Effect of postoperative systemic prednisolone on short-term and long-term outcomes in chronic rhinosinusitis with nasal polyps: A multi-centered randomized clinical trial

Abstract

IntroductionThe objective of this study was to determine whether postoperative additive systemic steroid administration in chronic rhinosinusitis with nasal polyps (CRSwNP) impacted selected endoscopic, subjective and objective outcome measures.MethodsThis was a prospective, randomized, double-blind, placebo-controlled, noninferiority multicenter trial of n=106 patients with CRSwNP. All patients underwent primary functional endoscopic sinus surgery (FESS) followed by topical nasal steroids. Patients were randomized to a systemic steroid or placebo for 1 month. Patients were followed up for 2 years over 9 time points. The primary outcome measures were the differences between groups with respect to the nasal polyp score (NPS) and sinonasal quality of life (SNQoL). Secondary outcome measures included interactions with respect to the Lund-Kennedy score (LKS), sinonasal symptoms, general quality of life (GQoL), 16-item odor identification test scores, recurrence rates, need for revision surgery and mucus biomarker levels.Results106 patients were randomized to either the placebo or the systemic steroid group (n=53 per group). Postoperative systemic steroids were not superior to placebo with respect to all primary (p= 0.077) and secondary outcome measures (p>0.05 for all). Reported adverse events were similar between the two groups.ConclusionIn conclusion, the addition of postoperative systemic steroids after primary FESS did not confer a benefit over topical steroid nasal spray alone with respect to NPS, SNQOL, LKS, GQOL, sinonasal symptoms, smell scores, recurrence rates, the need for revision surgery or biomarkers over a short-term follow-up of up to 9 months and a long-term follow-up of up to 24 months in CRSwNP patients. Functional endoscopic surgery did, however, show a strong effect on all outcome measures, which remained relatively stable up to the endpoint at 2 years.

Comparison of mucus and serum biomarker sampling in chronic rhinosinusitis with nasal polyps

“…For this reason, we have only displayed the recurrence versus non‐recurrence subgroup analysis. For further details on mucus, please see Mueller et al 28 …”

“…Medication (topical and systemic steroids) was standardized and tracked over the 24 months. Selected details of the trials are as follows: for the complete description, please see Mueller et al 28 In the trial, all patients received postoperative a topical steroid spray for 3 months and were randomized to either a systemic steroid or a placebo for 1 month postoperatively. Additional medications including steroids, antibiotics, aspirin, or leukotriene antagonists were assessed regularly over the whole time period.…”

“…These data are part of the clinical trials NCT04915456. The manuscript to the trial has been published, 28 and a subgroup analysis for smell outcomes has also been published 29 . CRSwNP was defined using the symptom burden (as later described in the ICAR:RS 5 criteria).…”