OBJECTIVES/HYPOTHESIS: Intranasal lysine-aspirin has been used as a method of desensitization in patients with aspirin-sensitive nasal polyps to control their recurrence and prevent frequent surgical intervention. However, the studies are limited in number, and their design is open to criticisms. Thus, we conducted a controlled trial to study the clinical effectiveness of topical lysine-aspirin in patients with aspirin-sensitive nasal polyposis. STUDY DESIGN: Prospective, randomized, double blind, placebo controlled, crossover trial. METHODS:Aspirin-sensitive patients confirmed by intranasal challenge were enrolled and randomized to receive 16 mg of topical lysine-aspirin every 48 hours or placebo for 6 months before crossover. Polyp growth and nasal and chest symptoms were monitored using acoustic rhinometry, nasal inspiratory peak flow, peak expiratory flow rate, and a daily diary of symptom scores. RESULTS:Twenty-two patients were enrolled. After withdrawals and drop outs, data were available on 11 patients for analysis. Multivariate analysis of measured parameters did not reveal a significant clinical benefit to patients receiving topical lysine-aspirin compared with placebo. Deterioration was similar while on lysine-aspirin or placebo. CONCLUSIONS: This is the first controlled clinical trial of topical desensitization in aspirin-sensitive nasal polyp patients. Despite the failure to demonstrate clinical benefit, tissue studies have shown a significant improvement at the microscopic level. Further work with larger numbers of patients along with conventional treatment may show a clinical improvement in these patients.
RCT Entities:
OBJECTIVES/HYPOTHESIS: Intranasal lysine-aspirin has been used as a method of desensitization in patients with aspirin-sensitive nasal polyps to control their recurrence and prevent frequent surgical intervention. However, the studies are limited in number, and their design is open to criticisms. Thus, we conducted a controlled trial to study the clinical effectiveness of topical lysine-aspirin in patients with aspirin-sensitive nasal polyposis. STUDY DESIGN: Prospective, randomized, double blind, placebo controlled, crossover trial. METHODS:Aspirin-sensitive patients confirmed by intranasal challenge were enrolled and randomized to receive 16 mg of topical lysine-aspirin every 48 hours or placebo for 6 months before crossover. Polyp growth and nasal and chest symptoms were monitored using acoustic rhinometry, nasal inspiratory peak flow, peak expiratory flow rate, and a daily diary of symptom scores. RESULTS: Twenty-two patients were enrolled. After withdrawals and drop outs, data were available on 11 patients for analysis. Multivariate analysis of measured parameters did not reveal a significant clinical benefit to patients receiving topical lysine-aspirin compared with placebo. Deterioration was similar while on lysine-aspirin or placebo. CONCLUSIONS: This is the first controlled clinical trial of topical desensitization in aspirin-sensitive nasal polyppatients. Despite the failure to demonstrate clinical benefit, tissue studies have shown a significant improvement at the microscopic level. Further work with larger numbers of patients along with conventional treatment may show a clinical improvement in these patients.
Authors: B A Stuck; C Bachert; P Federspil; W Hosemann; L Klimek; R Mösges; O Pfaar; C Rudack; H Sitter; M Wagenmann; R Weber; K Hörmann Journal: HNO Date: 2012-02 Impact factor: 1.284
Authors: B A Stuck; C Bachert; P Federspil; W Hosemann; L Klimek; R Mösges; O Pfaar; C Rudack; H Sitter; M Wagenmann; K Hörmann Journal: HNO Date: 2007-10 Impact factor: 1.284
Authors: Joshua M Levy; Luke Rudmik; Anju T Peters; Sarah K Wise; Brian W Rotenberg; Timothy L Smith Journal: Int Forum Allergy Rhinol Date: 2016-08-02 Impact factor: 3.858