Efficacy and safety of topical hirudin (Hirudex): a double-blind, placebo-controlled study
Randomized controlled trial published in Eur Rev Med Pharmacol Sci (2001)
Abstract
Hirudin, a thrombin inhibitor isolated from the leech Hirudo medicinalis, has been long known for its anticoagulant effects. In 1990, the former German BGA has published a monograph on Hirudo medicinalis extract (containing Hirudin and Eglin), stating that its local use is indicated in bruises with or without hematoma. The aim of this double-blind, placebo-controlled clinical trial was to evaluate the efficacy and safety of a Hirudin-containing cream (Hirudex cream; Hirudo medicinalis extract 280 UI/100 g) in patients affected with bruises with or without hematoma. 60 men and women between the ages of 18 and 65 years with a unilateral acute musculoskeletal injury (bruise) with or without hematoma were included. Dosage schedule and application route for both treatments were the following: 3-4 daily applications for 5 days for a total of 15-20 administrations during the whole study period. In the Hirudin group, a highly statistically and clinically significant improvement were noted. Although a statistical improvement was also seen in patients treated with placebo, this was less pronounced, and a highly significant between-group difference was noted for all three major efficacy parameters at each follow-up visit in favour of Hirudin. Both the patients and the investigator considered the overall assessment of efficacy at the end of the study to be significantly better (p < 0.001) in the Hirudin group than in the placebo group. Results of this study suggest that Hirudin is an effective local treatment in patients with mild to moderate bruises.
Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.
Summary
Double-blind placebo-controlled trial of Hirudex cream (Hirudo medicinalis extract, hirudin + eglin) in 60 patients with musculoskeletal contusions. Hirudin group showed highly significant improvement over placebo for bruise resolution.
Why This Matters for Hirudotherapy
This double-blind, placebo-controlled clinical trial evaluated the efficacy and safety of a topical hirudin-containing cream (Hirudex cream; Hirudo medicinalis extract 280 UI/100 g) in 60 patients aged 18–65 with unilateral acute bruises with or without hematoma. The hirudin group showed a highly statistically and clinically significant improvement compared to placebo across major efficacy parameters, with both patients and investigators rating efficacy significantly better (p < 0.001). This is relevant to ASH's domain as it examines a leech-derived component (hirudin, a thrombin inhibitor from Hirudo medicinalis) in a topical formulation for localized musculoskeletal injury. The study is limited to mild to moderate bruises/hematomas and evaluates a formulated cream rather than live leech therapy; the abstract does not discuss other indications.
Citation
Efficacy and safety of topical hirudin (Hirudex): a double-blind, placebo-controlled study.
Stamenova PK et al. · European review for medical and pharmacological sciences, 2001
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