility of balloon
catheter dilation of paranasal sinus ostia: a preliminary
investigation. Annals of Otology, Rhinology and Laryngology

2006;115(4):293–9.
Catalano 2009 {published data only}
Catalano PJ, Payne SC. Balloon dilation of the frontal recess
in patients with chronic frontal sinusitis and advanced sinus
disease: an initial report. Annals of Otology, Rhinology and
Laryngology 2009;118(2):107–12. [PUBMED: 19326760]
Friedman 2008 {published data only}
Friedman M, Schalch P, Lin HC, Mazloom N, Neidich M,
Joseph NJ. Functional endoscopic dilatation of the sinuses:
patient satisfaction, postoperative pa in, and cost. American
Journal of Rhinology 2008;22(2):204–9. [PUBMED:
18416981]
Kuhn 2008 {published data only}
Kuhn FA, Church CA, Goldberg AN, Levine HL, Sillers
MJ, Vaughan WC, et al.Balloon catheter sinusotomy: one-
year follow-up - outcomes and role in functional endoscopic
sinus surgery. Otolaryngology - Head and Neck Surgery 2008;
139(3 (Suppl 3)):S27–37.
Levine 200 8 {published data only}
Levine HL, Sertich AP, Hoisington DR, Weiss RL, Pritikin
J. Multicenter registry of balloon catheter sinusotomy
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and Laryngology 2008;117(4):263–70.
Luong 2008 {published data only}
Luong A, Batra PS, Fakhri S, Citardi MJ. Balloon catheter
dilatation for frontal sinus ostium stenosis in the office
setting. American Journal of Rhinology 2008;22(6):621–4.
[PUBMED: 19178802]
Ramadan 2009 {published data only}
Ramadan HH. Safety and feasibility of balloon sinuplasty

for treatment of chronic rhinosinusitis in children. Annals
of Otology, Rhinology and Laryngology 2009;118(3):161–5.
[PUBMED: 19374145]
Ramadan 2010 {published data only}
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Weiss 2008 {published data only}
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Vaughan WC. Long-term outcome analysis of balloon
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11Functional endoscopic balloon dilation of sinus ostia for chronic rhinosi nusitis (Review)

Copyright © 2011 The Cochrane Collaboration. Published by John Wil ey & Sons, L td.
C H A R A C T E R I S T I C S O F S T U D I E S
Characteristics of included s tudies [ordered by study ID]
Plaza 2010
Methods Randomised controlled trial
Participants Setting: University Hospital
Country: Spain
Median age: 41.25 years (range 20 to 65)
Percentage male: 63%
Clinical diagnosis: CRS including nasal polyposis
Number randomised: 34
12-month follow up
Interventions Balloon sinuplasty of the frontal sinuses plus FESS for the remaining paranasal sinuses
(hybrid) versus FESS (including Draf type 1/2a for frontal sinus drainage)
Outcomes Endoscopic visualisation of frontal recess
CT scores of frontal sinuses (Lund-Mackay score)
Symptom score (VAS/modified RSDI)
Notes -
Risk of bias
Bias Authors’ judgement Support for judgement
Adequate sequence generation? Low risk “randomisation was achieved using a sequence of random
numbers from a computer generated sequence”
Allocation concealment? Unclear risk “randomisation was achieved using a sequence of random
numbers from a computer generated sequence”. Unclear
whether this was an “open” list of random numbers, thus
providing the allocator with prior knowledge of which
intervention a participant was to receive
Blinding?
Hybrid
Low risk Patient and outcome assessor blinded to intervention

Blinding?
FESS only
Low risk Patient and outcome assessor blinded to intervention
Incomplete outcome data addressed?
Hybrid
Low risk One patient lost to follow up (moved away)
Incomplete outcome data addressed?
FESS only
Low risk One patient stopped follow up after suffering myocardial
ischaemia
12Functional endoscopic balloon dilation of sinus ostia for chronic rhinosi nusitis (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wil ey & Sons, L td.
Plaza 2010 (Continued)
Free of selective reporting? High risk Symptom scores not compared between groups postin-
tervention. Individual data and exact statistical results,
including confidence intervals, not presented
CRS: chronic rhinosinusitis
FESS: functional endoscopic sinus surgery
RSDI: Rhinosinusitis Disability Index
VAS: visual analogue scale
Characteristics of excluded studies [ordered by study ID]
Study Reason for exclusion
Bolger 2007 ALLOCATION:
No control group (same cohort as Kuhn 2008 and Weiss 2008)
Brown 2006 ALLOCATION:
Feasibility study, no control group
Catalano 2009 ALLOCATION:
Included revisions, no control group
Friedman 2008 ALLOCATION:
Non-randomised retrospective study

Kuhn 2008 ALLOCATION:
No control group (same cohort as
Bolger 2007 and Weiss 2008)
Levine 2008 ALLOCATION:
Retrospective chart review, no control group
Luong 2008 ALLOCATION:
Feasibility study, balloon sinus ostial dilation performed under local anaesthetic, no control group
Ramadan 2009 ALLOCATION:
Feasibility study, no control group
Ramadan 2010 ALLOCATION:
Non-randomised
Weiss 2008 ALLOCATION:
No control group (same cohort as
Bolger 2007 and Kuhn 2008)
13Functional endoscopic balloon dilation of sinus ostia for chronic rhinosi nusitis (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wil ey & Sons, L td.
D A T A A N D A N A L Y S E S
This review has no analyses.
A D D I T I O N A L T A B L E S
Table 1. Endonasal frontal sinus drainage procedures as outlined by Draf (1991)
Classification Description of procedure
1 Anterior ethmoidectomy including septa in th e frontal recess, but the mucosa of the frontal sinus outflow tract is
not touched
2 Removal of the floor of the frontal sinus to establish an opening between the lamina papyracea laterally and the
medially placed:
2a middle turbinate; or
2b nasal septum anterior to the ventral margin of the olf actory fossa
3 Bilateral type 2 drainage procedures connected by the removal of the upper nasal septum and the lower frontal sinus
septum
Reference: Draf 1991.

