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Study Title:

Efficacy of Bromelain along with Trypsin, Rutoside Trihydrate Enzymes and Diclofenac Sodium Combination Therapy for the treatment of TMJ Osteoarthritis - A Randomised Clinical Trial.

Study Abstract

INTRODUCTION:
Osteoarthritis (OA) is a degenerative disorder characterized by chronic inflammatory response of cartilage and articular surface involving Temporomandibular Joint (TMJ). Pain as one of the major symptom of osteoarthritis affects the quality of life and is usually managed by Non Steroidal Anti Inflammatory Drugs (NSAIDs) such as diclofenac sodium. Bromelain, trypsin and rutoside trihydrate formulation can be used to treat this disease because of anti-inflammatory and anti-oxidant effects.

AIM:
To assess the effectiveness of oral bromelain, trypsin, rutoside trihydrate enzymes and diclofenac sodium combination therapy over diclofenac sodium for the treatment of TMJ osteoarthritis.

MATERIALS AND METHODS:
Thirty Patients with symptomatic TMJ osteoarthritis were randomly divided into three groups. 10 patients were treated with diclofenac sodium (Group 1), 10 were given oral enzymes (bromelain, trypsin, rutoside trihydrate) and diclofenac sodium combination (Group 2), and 10 were treated with oral enzyme preparation (bromelain, trypsin, rutoside trihydrate) (Group 3). Patients were evaluated on day 1, day 4, day 7 and day 10. Comparison of pain rating within three groups was assessed using numeric rating scale. The efficacy criteria were analysed applying ANOVA followed by post-hoc test.

RESULTS:
Inter group comparison of the effectiveness of management of pain, resulted in a value p < 0.05 between Group 2 and other two groups, which indicated that Group 2 patients responded better than Group 1 and Group 3, while p > 0.05 between Group 1 and Group 3 showed both groups responded equally to the treatment.

CONCLUSION:
The trial showed significant improvement in reducing pain in patients treated with oral enzymes and diclofenac sodium combination therapy.