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

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-...

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Autores principales: Mueller, Sarina K., Wendler, Olaf, Mayr, Susanne, Traxdorf, Maximilian, Hosemann, Werner, Olze, Heidi, Steinhart, Helmut, Wiegand, Susanne, Teymoortash, Afshin, Kuehnel, Thomas, Hackenberg, Stephan, Hummel, Thomas, Ambrosch, Petra, Fazel, Azita, Schick, Bernhard, Baenkler, Hanns-Wolf, Koch, Michael, Buerner, Harald, Mantsopoulos, Konstantinos, Grundtner, Philipp, Nocera, Angela, Agaimy, Abbas, Bleier, Benjamin, Iro, Heinrich
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10032209/
https://www.ncbi.nlm.nih.gov/pubmed/36969262
http://dx.doi.org/10.3389/fimmu.2023.1075066
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author Mueller, Sarina K.
Wendler, Olaf
Mayr, Susanne
Traxdorf, Maximilian
Hosemann, Werner
Olze, Heidi
Steinhart, Helmut
Wiegand, Susanne
Teymoortash, Afshin
Kuehnel, Thomas
Hackenberg, Stephan
Hummel, Thomas
Ambrosch, Petra
Fazel, Azita
Schick, Bernhard
Baenkler, Hanns-Wolf
Koch, Michael
Buerner, Harald
Mantsopoulos, Konstantinos
Grundtner, Philipp
Nocera, Angela
Agaimy, Abbas
Bleier, Benjamin
Iro, Heinrich
author_facet Mueller, Sarina K.
Wendler, Olaf
Mayr, Susanne
Traxdorf, Maximilian
Hosemann, Werner
Olze, Heidi
Steinhart, Helmut
Wiegand, Susanne
Teymoortash, Afshin
Kuehnel, Thomas
Hackenberg, Stephan
Hummel, Thomas
Ambrosch, Petra
Fazel, Azita
Schick, Bernhard
Baenkler, Hanns-Wolf
Koch, Michael
Buerner, Harald
Mantsopoulos, Konstantinos
Grundtner, Philipp
Nocera, Angela
Agaimy, Abbas
Bleier, Benjamin
Iro, Heinrich
author_sort Mueller, Sarina K.
collection PubMed
description 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.
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spelling pubmed-100322092023-03-23 Effect of postoperative systemic prednisolone on short-term and long-term outcomes in chronic rhinosinusitis with nasal polyps: A multi-centered randomized clinical trial Mueller, Sarina K. Wendler, Olaf Mayr, Susanne Traxdorf, Maximilian Hosemann, Werner Olze, Heidi Steinhart, Helmut Wiegand, Susanne Teymoortash, Afshin Kuehnel, Thomas Hackenberg, Stephan Hummel, Thomas Ambrosch, Petra Fazel, Azita Schick, Bernhard Baenkler, Hanns-Wolf Koch, Michael Buerner, Harald Mantsopoulos, Konstantinos Grundtner, Philipp Nocera, Angela Agaimy, Abbas Bleier, Benjamin Iro, Heinrich Front Immunol Immunology 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. Frontiers Media S.A. 2023-03-08 /pmc/articles/PMC10032209/ /pubmed/36969262 http://dx.doi.org/10.3389/fimmu.2023.1075066 Text en 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 https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Immunology
Mueller, Sarina K.
Wendler, Olaf
Mayr, Susanne
Traxdorf, Maximilian
Hosemann, Werner
Olze, Heidi
Steinhart, Helmut
Wiegand, Susanne
Teymoortash, Afshin
Kuehnel, Thomas
Hackenberg, Stephan
Hummel, Thomas
Ambrosch, Petra
Fazel, Azita
Schick, Bernhard
Baenkler, Hanns-Wolf
Koch, Michael
Buerner, Harald
Mantsopoulos, Konstantinos
Grundtner, Philipp
Nocera, Angela
Agaimy, Abbas
Bleier, Benjamin
Iro, Heinrich
Effect of postoperative systemic prednisolone on short-term and long-term outcomes in chronic rhinosinusitis with nasal polyps: A multi-centered randomized clinical trial
title Effect of postoperative systemic prednisolone on short-term and long-term outcomes in chronic rhinosinusitis with nasal polyps: A multi-centered randomized clinical trial
title_full Effect of postoperative systemic prednisolone on short-term and long-term outcomes in chronic rhinosinusitis with nasal polyps: A multi-centered randomized clinical trial
title_fullStr Effect of postoperative systemic prednisolone on short-term and long-term outcomes in chronic rhinosinusitis with nasal polyps: A multi-centered randomized clinical trial
title_full_unstemmed Effect of postoperative systemic prednisolone on short-term and long-term outcomes in chronic rhinosinusitis with nasal polyps: A multi-centered randomized clinical trial
title_short Effect of postoperative systemic prednisolone on short-term and long-term outcomes in chronic rhinosinusitis with nasal polyps: A multi-centered randomized clinical trial
title_sort effect of postoperative systemic prednisolone on short-term and long-term outcomes in chronic rhinosinusitis with nasal polyps: a multi-centered randomized clinical trial
topic Immunology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10032209/
https://www.ncbi.nlm.nih.gov/pubmed/36969262
http://dx.doi.org/10.3389/fimmu.2023.1075066
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