PT - JOURNAL ARTICLE AU - Rabago, David AU - Zgierska, Aleksandra AU - Turnquist, Alyssa AU - Shara, Nawar AU - Tong, Sebastian AU - Fernandez, Stephen AU - Henningfield, Mary AU - Fencil, Charles AU - Tarn, Derjung AU - Krist, Alex AU - Merenstein, Daniel AU - Smith, Keisha Herbin AU - Blaker, Joshua AU - Sparenborg, Jessy AU - Franko, Nicholas AU - Barrett, Bruce AU - Casey, Cameron AU - Schramm, Danielle AU - Tan, Tina AU - Drose-Bigatel, Levelle AU - Whitfield, Michael AU - Stienecker, Sara AU - Mete, Mihriye AU - Sanghavi, Kavya TI - Adjunctive Saline Nasal Irrigation for Acute Rhinosinusitis: Results of a Randomized Pilot Study AID - 10.1370/afm.22.s1.6643 DP - 2024 Nov 20 TA - The Annals of Family Medicine PG - 6643 VI - 22 IP - Supplement 1 4099 - http://www.annfammed.org/content/22/Supplement_1/6643.short 4100 - http://www.annfammed.org/content/22/Supplement_1/6643.full SO - Ann Fam Med2024 Nov 20; 22 AB - CONTEXT Acute rhinosinusitis (ARS) affects 15% of the adult population annually, and accounts for 20% of adult outpatient antibiotic prescriptions. Evidence is needed to clarify effectiveness of standard treatment, which includes antibiotics and intra-nasal corticosteroids (INCS), and supportive care including saline nasal irrigation (SNI), which is reported safe and effective for limiting sino-nasal symptoms but is poorly studied in ARS.OBJECTIVE We assessed feasibility and patient-reported clinical outcomes of adjunctive use of SNI in ARS.STUDY DESIGN/INTERVENTION The PCORI-funded NOSES (Nasal Steroids, Nasal Irrigation, Oral Antibiotics and Subgroup Targeting for Effective Management of Sinusitis) study has completed a double-blind, 4-arm (antibiotics vs antibiotics+INCS vs INCS vs placebo antibiotics) feasibility RCT. Participants in six U.S. practice based research networks were followed in pre-randomized (days 0-9) and randomized (days 10-23) phases.INTERVENTION All participants were provided with SNI materials (neti pot, salt packets, and distilled water) and advised to use twice daily as part of supportive care.SETTING/POPULATION/OUTCOME MEASURES Outpatient, participants with ARS. Primary: days participants used SNI at least once assessed in daily diary. Secondary: average rate of SNI use, percentage of participants who used SNI at least 50% of study days; perceived effect on sino-nasal symptoms; association of SNI use with validated clinical outcomes instrument severity score.RESULTS: 140 participants in both phases of the study completed 1606 of 1727 possible diary entries (93%); 534 diary entries noted SNI use (33%). Pre-randomized participants reported using SNI 37.6% (SD=34.0) of the time independent of days in the study. Randomized participants used SNI 36.8% (SD=38.4) of days in the study. Among pre-randomized participants (n=110), 51 (46%) participants reported using SNI on a least 50% of study days; among randomized participants (n=87), 27 (31%) did so. SNI use varied by study site (P<.0001). 330 (81%) of diary entries noting SNI use reported it reduced nasal/sinus symptoms. SNI use and self-reported clinical outcomes scores were not associated in either study phase.CONCLUSIONS: Participants in this pilot study used SNI in both pre-randomized and randomized phases of the of the study, though adherence was low. Results suggest the need to enhance SNI adherence strategies.