COMPARISON OF TRAMADOL AND OXACEPROL IN PATIENTS WITH OSTEOARTHRITIS

Abstract

Introduction: Osteoarthritis (OA) is a chronic, degenerative disease of unknown origin which is characterised by gradual loss of articular cartilage. It is the most prevalent disease with a worldwide distribution. Earlier, osteoarthritis was seen as an inevitably progressive, degenerative disease process. Now it has been suggested that it is a dynamic process that may progress episodically. It is a heterogeneous group of diseases characterised by an adaptive response of synovial joints to a variety of genetic, environmental, aging and biomechanical stresses. NSAIDs intake increases the risk of gastritis and does not a have direct impact on the underlying pathogenesis of articular diseases. Tramadol augments serotonergic and noradrenergic neurotransmission, although it’s main active metabolite, O-desmethyltramadol. Oxaceprol is an atypical inhibitor of inflammation, used as a drug for joint disease without less side-effects with better safety profile than non-steroidal anti-inflammatory drugs (NSAIDs).
 Material and Methods: Participants were randomized in two study groups of 50 patients each sing computer generated random number list. Each group was given either oxaceprol 200 mg capsule or tramadol 50 mg capsule, thrice daily after food, for 12 weeks. The primary efficacy variable for this study was symptom relief stiffness, and physical function, measured on 100 mm Visual analogue scale (VAS) scale. Rescue medication used during the study period was also recorded. Complete blood count, blood glucose, liver function tests, and serum creatinine was recorded at the start of the study and. Vital signs were recorded at each visit and adverse events were reported. 
 Results: A total of 100 patients were included in the study of which 50 each were placed in tramadol group and oxaceprol group. No statistically significant difference was noted in both the group about baseline parameters about sex, age and blood pressure. Blood sugar was higher in Oxaceprol group as compared to tramadol group (P =0.0042) which was statistically significant. No statistically significant difference was observed between groups for WOMAC scores. Significant reduction in pain, stiffness and physical function was observed between oxaceprol and tramadol group at baseline and after 6 months follow-up. None of the adverse events were severe in nature in both the group commonest were dizziness and nausea.
 Conclusion: Oxaceprol efficacy and tolerability was comparable with tramadol and the drug can be considered as an alternative to low-potency opioids in the management of knee osteoarthritis. Further studies are required to confirm the clinical utility of oxaceprol in osteoarthritis.
 Keywords: OA, tramadol, oxaceprol, NSAID, WOMAC