A Combination of Gamma-Aminobutyric Acid, Glutamic Acid, Calcium, Thiamine, Pyridoxine, and Cyanocobalamin vs Ginger Extract in the Management of Chronic Motion Sickness: A Clinical Evaluation.

Background: Motion sickness (kinetosis) is a common and temporarily incapacitant ailment, manageable with behavioral as well as pharmacological measures. Objective: To assess the effectiveness and safety of a combination of gamma-aminobutyric acid, glutamic acid, calcium, thiamine, pyridoxine, and cyanocobalamin (Group A) (n = 170) and extract of Zingiber officinale (ginger) (Group B) (n = 165) in the management of chronic complaints consistent with motion sickness. Methods: Both groups were tested according to the following end points, under self-paired as well as comparative study designs: reduction of ≥20 score points in the total motion sickness assessment questionnaire (MSAQ) score, percentage of patients presenting a reduction of the total MSAQ score, absolute MSAQ score reduction, physician's assessment scores, final overall assessment of study medication, and willingness to continue treatment. Safety was also evaluated. Results: There was a statistically significant better performance under both study designs for Group A (P = 0.05 using different statistical tests) in all end points. Both regimens were safe, with different neurological and gastrointestinal tolerability outcomes. Conclusions: Group A and Group B regimens were effective and safe in the management of chronic complaints consistent with motion sickness and the Group A regimen was more effective than Group B.

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

PURPOSE: 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.

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.

CONTEXT: This 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. OBJECTIVES: To 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. METHODS: A 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. RESULTS: The 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. CONCLUSION: The 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.

Treatment of inflammatory neuropathy with dexamethasone plus B-vitamins: a clinical evaluation / Tratamento de neuropatia inflamatória com a associação de dexametasona e vitaminas B: uma avaliação clínica

We evaluated the use of a combination of vitamins B1, B6, and B12 with dexamethasone in the treatment of the signs and symptoms of inflammatory neuropathy of the upper and lower limbs, in an open-label clinical trial. Patients were submitted to a 9-day treatment period with three doses of study medication at three day intervals, and a series of clinical and laboratory assessments, prior to the first dose of study medication and at each of the following three visits to the study center. Efficacy evaluations at each study visit included a 100mm VAS pain scale and global and satisfaction surveys completed by the patient and the investigating physician. Safety evaluations included a comparison of changes in laboratory evaluations at each visit and the incidence, severity, duration, and outcome of adverse events. A total of sixty-one patients were enrolled in the trial. A clinically significant improvement in all of the efficacy measures was observed from the pre-treatment to end-of-study evaluations. No clinically significant alterations in clinical assessments were observed during the treatment period. Based on the results of this clinical study, we conclude that the combination of dexamethasone with the B-vitamins is safe and effective in the treatment of the signs and symptoms of inflammatory neuropathy.

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.