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Oral steroids for nasal polyps (Review)
Martinez-Devesa P, Patiar 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
http://www.thecochranelibrary.com
Oral steroids for nasal polyps (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
T A B L E O F C O N T E N T S
1HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
9AUTHORS’ CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
9ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
12CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
20DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
20APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
23WHAT’S NEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
24HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
24CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
24DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
24SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
25DIFFERENCES BETWEEN PROTOCOL AND REVIEW . . . . . . . . . . . . . . . . . . . . .
25INDEX TERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
iOral steroids for nasal polyps (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
[Intervention Review]
Oral steroids for nasal polyps
Pablo Martinez-Devesa1, Shalini Patiar2
1ENT Department, John Radcliffe Hospital - West Wing, Oxford, UK. 2Cancer Research UK, Molecular Oncology Laboratories,
Oxford, UK
Contact address: Pablo Martinez-Devesa, ENT Department, John Radcliffe Hospital - West Wing, Headley Way, Oxford, OX3 9DU,
UK. [email protected].
Editorial group: Cochrane Ear, Nose and Throat Disorders Group.
Publication status and date: New search for studies and content updated (conclusions changed), published in Issue 7, 2011.
Review content assessed as up-to-date: 11 October 2010.
Citation: Martinez-Devesa P, Patiar S. Oral steroids for nasal polyps. Cochrane Database of Systematic Reviews 2011, Issue 7. Art. No.:
CD005232. DOI: 10.1002/14651858.CD005232.pub3.
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
A B S T R A C T
Background
This is an update of a Cochrane Review first published in The Cochrane Library in Issue 1, 2007.
Benign nasal polyps are lesions that arise from the mucosa of the nasal cavity or one or more of the nasal sinuses. The presenting
symptoms are nasal obstruction, watery anterior rhinorrhoea (excessive nasal secretions) or mucopurulent postnasal drip (or both),
hyposmia and anosmia (reduced or absent sense of smell) with a concomitant alteration in taste and infrequently pain over the dorsum
of the nose, forehead and cheeks. The main aim of treatment is to relieve these symptoms. The aetiology of polyps is uncertain, therefore
treatment options differ, consisting of a combination of medical and surgical management. Medical therapy is mainly in the form of
steroids, administered topically or systemically via the oral route.
Objectives
To assess the effects of oral steroids in patients with multiple nasal polyps.
Search methods
We searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register; the Cochrane Central Register of Controlled
Trials (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 12 October 2010, following a previous
search in April 2006.
Selection criteria
Randomised controlled trials and controlled clinical trials comparing oral steroids with no intervention, or placebo, or comparing doses
or schedules of oral steroids in patients with multiple nasal polyps.
Data collection and analysis
Two authors independently assessed study quality. We contacted study authors for additional information.
1Oral steroids for nasal polyps (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Main results
Three trials (166 patients) met our inclusion criteria and showed a short-term benefit of a short (two to four-week) course of oral
steroids of variable doses and duration when compared to placebo. There was an objective reduction of polyp size and a subjective
improvement of nasal symptoms and quality of life. However, due to the moderate to low quality of these trials it was not possible to
quantify the overall size of this effect.
There was no report of significant adverse effects of treatment with a short course of steroids.
Authors’ conclusions
The authors found three randomised controlled trials, albeit of moderate to poor quality, that suggest a short-term benefit of oral
steroids in patients with multiple nasal polyps. To address the issue more thoroughly well-designed, prospective, randomised controlled
trials are still needed.
P L A I N L A N G U A G E S U M M A R Y
Oral steroids for nasal polyps
Benign nasal polyps are bags of watery tissue arising from the lining (mucosa) of the nasal cavity or the nasal sinuses that protrude into
the nasal passages, often on both sides of the nose. The symptoms are nasal obstruction, poor sinus drainage, loss of smell that affects a
person’s ability to taste, runny nose or nasal congestion. These can be troublesome or limit daily activities and ability to sleep so that well-
being and quality of life are reduced. Nasal polyps can be removed surgically or treated with steroid medication, given by nasal sprays
or drops (topically) or by mouth (orally). Treatment is either aimed at treating the initial problem or is aimed at preventing recurrence
of polyps. No single surgical technique has proved entirely curative and people often undergo repeat procedures. Oral steroids may
reduce the need for surgery but there are concerns about possible side effects with long-term oral steroid use. The side effects of short
courses of oral steroids are less clearly defined.
We found three trials, with a total of 166 patients, that met the inclusion criteria for the review. In these trials the 96 patients who were
randomised to receive oral prednisone showed an improvement in quality of life and nasal symptom scores and a significant reduction
in polyp size after two to four weeks of treatment compared to no steroid treatment. However, the trials were of moderate to low
methodological quality.
B A C K G R O U N D
This is an update of a Cochrane Review first published in The
Cochrane Library in Issue 1, 2007.
Benign nasal polyps are lesions (abnormal changes in structure)
that arise from the mucosa of the nasal cavity or one or more of
the nasal sinuses, often at the outflow tract of the sinuses. Their
aetiology is uncertain, therefore treatment options differ and no
one treatment has been found to be universally effective.
Prevalence and incidence
There is a higher incidence of polyps in males, with a male-to-
female ratio of between 2:1 and 4:1. They are found in all ethnic
groups although the comparative incidence has not been docu-
mented. They predominantly affect adults and usually present in
patients over the age of 20 years. In asthmatic patients aged over
40 the prevalence is four times greater than in asthmatic patients
under 40 (12.4% versus 3.1%, P < 0.01) (Settipane 1977). They
are rare in children under 10 years of age and may be the present-
ing feature or indicative of cystic fibrosis.
The true incidence of nasal polyps is difficult to assess but seems to
be far more common in autopsy studies than clinical studies have
shown. Endoscopic examination of cadavers revealed nasal polyps
in 22 out of 69 autopsies without a history of previous sinonasal
disease, with most of the polyps originating from the mucosa of
the ostia, clefts and recesses in the osteomeatal complex (the region
that drains the sinuses) (Larsen 2004). This is where the initial
stage of sinonasal polyposis seems to take place.
2Oral steroids for nasal polyps (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Aetiology
The aetiology of nasal polyps is unknown. Most theories consider
polyps a consequence of chronic inflammation and therefore con-
ditions leading to chronic inflammation in the nasal cavity can
lead to nasal polyps. The medical conditions most notably asso-
ciated with polyps are non-allergic asthma, aspirin hypersensitiv-
ity and cystic fibrosis. Nasal polyps are found in 36% of patients
with aspirin intolerance, 7% of those with asthma and about 20%
of those with cystic fibrosis (Settipane 1996). No evidence exists,
however, for an allergic origin (Drake-Lee 1984). In allergic rhini-
tis the prevalence of symptomatic nasal polyps is low (1.5%) and
similar to that in the normal population (1%) (Lund 1995). Polyps
are statistically more common in non-allergic asthma than allergic
asthma (13% versus 5%, P < 0.01) (Settipane 1996). There is a
well-recognised subgroup of patients with aspirin hypersensitivity
and asthma, this subgroup comprising 5% to 10% of patients with
nasal polyps.
Diagnosis
Macroscopically polyps appear as pale bags of oedematous tissue
arising most commonly from the middle meatus and prolapsing
into the nasal cavity. The pale colour is due to poor blood supply
but with repeated trauma and inflammation polyps may become
reddened and the surface becomes squamous rather than respira-
tory in type. They are most often bilateral and when unilateral
require histological examination to exclude the transitional cell
papilloma (also known as Ringert’s tumour or inverted papilloma)
or malignancy (Drake-Lee 2004).
Histologically polyps are characterised by ciliated columnar ep-
ithelium, thickening of the basement membrane, a loose avascular
grossly oedematous stroma and an infiltrate of plasma cells and
many eosinophils. Eosinophils are found in 85% to 90% of polyps.
The majority of the remaining cells in polyps are neutrophils.
The main presenting symptom of nasal polyps is nasal obstruction,
which is constant, although it will vary with the size and position of
polyps. Patients may also complain of watery anterior rhinorrhoea
(excessive nasal secretions) or mucopurulent postnasal drip, or
both. Hyposmia and anosmia (reduced or absent sense of smell)
with a concomitant alteration in taste are characteristic symptoms
of nasal polyps. Pain is an infrequent feature but does occur in
patients with polyps and is usually over the dorsum of the nose,
forehead and cheeks. It is worse when the nose is congested and
there is secondary infection of the sinuses (Drake-Lee 1997).
