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Kurzfristige‐orale Steroide als Zusatztherapie bei chronischer Rhinosinusitis

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Referencias

References to studies included in this review

Bülbül 2013 {published data only}

Bülbül T, Bülbül OG, Güçlü O, Bilsel AS, Gürsan SÖ. Effect of glucocorticoids on nasal polyposis, with detection of inflammatory response by measurement of nitric oxide levels in nasal polyp tissue. Journal of Laryngology and Otology 2013;27(6):584‐9. [DOI: 10.1017/S002221511300073X]

Ozturk 2011 {published data only}

Ozturk F, Bakirtas A, Ileri F, Turktas I. Efficacy and tolerability of systemic methylprednisolone in children and adolescents with chronic rhinosinusitis: a double‐blind, placebo‐controlled randomized trial. Journal of Allergy and Clinical Immunology 2011;128(2):348‐52.

References to studies excluded from this review

Alobid 2005 {published data only}

Alobid I, Benítez P, Bernal‐Sprekelsen M, Roca J, Alonso J, Picado C, et al. Nasal polyposis and its impact on quality of life: comparison between the effects of medical and surgical treatments. Allergy 2005;60(4):452‐8.

Alobid 2006 {published data only}

Alobid I, Benitez P, Pujols L, Maldonado M, Bernal‐Sprekelsen M, Morello A, et al. Severe nasal polyposis and its impact on quality of life. The effect of a short course of oral steroids followed by long‐term intranasal steroid treatment. Rhinology 2006;44(1):8‐13.

Alobid 2012 {published data only}

Alobid I, Benitez P, Valero A, Munoz R, Langdon C, Mullol J. Oral and intranasal steroid treatments improve nasal patency and paradoxically increase nasal nitric oxide in patients with severe nasal polyposis. Rhinology 2012;2:171‐7.

Alobid 2014 {published data only}

Alobid I, Benítez P, Cardelús S, de Borja Callejas F, Lehrer‐Coriat E, Pujols L, et al. Oral plus nasal corticosteroids improve smell, nasal congestion, and inflammation in sino‐nasal polyposis. Laryngoscope 2014;124(1):50‐6.

Benitez 2006 {published data only}

Benitez P, Alobid I, Haro J, Berenguer J, Bernal‐Sprekelsen, Pujols L, et al. A short course of oral prednisone followed by intranasal budesonide is an effective treatment of severe nasal polyps. Laryngoscope 2006;116(5):770‐5.

Blomqvist 2001 {published data only}

Blomqvist EH, Lundblad L, Anggard A, Haraldsson P‐O, Stjarne P. A randomized controlled study evaluating medical treatment versus surgical treatment in addition to medical treatment of nasal polyposis. Journal of Allergy and Clinical Immunology 2001;107(2):224‐8.

Blomqvist 2009 {published data only}

Blomqvist EH, Lundblad L, Bergstedt H, Stjarne P. A randomized prospective study comparing medical and medical‐surgical treatment of nasal polyposis by CT. Acta Oto‐Laryngologica 2009;129(5):545‐9.

Bonfils 1998 {published data only}

Bonfils P. Medical treatment of paranasal sinus polyposis: a prospective study in 181 patients [Le traitement medical de la polypose naso‐sinusienne: etude prospective sur une serie de 181 patients]. Annales d'Oto‐Laryngologie et de Chirurgie Cervico Faciale 1998;115(4):202‐14.

Bonfils 2003 {published data only}

Bonfils P, Nores J‐M, Halimi P, Avan P. Medical treatment of stage I nasal polyposis over a 3‐year follow‐up period. ORL; Journal of Oto‐Rhino‐Laryngology and Its Related Specialties 2004;66(1):27‐34.

Bonfils 2006 {published data only}

Bonfils P, Halimi P, Malinvaud D. Adrenal suppression and osteoporosis after treatment of nasal polyposis. Acta Oto‐Laryngologica 2006;126(11):1195‐200.

Chi 2011 {published data only}

ChiCTR‐TRC‐11001323. Research on clinical efficacy of oral glucocorticoid in the treatment of eosinophilic nasal polyps and non‐eosinophilic nasal polyps. http://www.chictr.org.cn/showprojen.aspx?proj=8216. [ChiCTR‐TRC‐11001323]

Chi Chan 1996 {published data only}

Chi Chan A, Couto y Arcos F, Martin Biasotti F, Bross Soriano D, Vazquez Valle MDC, Gonzalez Olvera S. Oral steroids as preoperative medication in nasal polyposis [Esteroides orales en la preparacion preoperatoria de poliposis nasal]. Anales de Otorrinolaringologia Mexicana 1996;41(3):155‐60.

Damm 1999 {published data only}

Damm M, Jungehulsing M, Eckel HE, Schmidt M, Theissen P. Effects of systemic steroid treatment in chronic polypoid rhinosinusitis evaluated with magnetic resonance imaging. Otolaryngology ‐ Head and Neck Surgery 1999;120(4):517‐23.

Ecevit 2015 {published data only}

Ecevit MC, Erdag TK, Dogan E, Sutay S. Effect of steroids for nasal polyposis surgery: a placebo‐controlled, randomized, double‐blind study. Laryngoscope 2015;125(9):2041‐5. [DOI: 10.1002/lary.25352]

Grammer 2013 {published data only}

Grammer LC. Doxycycline or oral corticosteroids for nasal polyps. Journal of Allergy and Clinical Immunology: In Practice 2013;1(5):541‐2.

Hessler 2007 {published data only}

Hessler JL, Piccirillo JF, Fang D, Vlahiotis A, Banerji A, Levitt RG, et al. Clinical outcomes of chronic rhinosinusitis in response to medical therapy: results of a prospective study. American Journal of Rhinology 2007;21(1):10‐8.

