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A novel treatment adjunct for aspirin exacerbated respiratory disease: the low‐salicylate diet: a multicenter randomized control crossover trial
Author(s) -
Sommer Doron D.,
Rotenberg Brian W.,
Sowerby Leigh J.,
Lee John M.,
Janjua Arif,
Witterick Ian J.,
Monteiro Eric,
Gupta Michael K.,
Au Michael,
Nayan Smriti
Publication year - 2016
Publication title -
international forum of allergy and rhinology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.503
H-Index - 46
eISSN - 2042-6984
pISSN - 2042-6976
DOI - 10.1002/alr.21678
Subject(s) - medicine , crossover study , asthma , aspirin , sinusitis , randomized controlled trial , confidence interval , perioperative , prospective cohort study , nasal polyps , gastroenterology , anesthesia , surgery , placebo , alternative medicine , pathology
Background Aspirin‐exacerbated respiratory disease (AERD) is a clinical triad consisting of aspirin/acetylsalicylic acid (ASA) sensitivity, bronchial asthma, and nasal polyposis. Although respiratory reactions following ingestion of ASA and other nonsteroidal anti‐inflammatory drugs (NSAIDs) are considered a hallmark of the condition, respiratory inflammation persists despite patients’ avoidance of NSAIDs. Treatment of this condition remains challenging and includes both medical and surgical options. Methods A prospective crossover single‐blind multicenter study involving 4 tertiary rhinology care centers (n = 30) was conducted in which patients were randomized to start with either 6 weeks of a regular diet or 6 weeks of a low‐salicylate diet and then crossed‐over for a total study duration of 12 weeks. Patients were evaluated at baseline, 6 weeks (at crossover) and 12 weeks using subjective measures (22‐item Sino‐Nasal Outcome Test‐22 [SNOT‐22], Nasal Sinus Symptom Scale [NSSS], and 7‐item Asthma Control Questionnaire [ACQ‐7]) and objective outcome instruments (Perioperative Sinus Evaluation [POSE] and Lund‐Kennedy Endoscopic Score [LKES]). Results Data was analyzed for 30 patients. Wilcoxon rank sum tests determined that patients had improvement in their median difference in scores, which were all statistically significant, when they followed the low‐salicylate diet compared to their regular diet: SNOT‐22: 15 (95% confidence interval [CI], 10 to 23.25), p < 0.001; NSSS: 3 (95% CI, 1.75 to 4), p < 0.001; ACQ‐7: 4.5 (95% CI, 1.5 to 8.5), p < 0.001; POSE 6 (95% CI, 2.5 to 10), p < 0.001; and LKES: 2.5 (95% CI, 1.5 to 4), p < 0.001). Conclusion The low‐salicylate diet may offer a novel treatment adjunct to the current management of AERD. Clinically and statistically significant improvements on both subjective and objective outcome measures were noted for the upper and lower respiratory tracts.