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Marco Antonio Naslausky Mibielli,1 Carlos Pereira Nunes,1,2 Henrique Goldberg,3 Luiz Buchman,2 Lisa Oliveira,4 Spyros GE Mezitis,5 Fernanda Wajnzstajn,6 Renato Kaufman,3 Rafael Nigri,7 Natasha Cytrynbaum,3 Karin Soares Cunha,8 Alessandra Santos,4 Stephanie Wrobel Goldberg,9 Natália Carvalho Platenik,1 Helio Rzetelna,10 Daniel Bertoluci Futuro,1 Adenilson de Souza Da Fonseca,1 Mauro Geller1,3,4 1UNIFESO Medical School, Teresópolis, Brazil; 2UERJ Medical School, Rio De Janeiro, Brazil; 3Instituto De Pós-Graduação Médica Carlos Chagas (ICC), Rio De Janeiro, Brazil; 4Federal University of Rio De Janeiro (UFRJ), Rio De Janeiro, Brazil; 5New York-Presbyterian Hospital/Weill-Cornell Medical Center, New York, NY, USA; 6Neurology Department, UConn Health, Farmington, CT, USA; 7Department of Medicine, Rutgers New Jersey Medical School, Newark, NJ, USA; 8Pathology Department, Universidade Federal Fluminense (UFF) Medical School, Niterói, Brazil; 9Tufts Medical Center, Boston, MA, USA; 10Santa Casa Da Misericórdia Do Rio De Janeiro, Rio De Janeiro, BrazilCorrespondence: Mauro Geller Av. Ataulfo de Paiva, 135/702 Rio de Janeiro, 22440-901, BrazilTel +55-21-3875-6660Email maurogeller@gmail.comPurpose: We report the results of low back pain treatment using a combination of nucleotides, uridine (UTP), cytidine (CMP) and vitamin B12, vs a combination of vitamins B1, B6, and B12.Patients and Methods: Randomized, double-blind, controlled trial, of a 60-day oral treatment: Group A (n=317) receiving nucleotides+B12 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+B12 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+B12 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.Keywords: low back pain, uridine, cytidine, vitamin B1, vitamin B6, vitamin B12 |
