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Nucleotides Cytidine and Uridine Associated with Vitamin B12 vs B-Complex Vitamins in the Treatment of Low Back Pain: The NUBES Study

PURPOSE: We report the results of low back pain treatment using a combination of nucleotides, uridine (UTP), cytidine (CMP) and vitamin B(12), vs a combination of vitamins B(1), B(6), and B(12). PATIENTS AND METHODS: Randomized, double-blind, controlled trial, of a 60-day oral treatment: Group A (n=...

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Autores principales: Mibielli, Marco Antonio Naslausky, Nunes, Carlos Pereira, Goldberg, Henrique, Buchman, Luiz, Oliveira, Lisa, Mezitis, Spyros G E, Wajnzstajn, Fernanda, Kaufman, Renato, Nigri, Rafael, Cytrynbaum, Natasha, Cunha, Karin Soares, Santos, Alessandra, Goldberg, Stephanie Wrobel, Platenik, Natália Carvalho, Rzetelna, Helio, Futuro, Daniel Bertoluci, Da Fonseca, Adenilson de Souza, Geller, Mauro
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Dove 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7568635/
https://www.ncbi.nlm.nih.gov/pubmed/33116795
http://dx.doi.org/10.2147/JPR.S277024
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author Mibielli, Marco Antonio Naslausky
Nunes, Carlos Pereira
Goldberg, Henrique
Buchman, Luiz
Oliveira, Lisa
Mezitis, Spyros G E
Wajnzstajn, Fernanda
Kaufman, Renato
Nigri, Rafael
Cytrynbaum, Natasha
Cunha, Karin Soares
Santos, Alessandra
Goldberg, Stephanie Wrobel
Platenik, Natália Carvalho
Rzetelna, Helio
Futuro, Daniel Bertoluci
Da Fonseca, Adenilson de Souza
Geller, Mauro
author_facet Mibielli, Marco Antonio Naslausky
Nunes, Carlos Pereira
Goldberg, Henrique
Buchman, Luiz
Oliveira, Lisa
Mezitis, Spyros G E
Wajnzstajn, Fernanda
Kaufman, Renato
Nigri, Rafael
Cytrynbaum, Natasha
Cunha, Karin Soares
Santos, Alessandra
Goldberg, Stephanie Wrobel
Platenik, Natália Carvalho
Rzetelna, Helio
Futuro, Daniel Bertoluci
Da Fonseca, Adenilson de Souza
Geller, Mauro
author_sort Mibielli, Marco Antonio Naslausky
collection PubMed
description PURPOSE: We report the results of low back pain treatment using a combination of nucleotides, uridine (UTP), cytidine (CMP) and vitamin B(12), vs a combination of vitamins B(1), B(6), and B(12). PATIENTS AND METHODS: Randomized, double-blind, controlled trial, of a 60-day oral treatment: Group A (n=317) receiving nucleotides+B(12) and Group B (n=317) receiving B vitamins. The primary endpoint was the percentage of subjects in each group presenting adverse events (AEs). Secondary endpoints were visual analog scale (VAS) pain scores at Visit 2 (day 30) and Visit 3 (day 60) in relation to pretreatment values, Roland–Morris Questionnaire (RMQ) scores and finger-to-floor distance (FFD) (percentage of subjects per group presenting improvement ≥5 points and ≥3cm, respectively). RESULTS: Seventy-five (24%) and 105 (33%) subjects (P=0.21) presented 133 and 241 AEs, with 3159% of subjects presenting ≥2 AEs (P=0.0019) in Group A and Group B, respectively. Twenty-four subjects in Group B were discontinued due to AEs, while no AE-related discontinuations occurred in Group A (P<0.0001). VAS score reduction after 30 and 60 days of treatment was statistically significant (P<0.0001) in both groups, with Group A showing greater reduction at Visit 2 (P<0.0001). RMQ score improvement ≥5 points occurred in 99% of subjects from each group, and FFD improvement ≥3 cm occurred in all subjects. CONCLUSION: Treatment with nucleotides+B(12) was associated with a lower number of total AEs, fewer AEs per subject, and no AE-related treatment discontinuation. Pain intensity (VAS) reduction was superior at 30 days of treatment in the nucleotides+B(12) group and equivalent between groups at 60 days of treatment. Improvements in efficacy measures RMQ and FFD were observed in both groups at treatment days 30 and 60.
