Evaluation of the safety and efficacy of an injectable B-vitamin combination in acute neuralgias

ABSTRACT

A clinical trial evaluating the safety and efficacy of the use of an intramuscular combination of vitamins B1, B6, and B12 in the treatment of the signs and symptoms of trigeminal and plantar neuralgia was performed. Patients were submitted to a 9-day, open-label treatment period with three administrations of the study medication, and underwent a series of clinical and laboratory evaluations prior to the first treatment dose and at each of the three following visits to the study center. The incidence of adverse events and the use of concomitant medications was monitored at each study visit, when efficacy evaluations were also performed, including a 100mm VAS pain assessment and global and satisfaction surveys completed by the patients and investigating physician. Additionally, at the end of the treatment period, the patients were evaluated on their willingness to continue treatment with the study medication.