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.

Clinical Evaluation of the Use of Ginger Extract in the Preventive Management of Motion Sickness.

BACKGROUND: Motion sickness can be triggered in a variety of situations and is characterized primarily by nausea and vomiting. Ginger is widely used in treating conditions including chemotherapy-associated gastrointestinal symptoms, morning sickness, postoperative nausea, and motion sickness. OBJECTIVES: The primary study objective was to evaluate Zingiber officinale extract in the treatment of motion sickness. Secondary objectives were to evaluate treatment effect on Motion Sickness Assessment Questionnaire (MSAQ) score and subscores before and after treatment, and to evaluate treatment tolerability. METHODS: Open-label, single-arm study assessing motion sickness outcomes with and without pre-travel oral treatment with Zingiber officinale 160 mg extract (containing 8 mg gingerols). All patients answered the MSAQ on 4 separate occasions following a trip of at least 15 minutes in duration: Trip 1 (pretreatment) and Trips 2, 3, and 4 (after oral treatment with study medication). The primary end point was percentage of patients presenting improvement ≥20 score points on the MSAQ during Trip 2, Trip 3, and Trip 4 in comparison to pretreatment score (Trip 1). Secondary end points included percentage of patients presenting improvement in MSAQ subscores during Trips 2, 3, and 4; percentage of patients presenting treatment-related adverse events; and pre- and posttreatment physician assessment scores. RESULTS: One hundred eighty-four patients were included and 174 completed treatment. A reduction of ≥20 points in total MSAQ score points occurred in 26.52%, 29.89%, and 29.31% of patients from Trips 2, 3, and 4, respectively. There was no significant difference at Trips 2, 3, and 4 in number of patients presenting improvement ≥20 score points (P = 0.9579). There was a significant reduction in total MSAQ scores from Trips 2, 3, and 4 (P < 0.0001) compared with Trip 1. Total MSAQ scores did not vary at each trip taken under treatment (P = 0.28). There were significant (P < .001) improvements in all domain subscores from Trips 2, 3, and 4 in relation to scores from Trip 1. There was a significant improvement in physician assessment scores at Visit 2 (P < .0001). Adverse events were reported among 31 patients, mainly affecting the gastrointestinal system. Twenty-four patients (13.04%) reported 39 adverse events considered related to treatment. No significant change in physical exam was noted at Visit 2 in relation to Visit 1. CONCLUSIONS: These open label, historically controlled study results suggest the need for randomized, blinded, placebo and active substance controlled clinical trials. (Curr Ther Res Clin Exp. 2020; 81:XXX-XXX).

Is Nonmicronized Diosmin 600 mg as Effective as Micronized Diosmin 900 mg plus Hesperidin 100 mg on Chronic Venous Disease Symptoms? Results of a Noninferiority Study.

BACKGROUND: Phlebotonics have beneficial effects on some symptoms related to chronic venous disease (CVD) of the lower limbs. The most commonly used one is diosmin, available in a pure semisynthetic form or as a micronized purified flavonoid fraction. Patients and Methods. The primary objective of this single-blind, randomized, parallel-group, prospective study was to assess the clinical noninferiority of nonmicronized diosmin 600 mg once daily (D-group) compared to micronized diosmin 900 mg plus hesperidin 100 mg once daily (D/H-group) over a 6-month treatment period. Adult patients with a symptomatic CVD of the lower limbs (C0-C3 grade; 20-60 mm on a 100 mm visual analog scale (VAS)) were included. The primary endpoint was the change (from baseline to last postbaseline value) of the intensity of the lower-limb symptoms on VAS. RESULTS: 114 patients (mean age, 44.4 years; women, 90.4%) were randomized in the per-protocol analysis (D-group, n = 57; D/H-group, n = 57; D/H-group, p < 0.0001) in the D-group and -22.8 mm (p < 0.0001) in the D-group and -22.8 mm (p < 0.0001) in the D-group and -22.8 mm (. CONCLUSION: Nonmicronized diosmin 600 mg was proven to have a noninferior efficacy compared to micronized diosmin 900 mg plus hesperidin 100 mg, associated with greater ease in swallowing the tablet.