The diagnosis is made by rhinoscopy, anterior and posterior. The
diagnosis is often easier if a small probe is used for gentle palpation
as polyps are insensitive and are mobile on their pedicles.
Plain radiographs of the paranasal sinuses are of no value in the
diagnosis of nasal polyps although they may confirm opacification
of the sinuses. A computed tomogram (CT) shows the anatomical
variations and the extent of the disease.
Treatment
Treatment of nasal polyps is a combination of medical and sur-
gical management dependent on individual patient assessment.
The aims of treatment are to relieve nasal obstruction, restore ol-
faction, improve sinus drainage and to treat any accompanying
rhinitic symptoms (Scadding 2002). Treatment may be divided
into two areas: primary (inducing remission) and secondary (pre-
venting recurrence). No single surgical technique has proved en-
tirely curative and patients often undergo repeat procedures and
receive long-term medical treatment. Recurrence is common and
between 5% and 10% of patients have recurrent severe disease
(Drake-Lee 2004). About 60% of patients will require a further
polypectomy in a five-year period, the rest having less frequent
recurrences (Larsen 1997). There are few direct comparisons of
medical and surgical treatment in the literature. Those that ex-
ist suggest that most patients should be treated medically, with
surgery reserved for patients who respond poorly.
The surgical management of nasal polyps has changed over the last
two decades with the advent of endoscopic sinus surgery. Intranasal
surgery for nasal polyps ranges from simple snare polypectomy
(surgical removal of nasal polyps using a snare with or without
an endoscope) to radical ethmo-fronto-sphenoidectomy (opening
and ventilating the frontal, ethmoid and sphenoid sinuses). Major
complications of endoscopic surgery are rare but can be devastat-
ing, including loss of vision and entering the skull base causing
leakage of fluid from around the brain (cerebrospinal fluid leak)
(Stammberger 1999).
Corticosteroids are the only medical therapy to have a proven ef-
fect on the symptoms and signs of nasal polyps and can be used
topically or systemically. The therapeutic modality that has been
best studied in controlled trials is that of topically applied steroids.
This reduces rhinitis symptoms, improves nasal breathing, reduces
the size of polyps and the recurrence rate, but has a negligible
effect on the sense of smell and on any sinus pathology. Topical
steroids can, as maintenance therapy, be used alone in mild cases,
or combined with systemic steroids/surgery in severe cases. Sys-
temic steroids, which are less well studied, have an effect on all
types of symptoms and pathology, including the sense of smell.
This type of treatment is only used for short-term improvement
due to the risk of adverse effects (Mygind 1996). The adverse ef-
fects of short-term steroid use are said to include glucose intoler-
ance, hypertension, adrenal suppression, gastrointestinal bleeding
and altered mental states. However, there are few or no published
data on the frequency of these effects. Adverse effects associated
with long-term use of oral steroids include gastrointestinal com-
plications, growth suppression, diabetes mellitus, hypertension,
psychotropic effects (e.g. mood changes), glaucoma, osteoporosis
and avascular osteonecrosis (bone death resulting from poor blood
supply to an area of bone).
In a recent retrospective review of litigation trends related to the
administration of corticosteroids and the reported complications
(Nash 2011) it was advised that physicians should obtain informed
3Oral steroids for nasal polyps (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
consent prior to steroid therapy. However, only three of 83 cases
reviewed involved otolaryngologists and the indication and ad-
ministration route of the steroid treatment was not the one for
nasal polyps or other nasal pathology.
There are few controlled trials on the effectiveness of oral steroids
in the treatment of nasal polyps. Oral steroids are most often used
in high dose for short duration in exacerbations of nasal polyposis.
There is however a lack of evidence regarding the optimal treat-
ment regimen of oral steroids with respect to indication, dose and
duration. The optimum usage of steroids is clinically important as
it may reduce the need for surgery by providing good symptomatic
control.
The 2007 European Position Paper on Rhinosinusitis and Nasal
Polyps (EPOS 2007) supports the use of a short course of oral
steroids followed by topical steroids in patients with chronic rhi-
nosinusitis with nasal polyps if the symptoms are severe (visual
analogue scale score > 7 on a 0 to 10 scale). This is based on ev-
idence from open studies and two randomised controlled trials
(Benitez 2006; Hissaria 2006) (evidence level Ib).
O B J E C T I V E S
To assess the effects of oral steroids in patients with multiple nasal
polyps.
M E T H O D S
Criteria for considering studies for this review
Types of studies
All identified randomised controlled trials which fulfilled the cri-
teria outlined below were included.
Types of participants
Inclusion criteria
Two or more of the criteria below.
• Patients with benign bilateral nasal polyps diagnosed
clinically in an ENT department
• Endoscopic evidence of nasal polyps
• Radiological evidence of nasal polyps
Exclusion criteria
• Children < 16 years
• Antrochoanal polyps (benign polyps originating from the
mucosa of the maxillary sinus)
• Cystic fibrosis
• Surgery for nasal polyps within three months prior to study
period
Types of interventions
• Oral steroids versus no intervention
• Oral steroids versus placebo
• Oral steroid versus other type of oral steroid, including:
◦ low-dose (equivalent to less than 20 mg prednisolone)
versus high-dose oral steroids (equivalent to more than 40 mg
prednisolone)
◦ short-course (less than two weeks) versus long-course
oral steroids (more than two weeks)
• Topical steroids combined with intervention in both
treatment arms in all the above
Types of outcome measures
Primary outcomes
Reduction in validated nasal symptom scores.
Secondary outcomes
• Change in nasal endoscopic findings
• Change in radiological/CT appearance
• Duration of effect
• Improvement in validated quality of life measures*
• Adverse effects
*We added this secondary outcome measure subsequent to pub-
lication of the protocol as we considered it to be an important
outcome measure which was overlooked at the time of writing the
protocol.
Search methods for identification of studies
We conducted systematic searches for randomised controlled tri-
als. There were no language, publication year or publication sta-
tus restrictions. The date of the last search was 12 October 2010,
following a previous search update in April 2006.
4Oral steroids for nasal polyps (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Electronic searches
We searched the following databases from 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 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 2009)). 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. In previous searches in 2006, we
contacted authors of published and unpublished trials and other
experts in the field but no additional trials were identified.
Data collection and analysis
Selection of studies
The two authors reviewed the titles and abstracts, where available,
of all studies identified by the searches and applied the inclusion/
exclusion criteria independently. We excluded articles that did not
meet the inclusion criteria. We obtained the full articles for those
studies that appeared to meet the inclusion criteria or where there
were insufficient data to make a decision. Any disagreement about
whether a study should be included was resolved by discussion
between the review authors.
Data extraction and management
The review authors independently extracted data from the stud-
ies using standardised data forms. We extracted data to allow an
intention-to-treat analysis. Where data were missing we wrote to
the authors of the study requesting further information.
Assessment of risk of bias in included studies
The two review authors assessed the quality of the included trials
independently and we resolved any differences in opinion by dis-
cussion. We used a modification of the method used by Chalmers
1990. We assessed the selected studies for the following character-
istics:
1. the adequacy of the randomisation process;
2. the potential for selection bias after allocation to study
group, i.e. losses to follow up and whether analysis was by
intention-to-treat;
3. whether there was blinding of outcome assessors to the
participants’ study group; and
4. the quality of outcome assessment.
Studies were graded A, B or C for their overall methodological
quality:
A: minimisation of bias in all four categories above, i.e. adequate
randomisation; few losses to follow up and intention-to-treat anal-
ysis; blinding of outcome assessors; high quality outcome assess-
ment;
B: each of the criteria in A partially met;
C: one or more of the criteria in A not met.
Data synthesis
We did not identify sufficient trials to allow data analysis. Should
suitable trials be identified for updates of the review we will employ
the following methods:
Data analysis will be on an intention-to-treat basis. If data are
comparable and of sufficient quality, we will combine data to give
a summary measure of effect, otherwise we will not combine data.
We will examine statistical heterogeneity by subgroup analysis as
appropriate. We will seek statistical advice as necessary.
R E S U L T S
Description of studies
See: Characteristics of included studies; Characteristics of excluded
studies; Characteristics of ongoing studies.
