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Are oral corticosteroids beneficial following endoscopic sinus surgery (ESS) in patients with chronic rhinosinusitis (CRS) without nasal polyps?
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.
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.
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.
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.
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.
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 = 1.71, η2 = 0.01 [95% CI, 0.00-0.05]) or Lund-Kennedy scores (F = 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 = 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.
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.
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 (email@example.com).
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.
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