Double-blind trial of solid lipid <i>Boswellia serrata</i> particles (SLBSP) vs. standardized <i>Boswellia serrata</i> gum extract (BSE) for osteoarthritis of knee
Preeti Kulkarni, Neena Damle, Sumer Singh, Krishnat S. Yadav, Minal R. Ghante, V. H. Bhaskar, Lal Hingorani, Vikram Gota
Abstract
Objectives The present study was planned to investigate the efficacy of SLBSP vs. standardized BSE for symptomatic knee osteoarthritis (OA) treatment. Methods It was a prospective, randomized, double-blind, double-dummy, placebo-controlled, and single-centre clinical trial for symptomatic osteoarthritis of knee. Subjects were randomized to receive SLBSP capsule+BSE Placebo or BSE tablet+SLBSP placebo for two months. Patients were allowed to take rescue analgesics (Acelofenac 100 mg). Improvement in pain and function was assessed utilizing WOMAC, VAS. Level of CTX-II in urine and serum levels of inflammatory cytokines including IL-2, IL-4, IL-6, TNF-α, and IFN-γ was measured initially and at end of treatment. Results and conclusions Western Ontario and McMaster Universities osteoarthritis index (WOMAC) and Visual Analog Scale score improved markedly in SLBSP as well as in BSE arm (p < 0.05). Difference in VAS and WOMAC scores between the two arms was not statistically significant. Most significant effect was observed in the need for rescue analgesics. SLBSP caused marked lowering of pro-inflammatory cytokines levels whereas a several fold increase was noted in the BSE arm (p < 0.05). Both groups showed marked improvement in pain, SLBSP being superior to BSE with respect to reducing the need for rescue analgesics in addition to modulating inflammatory cytokines.