Evidence map›Paper›PMID 36969262›Full record

Trial reportFrontiers in immunology2023

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 and 14 more

Open access · goldFull text readRandomized Controlled TrialMulticenter StudyEquivalence Trial
In one paragraph

Trial report in Frontiers in immunology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
3.7field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 11 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Review
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

24 authors at 10 institutions in 2 countries.

Sarina K MuellerDepartment of Otolaryngology, Head and Neck Surgery, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.
Olaf WendlerDepartment of Otolaryngology, Head and Neck Surgery, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.
Susanne MayrDepartment of Otolaryngology, Head and Neck Surgery, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.
Maximilian TraxdorfDepartment of Otolaryngology, Head and Neck Surgery, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.
Werner HosemannDepartment of Otolaryngology, Head and Neck Surgery, Helios Hanseklinikum Stralsund, Stralsund, Germany.
Heidi OlzeDepartment of Otolaryngology, Head and Neck Surgery, Universitätsklinikum Berlin, Berlin, Germany.
Helmut SteinhartDepartment of Otolaryngology, Head and Neck Surgery, Marienhospital Stuttgart, Stuttgart, Germany.
Susanne WiegandDepartment of Otolaryngology, Head and Neck Surgery, Phillips Universität Marburg, Marburg, Germany.
Afshin TeymoortashDepartment of Otolaryngology, Head and Neck Surgery, Phillips Universität Marburg, Marburg, Germany.
Thomas KuehnelDepartment of Otolaryngology, Head and Neck Surgery, Universitätsklinikum Regensburg, Regensburg, Germany.
Stephan HackenbergDepartment of Otolaryngology, Head and Neck Surgery, Universitätsklinikum Regensburg, Regensburg, Germany.
Thomas HummelDepartment of Otolaryngology, Head and Neck Surgery, Smell and Taste Clinic, Universitätsklinikum Carl Gustav Carus Dresden, Dresden, Germany.
Petra AmbroschDepartment of Otolaryngology, Head and Neck Surgery, Christian-Albrechts-Universität (CAU) Kiel, Kiel, Germany.
Azita FazelDepartment of Otolaryngology, Head and Neck Surgery, Christian-Albrechts-Universität (CAU) Kiel, Kiel, Germany.
Bernhard SchickDepartment of Otolaryngology, Head and Neck Surgery, Universitätsklinikum des Saarlandes, Homburg, Germany.
Hanns-Wolf BaenklerDepartment of Rheumatology and Immunology, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.
Michael KochDepartment of Otolaryngology, Head and Neck Surgery, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.
Harald BuernerDepartment of Otolaryngology, Head and Neck Surgery, Marienhospital Stuttgart, Stuttgart, Germany.
Konstantinos MantsopoulosDepartment of Otolaryngology, Head and Neck Surgery, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.
Philipp GrundtnerDepartment of Otolaryngology, Head and Neck Surgery, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.
Angela NoceraDepartment of Otolaryngology Harvard Medical School, Massachusetts Eye and Ear Infirmary, Boston, MA, United States.
Abbas AgaimyDepartment of Pathology, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.
Benjamin BleierDepartment of Otolaryngology Harvard Medical School, Massachusetts Eye and Ear Infirmary, Boston, MA, United States.
Heinrich IroDepartment of Otolaryngology, Head and Neck Surgery, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.
Friedrich-Alexander-Universität Erlangen-Nürnberg · DEHarvard University · USKiel University · DEMarienhospital Stuttgart · DEPhilipps University of Marburg · DEUniversitätsklinikum Aachen · DEUniversitätsklinikum des Saarlandes · DEUniversity Hospital Carl Gustav Carus · DEUniversity Hospital Regensburg · DEUniversity of Applied Sciences Stralsund · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Nasal PolypsRhinitisSinusitisHumansPrednisoloneProspective StudiesQuality of LifeSteroidsPrednisoloneSteroidschronic rhinosinusitislong-termnasal polyp (NP)postoperativeprednisolonerandomized controlled trial

Identifiers

PMID36969262
PMCPMC10032209
OpenAlexW4323545210

What OpenQuestion holds

Textfull text, public
LicenceCC BY
reference markers read1
measurements read32
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.