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

Laryngoscope. 2005 Aug;115(8):1385-90. doi: 10.1097/01.MLG.0000166702.38850.1B.

Abstract

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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Administration, Intranasal
  • Adult
  • Age Factors
  • Aged
  • Anti-Inflammatory Agents, Non-Steroidal / administration & dosage*
  • Aspirin / administration & dosage
  • Aspirin / analogs & derivatives*
  • Cross-Over Studies
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Drug Administration Schedule
  • Female
  • Follow-Up Studies
  • Humans
  • Lysine / administration & dosage
  • Lysine / analogs & derivatives*
  • Male
  • Middle Aged
  • Multivariate Analysis
  • Nasal Polyps / drug therapy*
  • Nasal Polyps / pathology*
  • Nasal Provocation Tests
  • Probability
  • Risk Factors
  • Sex Factors
  • Statistics, Nonparametric
  • Treatment Outcome

Substances

  • Anti-Inflammatory Agents, Non-Steroidal
  • Lysine
  • Aspirin
  • acetylsalicylic acid lysinate