Double-blind, randomized, controlled study on the efficacy and safety of a novel diclofenac epolamine gel formulated with lecithin for the treatment of sprains, strains and contusions.

Abstract

To evaluate the efficacy of the new diclofenac-N-(2-hydroxyethyl)-pyrrolidine gel formulated with lecithin (DHEP lecithin) compared with diclofenac-N-(2-hydroxyethyl)-pyrrolidine gel (DHEP gel) without lecithin in mild-to-moderate posttraumatic injuries (grade 1 ankle, knee and muscle injuries), a multicenter, double-blind, controlled study was carried out. A total of 100 patients were enrolled and randomly assigned to either DHEP lecithin (n = 52) or DHEP gel (n = 48) treatment. All patients concluded the treatment period except for five, who did not turn up to their respective investigational sites for the follow-up visits. According to an intention-to-treat approach, they were all included in the statistical analysis. As for the efficacy and safety analysis, the primary variable was "pain on movement" as measured by a Huskisson visual analog scale. During the first 3 days of treatment each group recorded a significant within-group decrease, but patients treated with DHEP lecithin showed a decrease in absolute value that was statistically greater than that obtained with DHEP gel (p = 0.025). At the end of the treatment period (day 10) the difference between groups was still statistically significant (p = 0.036). The statistical analysis of the secondary efficacy variables showed significant results in favor of DHEP lecithin treatment. These were superimposable on the results found for the primary variable. The global efficacy and tolerability judgments, reported either by patient or by physician, showed no statistical difference between treatment groups. Due to the presence of lecithin in the new gel formulation, DHEP lecithin showed a faster and significantly more marked therapeutic effect compared with that of DHEP gel.