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References

References to studies included in this review

Barlan 1997 {published data only}

Barlan IB, Erkan E, Bakir M, Berrak S, Basaran MM. Intranasal budesonide spray as an adjunct to oral antibiotic therapy for acute sinusitis in children. Annals of Allergy, Asthma & Immunology 1997;78:598‐601. CENTRAL

Dolor 2001 {published data only}

Dolor RJ, Witsell DL, Hellkamp AS, Williams JW, Califf RM, Simel DL. Comparison of cefuroxime with or without intranasal fluticasone for the treatment of rhinosinusitis. The CAFFS Trial: a randomized controlled trial. JAMA 2001;286:3097‐105. CENTRAL

Meltzer 2005 {published data only}

Meltzer EO, Bachert C, Staudinger H. Treating acute rhinosinusitis: comparing efficacy and safety of mometasone furoate nasal spray, amoxicillin and placebo. Journal of Allergy and Clinical Immunology 2005;116(6):1289‐95. CENTRAL

Nayak 2002 {published data only}

Nayak AS, Settipane GA, Pedinoff A, Charous BL, Meltzer EO, Busse WW, et al. Effective dose range of mometasone furoate nasal spray in the treatment of acute rhinosinusitis. Annals of Allergy, Asthma & Immunology 2002;89:271‐8. CENTRAL

References to studies excluded from this review

Bachert 2007 {published data only}

Bachert C, Meltzer EO. Effect of mometasone furoate nasal spray on quality of life of patients with acute rhinosinusitis. Rhinology 2007;45(3):190‐6. CENTRAL

Gehanno 2000 {published data only}

Gehanno P, Beauvillain C, Bobin S, Chobaut JC, Desaulty A, Dubreuil C, et al. Short therapy with amoxicillin‐clavulanate and corticosteroids in acute sinusitis: results of a multicentre study in adults. Scandinavian Journal of Infectious Diseases 2000;32:679‐84. CENTRAL

Jurkiewicz 2004 {published data only}

Jurkiewicz D, Zielnik‐Jurkiewicz B. Intranasal corticosteroid in the treatment of acute sinusitis. 5th European Congress of Oto‐Rhino‐Laryngology Head and Neck Surgery (EUFOS). 2004. CENTRAL

Meltzer 1993 {published data only}

Meltzer EO, Orgel HA, Backhaus JW, Busse WW, Druce HM, Metzger J, et al. Intranasal flunisolide spray as an adjunct to oral antibiotic therapy for sinusitis. Journal of Allergy and Clinical Immunology 1993;92:812‐23. CENTRAL

Meltzer 2000 {published data only}

Meltzer EO, Charous BL, Busse WW, Zinreich SJ, Lorber RR, Danzig MR, et al. Added relief in the treatment of acute recurrent sinusitis with adjunctive mometasone furoate nasal spray. Journal of Allergy and Clinical Immunology 2000;106:630‐7. CENTRAL

Quarnberg 1992 {published data only}

Quarnberg Y, Kantola O, Salo J, Toivanen M, Valtonen H, Vuori E. Influence of topical steroid treatment on maxillary sinusitis. Rhinology 1992;30:103‐12. CENTRAL

Tutkun 1996 {published data only}

Tutkun A, Inanli S, Batman C, Uneri C, Sehitoglu MA. The impact of intranasal steroid as an adjunct to therapy for sinusitis. Marmara Medical Journal 1996;9(1):11‐4. CENTRAL

Williamson 2007 {published data only}

Williamson IG, Rumsby K, Benge S, Moore M, Smith PW, Cross M, et al. Antibiotics and topical nasal steroid for treatment of acute maxillary sinusitis. JAMA 2007;298(21):2487‐96. CENTRAL

Yilmaz 2000 {published data only}

Yilmaz G, Varan B, Yilmaz T, Gurakan B. Intranasal budesonide spray as an adjunct to oral antibiotic therapy for acute sinusitis in children. European Archives of Oto‐rhino‐laryngology 2000;257(5):256‐9. CENTRAL

Ahovuo‐Saloranta 2011

Ahovuo‐Saloranta A, Rautakorpi UM, Borisenko OV, Liira H, Williams Jr JW, Makela M. Antibiotics for acute maxillary sinusitis. Cochrane Database of Systematic Reviews 2011, Issue 3. [DOI: 10.1002/14651858.CD000243.pub2]

Allen 2000

Allen DB. Do intranasal corticosteroids affect childhood growth?. Allergy 2000;55(Suppl 62):15‐8.

Becker 2003

Becker DG. Medical treatment of sinusitis. Journal of Long‐term Effects of Medical Implants 2003;13(3):195‐205.

Benninger 1997

Benninger MS, Anon J, Mabry RL. The medical management of rhinosinusitis. Otolaryngology ‐ Head and Neck Surgery 1997;117(3 Pt 2):S41‐9.

