SYSTEMIC ENZYME THERAPY WITH TRYPSIN-BROMELAIN-RUTOSIDE COMBINATION TO COUNTER POST-OPERATIVE WOUND INFLAMMATION – A RANDOMISED ACTIVE-CONTROLLED MULTICENTRE TRIAL

Girish D Bakhshi, Shashank Tiwari, Rajesh Kumar Prajapati, Girish H Rudrappa, Mrutyunjay I. Uppin*, Pratik J Vinchhi, Shrihari A Dhorepatil, Hemant L Dhusia, Gautam V Daftary, Ganesh H Divekar, James John and Pratik P Wadivkar

ABSTRACT

Background: Systemic enzyme therapy with combination of Trypsin, Bromelain and Rutoside is used worldwide to control inflammation and speed-up healing process. The combination is available in India in two formulations – a dispersible tablet form and a solid enteric-coated tablet form. The inflammation and tissue repair associated with post-operative wounds are expected to benefit from such therapy. Aim: To assess the impact of two formulations of Trypsin-Bromelain-Rutoside (TBR) against that of Serratiopeptidase on postoperative clinical markers of local (wound) inflammation. Materials and Methods: This study was designed as randomised, parallel group, comparative, 3-arm, multicentre, assessor-blind, active-controlled trial. Eligible subjects were randomised to one of the three groups – Group 1 (enteric-coated TBR), Group 2 (dispersible TBR) or Group 3 (Serratiopeptidase). The efficacy assessments were based on scores of post-operative swelling and pain and improvement in subjects’ and investigators’ global assessment. The data from the groups were compared using Chi-square test. Results: 309 subjects were enrolled in the study. Significantly (p<0.05) higher proportion of subjects in both Groups 1 and 2 reported none/mild swelling and no/mild pain on postoperative days 3 and 8, compared to Group 3. The incidence of subject-reported and investigator-reported global assessment scores indicating good to excellent pain relief and swelling reduction, on postoperative days 3 and 8, were also significantly (p<0.05) higher with Groups 1 and 2. Fewer subjects in Groups 1 and 2 required rescue medication. Conclusion: Systemic enzyme therapy with Trypsin-Bromelain-Rutoside provided significantly better control and resolution of post-operative pain and inflammation, compared to Serratiopeptidase.

Keywords: Bromelain, rutoside, trypsin, surgery, inflammation, proteases.