Aspirin Therapy Shows No Significant Benefit for Chronic Rhinosinusitis with Nasal Polyps in Randomized Trial
Key Insights
A randomized placebo-controlled Finnish study found that aspirin therapy after desensitization does not provide significant relief for patients with chronic rhinosinusitis with nasal polyps (search) who are hypersensitive to NSAIDs (search).
Only 25% of patients receiving aspirin could be classified as benefiting from therapy, while 18% had to discontinue treatment due to adverse effects including respiratory symptoms and bleeding tendency.
The findings challenge the current practice of long-term aspirin therapy for N-ERD (search) patients and suggest clinicians should consider more effective biologic treatments despite their higher cost.
A randomized placebo-controlled study conducted by Finnish researchers has demonstrated that aspirin therapy after desensitization (ATAD) does not provide significant clinical benefits for patients with chronic rhinosinusitis with nasal polyps (search) (CRSwNP) who are hypersensitive to non-steroidal anti-inflammatory drugs (NSAIDs (search)). The findings, published in the journal Allergy, challenge the current treatment approach for non-steroidal anti-inflammatory drug-exacerbated respiratory disease (N-ERD (search)).
Study Design and Patient Population
The joint study, performed by the University of Eastern Finland, University of Helsinki, and HUS Inflammation Center (search), involved 26 patients with N-ERD (search), asthma (search), and severe CRSwNP. All participants underwent aspirin desensitization therapy before being randomized into groups receiving either 250 mg aspirin or placebo orally for 11 months.
"ASA therapy is affordable, but there hasn't been sufficient evidence of its effectiveness. Obtaining information on the effectiveness of treatment is important because several biologic medications currently available to treat the symptoms are effective but also very expensive," explained Professor Sanna Toppila-Salmi from the University of Eastern Finland, who led the study.
Primary Outcomes Show No Significant Differences
The study found no statistically significant differences between the aspirin and placebo groups in key outcome measures including the Sino-Nasal Outcome Test-22 (SNOT-22), nasal polyp score, Asthma (search) Control Test, and EPOS 2012 CRS clinical control assessment at 11 months. Additionally, there was no difference between groups in lung function or the number of cortisone courses needed during exacerbation phases.
"There were signs that ASA therapy could slightly reduce nasal polyps and improve quality of life related to nasal symptoms compared to a placebo, but the difference was not statistically significant," noted Alma Helevä, Doctoral Researcher at the University of Helsinki.
Limited Response Rate and Safety Concerns
The study revealed that only four of 16 patients (25%) who received aspirin treatment could be classified as "responders" based on predefined criteria including decreased nasal polyp scores, improved SNOT-22 scores, better olfactory function, and fewer oral corticosteroid courses.
Adverse events were notably more common in the aspirin group, with 56.3% of aspirin-treated patients experiencing side effects compared to 30% in the placebo group. The adverse event-related dropout rate was higher in the aspirin versus placebo group (18.8% vs. 10%). Side effects in the aspirin group included respiratory symptoms, worsening of asthma (search), bleeding tendency, and abdominal symptoms.
Clinical Implications for Treatment Approach
The findings have significant implications for current clinical practice. Hospitals have been treating N-ERD (search) with long-term aspirin therapy for approximately 15 years, but this study provides the first robust placebo-controlled evidence questioning its effectiveness.
"Clinicians should be aware that the treatment of [NSAID exacerbated respiratory disease (N-ERD (search))] is shifting more toward biologics, as aspirin treatment after desensitization [ATAD] may not be effective for most patients, despite its low cost," Helevä told medical professionals.
Future Research Directions
The researchers emphasized the need for studies to identify which patients might benefit from ATAD. "We found a few patients who seemed to benefit from ATAD. However, we still do not know how to identify them in advance," Helevä explained. "Future studies should address how to distinguish which patients would likely respond to the treatment, as ATAD may benefit some patients, but not all."
The study's conclusions suggest that while aspirin therapy after desensitization remains an affordable treatment option, its limited effectiveness and significant side effect profile may warrant reconsideration of treatment algorithms for N-ERD (search) patients, particularly as more effective biologic therapies become available.