Efficacy and safety of serrapeptase on ankle sprain cases: A single center prospective comparative study.

Background: Non-steroid anti-inflammatory drugs (NSAIDs) rank among the frequently prescribed medications for addressing pain and inflammation. Although they are powerful pain relievers, their side effects are indisputable. Serrapeptase, a serine protease, exhibits anti-inflammatory and anti-oedemic activity without the side effects of NSAIDs. We aim to assess the efficacy and safety of serrapeptase in the treatment of pain and edema in ankle sprains. Methods: In a single-centre prospective comparative study, 76 patients aged 18-53 with Grade II ankle sprains were assigned to either a serrapeptase intervention group (n = 38) receiving 5 mg serrapeptase (two tablets, three times per day) for ten days, or a control group (n = 38) receiving 500 mg paracetamol (three times per day) for the same duration. Ankle joint edema was assessed using both Figure-of-Eight and water-displacement methods. Pain was assessed with Visual Analogue Scale (V.A.S.). Within-groups and between-groups analyses were performed in the 3rd and 10th day. Results: Both groups exhibited reduced edema and pain over time. Serrapeptase demonstrated a superior reduction in ankle joint edema on the third and tenth day compared to paracetamol, while pain management did not differ significantly. Conclusion: Serrapeptase exhibited better efficacy than paracetamol in reducing ankle joint edema, highlighting its potential as an alternative treatment. Level of evidence: Level II, prospective comparative trial without randomization.