Safety and efficacy of a B-vitamin combination in the treatment of osteoarthritis-related pain / Segurança e eficácia da associação das vitaminas B1, B6, B12 na analgesia da osteoartrite

RESUMO

We evaluated the safety and efficacy of the use of an oral combination of vitamins B1, B6, and B12 in the treatment of osteoarthritis-related pain and loss of mobility. A 14-day, open-label treatment period was adopted for patients presenting osteoarthritis of the knee or hip. Patients underwent a series of clinical and laboratory evaluations prior to the first treatment dose, following 7 days of treatment, and at the end of the 14-day drug administration period. The incidence of adverse events and use of concomitant medication was also monitored at each study visit. At each study visit, osteoarthritis evaluations were performed, including a 100mm VAS pain assessment, and global and satisfaction surveys completed by both patients and investigating physician. At the conclusion of the study, an additional assessment was performed to evaluate the patient's willingness to continue treatment with the B-vitamin combination.Clinical safety was evaluated by comparing the differences between the pretreatment, mid-study, and end-of-study clinical and laboratory evaluations as well as the incidence and severity of any adverse events. A comparison between the patient and physician assessments at each study visit was used to evaluate efficacy.A total of 54 patients were treated with the study medication. A clinically significant change was observed from pretreatment to end-of-study efficacy evaluations, including those for pain, mobility, and global osteoarthritis condition. The physician's evaluation of global patient condition and treatment satisfaction evaluation also presented a clinically significant change from pretreatment to the final study evaluation. No clinically significant changes in the patients clinical and laboratory evaluations were observed during the study.Based on the results of this clinical study, we conclude that the combination of cyanocobalamin, thiamine mononitrate and pyridoxine chlorihydrate at the concentrations employed is safe and effective in the treatment of the pain and loss of mobility associated with osteoarthritis.