Alcoholic Polyneuropathy: Clinical Assessment of Treatment Outcomes Following Therapy with Nucleotides and Vitamin B12

Nunes, Carlos Pereira; Jr, Ari; Goldberg, Henrique; Goldwasser, Gerson; Oliveira, Lisa; Rzetelna, Helio; Mibielli, Marco Antonio; Santos, Aritânia Sousa; Geller, Mauro

doi:10.5171/2013.208067

Cited by 4 publications

(8 citation statements)

References 16 publications

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“…A previous study performed by Goldberg et al (2009) assessed the use of this combination in the treatment of back pain and hip pain, reporting significant reduction in pain assessments as well as functionality. 10 As with the study of Goldberg and also another recent study in alcoholic polyneuropathy in which the authors compared the use of the combination of UTP + CMP + vitamin B 12 with the use of vitamin B 12 monotherapy, 17 there was a significant improvement over the treatment period in pain manifestations as compared to the monotherapy group, although the patients within the monotherapy group also displayed significant improvement throughout the treatment as compared to pretreatment status. This finding and that of our study highlights the importance the vitamin B 12 component in the treatment of these painful conditions.…”

Section: Discussionmentioning

confidence: 98%

A double-blind, randomized, comparative study of the use of a combination of uridine triphosphate trisodium, cytidine monophosphate disodium, and hydroxocobalamin, versus isolated treatment with hydroxocobalamin, in patients presenting with compressive neuralgias

Goldberg¹,

Mibielli²,

Nunes³

et al. 2017

JPR

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ContextThis paper reports on the results of treatment of compressive neuralgia using a combination of nucleotides (uridine triphosphate trisodium [UTP] and cytidine monophosphate disodium [CMP]) and vitamin B12.ObjectivesTo assess the safety and efficacy of the combination of nucleotides (UTP and CMP) and vitamin B12 in patients presenting with neuralgia arising from neural compression associated with degenerative orthopedic alterations and trauma, and to compare these effects with isolated administration of vitamin B12.MethodsA randomized, double-blind, controlled trial, consisting of a 30-day oral treatment period: Group A (n=200) receiving nucleotides + vitamin B12, and Group B (n=200) receiving vitamin B12 alone. The primary study endpoint was the percentage of subjects presenting pain visual analog scale (VAS) scores ≤20 at end of study treatment period. Secondary study endpoints included the percentage of subjects presenting improvement ≥5 points on the patient functionality questionnaire (PFQ); percentage of subjects presenting pain reduction (reduction in VAS scores at study end in relation to pretreatment); and number of subjects presenting adverse events.ResultsThe results of this study showed a more expressive improvement in efficacy evaluations among subjects treated with the combination of nucleotides + vitamin B12, with a statistically significant superiority of the combination in pain reduction (evidenced by VAS scores). There were adverse events in both treatment groups, but these were transitory and no severe adverse event was recorded during the study period. Safety parameters were maintained throughout the study in both treatment groups.ConclusionThe combination of uridine, cytidine, and vitamin B12 was safe and effective in the treatment of neuralgias arising from neural compression associated with degenerative orthopedic alterations and trauma.

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Section: Discussionmentioning

confidence: 98%

A double-blind, randomized, comparative study of the use of a combination of uridine triphosphate trisodium, cytidine monophosphate disodium, and hydroxocobalamin, versus isolated treatment with hydroxocobalamin, in patients presenting with compressive neuralgias

Goldberg¹,

Mibielli²,

Nunes³

et al. 2017

JPR

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“…Previous studies in smaller populations assessing these combinations utilized shorter treatment periods of up to 30 days, [9][10][11][12][13] however the longer treatment period employed in the present study does not appear to have resulted in a higher rate of AE occurrence. Comparing the results of the present study with those of the study by Goldberg et al, total AE rate in that study among 200 subjects who received the nucleotide+vitamin B 12 combination over 30 days of treatment was 19%, while total AE rate among subjects receiving the same treatment in the present study over 60 days was 24% (P=0.49).…”

