A double-blind, randomized, comparative study of the use of a combination of uridine triphosphate trisodium, cytidine monophosphate disodium, and hydroxocobalamin, versus isolated treatment with hydroxocobalamin, in patients presenting with compressive neuralgias

Abstract

Context

This paper reports on the results of treatment of compressive neuralgia using a combination of nucleotides (uridine triphosphate trisodium [UTP] and cytidine monophosphate disodium [CMP]) and vitamin B₁₂.

Objectives

To assess the safety and efficacy of the combination of nucleotides (UTP and CMP) and vitamin B₁₂ in patients presenting with neuralgia arising from neural compression associated with degenerative orthopedic alterations and trauma, and to compare these effects with isolated administration of vitamin B₁₂.

Methods

A randomized, double-blind, controlled trial, consisting of a 30-day oral treatment period: Group A (n=200) receiving nucleotides + vitamin B_12, and Group B (n=200) receiving vitamin B₁₂ alone. The primary study endpoint was the percentage of subjects presenting pain visual analog scale (VAS) scores ≤20 at end of study treatment period. Secondary study endpoints included the percentage of subjects presenting improvement ≥5 points on the patient functionality questionnaire (PFQ); percentage of subjects presenting pain reduction (reduction in VAS scores at study end in relation to pretreatment); and number of subjects presenting adverse events.

Results

The results of this study showed a more expressive improvement in efficacy evaluations among subjects treated with the combination of nucleotides + vitamin B₁₂, with a statistically significant superiority of the combination in pain reduction (evidenced by VAS scores). There were adverse events in both treatment groups, but these were transitory and no severe adverse event was recorded during the study period. Safety parameters were maintained throughout the study in both treatment groups.

Conclusion

The combination of uridine, cytidine, and vitamin B₁₂ was safe and effective in the treatment of neuralgias arising from neural compression associated with degenerative orthopedic alterations and trauma.

Keywords:

• uridine triphosphate trisodium
• cytidine monophosphate disodium
• hydroxocobalamin
• compressive neuralgia

Acknowledgments

The authors thank Renato Kaufman and Adenilson de Souza da Fonseca for participation in the study with subject recruitment, treatment, data review and contributions to the drafts of this paper. Thanks also to Alessandra Santos for clinical research form and data verification, and Daiane Bergamim, Silvia Maciel, Breno Lorch and Aline Pacheco for study monitoring.

Disclosure

The authors report no conflicts of interest in this work.