Hissaria 2006 {published data only}

Hissaria P, Smith W, Wormald PJ, Taylor J, Vadas M, Gillis D, et al. Short course of systemic corticosteroids in sinonasal polyposis: a double‐blind, randomized, placebo‐controlled trial with evaluation of outcome measures. Journal of Allergy and Clinical Immunology 2006;118(1):128‐33.

Jankowski 2003a {published data only}

Jankowski R, Bodino C. Evolution of symptoms associated to nasal polyposis following oral steroid treatment and nasalisation of the ethmoid ‐ radical ethmoidectomy is functional surgery for NPS. Rhinology 2003;41(4):211‐9.

Jankowski 2003b {published data only}

Jankowski R, Bodino C. Olfaction in patients with nasal polyposis: effects of systemic steroids and radical ethmoidectomy with middle turbinate resection (nasalisation). Rhinology 2003;41(4):220‐30.

Kapucu 2012 {published data only}

Kapucu B, Cekin E, Erkul BE, Cincik H, Gungor A, Berber U. The effects of systemic, topical, and intralesional steroid treatments on apoptosis level of nasal polyps. Otolaryngology ‐ Head and Neck Surgery 2012;147(3):563‐7. [DOI: 10.1177/0194599812446678]

Kirtsreesakul 2011 {published data only}

Kirtsreesakul V, Wongsritrang K, Ruttanaphol S. Clinical efficacy of a short course of systemic steroids in nasal polyposis. Rhinology 2011;49(5):525‐32.

Kirtsreesakul 2012 {published data only}

Kirtsreesakul V, Wongsritrang K, Ruttanaphol S. Does oral prednisolone increase the efficacy of subsequent nasal steroids in treating nasal polyposis?. American Journal of Rhinology & Allergy 2012;26(6):455‐62.

Kroflic 2006 {published data only}

Kroflic B, Baudoin T, Kalogjera L. Topical furosemide versus oral steroid in preoperative management of nasal polyposis. European Archives of Oto‐Rhino‐Laryngology 2006;263(8):767‐71.

Lildholdt 1988 {published data only}

Lildholdt T, Fogstrup J, Gammelgaard N, Kortholm B, Ulsoe C. Surgical versus medical treatment of nasal polyps. Acta Oto‐Laryngologica 1988;105(1‐2):140‐3.

Lildholdt 1989 {published data only}

Lildholdt T. Surgical versus medical treatment of nasal polyps. Rhinology. Supplement 1989;8:31‐3.

Martinez‐Anton 2008 {published data only}

Martínez‐Antón A, de Bolós C, Alobid I, Benítez P, Roca‐Ferrer J, Picado C, et al. Corticosteroid therapy increases membrane‐tethered while decreases secreted mucin expression in nasal polyps. Allergy: European Journal of Allergy and Clinical Immunology 2008;63(10):1368‐76.

NCT00841802 {published data only}

Chronic rhinosinusitis with or without nasal polyps steroid study. http://clinicaltrials.gov/ct2/show/NCT00841802. [NCT00841802]

NCT02367118 {published data only}

Prednisone in chronic rhinosinusitis without nasal polyps. http://clinicaltrials.gov/ct2/show/NCT02367118.

Nores 2003 {published data only}

Nores J‐M, Avan P, Bonfils P. Medical management of nasal polyposis: a study in a series of 152 consecutive patients. Rhinology 2003;41(2):97‐102.

Ragab 2006 {published data only}

Ragab S, Scadding GK, Lund VJ, Saleh H. Treatment of chronic rhinosinusitis and its effects on asthma. European Respiratory Journal 2006;28(1):68‐74.

Rasp 1997 {published data only}

Rasp G, Bujia J. Treatment of nasal polyposis with systemic and local corticoids. Acta Otorrinolaringologica Espanola 1997;48(1):37‐40.

Rasp 2000 {published data only}

Rasp G, Kramer MF, Ostertag P, Kastenbauer E. A new system for the classification of ethmoid polyposis. Effect of combined local and systemic steroid therapy. Laryngo‐Rhino‐Otologie 2000;79(5):266‐72.

Remer 2005 {published data only}

Remer M, Polberg K, Obszańska B, Klatka J. Chronic sinusitis therapy with antibiotics (axetyl cefuroxym, clarithromycin) and steroid (prednisone) [Leczenie zapalenia zatok z zastosowaniem antybiotykow (aksetyl cefuroksymu, klarytromycyna) w polaczeniu ze sterydem stosowanym doustnie (prednison)]. Polski Merkuriusz Lekarski 2005;19(111):343‐4.

Reychler 2015 {published data only}

Reychler G, Colbrant C, Huart C, Le Guellec S, Vecellio L, Liistro G, et al. Effect of three‐drug delivery modalities on olfactory function in chronic sinusitis. Laryngoscope 2015;125(3):549‐55.

Rupa 2010 {published data only}

Rupa V, Jacob M, Mathews MS, Seshadri MS. A prospective, randomised, placebo‐controlled trial of postoperative oral steroid in allergic fungal sinusitis. European Archives of Oto‐rhino‐laryngology 2010;267(2):233‐8. [DOI: 10.1007/s00405‐009‐1075‐8]

Sieskiewicz 2006 {published data only}

Sieskiewicz A, Olszewska E, Rogowski M, Grycz E. Preoperative corticosteroid oral therapy and intraoperative bleeding during functional endoscopic sinus surgery in patients with severe nasal polyposis: a preliminary investigation. Annals of Otology, Rhinology and Laryngology 2006;115(7):490‐4.

Sousa 2009 {published data only}

Sousa MC, Becker HM, Becker CG, Castro MM, Sousa NJ, Guimarães RE. Reproducibility of the three‐dimensional endoscopic staging system for nasal polyposis. Brazilian Journal of Otorhinolaryngology 2009;75(6):814‐20.

