It has been well
established that Systemic enzyme therapy (SET) aids better and faster healing
when compared to usual anti-inflammatory drugs like non-steroidal
anti-inflammatory drugs (NSAIDs) and opioid analgesics. Recently, SET with
trypsin (serine protease), bromelain (cysteine protease) and rutoside
(bioflavinoid) combination have gained popularity as a treatment for pain and inflammation.[1]
Given the above
scenario, Bakhshi D et al. conducted
a study to assess the impact of two formulations of Trypsin-Bromelain-Rutoside
(TBR) against that of Serratiopeptidase on post-operative clinical markers of
local (wound) inflammation. The findings revealed that Systemic enzyme therapy
with Trypsin-Bromelain-Rutoside provided significantly better control and
resolution of post-operative pain and inflammation compared to
Serratiopeptidase.[2] The results of the same were published in the European
Journal of Pharmaceutical and Medical Research.
Indian Evidence substantiating the efficacy of
TBR [2]
A randomised,
parallel-group, comparative, three-arm, multicentre, assessor-blind,
active-controlled trial was conducted by Bakhshi D et al..The study included 100 patients who took Phlogam
(enteric-coated TBR), 103 who took TBR Double Strength Dispersible Tablet, and
102 patients who took serratiopeptidase. 66, 27, and 7 subjects were put in the
Phlogam (enteric-coated TBR) group who underwent general, dental, and
orthopaedic surgery, respectively. 68, 27, and 8 subjects were placed in the
TBR Double Strength Dispersible Tablet group who underwent general, dental, and
orthopaedic surgery, respectively. 63, 26 and 13 subjects were put under the Serratiopeptidase
group who underwent general, dental, and orthopaedic surgery, respectively.
The results were
compared on day three and day eight post-surgery.
Swelling Reduction:-
1. On day three after surgery, 91% of patients who took
Phlogam (TBR Enteric Coated tablet) reported no/mild swelling. In
comparison, 84.4% and 62.7% of those who took TBR Double Strength
Dispersible Tablet and Serratiopeptidase reported no/ mild swelling,
respectively.
Adapted from Systemic enzyme therapy with trypsin-bromelain-rutoside
combination to counter post-operative wound inflammation – a randomised
active-controlled multicentre trial, Bakhshi D et al., 2019, ejpmr
6(8), 493-500
2. On day eight after surgery, patients who took Phlogam (TBR Enteric Coated tablet) reported no/mild swelling. In contrast, 98.1% and 85.3% reported no/ mild swelling who took TBR Double Strength Dispersible Tablet and Serratiopeptidase, respectively.
Adapted from Systemic enzyme therapy with
trypsin-bromelain-rutoside combination to counter post-operative wound
inflammation – a randomised active-controlled multicentre trial, Bakhshi D
et al., 2019, ejpmr 6(8), 493-500
Pain Relief:
1. 79% of patients who took Phlogam (TBR Enteric Coated tablet) reported no/ mild pain. In comparison, 76.1% and 46.1% who took TBR Double Strength Dispersible Tablet and Serratiopeptidase, respectively, on 3rd day of post-surgery reported no/ mild pain.
Adapted from Systemic enzyme therapy with
trypsin-bromelain-rutoside combination to counter post-operative wound
inflammation – a randomised active-controlled multicentre trial, Bakhshi D
et al., 2019, ejpmr 6(8), 493-500
2. 98% of patients reported no/ mild pain who took Phlogam (TBR Enteric Coated tablet). In comparison, 98.1% and 80.4% reported no/ mild pain who took TBR Double Strength Dispersible Tablet and Serratiopeptidase, respectively, on the 8th day of post-surgery.
Adapted from Systemic enzyme therapy with
trypsin-bromelain-rutoside combination to counter post-operative wound
inflammation – a randomised active-controlled multicentre trial, Bakhshi D
et al., 2019, ejpmr 6(8), 493-500
Subject Reported Assessment of Swelling Reduction
1. On evaluating the patient-reported global assessment of swelling reduction rated between good to excellent, 99% of patients who took Phlogam (TBR Enteric Coated tablet) reported a good to an excellent change in perception of swelling on day 3. In comparison, 96% and 50% of patients who took TBR Double Strength Dispersible Tablet and Serratiopeptidase, respectively, reported a good to an excellent change in perception of swelling.
Adapted from Systemic enzyme therapy with trypsin-bromelain-rutoside
combination to counter post-operative wound inflammation – a randomised
active-controlled multicentre trial, Bakhshi D et al., 2019, ejpmr
6(8), 493-500
2. On evaluating the patient-reported global assessment of swelling reduction rated between good to excellent, 99% of patients who took Phlogam (TBR Enteric Coated tablet) reported a good to an excellent change in perception of swelling on day 8. In comparison, 99% and 69.3% of patients who took TBR Double Strength Dispersible Tablet and Serratiopeptidase reported a good to an excellent change in perception of swelling.
Adapted from Systemic enzyme therapy with trypsin-bromelain-rutoside
combination to counter post-operative wound inflammation – a randomised
active-controlled multicentre trial, Bakhshi D et al., 2019, ejpmr
6(8), 493-500
Subject Reported Assessment of pain relief
1. Along the same lines, the patient reported global assessment of pain relief rated between good and excellent; 96% of patients who took Phlogam (TBR Enteric Coated tablet) reported a good to an excellent change in perception of pain relief on day 3, while 95.2% and 39.2% of patients reported a good to an excellent change in perception of pain who took TBR Double Strength Dispersible Tablet and Serratiopeptidase, respectively.
