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Oral Corticosteroids Following Endoscopic Sinus Surgery for Chronic Rhinosinusitis Without Nasal PolyposisA Randomized Clinical Trial

Educational Objective
To assess the efficacy of oral corticosteroids following endoscopic sinus surgery in patients with CRS without polyps.
1 Credit CME
Key Points

Question  Are oral corticosteroids beneficial following endoscopic sinus surgery (ESS) in patients with chronic rhinosinusitis (CRS) without nasal polyps?

Findings  In this prospective double-blinded, placebo-controlled, randomized clinical trial of 81 adults with CRS without polyps undergoing ESS, comparing longitudinal differences between treatment groups showed no clinically meaningful differences in Sinonasal Outcome Test-22 (SNOT-22) total scores, SNOT-22 rhinologic subdomain scores, or Lund-Kennedy endoscopy scores at any postoperative time point up to 6 months. However, patients who received prednisone had worse postoperative SNOT-22 psychologic subdomain scores compared with placebo.

Meaning  Oral corticosteroids following ESS for CRS without polyps did not have a measurable benefit in sinonasal outcomes compared with placebo, and may be associated with worse psychologic outcomes.

Abstract

Importance  Although oral corticosteroids are commonly prescribed following endoscopic sinus surgery (ESS) for chronic rhinosinusitis (CRS) without nasal polyposis, there are little data to suggest that this is a beneficial practice.

Objective  To assess the efficacy of oral corticosteroids following ESS in CRS without polyps.

Design, Setting, and Participants  This prospective double-blinded, placebo-controlled, randomized noninferiority clinical trial conducted in a single academic tertiary rhinology practice included adults with CRS without polyps undergoing ESS. Of 81 patients recruited, 72 completed the study.

Interventions  Patients were randomized into 2 treatment groups: a 12-day postoperative taper of oral prednisone vs matched placebo tablets. All study patients also received a uniform 2-week postoperative regimen of oral antibiotics, fluticasone nasal spray, and saline rinses.

Main Outcomes and Measures  The primary outcome measures were Sinonasal Outcome Test-22 (SNOT-22) scores and Lund-Kennedy endoscopy scores, collected preoperatively and postoperatively at 1 week, 1 month, 3 months, and 6 months. Scores were compared between treatment groups at each time point using longitudinal difference between treatment groups and analyzed using 2-way, repeated measures analysis of variance. Secondary outcome measures included treatment-related adverse effects.

Results  Overall, 72 patients (mean [SD] age, 49.4 [14.9] years; 36 men, 36 women) completed the study, with 33 in the prednisone arm and 39 in the placebo arm. When comparing longitudinal differences between treatment groups, there was no clinically meaningful difference observed in SNOT-22 total (F[4254] = 1.71, η2 = 0.01 [95% CI, 0.00-0.05]) or Lund-Kennedy scores (F[4247] = 1.23, η2 = 0.02 [95% CI, 0.00-0.50]). In SNOT-22 subdomain analyses, there was no clinically meaningful difference between treatment groups for rhinologic, extranasal rhinologic, ear/facial, or sleep subdomains. However, the prednisone group had worse longitudinal scores for psychological dysfunction compared with the placebo group (F[4254] = 3.18, η2 = 0.05 [95% CI, 0.02-0.09]). Reported adverse effects were similar between the 2 treatment groups.

Conclusions and Relevance  In this randomized clinical trial of patients with CRS without polyps, oral prednisone following ESS conferred no additional benefit over placebo in terms of SNOT-22 total scores, SNOT-22 rhinologic subscores, or Lund-Kennedy endoscopy scores up to 6 months after surgery. Patients receiving prednisone, however, did demonstrate worse SNOT-22 psychologic subdomain scores. These results suggest that the risks of oral corticosteroids may outweigh the benefits; thus use of oral corticosteroids after ESS for CRS without polyps should be carefully considered.

Trial Registration  ClinicalTrials.gov Identifier: NCT02748070

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CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.

Article Information

Accepted for Publication: January 6, 2021.

Published Online: March 4, 2021. doi:10.1001/jamaoto.2021.0011

Corresponding Author: Peter H. Hwang, MD, Professor and Vice Chair, Stanford University School of Medicine, Department of Otolaryngology–Head & Neck Surgery, 801 Welch Rd, Stanford, CA 94305 (hwangph@stanford.edu).

Author Contributions: Drs Chang and Noel had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Co-first authors: Drs Chang and Noel.

Concept and design: Noel, Ayoub, Nayak, Patel, Hwang.

Acquisition, analysis, or interpretation of data: All authors.

Drafting of the manuscript: Chang, Noel, Qian, Hwang.

