Oral enzyme combination therapy reduces systemic inflammation, urinary CTXII and pain in knee osteoarthritis: a proof-of-mechanism, randomised, crossover, double-blind, placebo-controlled trial
Authors' conclusion
One of the key findings of this proof-of-mechanism study is that OEC modulates IL-10 production, suggesting an anti-inflammatory effect in patients with knee OA.
Study context
- Population
- Patients aged ≥40 years, body mass index (BMI) ≤35 kg/m², with symptomatic knee osteoarthritis (OA)43 completed both sequences (mITT)
- Participants
- 45 patients
- Comparison
- Oral enzyme combination (OEC) (bromelain, trypsin and rutoside) 2×3 tablets/day for 8 weeks vs placebo, crossover after 4-week washout
Methodological detailscrossover, double-blind, placebo-controlled, proof-of-mechanism, exploratory; no correction for multiple comparisons
- Crossover
- Double-blind
- Placebo-controlled
- Proof-of-mechanism
- Exploratory; no correction for multiple comparisons
Primary result
As reported in the abstract
Blood/urinary markers of innate immunity, inflammation and cartilage degradation · 8 weeks
- OEC increased α2-macroglobulin
- p=0.038
- OEC increased IL-10
- p<0.0001
- OEC decreased urinary CTXII
- p=0.038
Further findings
KOOS Pain and Symptoms subdomains and global KOOS
- OEC improved KOOS Pain
- P = 0.0464
- OEC improved KOOS Symptoms
- P = 0.026
- No significant improvement in global KOOS
Safety
- OEC well tolerated; no serious related adverse events in either group
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Oral enzyme combination therapy reduces systemic inflammation, urinary CTXII and pain in knee osteoarthritis: a proof-of-mechanism, randomised, crossover, double-blind, placebo-controlled trial. RMD Open. Published 12 August 2025. doi:10.
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