Comparative Efficacy and Safety Study of Two Chondroitin Sulfate Preparations from Different Origin (Avian and Bovine) in Symptomatic Osteoarthritis of the Knee

Abstract: Introduction : Some argued that clinical efficacy of Chondroitin Sulfate (CS) could vary upon the product origin. The objective of this trial is to compare the effect of 2 CS medicinal products from different origin: Structum ® (avian, 1000mg/day) and Chondrosulf ® (bovine, 1200mg/day). Methods : This was a randomized, double-blind, double placebo, active-controlled, parallel-group study using a non-inferiority design. Symptomatic osteoarthritis of the knee patients, according to American College of Rheumatology criteria, aged 50-80 years received either Structum ® (500mg BID) or Chondrosulf ® (400mg TID) during 24 weeks. Inclusion criteria were: global pain in the target knee
40mm on a Visual Analog Scale (VAS 0-100 ), a Lequesne’s Algofunctional Index (LFI) score
7 (range: 0-24) and a radiological Kellgren-Lawrence grade 2 or 3. Primary outcome was the mean change over 24 weeks of pain VAS and LFI score. Secondary outcomes were patient’s and physician’s global assessments, Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International responders rate, analgesics intake and Medical Outcomes Survey Short-Form 12 (SF-12). Safety was assessed by recording adverse events. A non-inferiority test was performed on the Structum