Brannan 1997

Brannan MD, Herron JM, Affrime MB. Safety and tolerability of once‐daily mometasone furoate aqueous nasal spray in children. Clinical Therapeutics 1997;19:1330‐9.

Cable 2000

Cable BB, Wassmuth Z, Mann EA, Hommer D, Connely G, Klem C, et al. The effect of corticosteroids in the treatment of experimental sinusitis. American Journal of Rhinology 2000;14(4):217‐22.

Contopoulos 2003

Contopoulos‐Ioannidis DG, Ioannidis JP, Lau J. Acute sinusitis in children: current treatment strategies. Paediatric Drugs 2003;5(2):71‐80.

Corren 1999

Corren J. Intranasal corticosteroids for allergic rhinitis: how do different agents compare?. Journal of Allergy and Clinical Immunology 1999;104(4 Pt 1):S144‐9.

Davies 1997

Davies RJ, Nelson HS. Once‐daily mometasone furoate nasal spray: efficacy and safety of a new intranasal glucocorticoid for allergic rhinitis. Clinical Therapeutics 1997;19:27‐38.

Druce 1990

Druce HM. Adjuncts to medical management of sinusitis. Otolaryngology ‐ Head and Neck Surgery 1990;103:880‐3.

Druce 1991

Druce HM, Slavin RG. Sinusitis: critical need for further study. Journal of Allergy and Clinical Immunology 1991;88:675‐7.

Galant 2001

Galant SP, Wilkinson R. Clinical prescribing of allergic rhinitis medication in the preschool and young school‐age child: what are the options?. BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy 2001;15(7):453‐63.

Gawchik 2000

Gawchik SM, Saccar CL. A risk‐benefit assessment of intranasal triamcinolone acetonide in allergic rhinitis. Drug Safety 2000;23(4):309‐22.

Gwaltney 1994

Gwaltney JM, Phillips CD, Miller RD, Riker DK. Computed tomographic study of the common cold. New England Journal of Medicine 1994;330(1):25‐30.

Gwaltney 1995

Gwaltney JM, Jones JG, Kennedy DW. Medical management of sinusitis: educational goals and management guidelines: the International Conference on Sinus Disease. Annals of Otology, Rhinology and Laryngology Supplement 1995;167:22‐30.

Higgins 2011

Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from www.cochrane‐handbook.org. Chichester, UK: Wiley‐Blackwell.

Juniper 1990

Juniper EF, Guyatt GH, O'Byrne PM, Viveiros M. Aqueous beclomethasone dipropionate nasal spray: regular versus "as required" use in the treatment of seasonal allergic rhinitis. Journal of Allergy and Clinical Immunology 1990;86:380‐6.

Kaliner 1997

Kaliner MA, Osguthorpe JD, Fireman P, Anon J, Georgitis J, Davis ML, et al. Sinusitis: bench to bedside. Current findings, future directions. Journal of Allergy and Clinical Immunology 1997;99(Suppl):829‐48.

Lefebvre 2011

Lefebvre C, Manheimer E, Glanville J. Chapter 6: Searching for studies. In: Higgins JPT, Green S editor(s). Cochrane Handbook for Systematic Reviews of Interventions. Version 5.1.0 [updated March 2011]. The Cochrane Collaboration. Available from www.cochrane‐handbook.org. Chichester: Wiley‐Blackwell, 2011.

Little 2000

Little DR, Mann BL, Godbout CJ. How family physicians distinguish acute sinusitis from upper respiratory tract infections: a retrospective analysis. Journal of the American Board of Family Practice 2000;13(2):101‐6.

Mucha 2003

Mucha SM, Baroody FM. Sinusitis update. Current Opinion in Allergy and Clinical Immunology 2003;3(1):33‐8.

Mygind 1976

Mygind N, Prytz S, Sorensen H, Pedersen CB. Long term treatment of nasal polyps with beclomethasone dipropionate aerosol. Treatment and rationale. Acta Otolaryngologica (Stockholm) 1976;82:252‐5.

Mygind 2001

Mygind N, Nielsen LP, Hoffmann HJ, Shukla A, Blumberga G, Dahl R, et al. Mode of action of intranasal corticosteroids. Journal of Allergy and Clinical Immunology 2001;108(Suppl 1):16‐25.

Piccirillo 2001

Piccirillo JF, Mager D, Frisse M, Brophy RH, Goggin A. Impact of first‐line vs. second‐line antibiotics for the treatment of acute uncomplicated sinusitis. JAMA 2001;286(15):1849‐56.

RevMan 2012 [Computer program]

The Nordic Cochrane Centre, The Cochrane Collaboration. Review Manager (RevMan). Version 5.2. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2012.