Stevens 2001 {published data only}

Stevens MH. Steroid‐dependent anosmia. Laryngoscope 2001;111(2):200‐3.

Tuncer 2003 {published data only}

Tuncer U, Soylu L, Aydogan B, Karakus F, Akcali C. The effectiveness of steroid treatment in nasal polyposis. Auris Nasus Larynx 2003;30(3):263‐8.

Vaidyanathan 2011 {published data only}

Vaidyanathan S, Barnes M, Williamson P, Hopkinson P, Donnan PT, Lipworth B. Treatment of chronic rhinosinusitis with nasal polyposis with oral steroids followed by topical steroids: a randomized trial. Annals of Internal Medicine 2011;154:293‐302.

van Camp 1994 {published data only}

van Camp C, Clement PA. Results of oral steroid treatment in nasal polyposis. Rhinology 1994;32(1):5‐9.

Van Zele 2008 {published data only}

Van Zele T, Gevaert P, Holtappels G. Treatment of nasal polyposis with oral methylprednisolone: a double‐blind, randomized, placebo‐controlled trial with evaluation of clinical and biological activity. Journal of Allergy and Clinical Immunology 2008;121(2 Suppl 1):S265.

Van Zele 2010 {published data only}

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.e4.

NCT01676415 {published data only}

Northwestern University Feinberg School of Medicine. Corticosteroid therapy for chronic rhinosinusitis without nasal polyps (CRSsNP). http://clinicaltrials.gov/ct2/show/NCT01676415. [NCT01676415]

Balk 2012

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Burton 2008

Burton MJ, Harvey RJ. Idiopathic sudden sensorineural hearing loss. In: Gleeson M, Browning G, Burton MJ, Clarke R, Hibbert J, Jones NS, et al. editor(s). Scott‐Brown's Otorhinolaryngology, Head and Neck Surgery. 7th Edition. Vol. 3, London: Hodder Arnold, 2008:3577‐93.

Cho 2012

Cho SH, Hong SJ, Han B, Lee SH, Suh L, Norton J, et al. Age‐related differences in the pathogenesis of chronic rhinosinusitis. Journal of Allergy and Clinical Immunology 2012;129(3):858‐60.e2.

Chong 2016a

Chong LY, Head K, Hopkins C, Philpott C, Schilder AGM, Burton MJ. Different types of intranasal steroids for chronic rhinosinusitis. Cochrane Database of Systematic Reviews 2016, Issue 4. [DOI: 10.1002/14651858.CD011993.pub2]

Chong 2016b

Chong LY, Head K, Hopkins C, Philpott C, Schilder AGM, Burton MJ. Intranasal steroids versus placebo or no intervention for chronic rhinosinusitis. Cochrane Database of Systematic Reviews 2016, Issue 4. [DOI: 10.1002/14651858.CD011996.pub2]

Chong 2016c

Chong LY, Head K, Hopkins C, Philpott C, Glew S, Scadding G, et al. Saline irrigation for chronic rhinosinusitis. Cochrane Database of Systematic Reviews 2016, Issue 4. [DOI: 10.1002/14651858.CD011995.pub2]

Cohen 1988

Cohen J. Statistical Power Analysis in the Behavioral Sciences. 2nd Edition. Hillsdale (NJ): Lawrence Erlbaum Associates, Inc., 1988.

Côté 2011

Côté DWJ, Wright ED. Objective Outcomes in Endoscopic Sinus Surgery, Advances in Endoscopic Surgery. InTech, 2011.

Da Silva 2006

Da Silva JA, Jacobs JW, Kirwan JR, Boers M, Saag KG, Inês LB, et al. Safety of low dose glucocorticoid treatment in rheumatoid arthritis: published evidence and prospective trial data. Annals of the Rheumatic Diseases 2006;65:285‐93.

DeMarcantonio 2011

DeMarcantonio MA, Han JK. Nasal polyps: pathogenesis and treatment implications. Otolaryngologic Clinics of North America 2011;44(3):685‐95, ix.

Ebbens 2010

Ebbens FA, Toppila‐Salmi SK, Renkonen JA, Renkonen RL, Mullol J, van Drunen CM, et al. Endothelial L‐selectin ligand expression in nasal polyps. Allergy 2010;65(1):95‐102.

Ebbens 2011

Ebbens FA, Toppila‐Salmi S, de Groot EJ, Renkonen J, Renkonen R, van Drunen CM, et al. Predictors of post‐operative response to treatment: a double blind placebo controlled study in chronic rhinosinusitis patients. Rhinology 2011;49(4):413‐9.

Egger 1997

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EPOS 2012

Fokkens WJ, Lund VJ, Mullol J, Bachert C, Alobid I, Baroody F, et al. European Position Paper on Rhinosinusitis and Nasal Polyps 2012. Rhinology. Supplement 2012;50 Suppl 23:1‐298.

Fokkens 2007

Fokkens W, Lund V, Mullol J. European position paper on rhinosinusitis and nasal polyps 2007. Rhinology 45;Suppl 20:1‐139.

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Gliklich RE, Metson R. The health impact of chronic sinusitis in patients seeking otolaryngologic care. Otolaryngology ‐ Head and Neck Surgery 1995;113(1):104‐9.

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Hastan D, Fokkens WJ, Bachert C, Newson RB, Bislimovska J, Bockelbrink A, et al. Chronic rhinosinusitis in Europe ‐ an underestimated disease. A GA2LEN study. Allergy 2011;66(9):1216‐23.