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spelling pubmed-75686352020-10-27 Nucleotides Cytidine and Uridine Associated with Vitamin B12 vs B-Complex Vitamins in the Treatment of Low Back Pain: The NUBES Study Mibielli, Marco Antonio Naslausky Nunes, Carlos Pereira Goldberg, Henrique Buchman, Luiz Oliveira, Lisa Mezitis, Spyros G E Wajnzstajn, Fernanda Kaufman, Renato Nigri, Rafael Cytrynbaum, Natasha Cunha, Karin Soares Santos, Alessandra Goldberg, Stephanie Wrobel Platenik, Natália Carvalho Rzetelna, Helio Futuro, Daniel Bertoluci Da Fonseca, Adenilson de Souza Geller, Mauro J Pain Res Clinical Trial Report PURPOSE: We report the results of low back pain treatment using a combination of nucleotides, uridine (UTP), cytidine (CMP) and vitamin B(12), vs a combination of vitamins B(1), B(6), and B(12). PATIENTS AND METHODS: Randomized, double-blind, controlled trial, of a 60-day oral treatment: Group A (n=317) receiving nucleotides+B(12) and Group B (n=317) receiving B vitamins. The primary endpoint was the percentage of subjects in each group presenting adverse events (AEs). Secondary endpoints were visual analog scale (VAS) pain scores at Visit 2 (day 30) and Visit 3 (day 60) in relation to pretreatment values, Roland–Morris Questionnaire (RMQ) scores and finger-to-floor distance (FFD) (percentage of subjects per group presenting improvement ≥5 points and ≥3cm, respectively). RESULTS: Seventy-five (24%) and 105 (33%) subjects (P=0.21) presented 133 and 241 AEs, with 3159% of subjects presenting ≥2 AEs (P=0.0019) in Group A and Group B, respectively. Twenty-four subjects in Group B were discontinued due to AEs, while no AE-related discontinuations occurred in Group A (P<0.0001). VAS score reduction after 30 and 60 days of treatment was statistically significant (P<0.0001) in both groups, with Group A showing greater reduction at Visit 2 (P<0.0001). RMQ score improvement ≥5 points occurred in 99% of subjects from each group, and FFD improvement ≥3 cm occurred in all subjects. CONCLUSION: Treatment with nucleotides+B(12) was associated with a lower number of total AEs, fewer AEs per subject, and no AE-related treatment discontinuation. Pain intensity (VAS) reduction was superior at 30 days of treatment in the nucleotides+B(12) group and equivalent between groups at 60 days of treatment. Improvements in efficacy measures RMQ and FFD were observed in both groups at treatment days 30 and 60. Dove 2020-10-13 /pmc/articles/PMC7568635/ /pubmed/33116795 http://dx.doi.org/10.2147/JPR.S277024 Text en © 2020 Mibielli et al. http://creativecommons.org/licenses/by-nc/3.0/ This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (https://www.dovepress.com/terms.php).
spellingShingle Clinical Trial Report
Mibielli, Marco Antonio Naslausky
Nunes, Carlos Pereira
Goldberg, Henrique
Buchman, Luiz
Oliveira, Lisa
Mezitis, Spyros G E
Wajnzstajn, Fernanda
Kaufman, Renato
Nigri, Rafael
Cytrynbaum, Natasha
Cunha, Karin Soares
Santos, Alessandra
Goldberg, Stephanie Wrobel
Platenik, Natália Carvalho
Rzetelna, Helio
Futuro, Daniel Bertoluci
Da Fonseca, Adenilson de Souza
Geller, Mauro
Nucleotides Cytidine and Uridine Associated with Vitamin B12 vs B-Complex Vitamins in the Treatment of Low Back Pain: The NUBES Study
title Nucleotides Cytidine and Uridine Associated with Vitamin B12 vs B-Complex Vitamins in the Treatment of Low Back Pain: The NUBES Study
title_full Nucleotides Cytidine and Uridine Associated with Vitamin B12 vs B-Complex Vitamins in the Treatment of Low Back Pain: The NUBES Study
title_fullStr Nucleotides Cytidine and Uridine Associated with Vitamin B12 vs B-Complex Vitamins in the Treatment of Low Back Pain: The NUBES Study
title_full_unstemmed Nucleotides Cytidine and Uridine Associated with Vitamin B12 vs B-Complex Vitamins in the Treatment of Low Back Pain: The NUBES Study
title_short Nucleotides Cytidine and Uridine Associated with Vitamin B12 vs B-Complex Vitamins in the Treatment of Low Back Pain: The NUBES Study
title_sort nucleotides cytidine and uridine associated with vitamin b12 vs b-complex vitamins in the treatment of low back pain: the nubes study
topic Clinical Trial Report
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7568635/
https://www.ncbi.nlm.nih.gov/pubmed/33116795
http://dx.doi.org/10.2147/JPR.S277024
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