Serrapeptase for Inflammation and Pain: Lack of Evidence for Recommendation
Serrapeptase is not recommended as a treatment for inflammation and pain due to insufficient scientific evidence supporting its efficacy and safety. 1
Current Evidence Assessment
- The existing scientific evidence for serrapeptase as an analgesic and anti-inflammatory agent is based on clinical studies with poor methodology, small sample sizes, and inadequate reporting of dose, duration, and outcomes 1
- Systematic reviews have found that the clinical evidence supporting serrapeptase use is insufficient, with most studies lacking proper controls and rigorous design 1
- Long-term safety data for serrapeptase is notably lacking, making it difficult to recommend for regular use 1
Established First-Line Treatments for Inflammation and Pain
- NSAIDs remain the first-line drug treatment for inflammatory conditions with strong evidence supporting their efficacy for pain and inflammation 2
- For mild to moderate pain, paracetamol (acetaminophen) should be considered as initial treatment, followed by ibuprofen if needed 2
- For more severe inflammatory conditions, disease-modifying antirheumatic drugs (DMARDs) and biologics have established efficacy and safety profiles with clear guidelines for use 2
Specific Concerns with Serrapeptase
- Despite its promotion as having anti-inflammatory, anti-edemic, and analgesic properties, serrapeptase lacks the robust clinical evidence that supports conventional treatments 1
- There are reports suggesting serrapeptase may potentially cause spread of infection due to its fibrinolytic activity, particularly in cases of abscess 3
- The most recent comparative study (2024) showed serrapeptase may reduce edema in ankle sprains better than paracetamol, but this single study is insufficient to change clinical practice 4
Mechanism of Action
- Serrapeptase is a proteolytic enzyme that theoretically works by breaking down inflammatory proteins and reducing fluid retention 5
- While it has been proposed to have affinity for cyclooxygenase enzymes (similar to NSAIDs), this mechanism has not been conclusively demonstrated in high-quality clinical trials 5
Limited Positive Evidence
- Some small studies have shown potential benefits in reducing post-operative swelling, such as a 1989 study that found 50% reduction in ankle swelling by the third post-operative day compared to controls 6
- However, these older studies have not been replicated with modern methodological standards and larger sample sizes 1
Recommendations for Pain and Inflammation Management
- For inflammatory conditions, NSAIDs should be used as first-line pharmacological treatment, with appropriate consideration of gastrointestinal, cardiovascular, and renal risks 2, 7
- For patients who cannot tolerate NSAIDs, simple analgesics such as paracetamol and, if necessary, opioids might be considered for pain control 2
- Non-pharmacological approaches including patient education, regular exercise, and physical therapy should be incorporated into treatment plans for inflammatory conditions 2
- For specific inflammatory conditions like spondyloarthritis, treatment should follow established guidelines including NSAIDs, appropriate DMARDs, and biologics when indicated 2
Conclusion
Based on the current evidence, healthcare providers should rely on established treatments with proven efficacy and safety profiles rather than serrapeptase for managing inflammation and pain. Patients seeking alternative treatments should be informed about the limited evidence supporting serrapeptase and the availability of better-studied options.