Intranasal lysine-aspirin in aspirin-sensitive nasal polyposis: a controlled trial.
OBJECTIVE
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.


METHODS
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.
Parikh
Abhi A
AA
St. Mary's Hospital, Praed Street, London W2 1NY, UK. abhijeetparikh@hotmail.com
Scadding
Glenis K
GK
D000281:Administration, Intranasal; D000328:Adult; D000367:Age Factors; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage*; D001241:Aspirin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008239:Lysine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009298:Nasal Polyps / Q000188:drug therapy* / Q000473:pathology*; D009299:Nasal Provocation Tests; D011336:Probability; D012307:Risk Factors; D012737:Sex Factors; D018709:Statistics, Nonparametric; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; D008239:Lysine; D001241:Aspirin; C010395:acetylsalicylic acid lysinate