A Parallel Group, Double-Blind, Randomized Controlled Study Assessing the Efficacy and Tolerability of Oxaceprol, in Comparison to the Relatively Weak Opioid Tramadol, in the Treatment of Symptomatic Knee Osteoarthritis

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Abstract (English)

Abstract
Aim: The aim of the present study was to compare the efficacy and tolerability of oxaceprol,
in comparison to the relatively weak opioid tramadol, in the treatment of symptomatic knee
osteoarthritis.
Material & methods: A parallel group, double-blind, randomized controlled trial was carried
out in the Dept. of Pharmacology at DMCH, Laheriasarai, Darbhanga, Bihar, India for one
year. This comparative study was carried among patients diagnosed as Osteoarthritis. A total
of 200 patients were included in the study with knee joint pain intensity of at least 35 mm on a
100 mm visual analog scale (VAS) present for at least preceding 3 months and with confirmed
degenerative changes in knee skiagram.
Results: In tramadol group, 47% were males and 53% were females and mean age of
participants was 52.48 years whereas in Oxaceprol group 49% were males and 51% were
females and mean age of participants was 51.39 years. 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. 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.
Conclusion: Efficacy and tolerability of oxaceprol were comparable to tramadol, and the drug
can be considered as an alternative to low-potency opioids in the management of knee
osteoarthritis