A randomized double-blind placebo-controlled trial to investigate the effectiveness and safety of a novel green-lipped mussel extract -BioLex® -for managing pain in moderate to severe osteoarthritis of the hip and knee

Abstract

Background: Extracts from perna canaliculus, the Green Lipped Mussel (GLM) are widely used as a complimentary therapy by patients with osteoarthritis (OA). The current study investigated the potential of a novel GLM formulation as a treatment for OA. A randomized double-blind placebo-controlled trial was undertaken to assess potential impacts on pain and quality of life following 12weeks of treatment. Methods: Eighty patients with moderate to severe OA of the hip or knee were randomized to receive either 600mg of BioLex®-GLM daily or placebo for 12weeks. Entry criteria included a minimum 100mm Visual Analogue Scale pain score (VAS) of 30mm at baseline. The primary outcome was patient reported pain, measured by the Western Ontario and McMasters OA Index (WOMAC) pain subscale and VAS pain scale. Secondary outcomes included: quality of life (OAQol), total WOMAC score, WOMAC -20 responder criteria, and change in medication use over the study period. Participants were assessed at baseline, 12weeks (end of therapy) and 15weeks (3-weeks post-intervention). Results: At week 12, there were no significant differences in VAS or WOMAC pain subscale between active and placebo groups, nor significant improvement in the WOMAC-20 responder criteria or OAQol. Joint stiffness (measured by WOMAC-B stiffness) in the GLM group improved compared with placebo (p=0.046). There was a significant difference in paracetamol use between the GLM treated group and the placebo group after week 12 (p=0.001). Conclusions: BioLex® -GLM extract did not confer clinical benefit in moderate to severe OA over the intervention period, however, a significant difference in paracetamol use in the post-intervention period was observed between the BioLex® -GLM group and placebo group. Higher doses and/or longer treatment periods are worthy of future investigation. Trial registration: Australia and New Zealand Clinical Trials Registry: no. ACTRN12611000256976.