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Randomized Controlled Trial
. 2024 Dec 4;16(23):4187.
doi: 10.3390/nu16234187.

Evaluation of the Efficacy of the Addition of a Combination of Pyrimidine Nucleotides and Vitamin B1 and B12 to Standard Treatment in the Management of Painful Radiculopathy and in the Quality of Life of Patients

Jordi Monfort  1   2 , Irene Carrión-Barberà  1   2 , Laura Tío  2 , Javier Marante  3 , Alicia López Vázquez  4 , Teresa Bas  5 , Lola Fernandez-Fuente-Burson  6 , Miguel A Caracuel  7 , Antonio Oliveros-Cid  8 , Virginia Gallart  9 , Cintia Romera-López  10 , José A Román  11 , David Abejón  12 , Luis Javier Roca Ruíz  13 , Alba Gurt  14 , Fabiola Ojeda  1   2 , Pedro Grima  15 , Rebeca Aldonza  16
Affiliations
Randomized Controlled Trial

Evaluation of the Efficacy of the Addition of a Combination of Pyrimidine Nucleotides and Vitamin B1 and B12 to Standard Treatment in the Management of Painful Radiculopathy and in the Quality of Life of Patients

Jordi Monfort et al. Nutrients. .

Abstract

Background/Objectives: Radiculopathy leads to pain, consequently reducing patient's quality of life (QoL). Research indicates that certain nucleotides, such as cytidine and uridine, along with vitamins B1 and B12, may help alleviate pain and enhance QoL. This study assessed the impact of adding a supplement containing cytidine and uridine nucleotides and vitamins B1 and B12, alongside standard treatment, on radiculopathy-associated pain. Methods: A multicenter, prospective, two-cohort, randomized, open-label study was conducted. The control group received standard treatment, while the experimental group received standard treatment plus the supplement. The primary endpoint was pain reduction measured by a Visual Analog Scale (VAS). Secondary endpoints included functional improvement (Roland Morris questionnaire), clinical improvement (Clinical Global Impression [CGI] scale), and QoL improvement (EQ-5D-5L questionnaire). Results: A total of 122 patients were included from 17 centers across Spain. Both groups showed pain improvement, but the VAS reduction (control: 24.58 vs. experimental: 31.35) was not statistically significant. The Roland Morris score decreased significantly in the experimental group (estimate: -1.70, 95% CI -3.29 to -0.10; p = 0.038), and these patients were 5 times more likely to progress to a better CGI category (OR = 0.20, 95% CI 0.07 to 0.57; p = 0.003). No significant differences were observed in EQ-5D-5L scores or analgesic consumption. Conclusions: The addition of supplemental pyrimidine nucleotides and vitamins B1 and B12 to standard of care treatment improved radiculopathy functional and clinical outcomes. Regarding pain, however, although there was a numerical improvement, it did not reach statistical significance.

Keywords: Vitamins B; nucleotides; pain; quality of life; radiculopathy.

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Conflict of interest statement

Author Pedro Grima was an employer of Ferrer Internacional S.A. at the beginning of the study and was employed by the company Affinity Petcare. Rebeca Aldonza is full-time employee of Ferrer Internacional S.A. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The authors declare that this study received funding from Ferrer Internacional, S.A. The funder was not involved in the collection, analysis and interpretation of data.

Figures

Figure 1
Figure 1
Patient disposition diagram. VAS: pain visual analog scale, PP: per protocol, mITT: modified intent-to-treat.
Figure 2
Figure 2
Boxplots representing the evolution of the pain VAS score across the study visits by treatment group in the mITT population analysis set (a) and the PP population analysis set (b).
Figure 3
Figure 3
Boxplots representing the evolution of the degree of disability (Roland Morris Score) across the study visits by treatment group in the mITT population analysis set.
Figure 4
Figure 4
Bar chart representing the evolution of the Clinical Global Impression scale (CGI) across the study visits by treatment group in the mITT analysis population set.
See this image and copyright information in PMC

References

    1. Tawa N., Rhoda A., Diener I. Accuracy of clinical neurological examination in diagnosing lumbosacral radiculopathy: A systematic literature review. BMC Musculoskelet. Disord. 2017;18:93. doi: 10.1186/s12891-016-1383-2. - DOI - PMC - PubMed
    1. Woods B.I., Hilibrand A.S. Cervical radiculopathy: Epidemiology, etiology, diagnosis, and treatment. J. Spinal Disord. Tech. 2015;28:E251–E259. doi: 10.1097/BSD.0000000000000284. - DOI - PubMed
    1. Berry J.A., Elia C., Saini H.S., Miulli D.E. A Review of Lumbar Radiculopathy, Diagnosis, and Treatment. Cureus. 2019;11:e5934. doi: 10.7759/cureus.5934. - DOI - PMC - PubMed
    1. Deyo R.A., Weinstein J.N. Low back pain. N. Engl. J. Med. 2001;344:363–370. doi: 10.1056/NEJM200102013440508. - DOI - PubMed
    1. Schubert P., Kreutzberg G.W. Axonal transport of adenosine and uridine derivatives and transfer to postsynaptic neurons. Brain Res. 1974;76:526–530. doi: 10.1016/0006-8993(74)90828-2. - DOI - PubMed

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