Safety of long‐term high‐volume sinonasal budesonide irrigations for chronic rhinosinusitis
Bibliographic record
Abstract
BACKGROUND: Off-label high-volume sinonasal budesonide irrigations are commonly used during the management of chronic rhinosinusitis (CRS). Although short-term use (4 to 8 weeks) has been demonstrated to be safe, the long-term effects on the hypothalamic-pituitary-adrenal (HPA) axis remain unclear. The objective of this study is to determine whether CRS patients using long-term (minimum greater than 12 months) budesonide sinonasal irrigations have evidence of HPA axis suppression. METHODS: Patients with CRS being managed with high-volume sinonasal budesonide irrigations were recruited from 2 tertiary level rhinology clinics between March 2014 and July 2015. Inclusion criteria were as follows: (1) adult (age greater than 18 years); (2) guideline-based diagnosis of CRS; (3) previous endoscopic sinus surgery; (4) minimum of twice daily high-volume sinonasal budesonide irrigation (concentration of 1 mg per irrigation; total daily dose of 2 mg); and (5) a minimum of 12-month duration. Exclusion criteria included systemic corticosteroid use within 3 months of HPA axis testing. The primary outcomes were morning (am) serum cortisol levels and, when indicated, cosyntropin stimulation levels. RESULTS: A total of 35 patients fulfilled eligibility criteria and underwent HPA axis testing. Mean duration of budesonide sinonasal irrigation therapy use was 38.2 months (2.9 years). The mean ± standard deviation (SD) am serum cortisol was 431.2 ± 146.9 nmol/L (normal, 200 to 650 nmol/L). Subsequent cosyntropin stimulation tests, in indicated patients (n = 19), demonstrated no evidence of HPA axis suppression. CONCLUSION: Outcomes from this study suggest that daily high-volume sinonasal budesonide irrigations fail to produce evidence of HPA axis suppression with prolonged courses lasting longer than 2 years.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.007 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".