PMID- 33116795
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220417
IS  - 1178-7090 (Print)
IS  - 1178-7090 (Electronic)
IS  - 1178-7090 (Linking)
VI  - 13
DP  - 2020
TI  - Nucleotides Cytidine and Uridine Associated with Vitamin B12 vs B-Complex 
      Vitamins in the Treatment of Low Back Pain: The NUBES Study.
PG  - 2531-2541
LID - 10.2147/JPR.S277024 [doi]
AB  - 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.
CI  - (c) 2020 Mibielli et al.
FAU - Mibielli, Marco Antonio Naslausky
AU  - Mibielli MAN
AUID- ORCID: 0000-0001-7761-8499
AD  - UNIFESO Medical School, Teresopolis, Brazil.
FAU - Nunes, Carlos Pereira
AU  - Nunes CP
AUID- ORCID: 0000-0002-8761-312X
AD  - UNIFESO Medical School, Teresopolis, Brazil.
AD  - UERJ Medical School, Rio De Janeiro, Brazil.
FAU - Goldberg, Henrique
AU  - Goldberg H
AUID- ORCID: 0000-0003-0458-8414
AD  - Instituto De Pos-Graduacao Medica Carlos Chagas (ICC), Rio De Janeiro, Brazil.
FAU - Buchman, Luiz
AU  - Buchman L
AD  - UERJ Medical School, Rio De Janeiro, Brazil.
FAU - Oliveira, Lisa
AU  - Oliveira L
AUID- ORCID: 0000-0003-4186-377X
AD  - Federal University of Rio De Janeiro (UFRJ), Rio De Janeiro, Brazil.
FAU - Mezitis, Spyros G E
AU  - Mezitis SGE
AD  - New York-Presbyterian Hospital/Weill-Cornell Medical Center, New York, NY, USA.
FAU - Wajnzstajn, Fernanda
AU  - Wajnzstajn F
AD  - Neurology Department, UConn Health, Farmington, CT, USA.
FAU - Kaufman, Renato
AU  - Kaufman R
AD  - Instituto De Pos-Graduacao Medica Carlos Chagas (ICC), Rio De Janeiro, Brazil.
FAU - Nigri, Rafael
AU  - Nigri R
AUID- ORCID: 0000-0001-8866-5661
AD  - Department of Medicine, Rutgers New Jersey Medical School, Newark, NJ, USA.
FAU - Cytrynbaum, Natasha
AU  - Cytrynbaum N
AUID- ORCID: 0000-0001-7671-1026
AD  - Instituto De Pos-Graduacao Medica Carlos Chagas (ICC), Rio De Janeiro, Brazil.
FAU - Cunha, Karin Soares
AU  - Cunha KS
AD  - Pathology Department, Universidade Federal Fluminense (UFF) Medical School, 
      Niteroi, Brazil.
FAU - Santos, Alessandra
AU  - Santos A
AD  - Federal University of Rio De Janeiro (UFRJ), Rio De Janeiro, Brazil.
FAU - Goldberg, Stephanie Wrobel
AU  - Goldberg SW
AD  - Tufts Medical Center, Boston, MA, USA.
FAU - Platenik, Natalia Carvalho
AU  - Platenik NC
AD  - UNIFESO Medical School, Teresopolis, Brazil.
FAU - Rzetelna, Helio
AU  - Rzetelna H
AD  - Santa Casa Da Misericordia Do Rio De Janeiro, Rio De Janeiro, Brazil.
FAU - Futuro, Daniel Bertoluci
AU  - Futuro DB
AUID- ORCID: 0000-0001-9298-9247
AD  - UNIFESO Medical School, Teresopolis, Brazil.
FAU - Da Fonseca, Adenilson de Souza
AU  - Da Fonseca AS
AD  - UNIFESO Medical School, Teresopolis, Brazil.
FAU - Geller, Mauro
AU  - Geller M
AUID- ORCID: 0000-0002-5108-5054
AD  - UNIFESO Medical School, Teresopolis, Brazil.
AD  - Instituto De Pos-Graduacao Medica Carlos Chagas (ICC), Rio De Janeiro, Brazil.
AD  - Federal University of Rio De Janeiro (UFRJ), Rio De Janeiro, Brazil.
LA  - eng
PT  - Case Reports
PT  - Clinical Trial
DEP - 20201013
PL  - New Zealand
TA  - J Pain Res
JT  - Journal of pain research
JID - 101540514
PMC - PMC7568635
OTO - NOTNLM
OT  - cytidine
OT  - low back pain
OT  - uridine
OT  - vitamin B1
OT  - vitamin B12
OT  - vitamin B6
COIS- This study was sponsored by Laboratorio Gross S.A. (Rio de Janeiro, RJ, Brazil). 
      Fernanda Wajnzstajn reports being a PI for a clinical trial sponsored by Alnylam, 
      outside the submitted work. The authors report no other potential conflicts of 
      interest in this work.
EDAT- 2020/10/30 06:00
MHDA- 2020/10/30 06:01
PMCR- 2020/10/13
CRDT- 2020/10/29 05:49
PHST- 2020/08/14 00:00 [received]
PHST- 2020/09/08 00:00 [accepted]
PHST- 2020/10/29 05:49 [entrez]
PHST- 2020/10/30 06:00 [pubmed]
PHST- 2020/10/30 06:01 [medline]
PHST- 2020/10/13 00:00 [pmc-release]
AID - 277024 [pii]
AID - 10.2147/JPR.S277024 [doi]
PST - epublish
SO  - J Pain Res. 2020 Oct 13;13:2531-2541. doi: 10.2147/JPR.S277024. eCollection 2020.