Background The purpose of this study was to test whether cryotherapy is superior to a sham procedure for reducing symptoms of chronic rhinitis. Methods This study was a prospective, multicenter, 1:1 randomized, sham‐controlled, patient‐blinded trial. The predetermined sample size was 61 participants per arm. Adults with moderate/severe symptoms of chronic rhinitis who were candidates for cryotherapy under local anesthesia were enrolled. Participants were required to have minimum reflective Total Nasal Symptom Scores (rTNSSs) of 4 for total, 2 for rhinorrhea, and 1 for nasal congestion. Follow‐up visits occurred at 30 and 90 days postprocedure. Patient‐reported outcome measures included the rTNSS, standardized Rhinoconjunctivitis Quality of Life Questionnaire [RQLQ(S)], and Nasal Obstruction Symptom Evaluation (NOSE) questionnaires. Adverse events were also recorded. The primary endpoint was the comparison between the treatment and sham arms for the percentage of responders at 90 days. Responders were defined as participants with a 30% or greater reduction in rTNSS relative to baseline. Results Twelve US investigational centers enrolled 133 participants. The primary endpoint analysis included 127 participants (64 active, 63 sham) with 90‐day results. The treatment arm was superior at the 90‐day follow‐up with 73.4% (47 of 64) responders compared with 36.5% (23 of 63) in the sham arm (p < 0.001). There were greater improvements in the rTNSS, RQLQ(S), and NOSE scores for the active arm over the sham arm at the 90‐day follow‐up (p < 0.001). One serious procedure‐related adverse event of anxiety/panic attack was reported. Conclusion Cryotherapy is superior to a sham procedure for improving chronic rhinitis symptoms and patient quality of life.
Surgical treatments for nasal airway obstruction (NAO) are commonly offered as part of otolaryngology practice. Anatomic causes include septal deviation, inferior turbinate hypertrophy, and nasal valve collapse (NVC). This study was performed to determine the prevalence of anatomic contributors to NAO. A total of 1,906 patients with sinonasal complaints were surveyed by 50 otolaryngologists in varying U.S. geographic regions. Patients were first evaluated using the Nasal Obstruction Symptom Evaluation (NOSE) instrument to assess the NAO symptoms and their severity. Physicians then examined patients for the presence of the three anatomic contributors. Presence of septal deviation and turbinate hypertrophy was assessed through an internal nasal exam with direct or endoscopic visualization based on the physician's standard methodology for diagnosis. Presence of NVC was determined by the modified Cottle maneuver. Among all patients surveyed, prevalence was 67% for NVC, 76% for septal deviation, and 72% for inferior turbinate hypertrophy. We found that 64% of the patients (n = 1,211) had severe/extreme NOSE scores (≥55), representing the most likely nasal obstruction candidates for intervention. In these patients, the prevalence of NVC, septal deviation, and inferior turbinate hypertrophy was 73, 80, and 77%, respectively. Eighty-two percent of the 236 patients with severe/extreme NOSE scores who reported prior septoplasty and/or inferior turbinate reduction had NVC. Our study revealed a comparable prevalence of all three anatomic contributors across all patients and the subset with severe/extreme NOSE scores, highlighting the importance of evaluating the lateral nasal wall as a component of NAO treatment strategy.
We performed a population-based historical cohort study using the Surveillance, Epidemiology, and End Results (SEER) database to determine trends in the incidence of major salivary gland cancer and to evaluate the effect of sex, tumor size, histology, primary site, and extent of disease. Participants were men and women with major salivary gland cancer, diagnosed 1973-2009.
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