polipos nasales.pdf

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.

http://www.thecochranelibrary.com

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)


[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.


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)


mailto:[email protected]

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.



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



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.



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



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



(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



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



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.



R E F E R E N C E S

References to studies included in this review

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Clinical Immunology. 2008; Vol. 121 (2 (Suppl 1)):S265,

Abstract No. 1028.∗ Van Zele T, Gevaert P, Holtappels G, Beule A, Wormald

PJ, Mayr S, et al.Oral steroids and doxycycline: two

different approaches to treat nasal polyps. Journal of Allergy

and Clinical Immunology 2010;125(5):1069–76.

References to studies excluded from this review

Alobid 2005 {published data only}

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Picado C, et al.Nasal polyposis and its impact on quality of

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treatments. Allergy 2005;60(4):452–8.

Benitez 2006 {published data only}

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Sprekelsen M, Pujols L, et al.A short course of oral

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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



Hissaria 2006

Methods Randomised: participants were randomised by the hospital pharmacy, but the actual process

is 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


Allocation concealment (selection bias) Unclear risk B - Unclear

Van Zele 2010

Methods Randomised: 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



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


Allocation concealment (selection bias) Unclear risk B - Unclear

MRI: magnetic resonance imaging

RSOM: Rhinosinusitis Outcome Measure questionnaire

VAS: visual analogue scale



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


PARTICIPANTS


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


PARTICIPANTS

Nasal polyps diagnosed clinically and endoscopically

INTERVENTIONS

Oral steroids and topical steroids versus endoscopic sinus surgery and topical steroids

Blomqvist 2009 ALLOCATION


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





Cassano 1996 ALLOCATION

Non-randomised retrospective study



(Continued)

Chi Chan 1996 ALLOCATION


Damm 1999 ALLOCATION


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


Jankowski 2003a ALLOCATION


Jankowski 2003b ALLOCATION


Kroflic 2006 ALLOCATION


PARTICIPANTS


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



(Continued)

followed by continuous topical steroid treatment

Nores 2003 ALLOCATION


Ragab 2006 ALLOCATION


PARTICIPANTS

Chronic rhinosinusitis with or without nasal polyps diagnosed endoscopically and radiologically

INTERVENTIONS

Erythromycin, nasal douche and topical steroids versus surgery

Rasp 1997 ALLOCATION


Rasp 2000 ALLOCATION


Sieskiewicz 2006 ALLOCATION


PARTICIPANTS

Nasal polyps diagnosed clinically and radiologically

INTERVENTIONS

Oral steroids versus no intervention prior to endoscopic sinus surgery in both groups

Stevens 2001 ALLOCATION


Tuncer 2003 ALLOCATION


van Camp 1994 ALLOCATION


Van Zele 2008 Abstract of later publication: Van Zele 2010

MRI: magnetic resonance imaging



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



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


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



TADEXAMETHASONE or





AMETASONE


ONE or




(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






ROCORTONE or CORTEF


CORTESOL or MEDROL









PANA-

SOL or PREDNICENTX BE-

CLOMETASONE



TADEXAMETHASONE or





AMETASONE


ONE or







ROCORTONE or CORTEF


CORTESOL or MEDROL






SONE or

S16 TX PARAMETHASONE

or ARISTOCORT or VOLON

or ATOLONE or KENA-



(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









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-




TEROID*)

#3 TS=(BECLOMETASONE



TADEXAMETHASONE or





AMETASONE


ONE or


(nose OR nasal) AND (polyp%

OR papillom%)

1 (polyp* or papillom*).tw.

2 (NOSE* or NASAL* 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



TADEXAMETHASONE or




(

(nose OR nasal* OR paranasal*

OR sinonasal* OR intranasal*)

AND (polyp* OR papillom*)

) AND (STEROID* or GLU-




TEROID*)



(Continued)






ROCORTONE or CORTEF


CORTESOL or MEDROL









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









NOLONE or 124-94-7)

#5 #4 OR #3 OR #2

#6 #5 AND #1


AMETASONE


ONE or







ROCORTONE or CORTEF


CORTESOL or MEDROL









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









NOLONE or 124-94-7).tw.

10 7 OR 8 OR 9

11 5 AND 10



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.



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



polipos nasales.pdf

Documents

cochrane review

cochrane collaboration

cochrane ear

nasal polyps reviewcopyright

cochrane library2011

multiple nasal polyps

benign nasal polyps

nasal obstruction