Clinical study report: Double-blind, placebo controlled, multicentre trial assessing the efficacy and safety of chondroitin sulfate, 1 gram per day for 6 months, in patients with painful femorotibial osteoarthritis

This reference is based in information provided by a systematic review reporting unpublished data obtained from an internal document from Laboratoires Pierre Fabre in September 2000. This abstract has been prepared by collaborators of Epistemonikos. POPULATION: 145 male or female patients suffering from painful femorotibial osteoarthritis, fulfilling American College of Rheumatology (ACR) criteria. Age between 50 and 80 years, with an algo-functional Index (AFI) between 4 and 13, a pain score during activity of 30 mm or more on the Visual Analogue Scale (VAS), a radiographic grade II or III on the Kellgren-Lawrence Scale and a regular consumption of NSAID for a minimum of three weeks during the last three months before trial begin. COMPARISONS: 1. Chondroitin sulfate 1g/day (Structum®) (n=72) 2. Placebo (n=73) Follow-up: six months. OUTCOMES: The primary outcome measure was the change in the algo-functional index (AFI).