A P P E N D I C E S
Appendix 1. Search strategies
CENTRAL PubMed EMBASE (Ovid) CINAHL (EBSCO)
#1 MeSH descriptor Paranasal
Sinus Diseases explode all trees
#2 MeSH descriptor Rhinitis
explode all trees
#3 MeSH descriptor Paranasal
Sinuses explode all trees
#4 rhinosin* OR rhinit* OR
sinusit* OR nasosinusit* OR
pansinusit* OR ethmoiditis
OR antritis OR sphenoiditis
OR inflamm* NEAR sinus*
#5 (#1 OR #2 OR #3 OR #4)
#1 Paranasal Sinus Diseases
[Mesh] OR Rhinitis [Mesh]
OR Paranasal Sinuses [Mesh]
OR rhinosin* [tiab] O R rhinit*
[tiab] OR sinusit* [tiab] OR
nasosinusit* [tiab] OR pansi-
nusit* [tiab] OR ethmoidi-
tis [tiab] OR antritis [tiab]
OR sphenoiditis [tiab] OR
(inflamm* [tiab] AND sinus*
[tiab])
#2 Balloon Dilatation [Mesh]
1 e xp paranasal sinus/
2 e xp paranasal sinus disease/
3 e xp rhinitis/

4 (rhinosin* or rhinit* or si-
nusit* or nasosinusit* or pansi-
nusit* or ethmoiditis or antri-
tis or sphenoiditis or (inflamm*
and sinus*)).tw.
5 e xp balloon dilatation/
6 (balloon and (sinuplasty or di-
lat* or dilatation or inflat* or
S1 (MH “Paranasal Sinuses+”)
or (MH “Paranasal Sinus Dis-
eases+”)
S2 (MH “Rhinitis+”)
S3 TX (rhinosin* or rhinit*
or sinusit* or nasosinusit* or
pansinusit* or ethmoiditis or
antritis or sphenoiditis or (in-
flamm* and sinus*))
S4 S1 or S2 or S3
S5 (MH “Balloon
14Functional endoscopic balloon dilation of sinus ostia for chronic rhinosi nusitis (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wil ey & Sons, L td.
(Continued)
#6 MeSH descriptor Balloon
Dilatation explode all trees
#7 balloon AND (sinuplasty
OR dilat* ORdilatation OR in-
flat* OR catheter * OR tampon-
ade*)
#8 (#6 OR #7)
#9 (#5 AND #8)

OR (balloon [tiab] AND (sin-
uplasty [tiab] OR dilat* [tiab]
OR dilatation [tiab] O R inflat*
[tiab] OR catheter* [tiab] OR
tamponade* [tiab]))
#3 #1 AND #2
catheter* or tamponade*)).tw.
7 1 or 2 or 3 or 4
8 5 or 6
Dilatation+”)
S6 TX (balloon and (sinuplasty
or dilat* or dilatation or inflat*
or catheter* or tamponade*))
S7 S5 or S6
S8 S4 and S7
Web of Science/BIOSIS Pre-
views (Web of Knowledge)
Cochrane Ear Nose and
Throat Group Trials Register
(ProCite)
CAB Abstracts (Ovid) ISRCTN
#1 TS=(rhinosin* or rhinit*
or sinusit* or nasosinusit* or
pansinusit* or ethmoiditis or
antritis or sphenoiditis or (in-
flamm* and sinus*))
#2 TS=(balloon and (sinuplasty
or dilat* or dilatation or inflat*
or catheter* or tamponade*))
#3 #1 AND #2

balloon 1 e xp paranasal sinus/
2 e xp rhinitis/
3 (rhinosin* or rhinit* or si-
nusit* or nasosinusit* or pansi-
nusit* or ethmoiditis or antri-
tis or sphenoiditis or (inflamm*
and sinus*)).tw.
4 1 OR 2 OR 3
5 (balloon and (sinuplasty or di-
lat* or dilatation or inflat* or
catheter* or tamponade*)).tw.
6 4 AND 5
(rhinosinusitis or rhinitis or si-
nusitis or nasosinusitis or pansi-
nusitis or ethmoiditis or antritis
or sphenoiditis) AND balloon
H I S T O R Y
Protocol first published: Issue 5, 2010
Review first published: Issue 7, 2011
C O N T R I B U T I O N S O F A U T H O R S
Jahangir Ahmed searched, interpreted the literature and wrote the manuscript.
Surojit Pal searched, interpreted th e literature and h elped in developing the protocol.
Claire Hopkins provided valuable editorial support at all stages of manuscript development.
Samuel Jayaraj provided valuable editorial support at all stages of manuscript development.
15Functional endoscopic balloon dilation of sinus ostia for chronic rhinosi nusitis (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wil ey & Sons, L td.
D E C L A R A T I O N S O F I N T E R E S T
None known. The authors have no affiliation to Acclarent or any other manufacturer of similar surgical devices.
S O U R C E S O F S U P P O R T
Internal sources

• None, Not specified.
External sources
• None, Not specified.
I N D E X T E R M S
Medical Subject Headings (MeSH)
Catheterization [
∗
methods]; Endoscopy [methods]; Frontal Sinus; Frontal Sinusitis [
∗
therapy]; Randomized Controlled Trials as Topic;
Rhinitis [
∗
therapy]
MeSH check words
Humans
16Functional endoscopic balloon dilation of sinus ostia for chronic rhinosi nusitis (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wil ey & Sons, L td.