Results of the search
We considered 30 studies to be possibly relevant based on the
abstract and obtained the full articles.
Included studies
5Oral steroids for nasal polyps (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Three trials satisfied the inclusion criteria (Alobid 2006; Hissaria
2006; Van Zele 2010). The methods, participants, interven-
tions and outcomes of these studies are shown in the table of
’Characteristics of included studies’.
Excluded studies
Of the 30 studies retrieved in full text, we excluded 25.
Fourteen studies looked at the effects of oral steroids with or with-
out topical steroids on nasal polyps but were excluded as they were
non-randomised and non-controlled trials (Bonfils 1998; Bonfils
2003; Bonfils 2006; Cassano 1996; Chi Chan 1996; Hessler 2007;
Jankowski 2003a; Jankowski 2003b; Nores 2003; Rasp 1997; Rasp
2000; Stevens 2001; Tuncer 2003; van Camp 1994).
Two of the papers were duplicate publications and were excluded
as they compared intramuscular steroids against surgery (Lildholdt
1988; Lildholdt 1989).
Damm 1999 compared two different durations of oral steroid
treatment but had to be excluded, despite contacting the authors,
as the outcome data were combined for the two groups and were
thus not extractable.
We excluded Alobid 2005 as it compared oral steroids against en-
doscopic sinus surgery, as well as Blomqvist 2001 for the same
reason. We excluded Blomqvist 2009 as it was a duplicate publi-
cation of Blomqvist 2001.
We excluded Ragab 2006 as it compared medical therapies not
including oral steroids against surgery. Kroflic 2006 compared
oral steroids versus topical furosemide and was thus excluded.
One randomised controlled trial compared oral steroids against
no intervention prior to endoscopic sinus surgery in both groups
but only intraoperative surgical outcome measures were reported
so the study had to be excluded (Sieskiewicz 2006).
We excluded Benitez 2006 as a possible duplication of Alobid
2006. Both studies were carried out in the same department and
during the same period of time: February 1999 to July 2003 in
Alobid 2006 with 78 participants and February 1999 to November
2003 in Benitez 2006 with 84 patients recruited. The participants’
characteristics were also very similar. The main differences were
in the outcome measures and the subdivision of the treatment
group into patients with and without asthma in the second study
(Benitez 2006). We contacted the (same) corresponding author
for both trials but there was no comment on this point. After a
discussion between the review authors we decided not to include
Benitez 2006 so as to avoid possible bias (duplication of results).
We also identified two abstract publications of trials later to be pub-
lished (Van Zele 2010) or still awaiting publication (Vaidyanathan
2009). We made attempts to obtain unpublished details and data
from the latter trial (Vaidyanathan 2009) but were unsuccessful.
The summaries of excluded studies are listed in the table of ’
Characteristics of excluded studies’.
Risk of bias in included studies
Selection and performance bias
The included studies were randomised and controlled. On at-
tempting to contact the corresponding authors of all three stud-
ies, only the corresponding author of Alobid 2006 replied that
randomisation was computer-generated on a 1:3 ratio. Van Zele
2010 used randomisation codes. Hissaria 2006 did not explain the
method of randomisation (“…patients were randomised by the
hospital pharmacy…”).
With the exception of Alobid 2006, where of the 78 patients re-
cruited to the study only 18 (23%) were randomised to the con-
trol arm, the other studies showed more balanced study arms.
Alobid 2006, however, maintained a good proportion in the base-
line characteristics of the groups’ population, while Hissaria 2006
had a larger number of males, history of aspirin sensitivity, smok-
ers and subjects that had undergone previous polyp operations in
the control (placebo) group. Van Zele 2010 had a larger incidence
of asthma and aspirin intolerance also in the placebo group.
Concealment assignment was described in Hissaria 2006 and Van
Zele 2010. Subjects in both studies were blinded for the whole
duration of the study. No information on concealment was pro-
vided in Alobid 2006.
Attrition bias
Two participants in Alobid 2006 were lost to follow up in the con-
trol (placebo) group. One participant dropped out in the placebo
group in Hissaria 2006. Seven participants (15%) withdrew from
the placebo group before the first observation point in Van Zele
2010.
Detection bias
Alobid 2006 did not comment on blinding of assessors.
Hissaria 2006 used blind outcome assessors for the physician as-
sessment of nasal symptoms, the assessment of polyp size on mag-
netic resonance imaging (MRI) scan and on nasoendoscopy. Study
personnel were blinded to the treatment/placebo groups as well
as pre- and post-treatment observation points in the polyp size
assessments with MRI/nasoendoscopy. At the end of the study
participants were unblinded by an independent physician and all
who had taken placebo accepted were offered and were offered
and accepted a course of oral steroids.
Van Zele 2010 study personnel were also blinded for the duration
of the study.
The scales used to measure nasal symptoms score varied signifi-
cantly: a subset of six nasal symptoms of the Rhinosinusitis Out-
come Measure questionnaire (RSOM-31) in Hissaria 2006; a non-
validated scoring system (0 to 3) in Alobid 2006 and an unclear
6Oral steroids for nasal polyps (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
(possibly 0 to 3 points) scoring system in Van Zele 2010. Over-
all the assessment of nasal symptoms in the included studies was
poor.
One study (Hissaria 2006) was graded B for overall methodological
quality according to the stated criteria. The other two studies (
Alobid 2006; Van Zele 2010) were graded C.
Effects of interventions
Three trials comprising 166 participants were included in this re-
view. We analysed the prespecified primary and secondary out-
comes.
Primary outcome
Validated nasal symptoms scores
There was significant variation in the assessment of nasal symp-
toms. Hissaria 2006 used a subset of six nasal symptoms of the
Rhinosinusitis Outcome Measure (RSOM-31) questionnaire. The
nasal symptom scores were significantly reduced (reduction was
considered by an improvement of 20% or more) from before to
after two weeks of treatment in the treatment group (50 mg oral
prednisolone for 14 days) (64% reduction (P < 0.001)) versus the
control (placebo) group (11% reduction (P = non-significant)).
There was no long-term follow up in this study.
Alobid 2006 also showed a reduction in the scores of nasal symp-
toms (0 to 3 scoring system): nasal obstruction and loss of sense
of smell (P < 0.05) in the treatment group (reducing course of 30
mg oral prednisolone for two weeks) two weeks after commencing
treatment compared to the control (no treatment) group. After
the first assessment point at two weeks the nasal symptom scores
were still lower than at baseline at weeks 12, 24 and 48 in the
treatment group. However, the control group was not followed up
as due to ethical considerations this group was not kept “without
known effective treatment” for longer than six weeks.
Van Zele 2010 reported a decrease in nasal congestion at weeks
one, two and four after treatment in the treatment group (reduc-
ing course of 32 mg to 8 mg of methylprednisolone during 20
days) (week 1, P = 0.002; week 2, P = 0.007; week 4, P = 0.001)
compared to the placebo group. Post-nasal drip showed a score
reduction in the treatment group versus placebo (week 1, P = 0.31;
week 2, P = 0.007 and week 4, P = 0.001). Loss of sense of smell
also had a similar score reduction in the treatment group versus
placebo (week 1, P = 0.006; week 2, P = 0.001; week 4, P = 0.006).
Congestion and other nasal symptom scores worsened progres-
sively after week four and returned to baseline values. There was no
significant effect of oral steroid treatment on rhinorrhoea compare
to placebo. After week four there were 10 patients (52%) in the
placebo group and two patients (14%) in the oral steroid group
that needed rescue treatment. There was no long-term assessment.
Secondary outcomes
Change in nasal endoscopic findings
Alobid 2006 showed a significant reduction in endoscopic assess-
ment of polyp size (Lildholt classification, 0 to 3) at week two in
the treatment group versus control (P < 0.05) and the polyp size
was maintained in the treatment group at weeks 12, 24 and 48
(P < 0.05). Long-term effect was not comparable to the control
group.
In Hissaria 2006, at week two, there was a reduction in polyp size
of 48% (mean change; P < 0.005) compared to placebo.
Van Zele 2010 also showed a reduction of polyp size in the treat-
ment group after week one (P = 0.002) that become maximal at
week two (P < 0.0001) compared to placebo. There was still a
significant reduction in polyp size after two months in the oral
steroid group (P < 0.05) compared to placebo but there was no
difference of effect after three months.
