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
Studienprofil
- Design
- randomized clinical trial of a leech-saliva-extract liposomal topical gel (Tabriz University of Medical Sciences, Iran)
- Stichprobengröße (n)
- 60
- Intervention
- Topical liposome-based gel containing extracted Hirudo medicinalis saliva, applied to the symptomatic knee for 30 days
- Komparator
- Placebo gel (liposomal vehicle without leech saliva extract)
- Primärer Endpunkt
- Pain on VAS and Lequesne index for knee OA at day 30
- Primäres Ergebnis
- 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)
- Follow-up-Dauer
- 30 days
- PMID
- 29246745
Wichtigste Ergebnisse
- 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
Einschränkungen
- 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
Klinische Implikationen
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.
Verwandte Studien
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
Michalsen A, Moebus S, Spahn G, Esch T, Langhorst J, Dobos GJ (2002)
Randomised controlled trial with medical leeches for osteoarthritis of the knee
Stange R, Moser C, Hopfenmueller W, Mansmann U, Buehring M, Uehleke B (2012)
Efficacy of leech therapy in the management of osteoarthritis (Sandhivata)
Rai PK, Singh AK, Singh OP, Rai NP, Dwivedi AK (2011)