Serratiopeptidase Efficacy for Inflammation and Pain
The existing scientific evidence for serratiopeptidase is insufficient to support its use as an anti-inflammatory or analgesic agent, and it should not be recommended for clinical practice. 1
Evidence Quality Assessment
The clinical evidence base for serratiopeptidase is fundamentally flawed and does not meet modern standards for therapeutic recommendations:
A systematic review of 24 clinical studies found that all evidence supporting serratiopeptidase as an anti-inflammatory and analgesic agent is based on poor methodology. 1
The available randomized controlled trials are predominantly placebo-controlled with small sample sizes, unspecified dosing regimens, unclear treatment durations, and poorly defined outcome measures. 1
Data on the safety and long-term tolerability of serratiopeptidase is completely lacking in the published literature. 1
While one older double-blind trial from 1990 showed symptom regression in ear, nose, and throat disorders after 3-4 days of treatment, this single study is insufficient to establish clinical efficacy by contemporary evidence standards. 2
Mechanism and Theoretical Properties
Serratiopeptidase is a bacterial metalloprotease with proposed anti-inflammatory, anti-edemic, fibrinolytic, and caseinolytic properties. 1, 3 The enzyme theoretically possesses higher affinity for cyclooxygenase enzymes (COX-I and COX-II), which are associated with production of inflammatory mediators including interleukins, prostaglandins, and thromboxanes. 3
However, theoretical mechanisms do not translate to proven clinical efficacy, and the enzyme's properties remain largely unvalidated in rigorous clinical trials. 1
Safety Concerns
Beyond the lack of efficacy data, there are documented safety concerns:
A case report documented spread of a buccal space abscess into deeper muscular layers after serratiopeptidase administration, suggesting the enzyme's fibrinolytic activity may facilitate infection spread in abscess cases. 4
The enzyme's use should be avoided in cases of active infection or abscess due to its fibrinolytic properties that could promote bacterial dissemination. 4
The enzyme has limitations including sensitivity to environmental conditions and poor cellular penetration due to its large molecular size. 5
Comparison to Evidence-Based Alternatives
For inflammation and pain management, established therapies with robust evidence should be used instead:
NSAIDs are effective for musculoskeletal pain and inflammation with well-characterized risk profiles (gastrointestinal, cardiovascular, and renal risks). 6
Acetaminophen is recommended as first-line treatment for osteoarthritis and low back pain, with maximum daily doses of 3-4 grams to avoid hepatotoxicity. 6
For neuropathic pain, gabapentin (1800-3600 mg/day in divided doses) is the evidence-based first-line oral treatment. 6
Physical therapy, exercise therapy, and cognitive behavioral therapy have high-quality evidence for reducing pain and improving function in conditions like osteoarthritis, low back pain, and fibromyalgia. 6
Clinical Bottom Line
Serratiopeptidase cannot be recommended for any inflammatory or pain condition based on the current evidence. 1 The enzyme lacks the rigorous clinical validation required for therapeutic use, has concerning safety signals regarding infection spread, and has no advantage over established anti-inflammatory and analgesic therapies with proven efficacy and well-characterized safety profiles. 1, 4 Clinicians should rely on evidence-based treatments including NSAIDs, acetaminophen, gabapentinoids for neuropathic pain, and non-pharmacologic therapies rather than serratiopeptidase. 6