Head 2016a

Head K, Chong LY, Hopkins C, Philpott C, Burton MJ, Schilder AGM. Short‐course oral steroids alone for chronic rhinosinusitis. Cochrane Database of Systematic Reviews 2016, Issue 4. [DOI: 10.1002/14651858.CD011991.pub2]

Head 2016b

Head K, Chong LY, Piromchai P, Hopkins C, Philpott C, Schilder AGM, et al. Systemic and topical antibiotics for chronic rhinosinusitis. Cochrane Database of Systematic Reviews 2016, Issue 4. [DOI: 10.1002/14651858.CD011994.pub2]

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Keswani A, Chustz RT, Suh L, Carter R, Peters AT, Tan BK, et al. Differential expression of interleukin‐32 in chronic rhinosinusitis with and without nasal polyps. Allergy 2012;67(1):25‐32.

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Larsen P, Tos M. Origin of nasal polyps: an endoscopic autopsy study. Laryngoscope 2004;114(4):710‐9.

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Martinez‐Devesa P, Patiar S. Oral steroids for nasal polyps. Cochrane Database of Systematic Reviews 2011, Issue 7. [DOI: 10.1002/14651858.CD005232.pub3]

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Mygind N, Lildholdt T. Nasal polyps treatment: medical management. Allergy and Asthma Proceedings 1996;17:275‐82.

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Naber D, Sand P, Heigl B. Psychopathological and neuropsychological effects of 8‐days' corticosteroid treatment. A prospective study. Psychoneuroendocrinology 1996;21:25‐31.

Ragab 2004

Ragab SM, Lund VJ, Scadding G. Evaluation of the medical and surgical treatment of chronic rhinosinusitis: a prospective, randomised, controlled trial. Laryngoscope 2004;114(5):923‐30.

Ragab 2010

Ragab SM, Lund VJ, Scadding G, Saleh HA, Khalifa MA. Impact of chronic rhinosinusitis therapy on quality of life: a prospective randomized controlled trial. Rhinology 2010;48(3):305‐11.

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Tan BK, Li QZ, Suh L, Kato A, Conley DB, Chandra RK, et al. Evidence for intranasal antinuclear autoantibodies in patients with chronic rhinosinusitis with nasal polyps. Journal of Allergy and Clinical Immunology 2011;128(6):1198‐206.e1.

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van Drunen CM, Reinartz SM, Wigman J, Fokkens W. Inflammation in chronic rhinosinusitis and nasal polyposis. Immunology and Allergy Clinics of North America 2009;29(4):621‐9.

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References to other published versions of this review

Chong 2015

Chong LY, Head K, Hopkins C, Philpott C, Burton MJ. Short‐course oral steroids as an adjunct therapy for chronic rhinosinusitis. Cochrane Database of Systematic Reviews 2015, Issue 12. [DOI: 10.1002/14651858.CD011992]

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Bülbül 2013

Methods

3‐arm, non‐blinded, parallel‐group, with 21 days duration of treatment and follow‐up

Participants

Location: Turkey, 1 site

Setting of recruitment and treatment: ear, nose and throat department of Haydarpasa Numune education and research hospital, Istanbul

Sample size: 45

Number randomised (and completed): 15 in oral steroids and INCS, 15 in INCS alone, 15 in oral steroids alone (see notes below)

Participant (baseline) characteristics:

  • Mean age (SD): 34.7 ± 16.72 years (average for all 3 groups)

  • Gender (male/female): 25/20 (across all 3 groups)

  • Main diagnosis: volunteers who received a diagnosis of nasal polyposis

  • Polyps status: 100% with polyps

  • Polyp grade n (%):

‐ Grade 1: oral steroids and INCS: 1 (6.7%); INCS alone: 3 (13.3%)

‐ Grade 2: oral steroids and INCS: 9 (60%); INCS alone: 5 (33.3%)

‐ Grade 3: oral steroids and INCS: 5 (33.3%); INCS alone: 8 (53.3%)

  • Previous sinus surgery status: no information

  • Previous courses of steroids: no information

  • Positive skin prick test: INCS alone: 7; oral steroids and INCS: 6

Inclusion criteria: none stated. No information on polyp grading criteria (other than Rasp).

Exclusion criteria: patients in whom corticosteroid therapy was contraindicated (i.e. those with diabetes mellitus, hypertension, glaucoma, a history of tuberculosis or emotional instability), as well as those who had received corticosteroids within the last month

Interventions

Oral steroids and INCS (n = 15): oral methylprednisolone, 1 mg/kg and reduced progressively over a 21‐day treatment course

INCS alone (n = 15): no oral steroid treatment

Use of additional interventions (common to both treatment arms): budesonide, unclear method of administration except it states 'intranasal', 400 μg/day, 21 days

Outcomes

Primary outcomes: none reported

Secondary outcomes:

  • Polyps size: measured by endoscopic appearance and staging according to the Rasp Classification (1 to 4, 1 = least severe) at 21 days

Other outcomes reported by the study:

  • Measurement of nitric oxide levels

Funding sources

No information provided

Declarations of interest

"None declared"

Notes

The trial is a 3‐arm trial comparing "oral steroids alone", "INCS alone" and "oral steroids and INCS". The results for the "oral steroids alone" group are not presented here as they are not relevant to this review.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

High risk

Quote: "Patients were allocated in turn to either the first, second or third treatment group, depending on their order of presentation."

Comment: pg 585, col 1, para 4

Allocation concealment (selection bias)

High risk

Comment: as randomisation was completed based on order of presentation, there is a high risk of bias due to allocation concealment

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Comment: the study was not blinded

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Comment: there is no information regarding blinding of outcome assessment

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Comment: no patients dropped out of the study

Selective reporting (reporting bias)

Low risk

Comment: all outcomes are reported

Other bias

Unclear risk

Comment: Rasp classification used for endoscopic polyp staging. Unclear whether this has been validated and no details on stage used.

Baseline characteristics are not well described but the polyp grade seems to be unevenly distributed (although not statistically significant) with more severe patients in the placebo group, which may have affected the results. The small size of the trial makes it difficult to draw conclusions.