Section: Discussionmentioning

confidence: 68%

“…8 Evidence from previous exploratory clinical studies using either the combination of nucleotides and vitamin B 12 or the B vitamins (B 1 , B 6 , and B 12 ) has demonstrated symptomatic and functional improvement among patients treated for painful conditions including neuralgia, neuropathic pain manifestations, low back pain, and osteoarthritis-related pain. [9][10][11][12][13][14] The objective of this study was to compare the clinical tolerability and efficacy of the combination of uridine triphosphate, cytidine monophosphate and hydroxocobalamin vs the combination of thiamine nitrate, pyridoxine hydrochloride, and cyanocobalamin in patients presenting low back pain, over a 60-day treatment period.…”

Section: Introductionmentioning

confidence: 99%

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

Mibielli

Nunes

Goldberg

et al. 2020

JPR

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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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“…Afterward, the efficacy of the treatment was evaluated through sensorial motor tests as well as a visual evaluation of pain. With this, it was concluded that the treatment was effective and safe, reducing pain and improving the motor activity of the patients [66]. Negrão et al performed an observational clinical study of 212 patients with peripheral neuropathy and neuropathic pain, treated orally for 2 months with capsules of uridine monophosphate (UMP), folic acid, and hydroxycobalamin.…”

Section: Discussionmentioning

confidence: 99%

“…They observed that the group treated with the three elements achieved better efficacy-corresponding to an improvement in laboratory assessments, weight gain, and decreased pain-than the group treated only with nucleotides [65]. Another study evaluated the use of the three therapeutic elements in the treatment of patients with alcoholic polyneuropathy, and it was observed that their use was safe and effective, with decreased pain and improved motor coordination [66].…”

Section: Nucleotids and Cobalamin And Their Application For Regenerationmentioning

confidence: 99%

The Role of Nucleotides in Glial Cells during Peripheral Nerve Trauma and Compressive Disorders

Manhães¹,

César²,

Justo³

et al. 2017

Peripheral Nerve Regeneration - From Surgery to New Therapeutic Approaches Including Biomaterials and Cell-Based Therapies Deve

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Studies have shown that the administration of drugs containing pyrimidine nucleotides, such as uridine triphosphate (UTP) and cytidine monophosphate (CMP), has been effective in pain-intensity reductions in patients with painful conditions as diabetic neuropathy, back pain, and cervical and trauma-compressive changes. The combination of pyrimidine nucleotides UTP and CMP is part of a peripheral neuro-regenerative process. Its pharmacological properties are stimulation of nerve cells proteins synthesis, nerve cell membranes synthesis, myelin sheaths synthesis, and neurite sprouting through P2Y receptors activation. Herein, chapter will be discussed the combination of UTP and CMP, and in some cases, the inclusion of cobalamin (B12 vitamin) that appears to have analgesic effects in neuropathic pain secondary to spine structural disorders assigned to a complex pharmacodynamic. The mechanisms involved can be both indirect (protein synthesis in nerve cells, myelin synthesis, synthesis of MBP, etc.) and direct (P2Y receptor stimulation).

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Alcoholic Polyneuropathy: Clinical Assessment of Treatment Outcomes Following Therapy with Nucleotides and Vitamin B12

Cited by 4 publications

References 16 publications

A double-blind, randomized, comparative study of the use of a combination of uridine triphosphate trisodium, cytidine monophosphate disodium, and hydroxocobalamin, versus isolated treatment with hydroxocobalamin, in patients presenting with compressive neuralgias

A double-blind, randomized, comparative study of the use of a combination of uridine triphosphate trisodium, cytidine monophosphate disodium, and hydroxocobalamin, versus isolated treatment with hydroxocobalamin, in patients presenting with compressive neuralgias

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

The Role of Nucleotides in Glial Cells during Peripheral Nerve Trauma and Compressive Disorders

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