Critical revision of the manuscript for important intellectual content: Chang, Noel, Qian, Nayak, Patel, Hwang.

Statistical analysis: Chang, Qian, Hwang.

Administrative, technical, or material support: Chang, Noel, Ayoub, Dholakia, Nayak, Hwang.

Supervision: Noel, Nayak, Patel, Hwang.

Conflict of Interest Disclosures: All authors declare no conflicts of interests relevant to this study. Dr Hwang. is a consultant for Lyra Therapeutics, Third Wave Therapeutics, and Slate Therapeutics. Dr Nayak is a consultant for Medtronic, Olympus America, Cook Medical, Hydravascular, and Tissium. Dr Patel is a consultant for Medtronic, Stryker, and Intersect, and on the advisory board for Optinose.

Funding/Support: This study was funded by the Division of Rhinology within the Department of Otolaryngology–Head & Neck Surgery at Stanford University School of Medicine.

Role of the Funder/Sponsor: The Stanford University School of Medicine had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Data Sharing Statement: See Supplement 3.

Additional Contributions: We thank Aakanksha Rathor MD, Nour Ibrahim MD, Ximena Maul MD, Nicole Borchard BA, and Jane Wang NP for their contributions to this study. They were not compensated.

References
1.
Hox  V , Lourijsen  E , Jordens  A ,  et al.  Benefits and harm of systemic steroids for short- and long-term use in rhinitis and rhinosinusitis: an EAACI position paper.   Clin Transl Allergy. 2020;10:1. doi:10.1186/s13601-019-0303-6PubMedGoogle ScholarCrossref
2.
Lal  D , Hwang  PH .  Oral corticosteroid therapy in chronic rhinosinusitis without polyposis: a systematic review.   Int Forum Allergy Rhinol. 2011;1(2):136-143. doi:10.1002/alr.20024PubMedGoogle ScholarCrossref
3.
Poetker  DM , Reh  DD .  A comprehensive review of the adverse effects of systemic corticosteroids.   Otolaryngol Clin North Am. 2010;43(4):753-768. doi:10.1016/j.otc.2010.04.003PubMedGoogle ScholarCrossref
4.
Orlandi  RR , Kingdom  TT , Hwang  PH ,  et al.  International Consensus Statement on Allergy and Rhinology: Rhinosinusitis.   Int Forum Allergy Rhinol. 2016;6(S1)(suppl 1):S22-S209. doi:10.1002/alr.21695PubMedGoogle Scholar
5.
Orlandi  RR , Kingdom  TT , Smith  TL ,  et al.  International Consensus Statement on Allergy and Rhinology: Rhinosinusitis.   Int Forum Allergy Rhinol. Published online November 24, 2020. doi:10.1002/alr.22741PubMedGoogle Scholar
6.
Sealed Envelope Ltd. 2012. Power calculator for continuous outcome non-inferiority trial. Accessed January 2015. https://www.sealedenvelope.com/power/continuous-noninferior/
7.
Hopkins  C , Gillett  S , Slack  R , Lund  VJ , Browne  JP .  Psychometric validity of the 22-item sinonasal outcome test.   Clin Otolaryngol. 2009;34(5):447-454. doi:10.1111/j.1749-4486.2009.01995.xPubMedGoogle ScholarCrossref
8.
DeConde  AS , Mace  JC , Bodner  T ,  et al.  SNOT-22 quality of life domains differentially predict treatment modality selection in chronic rhinosinusitis.   Int Forum Allergy Rhinol. 2014;4(12):972-979. doi:10.1002/alr.21408PubMedGoogle ScholarCrossref
9.
Lund  VJ , Kennedy  DW ; The Staging and Therapy Group.  Quantification for staging sinusitis.   Ann Otol Rhinol Laryngol Suppl. 1995;167:17-21. doi:10.1177/000348949510410s02PubMedGoogle Scholar
10.
Walters  EH , Reid  DW , Johns  DP , Ward  C .  Nonpharmacological and pharmacological interventions to prevent or reduce airway remodelling.   Eur Respir J. 2007;30(3):574-588. doi:10.1183/09031936.00007306PubMedGoogle ScholarCrossref
11.
Hirsch  IB , Paauw  DS .  Diabetes management in special situations.   Endocrinol Metab Clin North Am. 1997;26(3):631-645. doi:10.1016/S0889-8529(05)70271-1PubMedGoogle ScholarCrossref
12.
Segal  BH , Sneller  MC .  Infectious complications of immunosuppressive therapy in patients with rheumatic diseases.   Rheum Dis Clin North Am. 1997;23(2):219-237. doi:10.1016/S0889-857X(05)70327-6PubMedGoogle ScholarCrossref