Sahay 1980

Sahay JN, Ibrahim NBN, Chatterjee SS, Nassar WY, Lodge KV, Jones CW. Long term study of flunisolide treatment in perennial rhinitis with special reference to nasal mucosal histology and morphology. Clinical Allergy 1980;10:451‐7.

Scadding 2000

Scadding GK. Other anti‐inflammatory uses of intranasal corticosteroids in upper respiratory inflammatory diseases. Allergy 2000;55(Suppl 62):19‐23.

Schenkel 2000

Schenkel EJ, Skoner DP, Bronsky EA, Miller SD, Pearlman DS, Rooklin A. Absence of growth retardation in children with perennial allergic rhinitis after one year of treatment with mometasone furoate aqueous nasal spray. Pediatrics 2000;105:E22.

Seigel 1988

Seigel SC. Topical intranasal corticosteroid therapy in rhinitis. Journal of Allergy and Clinical Immunology 1988;81:984‐91.

Shaikh 2012

Shaikh N, Wald ER, Pi M. Decongestants, antihistamines and nasal irrigation for acute sinusitis in children. Cochrane Database of Systematic Reviews 2012, Issue 9. [DOI: 10.1002/14651858.CD007909.pub3]

Shapiro 1992

Shapiro GG, Rachelefski GS. Introduction and definition of sinusitis. Journal of Allergy and Clinical Immunology 1992;90:417‐8.

Shrum 2001

Shrum KM, Grogg SE, Barton P, Shaw HH, Dyer RR. Sinusitis in children: the importance of diagnosis and treatment. Journal of the American Osteopathic Association 2001;101(Suppl 5):8‐13.

Slavin 2005

Slavin RG, Spector SL, Bernstein IL, Kaliner MA, Kennedy DW, Virant FS, et al. The diagnosis and management of sinusitis: a practice parameter update. Journal of Allergy and Clinical Immunology 2005;116(Suppl 6):13‐47.

Snow 2001

Snow V, Mottur‐Pilson C, Hickner JM. Principles of appropriate antibiotic use for acute sinusitis in adults. Annals of International Medicine 2001;134(6):495‐7.

Spector 1998

Spector SL, Bernstein IL, Li JT, Berger WE, Kaliner MA, Schuller DE, et al. Parameters for the diagnosis and management of sinusitis. Journal of Allergy and Clinical Immunology 1998;102(Suppl):107‐44.

Venekamp 2011

Venekamp RP, Thompson MJ, Hayward G, Heneghan CJ, Del Mar CB, Perera R, et al. Systemic corticosteroids for acute sinusitis. Cochrane Database of Systematic Reviews 2011, Issue 12. [DOI: 10.1002/14651858.CD008115.pub2]

Wald 1988

Wald ER. Sinusitis in children. Pediatric Infectious Disease Journal 1988;7(Suppl 11):150‐3.

Williams 1993

Williams JW, Simel DL. Practice variation for managing acute sinusitis. Clinical Research 1993;41:566A.

Winstead 2003

Winstead W. Rhinosinusitis. Primary Care 2003;30(1):137‐54.

Winther 1990

Winther B, Gwaltney JM. Therapeutic approach to sinusitis: antiinfectious therapy as the baseline of management. Otolaryngology ‐ Head and Neck Surgery 1990;103(5 (Pt 2)):876‐9.

Zeiger 1992

Zeiger RS. Prospects for ancillary treatment of sinusitis in the 1990s. Journal of Allergy and Clinical Immunology 1992;90:478‐95.

References to other published versions of this review

Zalmanovici 2007

Zalmanovici A, Yaphe J. Steroids for acute sinusitis. Cochrane Database of Systematic Reviews 2007, Issue 2. [DOI: 10.1002/14651858.CD005149.pub2]

Zalmanovici 2009

Zalmanovici A, Yaphe J. Intranasal steroids for acute sinusitis. Cochrane Database of Systematic Reviews 2009, Issue 4. [DOI: 10.1002/14651858.CD005149.pub3]

Zalmanovici Trestioreanu 2011

Zalmanovici Trestioreanu A, Yaphe J. Intranasal steroids for acute sinusitis. Cochrane Database of Systematic Reviews 2011, Issue 8. [DOI: 10.1002/14651858.CD005149.pub3]

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Jump to:

Barlan 1997

Methods

Randomised: method of randomisation not mentioned
Allocation concealment not mentioned
Double‐blind: yes
Intention‐to‐treat not mentioned
Follow‐up described
151 recruited; 89 (59%) completed study; 41% drop‐out
Design: parallel

