Marco Antonio Naslausky Mibielli 1 , Carlos Pereira Nunes 1 , 2 , Henrique Goldberg 3 , Luiz Buchman 2 , Lisa Oliveira 4 , Spyros G E 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 Geller 1 , 3 , 4
13 October 2020
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.
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).
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.
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.