Cryotherapy for treatment of chronic rhinitis: 3-month outcomes of a randomized, sham-controlled trial.
Int Forum Allergy Rhinol
; 12(1): 51-61, 2022 01.
Article
em En
| MEDLINE
| ID: mdl-34355872
ABSTRACT
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, 11 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.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Rinite
Tipo de estudo:
Clinical_trials
/
Observational_studies
Limite:
Adult
/
Humans
Idioma:
En
Ano de publicação:
2022
Tipo de documento:
Article