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.

Helio Rzetelna, Henrique Goldberg, Marco Antonio Mibielli, Carlos Pereira Nunes, Stephanie Wrobel Goldberg, Luiz Buchman, Spyros Ge Mezitis, Lisa Oliveira, Mauro Geller, Fernanda Wajnsztajn

Journal: Journal of pain research 2017;10():397-404

PMID: 28243144

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Plain Language Summary

Uridine and cytidine are nucleotides, which play several fundamental roles in cellular metabolism, including being components of DNA, energy transfer, intracellular signalling and neurotransmission. Vitamin B12 is essential for growth and maintenance of a variety of processes, including synthesis of myelin (an important structure of the nervous system) and nerve metabolism. The objectives of this randomised, double-blind, comparative, controlled clinical trial were to assess the safety and efficacy of the combination of nucleotides (uridine triphosphate, UTP and cytidine monophosphate, CMP) and vitamin B12 in patients presenting with pain due to neural compression, compared with vitamin B12 on its own. Patients received 15mg CMP, 9mg UTP and 6mg vitamin B12 or 6mg vitamin B12 only, for 30 days and were assessed before start and at 15 and 30 days of treatment. Outcome measures included a visual analog pain scale (VAS), and the Patient Functionality Questionnaire (PFQ), as well as adverse effects, including changes in blood parameters. 191 patients in each group completed the trial. Both groups showed statistically significant improvements at the end of the study in relation to pre-treatment PFQ and VAS scores, but improvements were statistically better in the combination therapy compared to vitamin B12 alone. Adverse events were reported in both treatment groups, but these were transient and no severe adverse event occurred during the study period. The authors conclude that the combination of uridine, cytidine, and vitamin B12 was effective in the treatment of neuropathic pain and that further, larger studies are warranted.

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 B.

OBJECTIVES

To assess the safety and efficacy of the combination of nucleotides (UTP and CMP) and vitamin B 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 B.

METHODS

A randomized, double-blind, controlled trial, consisting of a 30-day oral treatment period: Group A (n=200) receiving nucleotides + vitamin B and Group B (n=200) receiving vitamin B 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 B, 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 B was safe and effective in the treatment of neuralgias arising from neural compression associated with degenerative orthopedic alterations and trauma.

Address: UERJ Medical School, Rio de Janeiro, Brazil.; UNIFESO Medical School, Teresópolis, Brazil.; Washington University School of Medicine, St Louis, MO, USA.; Instituto de Pós-Graduação Médica Carlos Chagas (ICC), Rio de Janeiro, Brazil.; New York-Presbyterian Hospital/Weill-Cornell Medical Center, New York, NY, USA.; Santa Casa da Misericórdia do Rio de Janeiro, Rio de Janeiro, Brazil.; New York-Presbyterian Hospital/Columbia University Medical Center, Neurology, New York, NY, USA.

DOI: 10.2147/JPR.S123045