Participants

N = 89; 42 male, 47 female
Age 1 to 15 years
Inclusion criteria: 2 of 3 major criteria ‐ purulent nasal discharge, cough, purulent pharyngeal drainage or 1 major and 2 minor criteria: facial pain, periorbital oedema, earache, tooth pain, sore throat, headache, increased wheeze, fever, foul breath for more than 7 days and Rx criteria
Water radiographs at the beginning of study positive if complete opacification or maxillary mucoperiosteal thickening more than 4 mm. 79 participants had positive Rx
Exclusion criteria: history of allergic rhinitis, asthma, recurrent/chronic sinusitis
Baseline characteristics: similar in both groups, no significant differences
Patients maintained daily symptom cards and were examined by the same physician each week. Symptom scores were evaluated by a scale from 0 to 3

Interventions

Tx group: budesonide 50 µg bid nasal spray to each nostril, N = 43
C group: placebo nasal spray bid, N = 46
All participants in both groups received amoxicillin‐clavulanate potassium 40 mg/kg/day tid
Duration: 3 weeks

Outcomes

Difference in weekly symptom scores for cough and nasal discharge in the first, second and third week of the study in both groups, as difference between groups or change from baseline
Relapse: results were reported as medians of scores using non‐parametric tests because a wide range of scores without normal distribution

Notes

Marmara University Hospital Outpatient Clinic patients enrolled from November 1993 to October 1994
Informed consent signed by all parents. 151 patients enrolled, 89 completed study, 62 dropped out, no separate data for both groups
Reasons for drop‐outs: non‐compliance with weekly visits or not recording daily symptoms

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Randomised, method not mentioned

Allocation concealment (selection bias)

Unclear risk

Not mentioned

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

No separate data for groups, ITT not mentioned

Selective reporting (reporting bias)

Low risk

No evidence of reporting bias

Other bias

Unclear risk

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Double‐blind

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Dolor 2001

Methods

Multicentre randomisation ‐ permuted blocks scheme stratified by site with a block size of 4 generated using SAS version 6.12
Allocation concealment ‐ study kits administered sequentially by blinding site personnel to block size
Blinding: yes
Intention‐to‐treat: yes
Follow‐up described: yes
88 (93%) completed study
Design: parallel

Participants

N = 95; 30 men, 65 women
Age 30 to 50; median age 39 years
Inclusion criteria: older than 18 years, history of recurrent sinusitis or chronic rhinitis and clinical evidence of acute sinusitis confirmed Rx or by nasal endoscopy
Diagnosis of acute sinusitis: clinical criteria ‐ participants with 2 of the 5 following symptoms present were enrolled: headache, facial pain, nasal congestion, thick coloured nasal discharge, olfactory disturbance
Rx criteria: air‐fluid level, mucosal thickening or opacification of sinus
Exclusion criteria: previous sinus surgery, sinus lavage in the past 7 days, nasal polyposis, recurrent epistaxis, chronic bacterial sinusitis with failure of antibiotic therapy, INCS use within past 14 days, chronic use of corticosteroids or immunosuppressives, immunocompromised, allergy to penicillin/cephalosporins, participants without a telephone, pregnant, nursing women
Baseline characteristics ‐ similar in both groups, no significant differences
Participants assessed at baseline, 10, 21, 56 days by diary records and telephone follow‐up

Interventions

Tx group: nasal spray fluticasone propionate 2 puffs (total dose 200 µg) once daily in each nostril; N = 47
C group: nasal spray placebo 2 puffs once daily in each nostril; N = 48
All participants in both groups received 2 puffs xylometazoline hydrochloride in each nostril twice daily 10 minutes before the study nasal spray and 250 mg cefuroxime axetil twice daily for 10 days
Duration of study: 21 days
Follow‐up: 8 weeks
Allowed to continue: NSAIDs, analgesics, immunotherapy for allergies, orally inhaled corticosteroids
Not permitted during study: oral decongestants, mucolytics, corticosteroids oral or parenteral, antihistamines, immunosuppressives
Sinus lavage or sinus surgery was discouraged during the first 3 weeks of the trial, antibiotic use in the past 7 days or 21 days if longer half‐life was not permitted
Compliance with Tx: assessed by a standardised form given to patients for recording daily symptoms, Tx, adverse events, work attendance. 94% completed study Tx without difference between groups

Outcomes

Proportion of patients with clinical success (cured or much improved) at 10, 21, 56 days on telephone follow‐up
Time to clinical success differences over time in sinusitis and quality of life scores
Level of work performance
Total number of hours lost from work
Recurrences

Notes

Study conducted between October 1998 to April 2000 at 22 sites (12 primary care and 10 otolaryngology)
Equal proportions of participants from primary care and otolaryngology practices in both treatment arms
All study sites received standardised instructions for conducting the study
Study progress monitored by a research associate
Patients assessed symptoms on numeric scales and received booklets with specific instructions for use of nasal spray
High agreement between patient‐recorded and interviewer‐obtained symptoms
Drop‐outs:
Tx group: 1 ‐ rash, 1 ‐ unknown, 1 ‐ lost to follow‐up
44 completed 21‐day Tx and telephone follow‐up, 36 completed diary, 46 included in primary analysis
C group: 1 ‐ withdrew, 2 ‐ switched to different antibiotics
45 completed 21‐day Tx, 44 completed telephone follow‐up, 32 completed diary, 46 included in primary analysis

