Course: Oral Corticosteroids Following Endoscopic Sinus Surgery for Chronic Rhinosinusitis Without Nasal Polyposis: A Randomized Clinical Trial
CME Credits: 1.00
Released: 2021-03-04
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, -2?=-0.01 [95% CI, 0.00-0.05]) or Lund-Kennedy scores (F[4247]?=-1.23, -2?=-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, -2?=-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:
Educational Objective
To assess the efficacy of oral corticosteroids following endoscopic sinus surgery in patients with CRS without polyps.
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