Local action transcutaneous flurbiprofen in the treatment of soft tissue rheumatism.

The objective of the present study was to establish the efficacy and tolerability of local action transcutaneous flurbiprofen (flurbiprofen LAT) in the treatment of soft tissue lesions. A randomized, double-blind, parallel-group placebo-controlled study was carried out in two hospital outpatient rheumatology clinics. One hundred and four patients aged 18-75 yr were randomized to receive a non-woven polyester-backed patch supporting a formulation containing 40 mg flurbiprofen 12-hourly over 14 days; or a non-medicated (but otherwise identical) control. Statistically significant differences in favour of the active preparation were seen at both days 7 (P = 0.02) and 14 (P = 0.009) for the investigator's overall opinion of severity of the condition, and at day 7 for the investigator's assessment of pain severity (P = 0.04 intention-to-treat; P = 0.052 N.S. eligible data). The need for further treatment in the form of steroid injections after the trial was greater in the controls (29/44, 66%) than in the flurbiprofen LAT group (17/46, 37%) (chi 2 = 7.54 on 1 d.o.f., P = 0.006). Plasma flurbiprofen levels in 11 patients ranged from 13.4 to 338.7 ng/ml (mean 116; median 57.9). Eight out of 53 (15%) patients receiving flurbiprofen LAT reported a total of 10 adverse events, compared with three out of 51 (6%) reporting seven events among controls. Patients found the patch convenient and soothing. We conclude that flurbiprofen LAT is an effective and acceptable treatment for soft tissue lesions, and should be considered as an alternative therapy to local steroid injection.

RCT Entities:   Population Interventions Outcomes