Change in radiological appearance
There was also a reduction in the magnetic resonance imaging
(MRI) score in the treatment group of 45% (P < 0.001) versus
placebo in Hissaria 2006 at week two.
Quality of life
Alobid 2006 used the validated Medical Outcome Study Short
Form-36 (SF-36; 0 to 100, 100 being the better quality of life
score) to assess general quality of life. Both the physical and mental
components of SF-36 showed a significant score increase for the
treatment group compared to the control group at week two (P
< 0.05). This increase was maintained in the treatment group at
weeks 12, 24 and 48 (P < 0.05).
In Hissaria 2006, RSOM-31 also measured quality of life. There
was also a reduction in total RSOM score in both groups but
the level of improvement was significantly more in the treatment
group (treatment, 53% improvement, P < 0.001 versus placebo
21% improvement, P < 0.005).
Adverse effects
There was no record of adverse events in Alobid 2006 and when we
contacted the main author he reported that there were no adverse
effects in the trial.
Hissaria 2006 reported adverse effects in both treatment and con-
trol groups. The main adverse effects were insomnia (in eight
participants in the treatment group and two in the placebo
group) and mood disturbance (five in the treatment group, two
in placebo); and in fewer numbers headache, dyspepsia, increased
7Oral steroids for nasal polyps (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
appetite, fatigue, backache, gastrointestinal disturbance, acne and
feet oedema. There were no significant adverse effects.
Van Zele 2010 reported that 48.5% of the subjects in the study re-
ported at least one adverse event. There were no significant differ-
ences in adverse events between the treatment and placebo groups.
D I S C U S S I O N
Our objective in this 2010 update of the review was to assess the
effect of oral steroids in the treatment of nasal polyps. Despite
a large number of initial references retrieved, only three studies
met the inclusion criteria and were in general of moderate to poor
methodological quality (Hissaria 2006 grade B; Alobid 2006 and
Van Zele 2010 both grade C). Except for Alobid 2006, the format
used for presentation of data in the papers and lack of response
from the corresponding authors precluded a meta-analysis of the
results.
Hissaria 2006 and Alobid 2006 both compared treatment with
the oral steroid prednisolone at different doses (Hissaria 2006: 50
mg daily for two weeks; Alobid 2006: a reducing course starting
at 30 mg per day and reducing gradually during two weeks) versus
placebo. The study groups in Hissaria 2006 were more balanced
(20 patients each) than in Alobid 2006 (60 patients in the treat-
ment group; 18 in the control group). Two patients were lost in
Alobid 2006 and one in Hissaria 2006, in both cases in the placebo
group. Both studies showed improvement in the outcome mea-
sures. Alobid 2006 continued to measure only the treatment group
for up to 48 weeks and the study reported that the improvements
on all outcomes measured were maintained during this time.
Van Zele 2010 compared three arms in their study: oral steroid
(reducing course of methylprednisolone) versus antibiotic (doxy-
cycline) versus placebo. The groups were well-balanced with 14
patients each in the steroid and antibiotic groups and 19 in the
placebo group. However, there was a significant dropout of seven
patients (15%), all of them in the placebo group, after week four.
Up to this point in the study the treatment group showed a sig-
nificant improvement of most nasal symptoms (nasal congestion,
postnasal drip and sense of smell) in the steroid group. Congestion
and other nasal symptom scores worsened progressively after week
four and returned to baseline values. Oral steroid had no effect on
reducing rhinorrhoea when compared to placebo. Interestingly,
doxycycline significantly reduced postnasal drip and rhinorrhoea,
the former even more than in the steroid group. Polyp size also
was reduced in the steroid group when compared to placebo, with
maximal reduction after two weeks. Doxycycline also showed a
reduction in polyp size. After the four-week assessment point, fail-
ure of treatment resulted in rescue treatment for all groups (14%
in the steroid group; 28% in antibiotic group and 52% in the
placebo group). Although the study continued to assess the long-
term outcome measures for all groups, we considered the dropout
and rescue treatment rate inappropriate to include the long-term
effect data reported in this study in this review.
The individual study results in this review support the positive ef-
fect of a short course (and of different doses) of oral steroids in the
objective reduction of polyp size and the subjective improvement
of nasal symptoms and quality of life. As it was not possible to
conduct a meta-analysis we could not quantify the overall size of
this effect. There are no data to support the maintenance of this
effect in the long term (when compared to placebo) and without
this evidence this type of treatment could be relegated to an adju-
vant treatment in the management of nasal polyposis.
In the studies included in this review there was no report of signif-
icant adverse effects of treatment with a short course of steroids.
Hissaria 2006 and Van Zele 2010 reported some minor adverse
effects in both treatment and placebo groups.
In general the evidence from randomised controlled trials or meta-
analysis as to the adverse effects of steroids is both scarce and
variable.
A search through the Cochrane Reviews that compared the use of
steroids for the treatment of diverse conditions in adults identified
six reviews in which oral steroids were used. Three of these reviews
used a dose similar to that used for the treatment of nasal polyps
and there were some minor and short-lived adverse effects of oral
steroids (Buchbinder 2006; Walters 2005; Wei 2006), however
the adverse effect results were somewhat variable. In two of the
reviews the reported adverse effects were minor and short-lived
(Buchbinder 2006) or did not exist at all (Wei 2006). However,
in a third review on the use of oral steroids for chronic obstructive
pulmonary disease (COPD) (Walters 2005), the pooled adverse
effect from three of the studies in the review (111 participants)
showed an odds ratio of a major adverse effect of 7.76 (95% CI
2.34 to 25.70) or one major adverse effect for every nine people
treated. In one of the studies included in this review, the reported
osteocalcin level was significantly reduced in the oral steroid treat-
ment group. The authors, in their conclusions, warned about the
increased risk of adverse effects at doses that are unacceptable in
the long term.
In the other three reviews (Burton 2009; Cheng 1999; Mash
2001), the dose and/or duration of treatment with oral steroid
used was significantly higher than that used for the treatment of
nasal polyps and although minor adverse effects were reported
there was no information on long-term effect.
The common message from all these reviews is that the pros and
cons of oral steroid therapy should be considered in individual
patients. The conclusions of one of these reviews (Mash 2001)
suggested that a systematic review of the side effects of steroids
would be necessary to address this issue fully.
With regards to the adverse effects of oral steroids specifically in the
treatment of nasal polyposis, two non-randomised studies looked
8Oral steroids for nasal polyps (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
in particular at the effect on osteopenia and bone density and their
results and conclusions may be helpful:
One retrospective study (Rajasekaran 2010) looked at 197 patients
diagnosed with chronic rhinosinusitis with or without polyposis.
The mean age of the patients was 51.1 years (range 15 to 79) and
81.7% had concomitant asthma. The patients had received at least
5 mg of oral steroids daily for at least three months. The authors
observed a higher rate of osteopenia/osteoporosis or low bone den-
sity (LBD) among men > 50 years of age and postmenopausal
women, which was 62.5% and 62.2% respectively. Comparing
this population with their respective younger populations there
was a statistically significant low bone mass (P < 0.0001) in the
older population groups, with an odds ratio of 10.6 (3.9 to 28.7)
and 34.6 (7.4 to 161.5) for men > 50 and postmenopausal women
respectively. There was no difference on gender. The authors ad-
vised careful evaluation and treatment in this older age group to
prevent additional bone-related complications.
One of the non-randomised excluded studies in this review
(Bonfils 2006) reported on adrenal suppression and osteoporo-
sis in a prospective longitudinal study of 46 patients treated for
nasal polyposis with repeated short courses (more than 21 days
of treatment in total) of oral prednisolone 1 mg/kg body weight.
The mean age of the patients was 49.4 (+/- 1.6), 56.5% were male
and the mean duration of the treatment was 4.7 years (SD = 4.2)
with a mean number of oral steroid courses per year (seven to 10
days duration for each course) of 6.8 (SD = 4.7). Almost 80%
of these patients also received intranasal steroids simultaneously.
In 48.8% and 12.2% of patients there was osteopenia and os-
teoporosis (respectively) at the lumbar spine; 43.9% had osteope-
nia at the femoral neck (none had osteoporosis) and 40.5% and
54% had osteopenia and osteoporosis at the proximal femur. Also
20 of these patients (48.8%) had adrenal insufficiency on synac-
then test but only one patient was symptomatic. The authors of
this study concluded that patients with severe nasal polyposis and
a high steroid consumption have a high prevalence of glucocor-
ticoid-induced osteoporosis and secondary adrenal insufficiency.
