ABSTRACT
OBJECTIVE: This prospective, randomized, double-blind, three-arm study was performed to investigate the efficacy of a medicated plaster containing the combination of diclofenac epolamine (DHEP) 180 mg and heparin 5600 IU in the treatment of unilateral blunt soft tissue injuries involving the upper or lower limb, complicated by severe local haematoma. RESEARCH DESIGN AND METHODS: Patients with mild-to-moderate injuries complicated by local haematoma (< or =140 cm(2)) were included and randomly treated once daily with plasters containing DHEP/heparin, DHEP only, or placebo. Plasters were applied for at least 12 hours daily for 10 consecutive days. MAIN OUTCOME MEASURES: The time to complete haematoma dissolution was the primary efficacy endpoint; secondary endpoints were spontaneous pain reduction, pain on movement, muscle swelling and use of rescue analgesia. RESULTS: A total of 185 patients (90 males and 95 females, aged 18-80 years) were evaluated for efficacy. Baseline clinical and demographic characteristics were similar across the treatment groups. The time to complete haematoma dissolution was significantly shorter with the DHEP/heparin plaster compared with both the DHEP and placebo plasters (p < 0.05). Patients in the DHEP/heparin group had a 60% probability of achieving complete haematoma dissolution within the 10-day treatment period compared with patients receiving either DHEP or placebo plasters. Patient-rated reductions in pain on movement were significantly (p < 0.05) greater in the two active treatment groups compared with placebo. Overall, the DHEP/heparin, DHEP and placebo plasters were well-tolerated. While a reliance on patient self-reporting had the potential to limit the usefulness of some data obtained in this study, the investigators accounted for this accordingly. CONCLUSIONS: The plaster formulation combining DHEP and heparin relieves pain and induces faster dissolution of superficial haematomas, and may therefore contribute to a more rapid and complete recovery.
