A novel treatment adjunct for aspirin exacerbated respiratory disease: the low-salicylate diet: a multicenter randomized control crossover trial
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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.
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