A double-blind comparison of naproxen gel and placebo in the treatment of soft tissue injuries.
A double-blind study was carried out in 120 patients who had received soft tissue injuries within the preceding 48 hours to compare the effectiveness of naproxen gel (10%) with placebo gel (base alone). The injuries were predominantly synovitis and tendinitis. Standard clinical evaluations of the patients' condition were made by physicians and patients on entry and after 3 and 7 days of treatment. Both treatments resulted in a significant improvement in symptoms, but naproxen gel was significantly superior to placebo gel (p less than 0.05). The response produced by naproxen was more rapid; all symptoms were significantly improved by Day 3 (p less than 0.05). The greater efficacy of naproxen was reflected in a lower usage of active drug compared with placebo which was consistent throughout the study. While the physicians' global assessments of the two gels did not differ significantly, the patients showed a preference in favour of naproxen (p less than 0.05) Naproxen gel was well tolerated; only 1 adverse event of itching occurred. It is suggested that naproxen gel offers an effective and convenient alternative to systemic non-steroidal anti-inflammatory drugs for patients where side-effects are to be avoided or when oral administration is undesirable.