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.
ABSTRACT
The use of a combination of uridine triphosphate (UTP), cytidine monophosphate (CMP), and hydroxocobalamin was evaluated in a double-blind, randomized study in the treatment of neuralgia due to degenerative orthopedic alterations with neural compression. Following informed consent, 80 patients were randomized to a 30 day treatment period. The subjects received a thrice-daily oral treatment regimen of either the combination treatment (Group A: total daily dose of 9mg UTP, 15mg CMP, 6 mg hydroxocobalamin) or vitamin B12 alone (Group B: total daily dose of 6 mg hydroxocobalamin). Efficacy measures evaluated global patient condition from the perspective of the subject and the investigating physician pain ? measured by a visual-analog scale and functionality, using a patient-response questionnaire. The safety evaluation took into account physical evaluations and laboratory tests performed at each visit to the study center as well as the incidence and severity of adverse events. At the end of the 30-day treatment period, there were reductions in the pain scale scores in both groups, however there was a significantly larger reduction in the scores of the Group A patients. The Patient Global Evaluation scores improved in both groups but showed greater improvement in Group A, while the Physician Global Evaluation improved significantly only in Group A. A similar finding was observed in the scores of the Patient Functionality Questionnaire. Based on the findings of this clinical trial, we conclude that the combination of UTP, CMP, and vitamin B12 has a positive effect on pain and functionality improvement in the treatment of degenerative orthopedic alterations with neural compression, in the study population evaluated.