There is lack of studies evaluating the relative effectiveness of Pharmaceutical-grade CS. That is why the investigators conducted a prospective, randomized, 6-month, 3-arm, double-blind, double-dummy study to evaluate the efficacy of pharmaceutical grade CS in comparison with celecoxib and placebo. The study comprised a total of 604 patients, analyzed according to American College of Rheumatology (ACR) criteria. The analysis was initiated in five European countries and was observed for 182 days. During the study, the dosage was standardized according to European Medicines Agency guideline. The primary endpoints were the changes in pain assessed on Visual Analogue Scale (VAS) and in the Lequesne Index (LI). The secondary endpoints were defined as Minimal-Clinically Important Improvement (MCII) and Patient-Acceptable Symptoms State (PASS).

Overall results demonstrated that both CS and Celecoxib were superior to placebo in reducing pain and LI. During intention-to-treat (ITT), pain reduction in VAS and LI at day 182 in the CS group and celecoxib group, was found to be significantly greater than the placebo group but no variation was observed between CS and celecoxib. Significant improvement was noted in MCII and PASS at day 182 in the CS and Celecoxib groups. There were no safety concerns noted for any of the drugs.