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.

Comparison of the action of diclofenac alone versus diclofenac plus B vitamins on mobility in patients with low back pain.

Objective: To assess results of the finger-to-floor distance (FFD) and the Schober test performed during the DOLOR study, and to verify correlation between Visual Analog Pain Scale scores (VAS) with these measures. Research design and methods: Previously tabulated data from the Clinical Research Forms of the DOLOR study were analyzed (statistical significance defined with a two-tailed p value < 0.05 and confidence interval of 95%). For continuous variables, the Student's T- test or analysis of variance (ANOVA) was used, and differences between pre-treatment and Visits 2, 3, and 4 in the absolute number and percentage of patients with no change, improvement, or worsening of the Schober test and the FFD test scores were calculated, and the results were analyzed with the Chi-squared test. Spearman non-parametric correlation was used for correlating VAS scores with FFD and Schober test scores at each study visit. Main outcome measures: FFD, measured in centimeters; Schober test scores. Results: Throughout the treatment period, there was a statistically significant correlation between the VAS scores and the FFD in the total patient population and within treatment groups. This was not observed for the correlation between the Schober's test scores and the VAS scores. FFD scores within treatment groups improved progressively at each study visit, as did the Schober Test scores. Conclusions: The results of this post-hoc analysis show that combination therapy with diclofenac plus vitamins B1, B6, and B12 had additional positive effects on mobility restoration among the patients of the DOLOR study and serve to highlight the correlation between mobility and pain intensity among patients presenting with low back pain. The two fundamental goals of low back pain therapy are to provide improvements in pain and function. In this sense, the combination of diclofenac with the B vitamins was particularly effective in achieving both of these goals.

Supratrochlear and Supraorbital Nerve Stimulation for Chronic Headache: a Review.

Chronic daily headache accounts for a significant socioeconomic burden due to decreased productivity, work absenteeism, multiple office and ER visits, and hospital admissions for pain control. Associated comorbidities add to this cost. Current traditional medical therapies may fail to provide adequate relief leading to the search for and use of other therapeutic modalities such as innovative medical devices. It is in this setting of the urgent demand for better pain control and to assimilate chronic headache sufferers back into society that a variety of neuromodulatory approaches have been emerging. This review aims to familiarize the reader with current literature regarding supraorbital and supratrochlear nerve stimulation for chronic headache, point out the advantages of this approach, address unanswered questions about this subject, and highlight future directions.

Inpatient management of migraine.

Migraine is a frequently disabling disorder which may require inpatient treatment. Admission criteria for migraine include intractable migraine, nausea and/or vomiting, severe disability, and dependence on opioids or barbiturates. The inpatient treatment of migraine is based on observational studies and expert opinion rather than placebo-controlled trials. Well-established inpatient treatments for migraine include dihydroergotamine, neuroleptics/antiemetics, lidocaine, intravenous aspirin, and non-pharmacologic treatment such as cognitive-behavioral therapy. Short-acting treatments possibly associated with medication overuse, such as triptans, opioids, or barbiturate-containing compounds, are generally avoided. While the majority of persons with migraine are admitted on an emergency basis for only a few days, outcome studies and infusion protocols during elective admissions at tertiary headache centers suggest a longer length of stay may be needed for persons with intractable migraine.

Non-acute congestive heart failure with and without primary sodium retention: evaluation of laboratory and clinical parameters following treatment with furosemide and potassium chloride

Introduction: Congestive heart failure (CHF) is defined by a cardiac deficit in supplying normal oxygen and nutrient demands to the body. Among the many drug therapies for relief of CHF symptoms are diuretics in the treatment of edemas associated with this condition, which prevent fluid accumulation in tissues, and relieve the symptoms. Furosemide is a loop diuretic that is commonly used to this end, whose most common side effect is electrolyte imbalance, particularly hypokalemia. Potassium supplementation during treatment is recommended at a preventive measure. Objectives: To evaluate the clinical response to the use of the combination of furosemide and potassium chloride in patients presenting non-acute CHF, with respect to: 1) Signs and symptoms of CHF 2) Serum sodium and potassium levels registered in the patient chart 3) Incidence of laboratory alterations 4) Incidence of adverse events.Materials and Methods: This was a descriptive, analytic, retrospective study performed at Hospital Universitário Constantino Otaviano, UNIFESO, evaluating medical charts of patients presenting non-acute CHF who were treated with the combination of furosemide and potassium chloride. Only patients presenting laboratory data from before and after treatment were included. For each patient, the hospital chart was analyzed in order to complete the Clinical Research Form (CRF). The CRFs were filled, stored, coded, and the data were analyzed using GraphPad Prism 5.0 software. Results: There was a clinically significant decrease from pretreatment in the number of patients presenting all signs and symptoms of CHF, with the exception of nausea. Vital signs improved significantly in relation to pretreatment values. Sodium and potassium levels decreased, but remained within reference range, as did other laboratory evaluations performed. In addition to the furosemide + potassium chloride treatment, 59/60 patients were prescribed additional medications. A total of 35 adverse events were...