Ozturk 2011

Methods

2‐arm, double‐blind, parallel‐group RCT, with 15‐day duration of oral steroid treatment and 30‐day duration of follow‐up

Participants

Location: Turkey, 2 sites

Setting of recruitment and treatment: paediatric allergy and ear, nose, and throat outpatient clinics of 2 university hospitals

Sample size: 48

Number randomised: 24 in oral steroids and antibiotics, 24 in antibiotics alone

Number completed: 22 in intervention, 23 in antibiotics alone

Participant (baseline) characteristics: note: no. analysed not randomised

  • Mean age (SD): oral steroids and antibiotics: 8.5 (2.9); antibiotics alone: 8.0 (2.3)

  • Gender (M/F): oral steroids and antibiotics: 14/8 antibiotics alone: 15/8

  • Main diagnosis: children with chronic rhinosinusitis

  • Polyps status: 0% with polyps

  • Previous sinus surgery status: no information

  • Previous courses of steroids: information not provided

  • Atopy: oral steroids and antibiotics: 8 (36%); antibiotics alone: 10 (43%)

Inclusion criteria: children with CRS; CRS diagnosis made on a basis of sinonasal symptoms and signs present for a period of more than 3 months in the presence of abnormalities on coronal sinus computed tomographic (CT) scans. All patients presented with nasal purulence, postnasal purulence or both and 1 or more of the following symptoms: nasal obstruction, cough, halitosis, headache or facial pain/pressure. They had multiple courses (each 10 to 14 days, > 3 courses) of antimicrobial treatment with at least 2 or more of the following broad‐spectrum antibiotics before entry into the study: amoxicillin‐clavulanic acid, second‐generation cephalosporins (mostly cefuroxime) or clarithromycin

Patients with allergic rhinitis were also included if they also showed purulent rhinorrhoea, postnasal purulence or both

Exclusion criteria:

‐ Systemic corticosteroids in the last 2 months before the study

‐ Systemic antibiotics and inhaler or intranasal corticosteroids in the last 4 weeks before the study

‐ Other respiratory tract disorders (cystic fibrosis, ciliary dyskinesia, nasal polyps, large adenoids and asthma), immune deficiency

‐ Systemic disease, gastroesophageal reflux, aspirin sensitivity

‐ Acquired or congenital sinonasal abnormalities, contraindication to corticosteroid use

‐ Patients with pollen‐induced rhinitis if they were seen during the pollen season

Interventions

Intervention (n = 24): oral methylprednisolone tablets, 15 days according to the following schedule (doses were rounded up to the nearest 4 mg):
‐ 1 mg/kg/day (maximum, 40 mg/day) for 10 days
‐ 0.75 mg/kg/day for 2 days, 0.5 mg/kg/day for 2 days
‐ 0.25 mg/kg/day for 1 day

Comparator group (n = 24): placebo tablets for 15 days

Use of additional interventions (common to both treatment arms): antibiotics (oral amoxicillin/clavulanate) was administered at 45/6.4 mg/kg/day (maximum, 2000/285 mg/day) for 30 days

Outcomes

Primary outcomes:

1. Disease severity, assessed by the patients and their parents by using a visual analogue scale (VAS) (range 0 (no symptoms) to 10 (most severe)). The symptoms scored were: purulent nasal discharge, nasal obstruction, postnasal drainage, halitosis, cough, and facial pain or headache. Individual scores were combined to make a rhinosinusitis symptom score (range 0 to 60) at the end of treatment measured at 30 days.

Secondary outcomes:

2. CT scan, scored using the Lund‐Mackay staging system (0 to 24) measured at 30 days

Other outcomes reported by the study:

  • Compliance

  • Clinical recovery (definition in paper)

  • Relapse (definition in paper)

  • "Tolerability was evaluated by means of medical history, physical examination, and measurement of adverse events. Hypertension, edema, weight gain, increase in appetite, gastrointestinal disturbances, nervousness, agitation, psychosis, headache, mood swings, delirium, euphoria, moon face, skin atrophy, bruising, hyperpigmentation, muscle weakness, joint pain, and allergic reactions were defined as clinically significant adverse events"

Funding sources

No information provided

Declarations of interest

"The authors have declared that they have no conflicts of interest."

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "… a random allocation chart based on a table of random numbers."

Comment: pg 349, col 2, para 1

Allocation concealment (selection bias)

Low risk

Quote: "Randomization assignments were kept in sealed envelopes"

Comment: pg 349, col 2, para 1

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Quote: "Placebo tablets contained lactose and were of same size and colour as methylprednisolone (16 mg per tablet). Placebo and methylprednisolone tablets were dispensed in identical packets containing a minimum of 20 tablets each."

"The randomization code was kept by the nursing staff in the pediatric allergy department."

Comment: pg 349, col 2, para 1

Although the paper states that the tablets were equivalent with respect to size and colour, no mention was made about the taste of the tablets. As the taste of methylprednisolone is different to lactose, it may have been obvious which was the treatment. 1 patient in the treatment group dropped out due to unpalatability.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Comment: the study reports that the participants were blinded and so the patient‐reported outcomes are likely to have been blinded. For the CT scan outcome it is noted that the assessor was blind to treatment and sequence.

No mention of whether the analysis was completed blind.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Comment: although there was low drop‐out (3/48 = 6%) there are no clear reasons provided for 2 of the patients' "protocol violation" or why their results were not included in the analysis

Selective reporting (reporting bias)

High risk

Quote: "No clinically significant adverse events were reported. Twenty seven parents (16 in the methylprednisolone group and 11 in the placebo group) reported that their children's appetite and weight increased after treatment. At the end of the treatment, the mean ± SD changes in patients’ weights from baseline were 0.42 ± 0.26 kg in the methylprednisolone group versus 0.27 ± 0.30 kg in the placebo group. The difference was not significant (P = 0.08)"

Comment: although all of the efficacy outcomes are presented in the results section, the methods section classified increase in appetite and weight gain as clinically significant adverse events and the results indicated that there may be a difference between the groups

The summed scores for the individual symptom scores as presented in the paper do not add up to the total symptom score as presented

Other bias

Unclear risk

Comment: no information regarding the validation of visual analogue scales for reporting CRS symptoms. Nothing was made in the results of the finding that the placebo group benefited substantially from placebo treatment.

