Oral Corticosteroids Following Endoscopic Sinus Surgery for Chronic Rhinosinusitis Without Nasal Polyposis: A Randomized Clinical Trial

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.

Conflict of interest statement

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.

Figures

Figure 1.. CONSORT Flow Diagram

Summary of participant flow throughout the clinical trial.

Figure 2.. Adverse Effects

BP indicates blood pressure; DM2, type 2 diabetes mellitus; GI, gastrointestinal. Rate of adverse effects reported by patients.