They concluded that patients should be informed of the risks and
monitored during long-term steroid treatment.
In summary, the evidence relating to a short course of a moder-
ate dose of oral steroids indicates that is safe, although very few
studies have looked at the effect on osteopenia and bone density
and secondary adrenal insufficiency. The studies that looked at
these parameters do report a high prevalence of osteoporosis and
secondary adrenal insufficiency. In conclusion there is a lack of
strong evidence for significant adverse effect/s of oral steroids for
the treatment nasal polyps. We concur with the consensus opin-
ion that the balance of risks and benefits of oral steroid therapy
should be carefully considered in each individual patient and that
this information should be conveyed to the patient as part of the
informed choice regarding their treatment.
A short course of oral steroids could be beneficial in the short term
to patients with nasal polyps (provided there are no contraindica-
tions).
A U T H O R S ’ C O N C L U S I O N S
Implications for practice
A limited number of trials of moderate to poor methodological
quality showed a short-term improvement with a short (two to
four-week) and variable dose course of oral steroids in the treat-
ment of nasal polyps. The trials showed improvement in the ob-
jective reduction of polyp size and the subjective improvement of
nasal symptoms and quality of life. It was not possible to quantify
the overall size of this effect.
Without long-term supporting data, there is no evidence of a sus-
tained effect of this treatment and without this evidence this type
of treatment could be relegated to an adjuvant treatment in the
management of nasal polyposis.
There were reports of some adverse events in the included trials
but no significant adverse effects of treatment with a short course
of steroids were reported.
Implications for research
There is still a need for trials of high methodological quality on
the use of oral steroids for the treatment of nasal polyps.
Longer follow up is necessary to establish the long-term effect of
this intervention.
The presence or absence of adverse effects of treatment with oral
steroids should always be reported in a standardised manner with
short and long-term measures.
A C K N O W L E D G E M E N T S
The authors would like to thank the staff of the Cochrane ENT
Group for their help in producing this review, particularly Gemma
Sandberg for development of the search strategy and searching for
trials.
9Oral steroids for nasal polyps (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
R E F E R E N C E S
References to studies included in this review
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12Oral steroids for nasal polyps (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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 studies [ordered by study ID]
Alobid 2006
Methods Randomised: computer generation on a 1:3 ratio (explained by the main author when
contacted)
Allocation: not described
Blinding: not described
Participants 78 patients with nasal polyps diagnosed endoscopically and radiologically
Setting: hospital
Country: Spain
Mean age: 50 years (range 22 to 84 years)
% female: 35
Number randomised: 80 participants (20 to control group but 2 lost to follow up)
Aspirin sensitivity: 21% in treatment group; 6.4% in placebo group
Interventions Group A: oral prednisone 30 mg daily for 4 days followed by a dose reducing by 5 mg every
2 days for 10 days
Group B: no steroid treatment for 2 weeks
Outcomes The following outcomes were measured immediately before treatment and at 2 weeks:
nasal symptom score (unvalidated), polyp size score and quality of life assessment (Medical
Outcome Study Short Form-36 (SF-36) questionnaire)
Outcomes for the treatment group only (group A) were measured at 12, 24 and 48 weeks
Adverse events: not reported, but main author when contacted reported there were no
adverse effects in the trial
Notes Two weeks after commencing oral steroid treatment, group A was commenced on treatment
with intranasal budesonide and followed up but group B was not followed up as it was
considered unethical not to offer known effective treatment to the control group for longer
than 6 weeks
Quality score: C
Risk of bias
Bias Authors’ judgement Support for judgement
Allocation concealment (selection bias) Low risk Randomisation using a computer-generated
list on a 1:3 ratio
13Oral steroids for nasal polyps (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Hissaria 2006
Methods Randomised: participants were randomised by the hospital pharmacy, but the actual process
is not described
Allocation: not described
Blinding: participants and study personnel were blinded.
Participants 41 patients drawn mainly from allergy outpatient clinics who had nasal polyps diagnosed
endoscopically
Setting: hospital
Country: Australia
Mean age: 49 years for treatment group and 48 years for placebo group (range 18 to 65
years)
% female: 52
Number randomised: 41 participants (21 to control group but 1 lost to follow up)
Aspirin sensitivity: 10% in treatment group; 30% in placebo group
Interventions Treatment group: oral prednisone 50 mg daily for 14 days
Placebo group: placebo for 14 days
Outcomes The following outcomes were measured immediately before treatment and at 2 weeks:
physician assessment on a VAS (1 to 5 score) including grading of nasal symptoms (6 scales:
congestion, hyposmia, rhinorrhoea, sneezing, postnasal drip and itch); 6 nasal symptoms
score on part of Rhinosinusitis Outcome Measure (RSOM-31) questionnaire, polyp size
score on MRI and nasoendoscopy and quality of life assessment (total RSOM-31 score)
Adverse events: reported in both treatment and control groups. The main adverse effect
was insomnia (in 8 participants of the treatment group and 2 in the placebo group); mood
disturbance (5 in treatment, 2 in placebo); and in fewer numbers of headache, dyspepsia,
increased appetite, fatigue, backache, gastrointestinal disturbance, acne and feet oedema.
There were no significant adverse effects
Notes The study was not designed to look at long-term outcome
Quality score: B
Risk of bias
Bias Authors’ judgement Support for judgement
Allocation concealment (selection bias) Unclear risk B - Unclear
Van Zele 2010
Methods Randomised: not described
Allocation: not described
Blinding: study personnel and participants were blinded for the duration of the study
Participants 47 patients recruited from 4 ear, nose and throat departments in Europe and 1 in Australia.
Patients had recurrent nasal polyps after surgery or massive bilateral nasal polyps
Setting: hospital
Country: Europe (Belgium, The Netherlands, Germany) and Australia
14Oral steroids for nasal polyps (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Van Zele 2010 (Continued)
Mean age: 49 years for steroid treatment group, 55 years for antibiotic treatment group
and 55 years for placebo group (range 18 to 65 years)
% female: 20
Number randomised: 47 participants (14 to each treatment group and 19 to placebo group
but 7 lost to follow up in placebo group)
Aspirin sensitivity: 14% in steroid treatment group; 7% in antibiotic group and 26% in
placebo group
Interventions Steroid treatment group: oral methylprednisolone 32 mg daily for 5 days followed by a
reducing dose to 16 mg daily for 5 days and 8 mg daily for 10 days (total 20 days)
Antibiotic treatment group: oral doxycyline 200 mg on day 1, then 100 mg for 19 days
(total 20 days)
Placebo group: placebo for 20 days
Outcomes The following outcomes were measured immediately before treatment and at 1, 2, 4, 8 and
12 weeks: total polyp score (0 to 4 for each nostril); peak nasal inspiratory flow (PNIF)
measurement and nasal symptoms (anterior rhinorrhoea, nasal obstruction, postnasal drip
and loss of sense of smell); eosinophil, IL-5 and eosinophilic cationic protein (ECP) counts
in blood and; ECP, IgE, IL-5, matrix metallo-proteinase (MMP-9) and myeloperoxidase
counts in nasal secretions
Adverse events: reported 48.5% of the subjects in the study reported at least 1 adverse
event. There were no significant differences of adverse events between the treatments and
placebo groups
Notes After week 4 from the start of the study 52% of the participants assigned to the placebo
group underwent rescue treatment (either surgical or nasal steroids), 28% of the antibiotic
treatment group needed rescue treatment and likewise 14% of the steroid treatment group.
