Treatment of Acute, Non-traumatic Pain Using a Combination of Diclofenac-choiestyramine, Undine Triphosphate, Cytidine Monophosphate, and Hydroxycobalamin

摘要

This randomized, controlled, double-blind clinical study in parallel groups evaluated the safety and efficacy of an oral combination diclofenac-choiestyramine, nucleotides (uridine and cytidine) and vitamin B_(12) versus the oral combination of nucleotides and vitamin B_(12) in the treatment of acute, non-traumatic pain. Subjects received twice-daily, 10-day oral administration of diclofenac-choiestyramine + undine + cytidine + vitamin B_(12) (Group DN, n= 40) or uridine + cytidine + vitamin B_(12) (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-choiestyramine, nucleotides and Vitamin B_(12) 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 B_(12) (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-choiestyramine with uridine, cytidine and vitamin B_(12) 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.