Serratiopeptidase and Fibrin Removal: Insufficient Evidence for Clinical Use
The existing scientific evidence for serratiopeptidase's role in fibrin removal is insufficient to support its clinical use, and it should not be recommended as a therapeutic agent for fibrinolytic purposes. 1
Evidence Quality Assessment
The available research on serratiopeptidase consists primarily of poor-quality studies with significant methodological flaws:
- Systematic review findings reveal fundamental weaknesses: The clinical studies supporting serratiopeptidase are based on small sample sizes, lack clearly defined outcomes, and often fail to specify dosing or treatment duration 1
- No high-quality randomized controlled trials exist to support its fibrinolytic efficacy in clinical practice 1
- Safety data is notably absent: Long-term safety profiles and tolerability data are lacking across the available literature 1, 2
Claimed Mechanisms vs. Clinical Reality
While serratiopeptidase is marketed as having fibrinolytic properties, the evidence does not support these claims:
- Theoretical fibrinolytic activity has been proposed based on the enzyme's ability to break down fibrin 3, 4, 5
- No validated clinical outcomes: Despite anecdotal reports suggesting anti-atherosclerotic effects due to fibrinolytic properties, evidence-based recommendations cannot be made 1
- Promotional claims exceed scientific support: The enzyme is being promoted as a health supplement to prevent cardiovascular morbidity without adequate scientific backing 1
Critical Safety Concerns
A documented case report demonstrates potential harm: Serratiopeptidase administration in a patient with buccal space abscess resulted in spread of infection into deeper muscular layers, attributed to its fibrinolytic activity 3
- Contraindication in abscess cases: The fibrinolytic activity can facilitate spread of infection and should be avoided in such clinical scenarios 3
- Limited understanding of adverse effects: The enzyme's sensitivity to environmental conditions and poor cellular penetration due to large molecular size further limit its therapeutic potential 2
Comparison to Evidence-Based Fibrinolytic Agents
In stark contrast to serratiopeptidase, established fibrinolytic agents have robust evidence:
- Tranexamic acid has Level A evidence from the CRASH-2 trial for managing massive hemorrhage, with a loading dose of 1g over 10 minutes followed by 1g over 8 hours 6
- Tenecteplase is FDA-approved for massive pulmonary embolism with clear dosing protocols and demonstrated mortality benefits 6
- These agents have well-defined mechanisms, established safety profiles, and specific contraindications based on high-quality evidence 6
Clinical Bottom Line
Do not use serratiopeptidase for fibrin removal or fibrinolytic purposes. 1 If fibrinolytic therapy is clinically indicated (such as in massive hemorrhage with accelerated fibrinolysis, STEMI, or massive PE), use evidence-based agents like tranexamic acid or tenecteplase with established dosing protocols and safety profiles 6.
The promotion of serratiopeptidase as having fibrinolytic benefits represents a significant gap between marketing claims and scientific evidence 1. Until large-scale, well-designed randomized controlled trials demonstrate clear efficacy and safety, this enzyme cannot be recommended for any fibrinolytic indication 1, 2.