Serratiopeptidase: Limited Evidence Does Not Support Routine Clinical Use
Serratiopeptidase lacks sufficient high-quality evidence to recommend its use for inflammatory conditions, and the existing data shows inconsistent efficacy with potential safety concerns. 1
Evidence Quality Assessment
The most comprehensive and recent systematic review (2013) examining serratiopeptidase found that the clinical evidence is based on studies with poor methodology, small sample sizes, and unclear outcome definitions. 1 The review concluded that the existing scientific evidence is insufficient to support its use as an analgesic or anti-inflammatory agent. 1
Key Limitations of Available Evidence:
- Most studies are poorly designed randomized controlled trials with small sample sizes 1
- Dose and duration of treatment frequently not specified 1
- Long-term safety data is completely lacking 1
- Studies graded as low quality according to Scottish Intercollegiate Guidelines Network criteria 1
Proposed Mechanism vs. Clinical Reality
While laboratory studies suggest serratiopeptidase has proteolytic activity targeting cyclooxygenase enzymes (COX-I and COX-II) and may reduce inflammatory mediators like interleukins and prostaglandins 2, these theoretical benefits have not translated into robust clinical outcomes.
One older double-blind, placebo-controlled trial (1990) in 193 patients with ear, nose, and throat disorders showed symptom improvement with dosing of two tablets three times daily for 7-8 days. 3 However, this study predates modern clinical trial standards and lacks the rigor expected of contemporary evidence.
Safety Concerns
A critical safety issue exists: serratiopeptidase may promote spread of infection due to its fibrinolytic activity. 4 A case report documented a buccal space abscess that spread into deeper muscular layers after serratiopeptidase administration, requiring discontinuation and surgical drainage. 4 This fibrinolytic property makes it particularly contraindicated in cases of abscess or active infection. 4
Dosing Information (When Historically Used)
When serratiopeptidase has been used in clinical practice, typical dosing has been:
- Two tablets three times daily for acute inflammatory conditions 3
- Treatment duration: 7-8 days 3
- Specific milligram dosing varies by formulation and is often not standardized 1
Clinical Recommendation
Given the insufficient evidence base, lack of safety data, and availability of well-established anti-inflammatory agents with proven efficacy (NSAIDs, corticosteroids), serratiopeptidase cannot be recommended for routine clinical use. 1
For inflammatory conditions, prioritize evidence-based therapies:
- NSAIDs for acute inflammation 5
- Corticosteroids (1-2 mg/kg/day) for moderate inflammatory conditions 5
- Specific targeted therapies based on the underlying condition 5
Absolute Contraindications:
- Active abscess or localized infection (risk of spreading infection) 4
- Pregnancy (insufficient safety data) 1
- Any condition requiring proven therapeutic efficacy 1
The promotion of serratiopeptidase as a health supplement for cardiovascular disease prevention is not supported by evidence and should be discouraged. 1