Adapted from Systemic enzyme therapy with
trypsin-bromelain-rutoside combination to counter post-operative wound
inflammation – a randomised active-controlled multicentre trial, Bakhshi D
et al., 2019, ejpmr 6(8), 493-500
2. Similarly, the patient reported global assessment of pain relief rated between good and excellent; 99% of patients who took Phlogam (TBR Enteric Coated tablet) reported a good to an excellent change in perception of pain relief on day 8, while 98% and 61.4% of patients reported a good to an excellent change in perception of pain who took TBR Double Strength Dispersible Tablet and Serratiopeptidase, respectively.
Adapted from Systemic enzyme therapy with
trypsin-bromelain-rutoside combination to counter post-operative wound
inflammation – a randomised active-controlled multicentre trial, Bakhshi D
et al., 2019, ejpmr 6(8), 493-500
Investigator Reported Assessment of Swelling Reduction
1. On evaluating the investigator-reported assessment of swelling reduction rated between good to excellent, 96% of patients who took Phlogam (TBR Enteric Coated tablet) reported a good to an excellent change in perception of swelling on day 3. In comparison, 98% and 52.9% of patients who took TBR Double Strength Dispersible Tablet and Serratiopeptidase, respectively, reported a good to an excellent change in perception of swelling
Adapted from Systemic enzyme therapy with
trypsin-bromelain-rutoside combination to counter post-operative wound
inflammation – a randomised active-controlled multicentre trial, Bakhshi D
et al., 2019, ejpmr 6(8), 493-500
2. On evaluating the investigator-reported assessment of swelling reduction rated between good to excellent, 99% of patients who took Phlogam (TBR Enteric Coated tablet) reported a good to an excellent change in perception of swelling on day 8. In comparison, 100% and 69.2% of patients who took TBR Double Strength Dispersible Tablet and Serratiopeptidase, respectively, reported a good to an excellent change in perception of swelling.
Adapted from Systemic enzyme therapy with
trypsin-bromelain-rutoside combination to counter post-operative wound
inflammation – a randomised active-controlled multicentre trial, Bakhshi D
et al., 2019, ejpmr 6(8), 493-500
Investigator Reported Assessment of Pain Relief
1. Likewise, the investigator reported global assessment of pain relief rated between good and excellent; 97% of patients who took Phlogam (TBR Enteric Coated tablet) reported a good to an excellent change in perception of pain relief on day 3, while 98% and 41.2% of patients reported a good to an excellent change in perception of pain who took TBR Double Strength Dispersible Tablet and Serratiopeptidase, respectively.
Adapted from Systemic enzyme therapy with
trypsin-bromelain-rutoside combination to counter post-operative wound
inflammation – a randomised active-controlled multicentre trial, Bakhshi D
et al., 2019, ejpmr 6(8), 493-500
2. Along the same lines, the investigator reported global assessment of pain relief rated between good and excellent; 98% of patients who took Phlogam (TBR Enteric Coated tablet) reported a good to an excellent change in perception of pain relief on day 8, while 100% and 57.4% of patients reported a good to an excellent change in perception of pain who took TBR Double Strength Dispersible Tablet and Serratiopeptidase, respectively.
Adapted from Systemic enzyme therapy with
trypsin-bromelain-rutoside combination to counter post-operative wound
inflammation – a randomised active-controlled multicentre trial, Bakhshi D
et al., 2019, ejpmr 6(8), 493-500
Total Pain Relief in the First 8 hours
93% of patients achieved at least 50% of total pain relief in the first 8 hours who took Phlogam (TBR Enteric Coated tablet), while 100% and 60.8% achieved at least 50% of total pain relief in the first 8 hours who took TBR Double Strength Dispersible Tablet and Serratiopeptidase, respectively.
Adapted from Systemic enzyme therapy with
trypsin-bromelain-rutoside combination to counter post-operative wound
inflammation – a randomised active-controlled multicentre trial, Bakhshi D
et al., 2019, ejpmr 6(8), 493-500
It was concluded that
compared to Serratiopeptidase, SET with Trypsin-Bromelain-Rutoside
significantly improved postoperative pain control and pain resolution among
Indian post-operative patients undergoing different surgical interventions.
Key Message:
Inflammation is an
inevitable process of the injured body tissues so as an attempt to restore
homeostasis and facilitate healing. Patients’ sufferings, such as pain and
swelling, arise if the inflammatory responses are prolonged and exaggerated,
thus halting wound repair. Employment of anti-inflammatory enzymes like the
combination of trypsin, bromelain and rutoside have shown promising results in
pain alleviation by modulating the inflammatory cascade and could be considered
to be used as a primary choice in clinical settings.
References
1.Tiwari
S, Khemnar BM, John J, Divekar GH. Trypsin, bromelain and rutoside in
dental pathologies-synergistic action and qualitative metanalysis of investigator-initiated
studies. Int J Sci Rep 2022;8(10):308-12.
2. D
Bakhshi, Tiwari, Prajapati, Rudrappa, Uppin, Vinchhi, Dhorepatil, Dhusia,
Daftary, Divekar, John, & Wadivkar. (2019, July 16). Systemic enzyme
therapy with trypsin-bromelain-rutoside combination to counter
post-operative wound inflammation – a randomised active-controlled
multicentre trial. European journal
of pharmaceutical and medical research, 493–500. https://www.ejpmr.com
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