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.

Treatment of acute, non-traumatic pain using a combination of diclofenac-cholestyramine, uridine triphosphate, cytidine monophosphate, and hydroxycobalamin.

This randomized, controlled, double-blind clinical study in parallel groups evaluated the safety and efficacy of an oral combination diclofenac-cholestyramine, nucleotides (uridine and cytidine) and vitamin B12 versus the oral combination of nucleotides and vitamin B12 in the treatment of acute, non-traumatic pain. Subjects received twice-daily, 10-day oral administration of diclofenac-cholestyramine + uridine + cytidine + vitamin B12 (Group DN, n=40) or uridine + cytidine + vitamin B12 (Group NB, n=41). The primary study endpoint was the number of subjects with VAS reduction of >30mm after 10 days of treatment. Secondary endpoints included the number of patients with improvement >5 points in the Patient Functionality Questionnaire after 10 days of treatment, and the number of subjects presenting adverse events. Treatment with the combination of diclofenac-cholestyramine, nucleotides and Vitamin B12 resulted in a higher number of subjects with VAS score reductions >30mm after 10 days of treatment (87.5% subjects) than in the control group administered nucleotides and Vitamin B12 (51.23% of subjects), (p>0.0006). A significantly higher number of subjects in the DN group (80%) had a score reduction of >5 points in the Patient Functionality Questionnaire at after 10 days of treatment compared to Group NB (29.3%), (p<0.001). The number of subjects presenting AEs did not vary significantly between treatment groups (p=0.587). The combination of diclofenac-cholestyramine with uridine, cytidine and vitamin B12 was well-tolerated over a 10-day treatment period. The combination reduced pain and improved functionality among subjects presenting acute, non-traumatic pain in the lower back, hips, and neck.

Osteoarthritis: clinical evaluation of diclofenac combined with the B complex vitamins / Osteoartrite: avaliação clínica da ação do diclofenaco com as vitaminas do complexo B

A double-blind, placebo controlled evaluation was performed on parallel groups of patients presenting osteoarthritis of the knee, hip or hand. The study aimed to evaluate the use of a combination of sustained-release diclofenac and vitamins B1, B6 and B12 in the treatment of the signs and symptoms of osteoarthritis. After screening and informed consent, randomized subjects underwent a 7-day treatment period with twice-daily oral therapy. Osteoarthritis pain, mobility and satisfaction assessments by both the subjects and the investigating physician were performed at each of the three visits to the study center before, during and at the end of the treatment period, along with physical examinations, laboratory evaluations and monitoring of adverse events and concomitant medications. Results were compared between the active and placebo treated groups (Group A and Group B, respectively).The active treatment was found to be superior to placebo in all of the pain, mobility and satisfaction assessments. Patients treated with the active substance were more willing to continue treatment at the end of the study. No significant difference was observed between the treatment groups in the physical examinations and laboratory evaluations performed.Based on the results observed in this double-blind clinical evaluation, we conclude that the combination of sustained-release diclofenac and vitamins B1, B6 and B12 is both well-tolerated and superior to placebo in the treatment of the signs and symptoms of OA in the study population evaluated.

Safety and efficacy of a B-vitamin combination in the treatment of osteoarthritis-related pain / Segurança e eficácia da associação das vitaminas B1, B6, B12 na analgesia da osteoartrite

We evaluated the safety and efficacy of the use of an oral combination of vitamins B1, B6, and B12 in the treatment of osteoarthritis-related pain and loss of mobility. A 14-day, open-label treatment period was adopted for patients presenting osteoarthritis of the knee or hip. Patients underwent a series of clinical and laboratory evaluations prior to the first treatment dose, following 7 days of treatment, and at the end of the 14-day drug administration period. The incidence of adverse events and use of concomitant medication was also monitored at each study visit. At each study visit, osteoarthritis evaluations were performed, including a 100mm VAS pain assessment, and global and satisfaction surveys completed by both patients and investigating physician. At the conclusion of the study, an additional assessment was performed to evaluate the patient's willingness to continue treatment with the B-vitamin combination.Clinical safety was evaluated by comparing the differences between the pretreatment, mid-study, and end-of-study clinical and laboratory evaluations as well as the incidence and severity of any adverse events. A comparison between the patient and physician assessments at each study visit was used to evaluate efficacy.A total of 54 patients were treated with the study medication. A clinically significant change was observed from pretreatment to end-of-study efficacy evaluations, including those for pain, mobility, and global osteoarthritis condition. The physician's evaluation of global patient condition and treatment satisfaction evaluation also presented a clinically significant change from pretreatment to the final study evaluation. No clinically significant changes in the patients clinical and laboratory evaluations were observed during the study.Based on the results of this clinical study, we conclude that the combination of cyanocobalamin, thiamine mononitrate and pyridoxine chlorihydrate at the concentrations employed is safe and effective in the treatment of the pain and loss of mobility associated with osteoarthritis.

Infecções por Staphylococcus aureus: relato de caso e discussão da literatura / Staphylococcus aureus infections: case related and literature review

Os autores apresentam um caso clínico de sepse por Staphylococcus aureus, a partir de um foco primário cutâneo que evolui para osteomielite crônica, comprometendo a metáfise e a cartilagem de crescimento em criança de 12 anos de idade

Fixaçäo das fraturas da diáfise da tíbia com as hastes flexíveis de Ender / Fixation of fractures of the tibial shaft with Ender nailing

Quinze fraturas da diáfise tibial foram fixadas com as hastes de Ender, sem o uso de intensificador de imagens, baseando-se na técnica original de Ender. Foi ressaltada a importância do método para a formaçäo do calo externo e a contribuiçäo das fixaçöes elásticas para rápida deambulaçäo e para o menor tempo de consolidaçäo. Viu-se, contudo, que as fraturas com foco aberto demoraram mais para consolidar, em comparaçäo com as de foco fechado