Carlos Pereira Nunes

Diclofenac plus B vitamins versus diclofenac monotherapy in lumbago: the DOLOR study.

Abstract Objectives: To assess the influence of vitamins B1, B6 and B12 on the analgesia success achieved by diclofenac in subjects with acute lumbago. Research design and methods: A randomised, double blind controlled clinical study in parallel groups, in which subjects received twice-daily oral administration of either the combination therapy, Group DB (50 mg diclofenac plus 50 mg thiamine, 50 mg pyridoxine and 1 mg cyanocobalamin) or diclofenac monotherapy, Group D (50mg diclofenac). The study period lasted a maximum of 7 days. If sufficient pain reduction was achieved (defined as Visual Analogue Scale <20 mm and patients satisfaction), subjects could withdraw from the treatment after 3 or 5 days. All subjects gave written informed consent to participate in the study. Main outcome measures: The primary confirmatory study objective was to determine the number of patients with sufficient pain reduction after 3 days of treatment. Results: Three hundred and seventy-two subjects were allocated at random to either treatment group: Group DB – 187 subjects and Group D – 185 subjects. After 3 days of treatment, a statistically significant higher proportion of subjects in Group DB (n = 87; 46.5%) than in Group D (n = 55; 29%) terminated the study due to treatment success (χ2: 12.06; p = 0.0005). Furthermore, the combination therapy yielded superior results in pain reduction, improvement of mobility and functionality. Drug safety monitoring profile throughout the trial was within the expected safety profile of diclofenac. Conclusions: The combination of diclofenac with B vitamins was superior to diclofenac monotherapy in lumbago relief after 3 days of treatment. As a study drawback, daily VAS measurements were only recorded until subject withdrawal from treatment, whether after 3, 5, or 7 days. There were no differences in safety profile between the two study groups.

Clinical Assessment of Tribulus terrestris Extract in the Treatment of Female Sexual Dysfunction

This is a qualitative–quantitative study based on hospital records of female patients of reproductive age, presenting sexual dysfunction, and treated with 250 mg Tribulus terrestris extract (1 tablet thrice daily for 90 days). Safety monitoring included vital signs, physical examination, laboratory tests, and occurrence of adverse events. Efficacy analysis included results of the Female Sexual Function Index (FSFI), dehydroepiandrosterone (DHEA) levels together with total and free testosterone, and the patient and physician assessments. There was a statistically significant improvement in total FSFI scores (P < 0.0001) post-treatment, with improvement among 106 (88.33%) subjects. There was a statistically significant (P < 0.0001) increase in the level of DHEA, while the levels of both serum testosterone (P = 0.284) and free testosterone decreased (P < 0.0001). Most adverse events recorded were related to the gastrointestinal tract. Physical examination showed no significant changes post-treatment. Based on the results, it is concluded that the T. terrestris extract is safe and effective in the treatment of female sexual dysfunction.

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

Abstract 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.

Alcoholic Polyneuropathy: Clinical Assessment of Treatment Outcomes Following Therapy with Nucleotides and Vitamin B 12

The purpose of this study was to evaluate the clinical action of the combination of cytidine monophosphate (CMP), uridine triphosphate (UTP), and hydroxocobalamin in the treatment of patients presenting alcoholic polyneuropathy. Patients received a 6-day intramuscular treatment of: CMP 5.0mg; UTP 3.0mg; hydroxocobalamin 2.0mg; lidocaine 20mg, followed by a 30-day treatment period of thrice daily oral ingestion of: CMP 2.5mg; uridine triphosphate UTP 1.5mg; hydroxocobalamin 1.0mg. Efficacy assessments included a 100mm pain VAS, paresthesia testing, motor coordination evaluation, vibration perception testing, and 1-10 point overall condition questionnaire. Safety assessments included vital signs and adverse event monitoring throughout the study. A total of 120 patients were included in the study. The number of symptomatic patients at Assessment 4 was significantly lower in relation to pretreatment for pain (p=0.0009), paresthesia (p<0.0001), altered vibration perception (p=0.0004), and altered motor coordination (p=0.002). VAS score reduction at Assessment 4 was found to be statistically significant (p<0.0001), with improvement in overall condition assessment scores performed by the patients and the physician (p<0.0001 for both). Adverse events were observed among 27 patients, and were overall mild or moderate in severity, short-lasting, did not lead to study withdrawal. Based on the results observed in our study, we conclude that the combination of CMP, UTP, and vitamin B12 was safe and effective in the treatment of patients presenting alcoholic polyneuropathy. Treatment with the intramuscular injection form followed by oral treatment reduced pain in relation to pretreatment values, increased vitamin B12 levels and improved motor coordination among affected patients.