Therefore there was too large a number of dropouts in the study to assess long-term results
in any group
Quality score: C
Risk of bias
Bias Authors’ judgement Support for judgement
Allocation concealment (selection bias) Unclear risk B - Unclear
MRI: magnetic resonance imaging
RSOM: Rhinosinusitis Outcome Measure questionnaire
VAS: visual analogue scale
15Oral steroids for nasal polyps (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Characteristics of excluded studies [ordered by study ID]
Study Reason for exclusion
Alobid 2005 ALLOCATION
Randomised; randomisation method not given
PARTICIPANTS
Nasal polyps diagnosed endoscopically and radiologically
INTERVENTIONS
Oral steroids versus endoscopic sinus surgery
Benitez 2006 ALLOCATION
Randomised; randomisation method not given
PARTICIPANTS
Nasal polyps diagnosed endoscopically and radiologically
INTERVENTIONS
Oral steroids versus no treatment
The study was excluded as possible duplication of Alobid 2006. Both studies were carried out in the same
department and during the same period of time: February 1999 to July 2003 in Alobid 2006 with 78 participants
and February 1999 to November 2003 in Benitez 2006 with 84 patients recruited. The patient characteristics
were very similar. The main difference was in the outcome measures and the subgroups used in the second study
(Benitez 2006) where the treatment group was also subdivided into patients with and without asthma. We asked
the (same) corresponding author for both trials but they did not comment on this point
Blomqvist 2001 ALLOCATION
Randomised; randomisation method not given
PARTICIPANTS
Nasal polyps diagnosed clinically and endoscopically
INTERVENTIONS
Oral steroids and topical steroids versus endoscopic sinus surgery and topical steroids
Blomqvist 2009 ALLOCATION
Randomised; randomisation method not given
PARTICIPANTS
Nasal polyps diagnosed clinically and endoscopically
INTERVENTIONS
Oral steroids and topical steroids versus combined medical and surgical treatment
Bonfils 1998 ALLOCATION
Non-randomised, no control group
Bonfils 2003 ALLOCATION
Non-randomised, no control group
Bonfils 2006 ALLOCATION
Non-randomised, no control group
Cassano 1996 ALLOCATION
Non-randomised retrospective study
16Oral steroids for nasal polyps (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
(Continued)
Chi Chan 1996 ALLOCATION
Non-randomised, no control group
Damm 1999 ALLOCATION
Randomised; randomisation method not given
PARTICIPANTS
20 patients (40 nasal cavities) with chronic polypoid rhinosinusitis - 80% of these patients (33 nasal cavities) had
nasal polyps diagnosed radiologically
INTERVENTIONS
Group1: total dose of 560 mg oral fluocortolone 12 days
Group 2: total dose of 715 mg oral fluocortolone for 20 days
Reducing dose regimen in both groups
OUTCOMES
Trial rejected because data were not extractable. Change in MRI appearances were not reported separately for
groups 1 and 2. Changes in symptom visual analogue scales were reported for Groups 1 and 2 in the chronic
polypoid rhino-sinusitis patients but not for subset of patients with nasal polyps
Hessler 2007 ALLOCATION
Non-randomised, no control group
Jankowski 2003a ALLOCATION
Non-randomised, no control group
Jankowski 2003b ALLOCATION
Non-randomised, no control group
Kroflic 2006 ALLOCATION
Randomised; randomisation method not given
PARTICIPANTS
Nasal polyps diagnosed endoscopically and radiologically
INTERVENTIONS
Oral steroids versus topical furosemide
OUTCOMES
Trial rejected because only intraoperative surgical variables reported
Lildholdt 1988 ALLOCATION
Randomised using computer-generated random figures
PARTICIPANTS
Method of diagnosing nasal polyps not given
INTERVENTIONS
Intramuscular steroid versus surgery
Lildholdt 1989 ALLOCATION
Randomised using computer-generated random figures
PARTICIPANTS
Method of diagnosing nasal polyps not given
INTERVENTIONS
Surgical polypectomy followed by continuous topical steroid treatment versus a single dose of depot steroid
17Oral steroids for nasal polyps (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
(Continued)
followed by continuous topical steroid treatment
Nores 2003 ALLOCATION
Non-randomised, no control group
Ragab 2006 ALLOCATION
Randomised; randomisation method not given
PARTICIPANTS
Chronic rhinosinusitis with or without nasal polyps diagnosed endoscopically and radiologically
INTERVENTIONS
Erythromycin, nasal douche and topical steroids versus surgery
Rasp 1997 ALLOCATION
Non-randomised, no control group
Rasp 2000 ALLOCATION
Non-randomised, no control group
Sieskiewicz 2006 ALLOCATION
Randomised; randomisation method not given
PARTICIPANTS
Nasal polyps diagnosed clinically and radiologically
INTERVENTIONS
Oral steroids versus no intervention prior to endoscopic sinus surgery in both groups
Stevens 2001 ALLOCATION
Non-randomised, no control group
Tuncer 2003 ALLOCATION
Non-randomised, no control group
van Camp 1994 ALLOCATION
Non-randomised, no control group
Van Zele 2008 Abstract of later publication: Van Zele 2010
MRI: magnetic resonance imaging
18Oral steroids for nasal polyps (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Characteristics of ongoing studies [ordered by study ID]
Vaidyanathan 2009
Trial name or title A proof of concept study to investigate the clinical, histological and molecular predictors of response to oral
and intranasal corticosteroid in nasal polyposis
Methods Randomised, double-blind, controlled trial
Participants 60 adults 18 to 75 years of age
Interventions Treatment group: oral prednisolone 25 mg daily for 2 weeks followed by fluticasone nasal drops 800 µg/day
for 2 months followed by fluticasone nasal spray 400 µg/day for 4 months
Placebo group: oral placebo daily for 2 weeks followed by fluticasone nasal drops 800 µg/day for 2 months
followed by fluticasone nasal spray 400 µg/day for 4 months
Outcomes Primary outcome measure: endoscopy polyp grading
Secondary outcome measures: mini RQLQ, TNS-4, PNIF, anosmia score, scratch ’n’ sniff cards, OUCC, 1
µg synacthen test
Measurements at 0, 2, 10 and 28 weeks
Starting date May 2004
Contact information Mr S Vaidyanathan and Dr B Lipworth, University of Dundee, UK
Notes -
PNIF: peak nasal inspiratory flow
RQLQ: Rhinitis Quality of Life Questionnaire
19Oral steroids for nasal polyps (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
D A T A A N D A N A L Y S E S
This review has no analyses.
A P P E N D I C E S
Appendix 1. Search strategies
CENTRAL PubMed EMBASE (Ovid) CINAHL (EBSCO)
#1 NASAL POLYPS single
term (MeSH)
#2 POLYPS explode all trees
(MeSH)
#3 (polyp* OR papilloma*)
#4 NOSE explode all trees
(MeSH)
#5 (nose* OR nasal* OR nasi
OR intranasal* OR sinonasal*
OR paranasal*)
#6 (#2 OR #3)
#7 (#4 OR #5)
#8 (#6 AND #7)
#9 rhinopolyp*
#10 (#1 OR #8 OR #9)
#11 STEROIDS explode all
trees (MeSH)
#12 ADRENAL CORTEX
HORMONES explode all trees
(MeSH)
#13 GLUCOCORTICOIDS
explode all trees (MeSH)
#14 (steroid* OR glucocorti-
coid*
OR corticosteroid* OR glucos-
teroid* OR cyclocosteroid*)
#15 (beclomethasone OR be-
clometasone OR beclamet OR
beclocort OR becotide)
#16 (betamethasone OR be-
tadexam-
ethasone OR flubenisolone OR
celeston* OR cellestoderm OR
betnelan OR oradexon)
#17 (dexamethasone OR dex-
ameth OR dexone OR dexam-
#1 “NASAL POLYPS” [Mesh]
OR rhinopolyp* [tiab]
#2 “POLYPS” [Mesh] OR
POLYP* [tiab] OR PAPIL-
LOMA* [tiab]
#3 “NOSE”
[Mesh] OR NOSE* [tiab] OR
NASAL* [tiab] OR NASI [tiab]
OR INTRANASAL* [tiab] OR
SINONASAL* [tiab] OR
PARANASAL* [tiab]
#4 #1 OR (#2 AND #3)
#5 “STEROIDS” [Mesh] OR
“ADRENAL CORTEX HOR-
MONES” [Mesh] OR “GLU-
COCORTICOIDS” [Mesh]
#6 STEROID*[tiab] OR GLU-
COCORTICOID*[tiab] OR
CORTICOSTEROID*[tiab]
OR GLUCOSTEROID*[tiab]
OR CYCLOSTEROID*[tiab]
#7 BECLOMETASONE[tiab]
OR BECLAMET[tiab]
OR BECLOCORT[tiab]
OR BECOTIDE[tiab]
OR BETADEXAM-
ETHASONE[tiab] OR
FLUBENISOLONE[tiab]
OR CELESTON$1[tiab]
OR CELLESTODERM[tiab]
OR BETNELAN[tiab]
OR DEXAMETH[tiab]
OR DEXONE[tiab] OR
DEXAMETASONE[tiab]
OR DECADRON[tiab]
1 nose polyp/
2 polyp/ or polyposis/
3 (polyp* or papillom*).tw.