13.
Carnahan  MC , Goldstein  DA .  Ocular complications of topical, peri-ocular, and systemic corticosteroids.   Curr Opin Ophthalmol. 2000;11(6):478-483. doi:10.1097/00055735-200012000-00016PubMedGoogle ScholarCrossref
14.
Winblad  L , Larsen  CG , Håkansson  K , Abrahamsen  B , von Buchwald  C .  The risk of osteoporosis in oral steroid treatment for nasal polyposis: a systematic review.   Rhinology. 2017;55(3):195-201. doi:10.4193/Rhin15.367PubMedGoogle ScholarCrossref
15.
Price  DB , Trudo  F , Voorham  J ,  et al.  Adverse outcomes from initiation of systemic corticosteroids for asthma: long-term observational study.   J Asthma Allergy. 2018;11:193-204. doi:10.2147/JAA.S176026PubMedGoogle ScholarCrossref
16.
Ross  DA , Cetas  JS .  Steroid psychosis: a review for neurosurgeons.   J Neurooncol. 2012;109(3):439-447. doi:10.1007/s11060-012-0919-zPubMedGoogle ScholarCrossref
17.
Warrington  TP , Bostwick  JM .  Psychiatric adverse effects of corticosteroids.   Mayo Clin Proc. 2006;81(10):1361-1367. doi:10.4065/81.10.1361PubMedGoogle ScholarCrossref
18.
Kershner  P , Wang-Cheng  R .  Psychiatric side effects of steroid therapy.   Psychosomatics. 1989;30(2):135-139. doi:10.1016/S0033-3182(89)72293-3PubMedGoogle ScholarCrossref
19.
Mullol  J , López  E , Roca-Ferrer  J ,  et al.  Effects of topical anti-inflammatory drugs on eosinophil survival primed by epithelial cells: additive effect of glucocorticoids and nedocromil sodium.   Clin Exp Allergy. 1997;27(12):1432-1441. doi:10.1111/j.1365-2222.1997.tb02988.xPubMedGoogle ScholarCrossref
20.
Fernandes  AM , Valera  FC , Anselmo-Lima  WT .  Mechanism of action of glucocorticoids in nasal polyposis.   Braz J Otorhinolaryngol. 2008;74(2):279-283. doi:10.1016/S1808-8694(15)31101-0PubMedGoogle ScholarCrossref
21.
Van Zele  T , Gevaert  P , Holtappels  G ,  et al.  Oral steroids and doxycycline: two different approaches to treat nasal polyps.   J Allergy Clin Immunol. 2010;125(5):1069-1076.e4. doi:10.1016/j.jaci.2010.02.020PubMedGoogle ScholarCrossref
22.
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.   Ann Intern Med. 2011;154(5):293-302. doi:10.7326/0003-4819-154-5-201103010-00003PubMedGoogle ScholarCrossref
23.
Kirtsreesakul  V , Wongsritrang  K , Ruttanaphol  S .  Clinical efficacy of a short course of systemic steroids in nasal polyposis.   Rhinology. 2011;49(5):525-532.PubMedGoogle Scholar
24.
Wright  ED , Agrawal  S .  Impact of perioperative systemic steroids on surgical outcomes in patients with chronic rhinosinusitis with polyposis: evaluation with the novel Perioperative Sinus Endoscopy (POSE) scoring system.   Laryngoscope. 2007;117(11 Pt 2)(suppl 115):1-28. doi:10.1097/MLG.0b013e31814842f8PubMedGoogle Scholar
25.
Ikeda  K , Sakurada  T , Suzaki  Y , Takasaka  T .  Efficacy of systemic corticosteroid treatment for anosmia with nasal and paranasal sinus disease.   Rhinology. 1995;33(3):162-165.PubMedGoogle Scholar
26.
Subramanian  HN , Schechtman  KB , Hamilos  DL .  A retrospective analysis of treatment outcomes and time to relapse after intensive medical treatment for chronic sinusitis.   Am J Rhinol. 2002;16(6):303-312. doi:10.1177/194589240201600605PubMedGoogle ScholarCrossref
27.
Hessler  JL , Piccirillo  JF , Fang  D ,  et al.  Clinical outcomes of chronic rhinosinusitis in response to medical therapy: results of a prospective study.   Am J Rhinol. 2007;21(1):10-18. doi:10.2500/ajr.2007.21.2960PubMedGoogle ScholarCrossref
28.
Lal  D , Scianna  JM , Stankiewicz  JA .  Efficacy of targeted medical therapy in chronic rhinosinusitis, and predictors of failure.   Am J Rhinol Allergy. 2009;23(4):396-400. doi:10.2500/ajra.2009.23.3334PubMedGoogle ScholarCrossref
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