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

See methods

Allocation concealment (selection bias)

Low risk

See methods

Incomplete outcome data (attrition bias)
All outcomes

Low risk

See methods

Selective reporting (reporting bias)

Low risk

No evidence of selective reporting

Other bias

Low risk

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

See methods

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Meltzer 2005

Methods

Multicentre randomisation
1:1:1:1 ratio to 1 of 4 arms by computer‐generated code
Allocation concealment: not mentioned
Double‐blind: yes
Intention‐to‐treat: yes
Follow‐up described
10% drop‐out in Tx phase, 95% completed follow‐up phase
Design: parallel

Participants

N = 981; 338 men, 643 women
Age 12 to 76 years
Inclusion criteria: age more than 12 years with clinical criteria for acute sinusitis; MSS more than 5 but less than 12 at baseline, assessed by participant and investigator and no more than 3/5 symptoms rated severe (rhinorrhoea, PND nasal congestion, stuffiness, sinus headache and facial pain on pressure) adding cough to the TSS
Exclusion criteria: fulminant bacterial rhinosinusitis, chronic rhinosinusitis, nasal/sinus surgery within the last 6 months for this condition, otitis, atrophic rhinitis, nasal polyps, symptomatic seasonal allergic rhinitis, allergy to corticosteroids
Asthmatic participants needed to be stable last 30 days and FEV1 more than 65% last 3 months before screening
Rhinoscopic examination was performed at all visits
Participants were assessed at baseline days 8, 15, 29 and monitored by telephone on days 3 to 4. Response to Tx evaluated by participant and investigator as scores for symptoms on a scale from 0 to 3
Baseline characteristics similar for all the arms

Interventions

4 groups
Tx groups:
1. MFNS 200 µg once daily nasal spray + placebo nasal spray once daily + placebo capsules tid; N = 243
2. MFNS 200 µg nasal spray bid + placebo capsules tid; N = 235
3. amoxicillin 500 mg tid for 10 days + placebo nasal spray bid; N = 251
C group: placebo nasal spray bid + placebo capsules tid; N = 252
Duration of study: 15 days
Capsules given for 10 days
Follow‐up: 14 days
Not allowed during study: nasal saline, nasal cromolyn sodium, ipratropium bromide, corticosteroids (excluding oral inhaled corticosteroids for mild/moderate asthma), antihistamines, decongestants, leukotriene pathway modificants, analgesics, NSAID
Compliance assessed at days 8 and 15 by questioning whether drug had been taken
Each participant received at least 1 dose of study drug

Outcomes

Mean MSS
Mean TSS
Individual scores
Time to onset of action
Global response to Tx
Adverse events
Disease recurrence
Tx failure (worsening or not improvement in symptoms during the Tx phase)

Notes

Study conducted at 71 medical centres in 14 countries from January to September 2003
Drop‐outs: during the Tx phase in the 200 µg, 400 µg MFNS, amoxicillin, placebo were 9%, 9%, 8%, 13%
Reasons for discontinuation: adverse events, Tx failure, loss to follow‐up, did not wish to continue, non‐compliance with protocol, did not meet protocol criteria for entry

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

See methods

Allocation concealment (selection bias)

Unclear risk

See methods

Incomplete outcome data (attrition bias)
All outcomes

Low risk

See methods

Selective reporting (reporting bias)

Low risk

Other bias

Unclear risk

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

See methods

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Nayak 2002

Methods

Multicentre, randomised; method of randomisation not mentioned
Allocation concealment not mentioned
Double‐blind: yes
Follow‐up described: yes
864 (89%) participants included in the primary efficacy analysis
Design: parallel

Participants

N = 967; 402 men, 565 women
Age 8 to 78 years
Inclusion criteria: acute episode of rhinosinusitis, at least 1 moderate/severe nasal symptom (these may include purulent rhinorrhoea, stuffiness/congestion, post‐nasal drip, sinus headache, facial pain, cough), purulent rhinorrhoea present, sinusitis confirmed by a CT scan, which is read by a radiologist at each study site at baseline, a total symptom score more than 6
Exclusion criteria: nasal polyps, cystic fibrosis, Kartagener syndrome, expected immediate sinus or nasal surgery, glaucoma, history of subcapsular cataracts, clinical significant diseases
Symptoms evaluated at baseline (day 1) and day 21 by patient and investigator by scales. Patients evaluated at baseline, 15, 21 days
CT scans of paranasal sinuses at baseline and 21 days evaluated by an independent blinded radiologist
Similar baseline characteristics and baseline symptoms scores in all 3 groups
Patients recorded symptom scores, adverse events and use of medication twice daily

