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

Sarina K Mueller; Olaf Wendler; Susanne Mayr; Maximilian Traxdorf; Werner Hosemann; Heidi Olze; Helmut Steinhart; Susanne Wiegand; Afshin Teymoortash; Thomas Kuehnel; Stephan Hackenberg; Thomas Hummel; Petra Ambrosch; Azita Fazel; Bernhard Schick; Hanns-Wolf Baenkler; Michael Koch; Harald Buerner; Konstantinos Mantsopoulos; Philipp Grundtner; Angela Nocera; Abbas Agaimy; Benjamin Bleier; Heinrich Iro

doi:10.3389/fimmu.2023.1075066

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

Front Immunol. 2023 Mar 8:14:1075066. doi: 10.3389/fimmu.2023.1075066. eCollection 2023.

Authors

Sarina K Mueller¹, Olaf Wendler¹, Susanne Mayr¹, Maximilian Traxdorf¹, Werner Hosemann², Heidi Olze³, Helmut Steinhart⁴, Susanne Wiegand^{5

6}, Afshin Teymoortash⁵, Thomas Kuehnel⁷, Stephan Hackenberg^{7

8}, Thomas Hummel⁹, Petra Ambrosch¹⁰, Azita Fazel¹⁰, Bernhard Schick¹¹, Hanns-Wolf Baenkler¹², Michael Koch¹, Harald Buerner⁴, Konstantinos Mantsopoulos¹, Philipp Grundtner¹, Angela Nocera¹³, Abbas Agaimy¹⁴, Benjamin Bleier¹³, Heinrich Iro¹

Affiliations

¹ Department of Otolaryngology, Head and Neck Surgery, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.
² Department of Otolaryngology, Head and Neck Surgery, Helios Hanseklinikum Stralsund, Stralsund, Germany.
³ Department of Otolaryngology, Head and Neck Surgery, Universitätsklinikum Berlin, Berlin, Germany.
⁴ Department of Otolaryngology, Head and Neck Surgery, Marienhospital Stuttgart, Stuttgart, Germany.
⁵ Department of Otolaryngology, Head and Neck Surgery, Phillips Universität Marburg, Marburg, Germany.
⁶ Department of Otolaryngology, Head and Neck Surgery, Universitätsklinikum Leipzig, Leipzig, Germany.
⁷ Department of Otolaryngology, Head and Neck Surgery, Universitätsklinikum Regensburg, Regensburg, Germany.
⁸ Department of Otorhinolaryngology, Head and Neck Surgery, Universitätsklinikum Aachen, Aachen, Germany.
⁹ Department of Otolaryngology, Head and Neck Surgery, Smell and Taste Clinic, Universitätsklinikum Carl Gustav Carus Dresden, Dresden, Germany.
¹⁰ Department of Otolaryngology, Head and Neck Surgery, Christian-Albrechts-Universität (CAU) Kiel, Kiel, Germany.
¹¹ Department of Otolaryngology, Head and Neck Surgery, Universitätsklinikum des Saarlandes, Homburg, Germany.
¹² Department of Rheumatology and Immunology, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.
¹³ Department of Otolaryngology Harvard Medical School, Massachusetts Eye and Ear Infirmary, Boston, MA, United States.
¹⁴ Department of Pathology, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.

Abstract

Introduction: The 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.

Methods: This 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.

Results: 106 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.

Conclusion: In 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.

Keywords: chronic rhinosinusitis; long-term; nasal polyp (NP); postoperative; prednisolone; randomized controlled trial.

Copyright © 2023 Mueller, Wendler, Mayr, Traxdorf, Hosemann, Olze, Steinhart, Wiegand, Teymoortash, Kuehnel, Hackenberg, Hummel, Ambrosch, Fazel, Schick, Baenkler, Koch, Buerner, Mantsopoulos, Grundtner, Nocera, Agaimy, Bleier and Iro.

Publication types

Randomized Controlled Trial
Multicenter Study
Research Support, Non-U.S. Gov't

MeSH terms

Humans
Nasal Polyps* / complications
Nasal Polyps* / drug therapy
Nasal Polyps* / surgery
Prednisolone / therapeutic use
Prospective Studies
Quality of Life
Rhinitis* / complications
Rhinitis* / drug therapy
Rhinitis* / surgery
Sinusitis* / complications
Sinusitis* / drug therapy
Sinusitis* / surgery
Steroids

Substances

Prednisolone
Steroids

Grants and funding

This research received funding from Merck. The funder had the following involvement in the study: payment of patients' insurances. The funder was not involved in the study design, collection, analysis, interpretation of data, the writing of this article, or the decision to submit it for publication.