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.
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Authors | A Klainguti, A Forgacs, I Berkes, E Castellacci |
Journal | Current medical research and opinion
(Curr Med Res Opin)
Vol. 26
Issue 9
Pg. 2243-51
(Sep 2010)
ISSN: 1473-4877 [Electronic] England |
PMID | 20684664
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anti-Inflammatory Agents, Non-Steroidal
- Anticoagulants
- Placebos
- diclofenac hydroxyethylpyrrolidine
- Diclofenac
- Heparin
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Topics |
- Adolescent
- Adult
- Aged
- Aged, 80 and over
- Anti-Inflammatory Agents, Non-Steroidal
(administration & dosage, adverse effects)
- Anticoagulants
(administration & dosage, adverse effects)
- Casts, Surgical
- Contusions
(complications, drug therapy)
- Diclofenac
(administration & dosage, adverse effects, analogs & derivatives)
- Double-Blind Method
- Female
- Hematoma
(complications, drug therapy)
- Heparin
(administration & dosage, adverse effects)
- Humans
- Male
- Middle Aged
- Muscular Diseases
(complications, drug therapy)
- Placebos
- Severity of Illness Index
- Sprains and Strains
(complications, drug therapy)
- Young Adult
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