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.
Resumen
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.
Por qué esto importa para la hirudoterapia
Este ensayo clínico doble ciego, controlado con placebo, evaluó la eficacia y la seguridad de una crema tópica que contiene hirudina (crema Hirudex; extracto de Hirudo medicinalis 280 UI/100 g) en 60 pacientes de 18 a 65 años con contusiones agudas unilaterales con o sin hematoma. El grupo de hirudina mostró una mejoría altamente significativa tanto estadística como clínicamente en comparación con el placebo en los principales parámetros de eficacia, con una calificación de eficacia significativamente mejor por parte de los pacientes y de los investigadores (p < 0,001). Esto es relevante para el dominio de la ASH, ya que examina un componente derivado de la sanguijuela (hirudina, un inhibidor de trombina procedente de Hirudo medicinalis) en una formulación tópica para una lesión musculoesquelética localizada. El estudio se limita a contusiones/hematomas leves a moderados y evalúa una crema formulada en lugar de la terapia con sanguijuelas vivas; el resumen no aborda otras indicaciones.
Citación
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
Contexto clínico relacionado
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Añadido a la biblioteca ASH: May 27, 2026 · Última actualización del sitio: 18 de junio de 2026