Cryotherapy for treatment of chronic rhinitis: 3‐month outcomes of a randomized, sham‐controlled trial

Signore, Anthony G. Del; Greene, Joshua B.; Russell, Joseph L.; Yen, David M.; O’Malley, Ellen M.; Schlosser, Rodney J.

doi:10.1002/alr.22868

Cited by 29 publications

(81 citation statements)

References 28 publications

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“…Except for the single-centre study by Krespi et al [13], all were multi-centre studies. Del Signore et al used variable block size distribution by site with a 1:1 allocation [15]. Stolovitzky et al used a 2:1 site-stratified block randomization [16].…”

Section: Study Characteristicsmentioning

confidence: 99%

“…All were carried out in the USA and six out of the eight had industry sponsorship. Follow up periods varied between 3 months [13,14,15,16], 9 months [17], 12 months [18,19], and 24 months [20].…”

Section: Study Characteristicsmentioning

confidence: 99%

“…Gerka Stuyt et al specified that patients must have had failure of trial of medical therapy for at least 3 months [19]. Four studies required patients to discontinue ipratropium bromide at least 3-days pre-procedure and throughout the follow up period [14,15,17,20].…”

Section: F O R P U B L I C a T I O Nmentioning

confidence: 99%

Section: Interventionmentioning

confidence: 99%

“…Bilateral PNNN was performed as a single procedure in all studies, using a single surgical modality of either cryotherapy [14,15,17,18,19,20], radiofrequency [16], or continuous wave laser [13] (Table 3). Five studies used ClariFix (Stryker ENT, Plymouth MN, USA) to perform the cryoablation endoscopically in line with the manufacturer's guidance [14,15,17,18,20]. In the sham control arm of the study by Del Signore et al the cryoprobe was held in place while a separate device with a canister loaded was held near the participant and activated to provide the sound of gas release [15].…”

Section: Interventionmentioning

confidence: 99%

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Posterior nasal nerve neurectomy for the treatment of rhinitis: a systematic review and meta-analysis

Balai¹,

Gupta²,

Jolly³

et al. 2023

Eur Ann Allergy Clin Immunol

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BackgroundPosterior nasal nerve neurectomy (PNNN) is a surgical option for the treatment of refractory chronic rhinitis. It can be performed by surgical dissection, cryotherapy, or laser ablation. ObjectiveThis systematic review aimed to assess the effect of PNNN on Total Nasal Symptom Score (TNSS) in adults with chronic rhinitis. MethodsA systematic review of EMBASE, MEDLINE, PubMed and ClinicalKey databases was conducted in November 2021. Studies reporting PNNN performed as a single procedure in adult patients with allergic, non-allergic or mixed chronic rhinitis, and TNSS as the outcome measure, were included. M a n u s c r i p t a c c e p t e d f o r p u b l i c a t i o n ResultsDatabase search identified 39 articles, of which 8 (463 patients) were included in the review. Two were randomised sham-controlled trials and six were prospective singlearm, unblinded and uncontrolled studies. Pooled analysis of data from the two randomized controlled trials found active treatment was associated with a significantly greater responder (≥30% reduction in TNSS from baseline) rate (OR 3.85, 95% CI 2.23 -6.64, p<0.00001). ConclusionsThis systematic review identified there is some limited evidence to suggest cryotherapy or radiofrequency ablation of the posterior nasal nerve can improve TNSS in adult patients. However, this is from a limited number of trials with short follow-up. Future research should focus on prospective randomised controlled trials with larger numbers of participants and medium to long term follow up in order to help draw more valid conclusions regarding the true effectiveness of PNNN in this patient cohort.

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Section: Study Characteristicsmentioning

confidence: 99%

Section: Study Characteristicsmentioning

confidence: 99%

Section: F O R P U B L I C a T I O Nmentioning

confidence: 99%

Section: Interventionmentioning

confidence: 99%

Section: Interventionmentioning

confidence: 99%

See 3 more Smart Citations

Posterior nasal nerve neurectomy for the treatment of rhinitis: a systematic review and meta-analysis

Balai¹,

Gupta²,

Jolly³

et al. 2023

Eur Ann Allergy Clin Immunol

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Cryotherapy for treatment of chronic rhinitis: 3‐month outcomes of a randomized, sham‐controlled trial

Signore

Greene

Russell

et al. 2021

Int Forum Allergy Rhinol

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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.

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Temperature‐controlled radiofrequency neurolysis for treatment of chronic rhinitis: 12‐month outcomes after treatment in a randomized controlled trial

Takashima

Stolovitzky

et al. 2022

Int Forum Allergy Rhinol

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Background Temperature‐controlled radiofrequency (TCRF) neurolysis of the posterior nasal nerve (PNN) area for the treatment of chronic rhinitis was previously reported as superior to a sham‐control procedure at 3 months postprocedure in a randomized controlled trial (RCT). The primary endpoint was a responder rate of ≥30% improvement (decrease) for 24‐hour reflective total nasal symptom score (rTNSS) compared with baseline. Herein, 12‐month outcomes after active treatment are reported. Methods In this prospective, multicenter, patient‐blinded RCT, patients in the index active treatment arm were unblinded at 3 months and followed through 12 months. At 3 months, eligible patients from the sham‐control arm of the study were invited to crossover to active treatment. Eligibility criteria included rTNSS ≥6, with moderate‐severe rhinorrhea and mild‐severe congestion. The TCRF stylus was applied bilaterally to nonoverlapping areas in the region of the PNN. Results Patients in the index active treatment arm (n = 77) had a mean baseline rTNSS of 8.3 (95% confidence interval [CI], 7.9‐8.7). At 12 months, the responder rate was 80.6% (n = 67) (95% CI, 69.1%‐89.2%). At 12 months, the mean change in rTNSS was −4.8 (95% CI, −5.5 to −4.1; p < 0.001), a 57.8% improvement. The available initial rTNSS‐based outcomes in the crossover active treatment arm (n = 27) were following the same course as the index treatment arm. No serious adverse events and 8 adverse events related to the device/procedure were reported in the trial to date. Conclusion TCRF neurolysis of the PNN area is safe and the symptom burden improvement that was superior to a sham procedure at 3 months was sustained through 12 months.

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Cryotherapy for treatment of chronic rhinitis: 3‐month outcomes of a randomized, sham‐controlled trial

Cited by 29 publications

References 28 publications

Posterior nasal nerve neurectomy for the treatment of rhinitis: a systematic review and meta-analysis

Posterior nasal nerve neurectomy for the treatment of rhinitis: a systematic review and meta-analysis

Cryotherapy for treatment of chronic rhinitis: 3‐month outcomes of a randomized, sham‐controlled trial

Temperature‐controlled radiofrequency neurolysis for treatment of chronic rhinitis: 12‐month outcomes after treatment in a randomized controlled trial

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