4 2 or 3
5 exp *nose/
6 (NOSE* or NASAL* or
NASI or INTRANASAL* or
SINONASAL* or
PARANASAL*).tw.
7 5 or 6
8 4 and 7
9 rhinopolyp*.tw.
10 1 or 8 or 9
11 exp Corticosteroid/
12 (STEROID* or GLUCO-
CORTICOID*
or CORTICOSTEROID* or
GLUCOSTEROID* or CY-
CLOSTEROID*).tw.
13 (BECLOMETASONE
or BECLAMET or BECLO-
CORT or BECOTIDE or BE-
TADEXAMETHASONE or
FLUBENISOLONE or CELE-
STON* or CELLESTODERM
or BETNELAN or DEXAM-
ETH or DEXONE or DEX-
AMETASONE
or DECADRON or DEXAS-
ONE or
HEXADECADRON or HEX-
ADROL or ETHYLFLU OR-
PREDNISOLONE or MIL-
LIC ORTEN or ORADEXON
or CORTISOL or CORTI-
S1 (MH “Nasal Polyps”)
S2 (MH “Polyps+”)
S3 TX polyp* OR papilloma*
S4 S2 or S3
S5 (MH “Nose+”)
S6 TX NOSE* or NASAL* or
NASI or INTRANASAL* or
SINONASAL* or
PARANASAL*
S7 S5 or S6
S8 S4 and S7
S9 TX rhinopolyp*
S10 S1 or S8 or S9
S11 (MH “Steroids+”)
S12 (MH “Glucocorticoids”)
S13 (MH “Adrenal Cortex
Hormones+”)
S14 TX STEROID* or GLU-
COCORTICOID* or COR-
TICOSTEROID* or GLU-
COSTEROID* or CYCLOS-
TEROID*
S15 TX BECLOMETASONE
or BECLAMET or BECLO-
CORT or BECOTIDE or BE-
TADEXAMETHASONE or
FLUBENISOLONE or CELE-
STON* or CELLESTODERM
or BETNELAN or DEXAM-
ETH or DEXONE or DEX-
AMETASONE
or DECADRON or DEXAS-
ONE or
HEXADECADRON or HEX-
20Oral steroids for nasal polyps (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
(Continued)
etasone OR decadron OR dex-
asone OR hexadecadron OR
hexadrol OR methylfluorpred-
nisolone OR millicorten)
#18 (flunisolide OR fluticasone
OR hydrocortisone OR corti-
sol OR cortifair OR cortril OR
hyrocortone OR cortef OR epi-
cortisol OR efcortesol)
#19 (methylprednisolone OR
medrol OR metripred OR ur-
bason)
#20 (mometasone OR pred-
nisolone OR precortisyl OR
deltacortril OR deltastab OR
prednesol OR deltasone OR
prednisone OR cortan OR liq-
uid NEXT pred OR meti-
corten)
#21 (paramethasone OR tri-
amcinolone OR aristocort OR
volon OR atolone OR kenacort
OR orasone OR panasol OR
prednicen)
#22 (#11 OR #12 OR #13 OR
#14 OR #15 OR #16 OR #17
or #18 or #19 or #20 or #21)
#23 (#10 AND #22)
OR DEXASONE[tiab] OR
HEXADECADRON[tiab]
OR HEXADROL[tiab]
OR ETHYLFLU[tiab] OR-
PREDNISOLONE[tiab] OR
MILLIC[tiab] ORTEN[tiab]
OR[tiab] ORADEXON[tiab]
OR CORTISOL[tiab]
OR CORTIFAIR[tiab]
OR CORTRIL[tiab] OR
HYROCORTONE[tiab]
OR CORTEF[tiab] OR
EPICORTISOL[tiab]
OR EFCORTESOL[tiab]
OR MEDROL[tiab] OR
METRIPRED[tiab] OR
URBASON[tiab] OR
MOMETASONE[tiab] OR
PRECORTISYL[tiab] OR
DELTACORTRIL[tiab]
OR DELTASTAB[tiab]
OR PREDNESOL[tiab]
OR DELTASONE[tiab]
OR CORTAN[tiab] OR
“LIQUID PRED”[tiab] OR
METICORTEN[tiab] OR
ORASONE[tiab] OR PANA-
SOL[tiab] OR PREDNICEN
[tiab]
#8 PARAMETHASONE[tiab]
OR ARISTOCORT[tiab] OR
VOLON[tiab]
OR ATOLONE[tiab] OR KE-
NACORT[tiab] OR BE-
CLOMETHASONE[tiab] OR
4419-39-0[tiab] OR BE-
TAMETHASONE[tiab] OR
378-44-9 [tiab] OR BUDES-
ONIDE[tiab] OR 51333-22-3
[tiab] OR CORTISONE[tiab]
OR 53-06-5[tiab] OR DEX-
AMETHA-
SONE[tiab] OR 50-02-2 [tiab]
OR FLUNISOLIDE[tiab] OR
3385-03-3[tiab] OR FLUTI-
CASONE[tiab] OR 90566-
53-3[tiab] OR “FLUTICAS-
ONE PROPIONATE” [tiab]
FAIR or CORTRIL or HY-
ROCORTONE or CORTEF
or EPICORTISOL or EF-
CORTESOL or MEDROL
or METRIPRED or URBA-
SON or MOMETASONE or
PRECORTISYL or DELTA-
CORTRIL or DELTASTAB
or PREDNESOL or DELTA-
SONE or CORTAN or (LIQ-
UID adj PRED) or METI-
CORTEN or ORASONE or
PANASOL or PREDNICEN).
tw.
14 (PARAMETHASONE or
ARISTOCORT or VOLON or
ATOLONE or KENACORT
or BECLOMETHASONE or
4419-39-0 or BETAMETHA-
SONE or 378-44-9 or BUDES-
ONIDE
or 51333-22-3 or CORTI-
SONE or 53-06-5 or DEX-
AMETHASONE or 50-02-2
or FLUNISOLIDE or 3385-
03-3 or FLUTICASONE or
90566-53-3 or (FLUTICAS-
ONE adj PROPIONATE) or
80474-14-2 or HYDROCOR-
TISONE or CORTISOL or
50-23-7 or METHYLPRED-
NISOLONE or 83-43-2 or
MOMETASONE or 105102-
22-5 or PREDNISOLONE
or 50-24-8 or PREDNISONE
or 53-03-2 or TRIAMCI-
NOLONE or 124-94-7).tw.
