Nebulized bacitracin/colimycin: a treatment option in recalcitrant chronic rhinosinusitis with Staphylococcus aureus? A double-blind, randomized, placebo-controlled, cross-over pilot study.
Bibliographic record
Abstract
INTRODUCTION: Despite optimal medical therapy and endoscopic sinus surgery there still remains a group of unfortunate patients suffering from exacerbations of recalcitrant chronic sinusitis. We have performed a pilot study in order to determine whether nebulized topical antibiotic therapy improves sinusitis symptoms more than saline-based placebo in patients with recalcitrant chronic rhinosinusitis. PATIENTS AND METHODS: A randomized, placebo-controlled, double-blind, cross-over pilot study was conducted in 14 patients with recalcitrant CRS. Nasal irrigation with bacitracin/colimycin or placebo using the RhinoFlow nebulizer twice daily was administered in combination with oral levofloxacin. Severity of a diversity of symptoms was measured using the VAS score, a Disease-Specific Symptom Score and the SF-36 questionnaire. Nasal endoscopic findings were also assessed. RESULTS: For most VAS items and Disease-Specific Symptom Scores, a reduction in severity of symptoms was noted in both the bacitracin/colimycin and the placebo group. No significant difference was found between the 2 arms (bacitracin/colimycin vs. placebo). Most SF-36 items improved, compared with the situation before treatment in both groups. However no significant difference was found between the verum and placebo arm. Endoscopic findings did not reveal significant differences when comparing the 2 treatments. CONCLUSION AND DISCUSSION: The outcome of this study suggests a beneficial effect of nebulizing the nose with saline. This study again shows that adding antibiotics to local saline is not effective. Although the placebo-controlled studies looking at the effect of local antibiotics are all small they all point to the same direction: no effect. Definite conclusions however need a large randomized, multicenter study.
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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 | 0.003 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.003 | 0.002 |
| Insufficient payload (model declined to judge) | 0.004 | 0.001 |
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".