CRS: chronic rhinosinusitis
CT: computerised tomography
INCS: intranasal steroids
RCT: randomised controlled trial
SD: standard deviation

Characteristics of excluded studies [ordered by study ID]

Study

Reason for exclusion

Alobid 2005

INTERVENTION: oral steroids versus surgery

Alobid 2006

INTERVENTION: oral steroids alone versus no steroid treatment

Alobid 2012

INTERVENTION: oral steroids alone versus no steroid treatment

Alobid 2014

INTERVENTION: oral steroids alone versus no steroid treatment

Benitez 2006

INTERVENTION: oral steroids alone versus no steroid treatment

Blomqvist 2001

INTERVENTION: surgery

Blomqvist 2009

INTERVENTION: combined medical and surgical treatment

Bonfils 1998

STUDY DESIGN: not randomised

Bonfils 2003

STUDY DESIGN: not randomised

Bonfils 2006

STUDY DESIGN: not randomised

Chi 2011

INTERVENTION: oral steroid alone versus placebo

(Ongoing study)

Chi Chan 1996

STUDY DESIGN: not randomised

Damm 1999

INTERVENTION: oral steroid (12 days) + INCS versus oral steroid (20 days) + INCS

Ecevit 2015

INTERVENTION: oral steroids alone versus placebo

Grammer 2013

STUDY DESIGN: review of previous oral steroids trials

Hessler 2007

STUDY DESIGN: not randomised

Hissaria 2006

INTERVENTION: oral steroids alone versus placebo

Jankowski 2003a

STUDY DESIGN: not randomised

Jankowski 2003b

STUDY DESIGN: not randomised

Kapucu 2012

INTERVENTION: 4‐arm trial: (1) oral steroids, (2) intranasal steroids, (3) steroid injection into polyp, (4) no treatment

Kirtsreesakul 2011

INTERVENTION: oral steroid alone then INCS versus placebo then INCS (note: oral steroids and INCS not given concurrently)

Kirtsreesakul 2012

INTERVENTION: oral steroid alone then INCS versus placebo then INCS (note: oral steroids and INCS not given concurrently)

Kroflic 2006

INTERVENTION: endoscopic polypectomy with ethmoidectomy

Lildholdt 1988

INTERVENTION: surgical removal versus systemic corticosteroids

Lildholdt 1989

INTERVENTION: surgical polypectomy followed by continuous topical steroid treatment versus a single dose of depot steroid

Martinez‐Anton 2008

INTERVENTION: oral steroids alone versus no steroid treatment

NCT00841802

INTERVENTION: oral steroids alone versus no steroid treatment

(Ongoing study)

NCT02367118

INTERVENTION: oral steroids alone versus placebo

(Ongoing study)

Nores 2003

STUDY DESIGN: not randomised

Ragab 2006

INTERVENTION: medical versus surgical treatment

Rasp 1997

STUDY DESIGN: not randomised

Rasp 2000

STUDY DESIGN: not randomised

Remer 2005

STUDY DESIGN: not randomised

Reychler 2015

INTERVENTION: oral steroid versus INCS

Rupa 2010

POPULATION: allergic fungal sinusitis

Sieskiewicz 2006

STUDY DESIGN: surgical outcomes paper

Sousa 2009

STUDY DESIGN: not randomised

Stevens 2001

STUDY DESIGN: not randomised

Tuncer 2003

STUDY DESIGN: not randomised

Vaidyanathan 2011

INTERVENTION: oral steroids alone then INCS versus placebo then INCS (note: oral steroids and INCS not given concurrently)

van Camp 1994

STUDY DESIGN: not randomised

Van Zele 2008

INTERVENTION: oral steroids alone then INCS versus placebo then INCS (note: oral steroids and INCS not given concurrently)

Van Zele 2010

INTERVENTION: oral steroids alone then INCS versus placebo then INCS (note: oral steroids and INCS not given concurrently)

INCS: intranasal steroids

Characteristics of ongoing studies [ordered by study ID]

NCT01676415

Trial name or title

Corticosteroid therapy for chronic rhinosinusitis without nasal polyps (CRSsNP)

Methods

2‐arm, randomised, controlled, parallel‐group, open study

Participants

40 patients (18 to 80 years old) with CRS without nasal polyps

Interventions

Group 1: systemic prednisone: starting dose of 40 mg for 5 days followed by a taper decreasing by 10 mg every 5 days. Followed by topical mometasone (INCS) until the end of the study.

Group 2: topical mometasone (INCS) at the standard dose of 2 sprays into each nostril once daily until the end of the study.

Both groups: 3‐week course of a broad‐spectrum antibiotic, amoxicillin/clavulanate, at a daily dose of 875 mg twice daily. If the participant is allergic to penicillin and its derivatives or has had an adverse reaction to amoxicillin/clavulanate, a 3‐week course of clarithromycin instead.

Outcomes

Primary: Lund‐MacKay score from CT scan

Secondary: Taskforce symptom inventory, SNOT‐22 questionnaire, medication side effects and compliance inventory

All outcomes measured at 4 to 6 weeks and 3 months after initiation of treatment

Starting date

August 2012

Contact information

Bruce Tan, MD, Assistant Professor, Dept of Otolaryngology, Northwestern University Feinberg School of Medicine (contact: [email protected])

Notes

Results expected June 2017

CRS: chronic rhinosinusitis
CT: computerised tomography
INCS: intranasal corticosteroids
SNOT‐22: Sino‐Nasal Outcome Test‐22

Data and analyses

Open in table viewer
Comparison 1. Oral corticosteroids versus no treatment (intranasal steroids in both groups)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Nasal polyp grading Show forest plot

1

30

Mean Difference (IV, Fixed, 95% CI)

‐0.46 [‐0.87, ‐0.05]

Analysis 1.1

Comparison 1 Oral corticosteroids versus no treatment (intranasal steroids in both groups), Outcome 1 Nasal polyp grading.