15 11 or 12 or 13 or 14
16 10 and 15
ADROL or ETHYLFLU OR-
PREDNISOLONE or MIL-
LIC ORTEN or ORADEXON
or CORTISOL or CORTI-
FAIR or CORTRIL or HY-
ROCORTONE or CORTEF
or EPICORTISOL or EF-
CORTESOL or MEDROL
or METRIPRED or URBA-
SON or MOMETASONE or
PRECORTISYL or DELTA-
CORTRIL or DELTASTAB
or PREDNESOL or DELTA-
SONE or CORTAN or (LIQ-
UID adj PRED) or METI-
CORTEN or ORASONE or
PANA-
SOL or PREDNICENTX BE-
CLOMETASONE
or BECLAMET or BECLO-
CORT or BECOTIDE or BE-
TADEXAMETHASONE or
FLUBENISOLONE or CELE-
STON* or CELLESTODERM
or BETNELAN or DEXAM-
ETH or DEXONE or DEX-
AMETASONE
or DECADRON or DEXAS-
ONE or
HEXADECADRON or HEX-
ADROL or ETHYLFLU OR-
PREDNISOLONE or MIL-
LIC ORTEN or ORADEXON
or CORTISOL or CORTI-
FAIR or CORTRIL or HY-
ROCORTONE or CORTEF
or EPICORTISOL or EF-
CORTESOL or MEDROL
or METRIPRED or URBA-
SON or MOMETASONE or
PRECORTISYL or DELTA-
CORTRIL or DELTASTAB
or PREDNESOL or DELTA-
SONE or
S16 TX PARAMETHASONE
or ARISTOCORT or VOLON
or ATOLONE or KENA-
21Oral steroids for nasal polyps (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
(Continued)
OR 80474-14-2[tiab] OR HY-
DROCORTISONE[tiab] OR
CORTISOL[tiab] OR 50-23-
7[tiab] OR METHYLPRED-
NISOLONE[tiab] OR
83-43-2 [tiab] OR MOMETA-
SONE[tiab] OR 105102-22-5
[tiab] OR PRED-
NISOLONE[tiab] OR 50-24-
8 [tiab]
OR PREDNISONE[tiab] OR
53-03-2[tiab] OR TRIAMCI-
NOLONE[tiab] OR 124-94-7
[tiab]
#9 #5 OR #6 OR #7 OR #8
#10 #4 AND #9
CORT or BECLOMETHA-
SONE or 4419-39-0 or BE-
TAMETHASONE or 378-44-
9 or BUDESONIDE or 51333-
22-3 or CORTISONE or 53-
06-5 or DEXAMETHASONE
or 50-02-2 or FLUNISOLIDE
or 3385-03-3 or FLUTICAS-
ONE
or 90566-53-3 or (FLUTICA-
SONE adj PROPIONATE) or
80474-14-2 or HYDROCOR-
TISONE or CORTISOL or
50-23-7 or METHYLPRED-
NISOLONE or 83-43-2 or
MOMETASONE or 105102-
22-5 or PREDNISOLONE
or 50-24-8 or PREDNISONE
or 53-03-2 or TRIAMCI-
NOLONE or 124-94-7
S17 S11 or S12 or S13 or S14
or S15 or S16
S18 S10 and S17
Web of Science/ BIOSIS Pre-
views (Web of Knowledge)
ISRCTN (mRCT) CAB Abstracts (Ovid) Cochrane Ear, Nose
and Throat Disorders Group
Trials Register
#1 TS=(nose OR nasal* OR
paranasal* OR sinonasal* OR
intranasal*) AND (polyp* OR
papillom*)) OR rhinopolyp*)
#2 TS=(STEROID* or GLU-
COCORTICOID* or COR-
TICOSTEROID* or GLU-
COSTEROID* or CYCLOS-
TEROID*)
#3 TS=(BECLOMETASONE
or BECLAMET or BECLO-
CORT or BECOTIDE or BE-
TADEXAMETHASONE or
FLUBENISOLONE or CELE-
STON* or CELLESTODERM
or BETNELAN or DEXAM-
ETH or DEXONE or DEX-
AMETASONE
or DECADRON or DEXAS-
ONE or
HEXADECADRON or HEX-
(nose OR nasal) AND (polyp%
OR papillom%)
1 (polyp* or papillom*).tw.
2 (NOSE* or NASAL* or
NASI or INTRANASAL* or
SINONASAL* or
PARANASAL*).tw.
3 1 AND 2
4 rhinopolyp*.tw.
5 3 OR 4
6 exp Corticosteroid/
7 (STEROID* or GLUCO-
CORTICOID*
or CORTICOSTEROID* or
GLUCOSTEROID* or CY-
CLOSTEROID*).tw.
8 (BECLOMETASONE
or BECLAMET or BECLO-
CORT or BECOTIDE or BE-
TADEXAMETHASONE or
FLUBENISOLONE or CELE-
STON* or CELLESTODERM
or BETNELAN or DEXAM-
(
(nose OR nasal* OR paranasal*
OR sinonasal* OR intranasal*)
AND (polyp* OR papillom*)
) AND (STEROID* or GLU-
COCORTICOID* or COR-
TICOSTEROID* or GLU-
COSTEROID* or CYCLOS-
TEROID*)
22Oral steroids for nasal polyps (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
(Continued)
ADROL or ETHYLFLU OR-
PREDNISOLONE or MIL-
LIC ORTEN or ORADEXON
or CORTISOL or CORTI-
FAIR or CORTRIL or HY-
ROCORTONE or CORTEF
or EPICORTISOL or EF-
CORTESOL or MEDROL
or METRIPRED or URBA-
SON or MOMETASONE or
PRECORTISYL or DELTA-
CORTRIL or DELTASTAB
or PREDNESOL or DELTA-
SONE or CORTAN or (LIQ-
UID adj PRED) or METI-
CORTEN or ORASONE or
PANASOL or PREDNICEN)
#4 TS=(PARAMETHASONE
or ARISTOCORT or VOLON
or ATOLONE or KENA-
CORT or BECLOMETHA-
SONE or 4419-39-0 or BE-
TAMETHASONE or 378-44-
9 or BUDESONIDE or 51333-
22-3 or CORTISONE or 53-
06-5 or DEXAMETHASONE
or 50-02-2 or FLUNISOLIDE
or 3385-03-3 or FLUTICAS-
ONE
or 90566-53-3 or (FLUTICA-
SONE adj PROPIONATE) or
80474-14-2 or HYDROCOR-
TISONE or CORTISOL or
50-23-7 or METHYLPRED-
NISOLONE or 83-43-2 or
MOMETASONE or 105102-
22-5 or PREDNISOLONE
or 50-24-8 or PREDNISONE
or 53-03-2 or TRIAMCI-
NOLONE or 124-94-7)
#5 #4 OR #3 OR #2
#6 #5 AND #1
ETH or DEXONE or DEX-
AMETASONE
or DECADRON or DEXAS-
ONE or
HEXADECADRON or HEX-
ADROL or ETHYLFLU OR-
PREDNISOLONE or MIL-
LIC ORTEN or ORADEXON
or CORTISOL or CORTI-
FAIR or CORTRIL or HY-
ROCORTONE or CORTEF
or EPICORTISOL or EF-
CORTESOL or MEDROL
or METRIPRED or URBA-
SON or MOMETASONE or
PRECORTISYL or DELTA-
CORTRIL or DELTASTAB
or PREDNESOL or DELTA-
SONE or CORTAN or (LIQ-
UID adj PRED) or METI-
CORTEN or ORASONE or
PANASOL or PREDNICEN).
tw.
9 (PARAMETHASONE or
ARISTOCORT or VOLON or
ATOLONE or KENACORT
or BECLOMETHASONE or
4419-39-0 or BETAMETHA-
SONE or 378-44-9 or BUDES-
ONIDE
or 51333-22-3 or CORTI-
SONE or 53-06-5 or DEX-
AMETHASONE or 50-02-2
or FLUNISOLIDE or 3385-
03-3 or FLUTICASONE or
90566-53-3 or (FLUTICAS-
ONE adj PROPIONATE) or
80474-14-2 or HYDROCOR-
TISONE or CORTISOL or
50-23-7 or METHYLPRED-
NISOLONE or 83-43-2 or
MOMETASONE or 105102-
22-5 or PREDNISOLONE
or 50-24-8 or PREDNISONE
or 53-03-2 or TRIAMCI-
NOLONE or 124-94-7).tw.
10 7 OR 8 OR 9
11 5 AND 10
23Oral steroids for nasal polyps (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
W H A T ’ S N E W
Last assessed as up-to-date: 11 October 2010.
Date Event Description
17 February 2011 New search has been performed We ran full new searches in October 2010.
17 February 2011 New citation required and conclusions have changed We included two new studies (Hissaria 2006; Van Zele
2010) and excluded a further nine. The review conclu-
sions have been strengthened. High-quality studies with
long-term follow up are still necessary
H I S T O R Y
Protocol first published: Issue 2, 2005
Review first published: Issue 1, 2007
Date Event Description
26 October 2008 Amended Converted to new review format.
C O N T R I B U T I O N S O F A U T H O R S
Pablo Martinez-Devesa: co-ordination of the review, screening search results, screening retrieved papers against inclusion criteria and
editing of review, writing to authors of papers for additional information and writing of review.
Shalini Patiar: co-ordination of review, screening search results, organising retrieval of papers, screening retrieved papers against inclusion
criteria, writing to authors of papers for additional information, writing to experts in field and writing of review.
D E C L A R A T I O N S O F I N T E R E S T
None known.
24Oral steroids for nasal polyps (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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.
D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W
We added the secondary outcome measure ’Improvement in validated quality of life measures’.
I N D E X T E R M S
Medical Subject Headings (MeSH)
Administration, Oral; Nasal Obstruction [etiology]; Nasal Polyps [complications; ∗drug therapy]; Olfaction Disorders [etiology];
Prednisone [∗administration & dosage]; Randomized Controlled Trials as Topic; Steroids [∗administration & dosage]
MeSH check words
Humans
25Oral steroids for nasal polyps (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.