ABSTRACT
A double-blind, placebo controlled evaluation was performed on parallel groups of patients presenting osteoarthritis of the knee, hip or hand. The study aimed to evaluate the use of a combination of sustained-release diclofenac and vitamins B1, B6 and B12 in the treatment of the signs and symptoms of osteoarthritis. After screening and informed consent, randomized subjects underwent a 7-day treatment period with twice-daily oral therapy. Osteoarthritis pain, mobility and satisfaction assessments by both the subjects and the investigating physician were performed at each of the three visits to the study center before, during and at the end of the treatment period, along with physical examinations, laboratory evaluations and monitoring of adverse events and concomitant medications. Results were compared between the active and placebo treated groups (Group A and Group B, respectively).The active treatment was found to be superior to placebo in all of the pain, mobility and satisfaction assessments. Patients treated with the active substance were more willing to continue treatment at the end of the study. No significant difference was observed between the treatment groups in the physical examinations and laboratory evaluations performed.Based on the results observed in this double-blind clinical evaluation, we conclude that the combination of sustained-release diclofenac and vitamins B1, B6 and B12 is both well-tolerated and superior to placebo in the treatment of the signs and symptoms of OA in the study population evaluated.