Comparison 1 Oral corticosteroids versus no treatment (intranasal steroids in both groups), Outcome 1 Nasal polyp grading.

Open in table viewer
Comparison 2. Oral corticosteroids versus placebo (antibiotics in both arms)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Total symptom score Show forest plot

1

45

Mean Difference (IV, Fixed, 95% CI)

‐7.10 [‐9.59, ‐4.61]

Analysis 2.1

Comparison 2 Oral corticosteroids versus placebo (antibiotics in both arms), Outcome 1 Total symptom score.

Comparison 2 Oral corticosteroids versus placebo (antibiotics in both arms), Outcome 1 Total symptom score.

2 Nasal obstruction Show forest plot

1

45

Mean Difference (IV, Fixed, 95% CI)

‐3.50 [‐4.71, ‐2.29]

Analysis 2.2

Comparison 2 Oral corticosteroids versus placebo (antibiotics in both arms), Outcome 2 Nasal obstruction.

Comparison 2 Oral corticosteroids versus placebo (antibiotics in both arms), Outcome 2 Nasal obstruction.

3 Purulent nasal discharge Show forest plot

1

45

Mean Difference (IV, Fixed, 95% CI)

‐0.20 [‐1.54, 1.14]

Analysis 2.3

Comparison 2 Oral corticosteroids versus placebo (antibiotics in both arms), Outcome 3 Purulent nasal discharge.

Comparison 2 Oral corticosteroids versus placebo (antibiotics in both arms), Outcome 3 Purulent nasal discharge.

4 Headache/facial pain Show forest plot

1

45

Mean Difference (IV, Fixed, 95% CI)

‐1.3 [‐2.55, ‐0.05]

Analysis 2.4

Comparison 2 Oral corticosteroids versus placebo (antibiotics in both arms), Outcome 4 Headache/facial pain.

Comparison 2 Oral corticosteroids versus placebo (antibiotics in both arms), Outcome 4 Headache/facial pain.

5 Cough Show forest plot

1

45

Mean Difference (IV, Fixed, 95% CI)

‐2.10 [‐3.35, ‐0.85]

Analysis 2.5

Comparison 2 Oral corticosteroids versus placebo (antibiotics in both arms), Outcome 5 Cough.

Comparison 2 Oral corticosteroids versus placebo (antibiotics in both arms), Outcome 5 Cough.

6 CT score Show forest plot

1

45

Mean Difference (IV, Fixed, 95% CI)

‐2.90 [‐4.91, ‐0.89]

Analysis 2.6

Comparison 2 Oral corticosteroids versus placebo (antibiotics in both arms), Outcome 6 CT score.

Comparison 2 Oral corticosteroids versus placebo (antibiotics in both arms), Outcome 6 CT score.

Process for sifting search results and selecting studies for inclusion.
Figuras y tablas -
Figure 1

Process for sifting search results and selecting studies for inclusion.

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
Figuras y tablas -
Figure 2

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

'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figuras y tablas -
Figure 3

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

Comparison 1 Oral corticosteroids versus no treatment (intranasal steroids in both groups), Outcome 1 Nasal polyp grading.
Figuras y tablas -
Analysis 1.1

Comparison 1 Oral corticosteroids versus no treatment (intranasal steroids in both groups), Outcome 1 Nasal polyp grading.

Comparison 2 Oral corticosteroids versus placebo (antibiotics in both arms), Outcome 1 Total symptom score.
Figuras y tablas -
Analysis 2.1

Comparison 2 Oral corticosteroids versus placebo (antibiotics in both arms), Outcome 1 Total symptom score.

Comparison 2 Oral corticosteroids versus placebo (antibiotics in both arms), Outcome 2 Nasal obstruction.
Figuras y tablas -
Analysis 2.2

Comparison 2 Oral corticosteroids versus placebo (antibiotics in both arms), Outcome 2 Nasal obstruction.

Comparison 2 Oral corticosteroids versus placebo (antibiotics in both arms), Outcome 3 Purulent nasal discharge.
Figuras y tablas -
Analysis 2.3

Comparison 2 Oral corticosteroids versus placebo (antibiotics in both arms), Outcome 3 Purulent nasal discharge.

Comparison 2 Oral corticosteroids versus placebo (antibiotics in both arms), Outcome 4 Headache/facial pain.
Figuras y tablas -
Analysis 2.4

Comparison 2 Oral corticosteroids versus placebo (antibiotics in both arms), Outcome 4 Headache/facial pain.

Comparison 2 Oral corticosteroids versus placebo (antibiotics in both arms), Outcome 5 Cough.
Figuras y tablas -
Analysis 2.5

Comparison 2 Oral corticosteroids versus placebo (antibiotics in both arms), Outcome 5 Cough.

Comparison 2 Oral corticosteroids versus placebo (antibiotics in both arms), Outcome 6 CT score.
Figuras y tablas -
Analysis 2.6

Comparison 2 Oral corticosteroids versus placebo (antibiotics in both arms), Outcome 6 CT score.

