{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T18:29:00Z","timestamp":1791916140455,"version":"4.3.4"},"reference-count":28,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2021,8,6]],"date-time":"2021-08-06T00:00:00Z","timestamp":1628208000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Int Forum Allergy Rhinol"],"published-print":{"date-parts":[[2022,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>The purpose of this study was to test whether cryotherapy is superior to a sham procedure for reducing symptoms of chronic rhinitis.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This study was a prospective, multicenter, 1:1 randomized, sham\u2010controlled, patient\u2010blinded 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\u2010up visits occurred at 30 and 90 days postprocedure. Patient\u2010reported 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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Twelve US investigational centers enrolled 133 participants. The primary endpoint analysis included 127 participants (64 active, 63 sham) with 90\u2010day results. The treatment arm was superior at the 90\u2010day follow\u2010up with 73.4% (47 of 64) responders compared with 36.5% (23 of 63) in the sham arm (<jats:italic>p<\/jats:italic> &lt; 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\u2010day follow\u2010up (<jats:italic>p<\/jats:italic> &lt; 0.001). One serious procedure\u2010related adverse event of anxiety\/panic attack was reported.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Cryotherapy is superior to a sham procedure for improving chronic rhinitis symptoms and patient quality of life.<\/jats:p><\/jats:sec>","DOI":"10.1002\/alr.22868","type":"journal-article","created":{"date-parts":[[2021,8,6]],"date-time":"2021-08-06T11:41:27Z","timestamp":1628250087000},"page":"51-61","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":49,"title":["Cryotherapy for treatment of chronic rhinitis: 3\u2010month outcomes of a randomized, sham\u2010controlled trial"],"prefix":"10.1002","volume":"12","author":[{"given":"Anthony G.","family":"Del Signore","sequence":"first","affiliation":[{"name":"Mount Sinai Hospital System  New York NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joshua B.","family":"Greene","sequence":"additional","affiliation":[{"name":"Ascension St. Vincent Anderson  Anderson IN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph L.","family":"Russell","sequence":"additional","affiliation":[{"name":"National Allergy &amp; ENT  North Charleston SC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David M.","family":"Yen","sequence":"additional","affiliation":[{"name":"Specialty Physician Associates  Bethlehem PA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ellen M.","family":"O'Malley","sequence":"additional","affiliation":[{"name":"Clinical Affairs Stryker ENT  Plymouth MN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rodney J.","family":"Schlosser","sequence":"additional","affiliation":[{"name":"Medical University of South Carolina  Charleston SC"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2021,8,6]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.1017\/S0022215100057716"},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.1001\/archotol.1994.01880360045009"},{"key":"e_1_2_6_4_1","doi-asserted-by":"publisher","DOI":"10.1177\/194589240602000216"},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.otot.2007.05.010"},{"key":"e_1_2_6_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.anl.2011.11.006"},{"key":"e_1_2_6_7_1","doi-asserted-by":"publisher","DOI":"10.1177\/1945892418800879"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.otc.2018.05.010"},{"key":"e_1_2_6_9_1","doi-asserted-by":"publisher","DOI":"10.1017\/S0022215100075927"},{"key":"e_1_2_6_10_1","first-page":"353","article-title":"Cryosurgery: scientific basis and clinical application in otolaryngology","volume":"55","author":"Yousuf M","year":"1976","journal-title":"Ear Nose Throat J."},{"key":"e_1_2_6_11_1","doi-asserted-by":"publisher","DOI":"10.1288\/00005537-197005000-00004"},{"key":"e_1_2_6_12_1","doi-asserted-by":"publisher","DOI":"10.1288\/00005537-198404000-00021"},{"key":"e_1_2_6_13_1","doi-asserted-by":"publisher","DOI":"10.1017\/S0022215100131160"},{"key":"e_1_2_6_14_1","volume-title":"Food and Drug Administration 510(k) Premarket Notification. 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