Interventions

3 groups
Tx groups:
1 MFNS 400 µg nasal spray twice daily; N = 324
2 MFNS 200 µg nasal spray twice daily; N = 318
C group:
Matching placebo nasal spray twice daily; N = 325
All participants in all groups received amoxicillin‐clavulanate potassium 875 mg twice daily for 21 days
Not allowed during study: any form of corticosteroid, nasal decongestants, antihistamines
Washout period before the baseline visit for previous use of antibiotics, intranasal or systemic corticosteroids, decongestants
Adherence to therapy assessed by weighing the nasal spray dosing containers without patients' knowledge

Outcomes

Improvement in total symptoms score
Improvement in individual symptom score
Overall response to treatment: proportion of participants with complete or marked relief
Onset of relief
Evaluation of changes in CT scans of sinuses
Adverse events

Notes

Outpatients from 61 Tx centres in the US
967 participants randomised, 103 participants (11%) not included in analysis because CT did not confirm sinusitis and excluded post‐randomisation, diary data not available, less than 80% compliance with Tx, less than 7 days Tx (32, 36, 35 in the MFNS 400, 200 µg and placebo groups)
Reasons for exclusion or discontinuation were evenly distributed among the groups
Physician evaluation of symptoms at day 21 was consistent with patient‐recorded evaluation

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

See methods

Allocation concealment (selection bias)

Unclear risk

See methods

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

See notes

Selective reporting (reporting bias)

Unclear risk

Other bias

Unclear risk

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

See methods

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

bid: twice daily
C: control
CT: computed tomography
FEV1: forced expiratory volume in one second
INCS: intranasal corticosteroid
ITT: intention‐to‐treat
MFNS: mometasone furoate
MSS: major symptom score
NSAID: non‐steroidal anti‐inflammatory drugs
PND: post‐nasal drip
Rx: radiological
tid: three times daily
TSS: total symptom score
Tx: treatment

Characteristics of excluded studies [ordered by study ID]

Jump to:

Study

Reason for exclusion

Bachert 2007

Study on quality of life. Outcome for a subset of patients from one of the included studies (Meltzer 2005)

Gehanno 2000

Allocation: randomised, parallel
Participants: N = 433 adults with confirmed acute sinusitis
Intervention: amoxicillin‐clavulanate and methylprednisolone or placebo per oral administration
No intranasal steroids used

Jurkiewicz 2004

Abstract and full paper not available

Meltzer 1993

Allocation: randomised, parallel
Participants: N = 175 participants 14 years or older with confirmed acute or chronic sinusitis
Intervention: amoxicillin‐clavulanate potassium combined with nasal spray of either flunisolide or placebo
No separate arms for acute and chronic sinusitis reported

Meltzer 2000

Missing data ‐ number randomised, numbers included in analyses, drop‐outs and reasons for drop‐out. The numbers reported do not add up to 100%. An email was sent to the author but there was no reply

Quarnberg 1992

Allocation: randomised, parallel
Participants: N = 40 participants 16 years or older with confirmed recurrent or chronic sinusitis
Intervention: erythromycin and either budesonide or placebo aerosol
Separate arms for acute recurrent and chronic sinusitis were not reported

Tutkun 1996

Missing data ‐ not mentioned acute/chronic sinusitis, diagnostic criteria not reported, drop‐outs not reported. Email was sent to the author but there was no reply

Williamson 2007

Inclusion criteria for the review were not met

Yilmaz 2000

Allocation: randomised, parallel
Participants: 52 children with confirmed acute sinusitis
Intervention: cefaclor and either oral pseudoephedrine or intranasal budesonide
No placebo used in the control group

Data and analyses

Open in table viewer
Comparison 1. Intranasal corticosteroids versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Proportion of participants with resolution of symptoms or improved (MFNS 400 µg daily) Show forest plot

2

1130

Risk Ratio (M‐H, Fixed, 95% CI)

1.10 [1.02, 1.18]

Analysis 1.1

Comparison 1 Intranasal corticosteroids versus placebo, Outcome 1 Proportion of participants with resolution of symptoms or improved (MFNS 400 µg daily).

Comparison 1 Intranasal corticosteroids versus placebo, Outcome 1 Proportion of participants with resolution of symptoms or improved (MFNS 400 µg daily).

2 Proportion of participants with resolution of symptoms or improved (MFNS 200 µg daily) Show forest plot

2

590

Risk Ratio (M‐H, Fixed, 95% CI)

1.04 [0.98, 1.11]

Analysis 1.2

Comparison 1 Intranasal corticosteroids versus placebo, Outcome 2 Proportion of participants with resolution of symptoms or improved (MFNS 200 µg daily).

