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

Abstract

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.

• Authors: Marco Antonio Mibielli, Carlos Pereira Nunes, José Carlos Cohen, Ari Boulanger Scussel Jr, Rafael Higashi, Gabriel Gherman Bendavit, Lisa Oliveira, Mauro Geller
• Journal: Proceedings of the Western Pharmacology Society (Proc West Pharmacol Soc) Vol. 53 Pg. 5-12 ( 2010) ISSN: 0083-8969 [Print] United States
• PMID: 22128442 (Publication Type: Journal Article, Randomized Controlled Trial)

Chemical References

• Anti-Inflammatory Agents, Non-Steroidal
• Cholestyramine Resin
• Diclofenac
• Cytidine Monophosphate
• Hydroxocobalamin
• Uridine Triphosphate

Topics

• Acute Disease
• Adult
• Anti-Inflammatory Agents, Non-Steroidal (administration & dosage)
• Cholestyramine Resin (administration & dosage, adverse effects)
• Cytidine Monophosphate (administration & dosage, adverse effects)
• Diclofenac (administration & dosage, adverse effects)
• Double-Blind Method
• Drug Therapy, Combination
• Female
• Humans
• Hydroxocobalamin (administration & dosage, adverse effects)
• Male
• Middle Aged
• Pain (drug therapy)
• Uridine Triphosphate (administration & dosage, adverse effects)