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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

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          Abstract

          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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          Most cited references 36

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          Non-specific low back pain.

          Non-specific low back pain affects people of all ages and is a leading contributor to disease burden worldwide. Management guidelines endorse triage to identify the rare cases of low back pain that are caused by medically serious pathology, and so require diagnostic work-up or specialist referral, or both. Because non-specific low back pain does not have a known pathoanatomical cause, treatment focuses on reducing pain and its consequences. Management consists of education and reassurance, analgesic medicines, non-pharmacological therapies, and timely review. The clinical course of low back pain is often favourable, thus many patients require little if any formal medical care. Two treatment strategies are currently used, a stepped approach beginning with more simple care that is progressed if the patient does not respond, and the use of simple risk prediction methods to individualise the amount and type of care provided. The overuse of imaging, opioids, and surgery remains a widespread problem.
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            Prognostic factors for duration of sick leave in patients sick listed with acute low back pain: a systematic review of the literature.

            The percentages of patients with acute low back pain (LBP) that go on to a chronic state varies between studies from 2% to 34%. In some of these cases low back pain leads to great costs. To evaluate the evidence for prognostic factors for return to work among workers sick listed with acute LBP. Systematic literature search with a quality assessment of studies, assessment of levels of evidence for all factors, and pooling of effect sizes. Inclusion of studies in the review was restricted to inception cohort studies of workers with LBP on sick leave for less than six weeks, with the outcome measured in absolute terms, relative terms, survival curve, or duration of sick leave. Of the studies, 18 publications (14 cohorts) fulfilled all inclusion criteria. One low quality study, four moderate quality studies, and nine high quality studies were identified; 79 prognostic factors were studied and grouped in eight categories for which the evidence was assessed. Specific LBP, higher disability levels, older age, female gender, more social dysfunction and more social isolation, heavier work, and receiving higher compensation were identified as predictors for a longer duration of sick leave. A history of LBP, job satisfaction, educational level, marital status, number of dependants, smoking, working more than 8 hour shifts, occupation, and size of industry or company do not influence duration of sick leave due to LBP. Many different constructs were measured to identify psychosocial predictors of long term sick leave, which made it impossible to determine the role of these factors.
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              Systemic Pharmacologic Therapies for Low Back Pain: A Systematic Review for an American College of Physicians Clinical Practice Guideline.

              A 2007 American College of Physicians guideline addressed pharmacologic options for low back pain. New evidence and medications have now become available.
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                Author and article information

                Journal
                J Pain Res
                J Pain Res
                jpr
                jpainres
                Journal of Pain Research
                Dove
                1178-7090
                13 October 2020
                2020
                : 13
                : 2531-2541
                Affiliations
                [1 ]UNIFESO Medical School , Teresópolis, Brazil
                [2 ]UERJ Medical School , Rio De Janeiro, Brazil
                [3 ]Instituto De Pós-Graduação Médica Carlos Chagas (ICC) , Rio De Janeiro, Brazil
                [4 ]Federal University of Rio De Janeiro (UFRJ) , Rio De Janeiro, Brazil
                [5 ]New York-Presbyterian Hospital/Weill-Cornell Medical Center , New York, NY, USA
                [6 ]Neurology Department, UConn Health , Farmington, CT, USA
                [7 ]Department of Medicine, Rutgers New Jersey Medical School , Newark, NJ, USA
                [8 ]Pathology Department, Universidade Federal Fluminense (UFF) Medical School , Niterói, Brazil
                [9 ]Tufts Medical Center , Boston, MA, USA
                [10 ]Santa Casa Da Misericórdia Do Rio De Janeiro , Rio De Janeiro, Brazil
                Author notes
                Correspondence: Mauro Geller Av. Ataulfo de Paiva, 135/702 Rio de Janeiro, 22440-901, BrazilTel +55-21-3875-6660 Email maurogeller@gmail.com
                Article
                277024
                10.2147/JPR.S277024
                7568635
                © 2020 Mibielli et al.

                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).

                Page count
                Figures: 3, Tables: 8, References: 37, Pages: 11
                Categories
                Clinical Trial Report

                Anesthesiology & Pain management

                vitamin b12, low back pain, uridine, cytidine, vitamin b1, vitamin b6

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