Effectiveness of topical gel of medical leech (Hirudo medicinalis) saliva extract on patients with knee osteoarthritis: a randomized clinical trial
Shakouri A, Adljouy N, Balkani S, Mohamadi M, Hamishehkar H, Abdolalizadeh J, Kazem Shakouri S (2017) · Complementary Therapies in Clinical Practice · n=60
Характеристика исследования
- Дизайн
- randomized clinical trial of a leech-saliva-extract liposomal topical gel (Tabriz University of Medical Sciences, Iran)
- Размер выборки (n)
- 60
- Вмешательство
- Topical liposome-based gel containing extracted Hirudo medicinalis saliva, applied to the symptomatic knee for 30 days
- Компаратор
- Placebo gel (liposomal vehicle without leech saliva extract)
- Первичная конечная точка
- Pain on VAS and Lequesne index for knee OA at day 30
- Основной результат
- After 30 days of leech-saliva liposomal gel, patient pain was reduced approximately 50% with concurrent reduction in joint inflammation and stiffness and improved range of motion and quality of life (p<0.001)
- Длительность наблюдения
- 30 days
- PMID
- 29246745
Ключевые выводы
- First RCT to test a leech-saliva-extract pharmaceutical formulation (vs. live leeches) for knee OA
- Nano-liposomal encapsulation used to enhance transdermal absorption of leech salivary proteins
- VAS pain reduction approximately 50% over 30 days vs. placebo gel
- Improvements reported in Lequesne index, joint stiffness, and self-reported quality of life
- Provides proof-of-concept for non-invasive leech-derived therapeutics as an alternative to live-animal application
Ограничения
- Single center (Tabriz University of Medical Sciences)
- Short follow-up (30 days)
- Salivary extract characterization and standardization not fully reported — batch-to-batch consistency unclear
- No comparison with live leech therapy — cannot determine relative efficacy
- Limited methodological detail on randomization and blinding in published report
Клиническое значение
Shakouri 2017 is a significant departure from the live-leech literature: instead of applying intact Hirudo medicinalis, the investigators extracted leech salivary proteins, encapsulated them in nano-liposomes, and applied them as a topical gel. This is the first RCT testing whether the active pharmacology of leech saliva can be delivered without the live-animal interface. For the ASH community, this is an important translational signal — though small and single-center, it suggests a pharmaceutical-grade leech-derived topical may eventually compete with live application for patients unwilling to undergo live-leech therapy. Clinicians should view this as exploratory until independent replication and full pharmacological characterization are available.
Связанные исследования
Effectiveness of leech therapy in osteoarthritis of the knee: a randomized, controlled trial
Michalsen A, Klotz S, Lüdtke R, Moebus S, Spahn G, Dobos GJ (2003)
Leech therapy for symptomatic treatment of knee osteoarthritis: results and implications of a pilot study
Andereya S, Stanzel S, Maus U, Mueller-Rath R, Mumme T, Miltner O (2006)
Comparison of modern leech therapy with intra-articular hyaluronic acid injections for symptomatic relief of knee osteoarthritis
Andereya S, Stanzel S, Maus U, Mueller-Rath R, Mumme T, Miltner O, Andereya S (2008)
A systematic review and meta-analysis of medical leech therapy for osteoarthritis of the knee
Lauche R, Cramer H, Langhorst J, Dobos G (2014)