Neural compression-induced neuralgias: clinical evaluation of the effect of nucleotides associated with vitamin B12

The use of a combination of uridine triphosphate (UTP), cytidine monophosphate (CMP), and hydroxocobalamin was evaluated in a double-blind, randomized study in the treatment of neuralgia due to degenerative orthopedic alterations with neural compression. Following informed consent, 80 patients were randomized to a 30 day treatment period. The subjects received a thrice-daily oral treatment regimen of either the combination treatment (Group A: total daily dose of 9mg UTP, 15mg CMP, 6 mg hydroxocobalamin) or vitamin B12 alone (Group B: total daily dose of 6 mg hydroxocobalamin). Efficacy measures evaluated global patient condition from the perspective of the subject and the investigating physician pain ? measured by a visual-analog scale and functionality, using a patient-response questionnaire. The safety evaluation took into account physical evaluations and laboratory tests performed at each visit to the study center as well as the incidence and severity of adverse events. At the end of the 30-day treatment period, there were reductions in the pain scale scores in both groups, however there was a significantly larger reduction in the scores of the Group A patients. The Patient Global Evaluation scores improved in both groups but showed greater improvement in Group A, while the Physician Global Evaluation improved significantly only in Group A. A similar finding was observed in the scores of the Patient Functionality Questionnaire. Based on the findings of this clinical trial, we conclude that the combination of UTP, CMP, and vitamin B12 has a positive effect on pain and functionality improvement in the treatment of degenerative orthopedic alterations with neural compression, in the study population evaluated.

Efficacy and tolerability of a combination of uridine, cytidine, and vitamin B12 in anemia. A double-blind, comparative study versus nucleotide monotherapy

Background: Deficiency in vitamin B12 is commonly associated with pernicious anemia, presenting a number of clinical symptoms resulting from neurological alterations due to modifications in myelin formation. Treatment consists of oral or parenteral vitamin B12 supplementation. Vitamin B12 has also been shown to have analgesic action whether administered alone or in combination with other therapeutic agents. Oral or parenteral pyrimidine ribonucleotide supplementation may be advantageous in the treatment of peripheral neuropathies. Objectives: To evaluate and compare the efficacy and tolerability of an orally administered combination of vitamin B12, uridine and cytidine, versus administration of the nucleotides alone in the treatment of the signs and symptoms of anemia. Study design: Study goal was normalization of MCV and MCH and serum vitamin B12 as well as improvement in pain and paresthesia among patients presenting these symptoms at Pretreatment. The study was designed as a double-blind, randomized trial in two arms: Group A patients were treated with the vitamin + nucleotide combination Group B patients received nucleotides alone. Treatment lasted 60 days, with two interim visits at 20 and 40 days of treatment and a final evaluation after 60 days of treatment. Setting: Patients were attended in an ambulatory setting of a UNIFESO university hospital. Patients: Eligible patients were between 18-65 years of age, with clinical and laboratory presentation of anemia with or without underlying autoimmune disease, caused by vitamin B12 deficiency. Female patients were not pregnant and were required to use birth control for the duration of the treatment period. Eighty patients were randomized, with 40 patients in each treatment group. Treatment consisted of 3 daily oral doses of: 1.0 mg hydroxocobalamin acetate, 2.5 mg cytidine 5'-{sodium P'(2-(trimethylammonio)-ethyl) hydrogen diphosphate}, and 1.5 mg uridine 5'-trisodium triphosphate for Group A patients, while patients in Group B received 2.5 mg cytidine 5'-{sodium P'(2-(trimethylammonio)-ethyl) hydrogen diphosphate}, and 1.5 mg uridine 5'-trisodium triphosphate in identical capsule forms. Main outcome measure: Primary outcome measures defined in the protocol included improvements in MCV, MCH and vitamin B12 reaching laboratory reference range, 3-point improvements in Global, Pain, and Paresthesia evaluations and a 20% reduction in VAS scores. Results: Normalization of laboratory evaluations occurred only in Group A. Three-point improvement in Global evaluation by the physician was observed only in Group A, while both groups showed improvement in Global evaluation by the patient. Patient's assessment of pain improved only in Group A, although VAS score decrease was noted in both groups both groups also had improvement in paresthesia evaluations. Vital signs did not change, while weight gain was observed in both groups. Adverse events seen in both groups included nausea, diarrhea, headache and abdominal cramps. Alterations in laboratory evaluations were reported in both groups, but could be directly attributed to anemia. Conclusion: The combination of vitamin B12, uridine and cytidine was found to be safe and effective in the treatment of the signs and symptoms of anemia in the population studied. The pain reduction observed in both groups may be attributed to activity of the nucleotides.