Background:
Osteoarthritis is a degenerative joint
disorder commonly presenting with pain, swelling, stiffness, and restricted
joint mobility. Curcuminoids has been extensively studied for its
anti-inflammatory and therapeutic effects in chronic inflammatory disorders,
including musculoskeletal conditions such as osteoarthritis and low back pain.
Methodology:
This randomized, multicentric, double-blinded,
four-arm clinical study evaluated the efficacy and safety of CurcIR (200mg of
95% curcuminoids – T1) and CurcXR (200mg of 20% curcuminoids – T2) formulations
in comparison with standard Turmeric Extract (1000 mg of 95% curcuminoids - C)
and placebo (P) for their anti-inflammatory effects and pain reduction. A total
of 100 participants both male and female aged between 30 and 80 years with
osteoarthritis and low back pain, classified under American College of
Rheumatology (ACR) Osteoarthritis as Class III, were equally randomized into
four treatment groups and followed for 8 weeks. Clinical outcomes included pain
intensity assessed using the Visual Analog Scale (VAS); inflammation assessed
using inflammatory markers, namely C-reactive protein and erythrocyte
sedimentation rate; and quality-of-life parameters assessed using the SF-12,
OMERACT-OARSI criteria, WOMAC index, and Patient Global Assessment.
Results: VAS scores showed
statistically significant within-group pain reduction from week 4 onward in the
CurcIR and Comparator groups, whereas the CurcXR and placebo groups showed
significant improvement only at week 8. Between-group analysis demonstrated
that both CurcIR and CurcXR achieved significantly greater pain reduction than
placebo from week 4 onward, with sustained effects. The Comparator showed
efficacy comparable to CurcIR and CurcXR. CRP levels showed mild reductions
across all groups, with no statistically significant within- or between-group
differences, and CurcIR and CurcXR showed inflammatory profiles comparable to
the Comparator. ESR levels showed statistically significant within-group
reductions in all four groups, including placebo; however, no significant
between-group differences were observed, and the placebo effect was likely
influenced by concomitant medication use. WOMAC pain, stiffness, and physical function
scores improved significantly at week 8 in the CurcIR and CurcXR groups, with
selective improvements in the Comparator group, while placebo showed no change.
Between-group analysis favored CurcIR and CurcXR over placebo. OMERACT-OARSI
and PGA scores showed significant and sustained improvements in CurcIR and
CurcXR compared with placebo, with Comparator demonstrating comparable
efficacy.
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