Summary
One hundred patients were enrolled in a single-blind, randomized, parallel group study to compare naproxen gel (10%) with fluf enamic 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 I (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<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<0.05) than for patients using fluf enamic 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<0.0.5). 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.