Comparison 1 Intranasal corticosteroids versus placebo, Outcome 2 Proportion of participants with resolution of symptoms or improved (MFNS 200 µg daily).

3 Proportion of participants with resolution of symptoms or improved (combined MFNS 200, 400 and 800 µg daily) Show forest plot

3

1792

Risk Ratio (M‐H, Fixed, 95% CI)

1.11 [1.04, 1.18]

Analysis 1.3

Comparison 1 Intranasal corticosteroids versus placebo, Outcome 3 Proportion of participants with resolution of symptoms or improved (combined MFNS 200, 400 and 800 µg daily).

Comparison 1 Intranasal corticosteroids versus placebo, Outcome 3 Proportion of participants with resolution of symptoms or improved (combined MFNS 200, 400 and 800 µg daily).

4 Number of participants that dropped out from the study (MFNS 400 µg daily) Show forest plot

2

1130

Risk Ratio (M‐H, Fixed, 95% CI)

0.86 [0.61, 1.20]

Analysis 1.4

Comparison 1 Intranasal corticosteroids versus placebo, Outcome 4 Number of participants that dropped out from the study (MFNS 400 µg daily).

Comparison 1 Intranasal corticosteroids versus placebo, Outcome 4 Number of participants that dropped out from the study (MFNS 400 µg daily).

5 Number of participants that dropped out from the study (MFNS 200 µg daily) Show forest plot

2

590

Risk Ratio (M‐H, Fixed, 95% CI)

0.75 [0.46, 1.21]

Analysis 1.5

Comparison 1 Intranasal corticosteroids versus placebo, Outcome 5 Number of participants that dropped out from the study (MFNS 200 µg daily).

Comparison 1 Intranasal corticosteroids versus placebo, Outcome 5 Number of participants that dropped out from the study (MFNS 200 µg daily).

6 Number of participants that dropped out from the study (combined MFNS 200, 400 and 800 µg daily) Show forest plot

3

1792

Risk Ratio (M‐H, Fixed, 95% CI)

0.85 [0.64, 1.12]

Analysis 1.6

Comparison 1 Intranasal corticosteroids versus placebo, Outcome 6 Number of participants that dropped out from the study (combined MFNS 200, 400 and 800 µg daily).

Comparison 1 Intranasal corticosteroids versus placebo, Outcome 6 Number of participants that dropped out from the study (combined MFNS 200, 400 and 800 µg daily).

7 Relapse (combined 200 and 400 µg daily) Show forest plot

2

825

Risk Ratio (M‐H, Fixed, 95% CI)

0.71 [0.44, 1.15]

Analysis 1.7

Comparison 1 Intranasal corticosteroids versus placebo, Outcome 7 Relapse (combined 200 and 400 µg daily).

Comparison 1 Intranasal corticosteroids versus placebo, Outcome 7 Relapse (combined 200 and 400 µg daily).

'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figures and Tables -
Figure 1

'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
Figures and Tables -
Figure 2

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.

Comparison 1 Intranasal corticosteroids versus placebo, Outcome 1 Proportion of participants with resolution of symptoms or improved (MFNS 400 µg daily).
Figures and Tables -
Analysis 1.1

Comparison 1 Intranasal corticosteroids versus placebo, Outcome 1 Proportion of participants with resolution of symptoms or improved (MFNS 400 µg daily).

Comparison 1 Intranasal corticosteroids versus placebo, Outcome 2 Proportion of participants with resolution of symptoms or improved (MFNS 200 µg daily).
Figures and Tables -
Analysis 1.2

Comparison 1 Intranasal corticosteroids versus placebo, Outcome 2 Proportion of participants with resolution of symptoms or improved (MFNS 200 µg daily).

Comparison 1 Intranasal corticosteroids versus placebo, Outcome 3 Proportion of participants with resolution of symptoms or improved (combined MFNS 200, 400 and 800 µg daily).
Figures and Tables -
Analysis 1.3

Comparison 1 Intranasal corticosteroids versus placebo, Outcome 3 Proportion of participants with resolution of symptoms or improved (combined MFNS 200, 400 and 800 µg daily).

Comparison 1 Intranasal corticosteroids versus placebo, Outcome 4 Number of participants that dropped out from the study (MFNS 400 µg daily).
Figures and Tables -
Analysis 1.4

Comparison 1 Intranasal corticosteroids versus placebo, Outcome 4 Number of participants that dropped out from the study (MFNS 400 µg daily).

Comparison 1 Intranasal corticosteroids versus placebo, Outcome 5 Number of participants that dropped out from the study (MFNS 200 µg daily).
Figures and Tables -
Analysis 1.5

Comparison 1 Intranasal corticosteroids versus placebo, Outcome 5 Number of participants that dropped out from the study (MFNS 200 µg daily).

