One hundred patients were enrolled in a single-blind, randomized, parallel group study to compare
naproxen gel (10%) with
flufenamic acid gel (3%) for the treatment of
soft tissue injuries. Demographic variables, the distribution of diagnoses (
tendinitis,
bursitis/
synovitis,
synovitis,
periarthritis, epicondylitis) and initial severity of the complaint were similar between the two groups. The
gels were applied 2 to 6 times per day, as required, and conventional clinical indices were evaluated at Day 1 (on entry to the study), Day 3 and Day 7. Global assessments of efficacy were made by both physicians and patients at the end of the study. By Day 7 both treatments had produced a highly significant improvement in symptoms (p less than 0.001). The patients using
naproxen gel, however, improved more rapidly. At Day 3 the number of patients rating 'swelling', 'tenderness to firm palpation' or 'limitation of use' as 'severe' or 'moderate' was significantly less (p less than 0.05) than for patients using
flufenamic acid gel. At the end of the study the physician's global efficacy rating showed no significant differences between the two
gels; patients, in contrast, showed a significant preference for
naproxen gel (p less than 0.05). Both
gels were well tolerated. The more rapid onset of effect and patient preference for
naproxen gel may be important factors in the choice of medication.