Summary of findings for the main comparison. Short‐course oral corticosteroids compared to no oral corticosteroid treatment (intranasal steroids in both groups) for chronic rhinosinusitis

Short‐course oral corticosteroids compared to no oral corticosteroid treatment (intranasal steroids in both arms) for chronic rhinosinusitis

Patient or population: chronic rhinosinusitis
Setting: ENT departments
Intervention: short‐course oral steroids and intranasal steroids
Comparison: intranasal steroids alone (no oral steroid treatment)

Outcomes

No. of participants

(studies)

Relative effect (95% CI)

Anticipated absolute effects* (95% CI)

Quality

What happens

Without oral steroids

With oral steroids

Difference

Disease‐specific health‐related quality of life

No RCT reported this outcome

Disease severity ‐ patient‐reported symptom score

No RCT reported this outcome

Adverse effect: mood or behavioural disturbances

No RCT reported this outcome

Health‐related quality of life

No RCT reported this outcome

Adverse effect: insomnia

No RCT reported this outcome

Adverse effect: gastrointestinal disturbances ‐ not measured

No RCT reported this outcome

*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: confidence interval;RCT: randomised controlled trial

GRADE Working Group grades of evidence
High quality: We are very confident that the true effect lies close to that of the estimate of the effect
Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

Figuras y tablas -
Summary of findings for the main comparison. Short‐course oral corticosteroids compared to no oral corticosteroid treatment (intranasal steroids in both groups) for chronic rhinosinusitis
Summary of findings 2. Short‐course oral corticosteroids compared to placebo (antibiotics in both arms) for chronic rhinosinusitis

Short‐course oral corticosteroids compared to placebo (antibiotics in both groups) for chronic rhinosinusitis

Patient or population: chronic rhinosinusitis
Setting: paediatric allergy and ENT department
Intervention: oral corticosteroids and antibiotics
Comparison: placebo and antibiotics

Outcomes

No of participants (studies)

Anticipated absolute effects* (95% CI)

Quality

What happens

Without oral steroids

With oral steroids

Difference

Disease‐specific health‐related quality of life

No RCT reported this outcome

Disease severity ‐ patient‐reported symptom score, assessed with: 4 individual symptoms measured on 0 to 10 visual analogue scale summed to provide a range of 0 to 40
Follow‐up: 30 days 2

No. of participants: 45
(1 RCT)

The mean disease severity score without oral steroids was 15.2

The mean disease severity score with oral steroids was 3.6

The mean disease severity score in the intervention group was 7.10 lower (9.59 lower to 4.61 lower)

⊕⊕⊝⊝
LOW 1

A lower score indicates less severe symptoms. The results relate to a standardised mean difference of 1.61 standard deviations lower (‐2.29 to 0.93 lower), corresponding to a large difference.

Adverse effect: mood or behavioural disturbances

No RCT reported this outcome

Health‐related quality of life

No RCT reported this outcome

Adverse effect: insomnia

No RCT reported this outcome

Adverse effect: gastrointestinal disturbances

No RCT reported this outcome

*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: confidence interval; RCT: randomised controlled trial

GRADE Working Group grades of evidence
High quality: We are very confident that the true effect lies close to that of the estimate of the effect
Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

1Study completed only in children (mean age 8 years old). Study follow‐up time was less than 3 months (1 month). Scales were not validated and were completed by "parents and children".

2Symptoms included in this score were: purulent nasal discharge, nasal obstruction, cough and facial pain/headache.

Figuras y tablas -
Summary of findings 2. Short‐course oral corticosteroids compared to placebo (antibiotics in both arms) for chronic rhinosinusitis
Table 1. Summary of the most commonly reported side effects of systemic steroids

System

Adverse events

Notes

Musculoskeletal

Osteoporosis

Largely limited to long‐term use

Significantly increased risk of fractures with prolonged use

Osteonecrosis

Rare; appears to be dose‐dependent

Endocrine

Hyperglycaemia

Common; dose‐dependent, usually reversible

Cardiovascular

Hypertension

Common; dose‐dependent, usually reversible

Dermatological

Striae, bruising

Dose‐dependent, occurs after > 1 month usage

Ophthalmological

Cataracts

Irreversible; largely related to long‐term usage

Glaucoma

High risk with pre‐existing disease

Gastrointestinal tract

Peptic ulceration

Increased risk largely due to concomitant NSAIDs

Psychological

Psychosis

Common; increased risk with dosages > 40 mg/day

References: Da Silva 2006; Naber 1996; Stanbury 1998

NSAIDs: non‐steroidal anti‐inflammatory drugs

Figuras y tablas -
Table 1. Summary of the most commonly reported side effects of systemic steroids
Comparison 1. Oral corticosteroids versus no treatment (intranasal steroids in both groups)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Nasal polyp grading Show forest plot

1

30

Mean Difference (IV, Fixed, 95% CI)

‐0.46 [‐0.87, ‐0.05]

Figuras y tablas -
Comparison 1. Oral corticosteroids versus no treatment (intranasal steroids in both groups)
Comparison 2. Oral corticosteroids versus placebo (antibiotics in both arms)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Total symptom score Show forest plot

1

45

Mean Difference (IV, Fixed, 95% CI)

‐7.10 [‐9.59, ‐4.61]

2 Nasal obstruction Show forest plot

1

45

Mean Difference (IV, Fixed, 95% CI)

‐3.50 [‐4.71, ‐2.29]

3 Purulent nasal discharge Show forest plot

1

45

Mean Difference (IV, Fixed, 95% CI)

‐0.20 [‐1.54, 1.14]

4 Headache/facial pain Show forest plot

1

45

Mean Difference (IV, Fixed, 95% CI)

‐1.3 [‐2.55, ‐0.05]

5 Cough Show forest plot

1

45

Mean Difference (IV, Fixed, 95% CI)

‐2.10 [‐3.35, ‐0.85]

6 CT score Show forest plot

1

45

Mean Difference (IV, Fixed, 95% CI)

‐2.90 [‐4.91, ‐0.89]

Figuras y tablas -
Comparison 2. Oral corticosteroids versus placebo (antibiotics in both arms)