A prospective, randomized, multicentre, open, crossover study of the comparative efficacy, tolerability and acceptability of two topical nonsteroidal anti-inflammatory drug (NSAID) therapies, flurbiprofen local-action transcutaneous (LAT) patch (40 mg b.d.) and piroxicam gel (3 cm, 0.5% q.d.s), was conducted in general practice in the UK in 137 men and women with soft-tissue rheumatism of the shoulder or elbow (e.g. epicondylitis, tendinitis, bursitis and adhesive capsulitis). Patients received one therapy for 4 days before crossing over to the other NSAID for a further 4 days, followed by 6 days of their preferred therapy. Clinical assessment of severity of pain, tenderness and overall clinical condition was carried out at baseline and after 4, 8 and 14 days. Patients self-assessed the severity of pain during the day and at night, and also the quality of their sleep during each treatment phase.
More patients showed a greater improvement in all of the clinical assessments of efficacy following treatment with flurbiprofen LAT during the crossover phase. There was a statistically significant reduction in the severity of pain, the principal measure of efficacy, in favour of flurbiprofen LAT: 42% of patients showed greater improvement with flurbiprofen LAT compared with 26% who showed a greater improvement with piroxicam gel (p=0.012; n=131, intent-to-treat). Eligible dataset (n=126) analysis revealed statistically significant differences in favour of flurbiprofen LAT in the severity of lesion tenderness (p=0.03) and the overall change in clinical condition (p=0.04) compared with baseline status. Superior efficacy for flurbiprofen LAT was also indicated in the patients' assessment at the end of the crossover phase (day 8), at which 69% chose to continue treatment with flurbiprofen LAT compared with only 31% of patients who chose piroxicam gel (n=126; p<0.001). There were, in addition, statistically significant differences in favour of flurbiprofen LAT in assessments for night pain (p<0.001), quality of sleep (p=0.004) and the patients' overall opinion of treatment (p<0.001). Both treatments were well tolerated with a low incidence of mainly local adverse events. These results showed that flurbiprofen LAT had a greater efficacy than piroxicam gel, and was also preferred by patients in the treatment of painful soft-tissue rheumatism of the shoulder and elbow.
Key words Transdermal Nonsteroidal Anti-Inflammatory Drugs - Flurbiprofen - Piroxicam Gel - Soft Tissue Rheumatism
On behalf of the General Practice Research Group: P.J.M. Milroy, P. Roylance, G. Hamilton, F.G. De, L. Wright, M.M.G.B. Scott, S. R. Fisher, B.A. Hakin, P.A. Vakil, J.A.G. Jones.