Serrapeptase: Lack of Evidence for Clinical Use
There is insufficient scientific evidence to support the use of serrapeptase as a treatment option for any medical condition. 1
Evidence Assessment
- The clinical evidence supporting serrapeptase's use as an anti-inflammatory and analgesic agent is based on studies with poor methodology, small sample sizes, and inadequate reporting of outcomes 1
- A systematic review of serrapeptase found that existing scientific evidence is insufficient to support its use as an analgesic or health supplement 1
- Long-term safety data for serrapeptase is lacking, making it difficult to assess potential risks associated with its use 1
Potential Mechanisms and Claims
- Serrapeptase is a proteolytic enzyme that has been claimed to have anti-inflammatory, anti-edemic, analgesic, fibrinolytic, and caseinolytic properties 1, 2
- It has been prescribed in various specialties including surgery, orthopedics, otorhinolaryngology, gynecology, and dentistry despite limited evidence 1
- Some proponents suggest it has anti-atherosclerotic effects due to its fibrinolytic properties, but evidence-based recommendations on this claim are lacking 1
Recent Research
- A 2024 study compared serrapeptase to paracetamol in ankle sprain cases and reported that serrapeptase showed better efficacy in reducing ankle joint edema, but similar pain management outcomes 3
- Some research suggests serrapeptase may have effects on bacterial biofilms, particularly against Pseudomonas aeruginosa, but this remains experimental and not clinically validated 4
Safety Concerns
- There are case reports of serrapeptase potentially causing spread of infection in cases of abscess due to its fibrinolytic activity 5
- The enzyme has been promoted as a health supplement without adequate safety data 1
- Unlike established medications such as NSAIDs, metoclopramide, or ondansetron, serrapeptase lacks rigorous clinical trials evaluating its safety profile 1
Clinical Implications
- Despite its widespread use in some regions, serrapeptase should not be recommended as a treatment option due to insufficient evidence supporting its efficacy and safety 1
- For conditions where serrapeptase might be considered (inflammation, pain), clinicians should instead use evidence-based treatments with established efficacy and safety profiles 1
- Patients seeking anti-inflammatory or analgesic treatments should be directed toward therapies with stronger evidence bases 1
Research Needs
- High-quality randomized controlled trials with adequate sample sizes, clearly defined outcomes, and proper reporting of adverse events are needed to evaluate serrapeptase's efficacy and safety 1
- Future studies should specify appropriate dosing, duration of treatment, and include long-term safety monitoring 1