Comparison 1 Intranasal corticosteroids versus placebo, Outcome 6 Number of participants that dropped out from the study (combined MFNS 200, 400 and 800 µg daily).
Figures and Tables -
Analysis 1.6

Comparison 1 Intranasal corticosteroids versus placebo, Outcome 6 Number of participants that dropped out from the study (combined MFNS 200, 400 and 800 µg daily).

Comparison 1 Intranasal corticosteroids versus placebo, Outcome 7 Relapse (combined 200 and 400 µg daily).
Figures and Tables -
Analysis 1.7

Comparison 1 Intranasal corticosteroids versus placebo, Outcome 7 Relapse (combined 200 and 400 µg daily).

Table 1. Adverse events

Study

Intervention

Side effects

Comments

Dolor 2001

Fluticasone propionate 2 puffs ‐ total dose 200 µg or placebo nasal spray once daily in addition to 250 mg cefuroxime axetil orally twice daily and 2 puffs of xylometazoline hydrochloride twice daily

Headache, bloody nose, vaginal itching, yeast infection, nausea, stomach irritation, diarrhoea, increased congestion, hay fever, light‐headed, sore throat, thirsty, itching, rash, cough, fatigue, metallic taste, felt dried out, nasal tissue felt inflamed

No serious unexpected adverse events reported

Any adverse event ‐ 37% in the fluticasone group versus 20% in the placebo group (P value = 0.7) no statistical significant difference

Adverse events could be attributed also to the co‐treatment

Nayak 2002

Amoxicillin‐clavulanate potassium 875 mg
twice daily orally and MFNS 200, 400 µg or placebo nasal spray twice daily

Epistaxis was the most frequently reported adverse event
Nasal burning, irritation and headache occurred in less than 2% of any treatment group

Treatment well‐tolerated, adverse events similar for all 3 arms of mild/moderate intensity: 12%, 15%, 15% in the MFNS 400, 800 µg and placebo arms

50 patients discontinued treatment because of adverse events, most commonly diarrhoea and nausea due to the antibiotic and were equally distributed among groups. Epistaxis, nasal burning, irritation or infection were not a cause for discontinuation of treatment

Barlan 1997

Budesonide 50 µg or placebo nasal spray to each nostril bid in addition to amoxicillin clavulanate potassium 40 mg/kg/day tid

Rash after 1 week attributed to the antibiotic in 1 subject that was switched to cefaclor

No specific adverse events related to the INCS use were reported

Meltzer 2005

MFNS 200 µg once daily or twice daily nasal spray
Amoxicillin 500 mg tid
Placebo nasal spray and capsules

Headache and epistaxis were most common reported

Most adverse events were mild or moderate with a similar incidence among treatment groups: 36.2%,
35.4%, 33.5% and 38.1% with MFNS 200 µg, 400 µg,
amoxicillin and placebo
1%, 3%, 2% and 2% of participants discontinued treatment because of adverse events in the 200 µg, 400 µg INCS, antibiotic and placebo arms

bid: twice daily
INCS: intranasal corticosteroid
MFNS: mometasone furoate
tid: three times daily

Figures and Tables -
Table 1. Adverse events
Comparison 1. Intranasal corticosteroids versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Proportion of participants with resolution of symptoms or improved (MFNS 400 µg daily) Show forest plot

2

1130

Risk Ratio (M‐H, Fixed, 95% CI)

1.10 [1.02, 1.18]

2 Proportion of participants with resolution of symptoms or improved (MFNS 200 µg daily) Show forest plot

2

590

Risk Ratio (M‐H, Fixed, 95% CI)

1.04 [0.98, 1.11]

3 Proportion of participants with resolution of symptoms or improved (combined MFNS 200, 400 and 800 µg daily) Show forest plot

3

1792

Risk Ratio (M‐H, Fixed, 95% CI)

1.11 [1.04, 1.18]

4 Number of participants that dropped out from the study (MFNS 400 µg daily) Show forest plot

2

1130

Risk Ratio (M‐H, Fixed, 95% CI)

0.86 [0.61, 1.20]

5 Number of participants that dropped out from the study (MFNS 200 µg daily) Show forest plot

2

590

Risk Ratio (M‐H, Fixed, 95% CI)

0.75 [0.46, 1.21]

6 Number of participants that dropped out from the study (combined MFNS 200, 400 and 800 µg daily) Show forest plot

3

1792

Risk Ratio (M‐H, Fixed, 95% CI)

0.85 [0.64, 1.12]

7 Relapse (combined 200 and 400 µg daily) Show forest plot

2

825

Risk Ratio (M‐H, Fixed, 95% CI)

0.71 [0.44, 1.15]

Figures and Tables -
Comparison 1. Intranasal corticosteroids versus placebo