Comparison of the effectiveness of medicinal leech and TENS therapy in the treatment of primary osteoarthritis of the knee: a randomized controlled trial
Isik M, Ugur M, Yakisan RS, Sari T, Yilmaz N (2017) · Zeitschrift für Rheumatologie · n=90
Study Profile
- Design
- single-center, prospective, randomized, single-blind, parallel-group RCT (Atatürk University, Erzurum, Turkey)
- Sample size (n)
- 90
- Intervention
- Five Hirudo medicinalis leeches applied to the affected knee once weekly for 3 weeks (leech group, n=46)
- Comparator
- Transcutaneous electrical nerve stimulation (TENS) therapy following a standardized regimen (TENS group, n=44)
- Primary endpoint
- Change in pain on VAS and WOMAC scores at days 0, 21, and 180
- Primary result
- VAS pain score decreased similarly in both groups by day 21 (p<0.001 within-group); between-group course of change in pain similar throughout; all WOMAC subscores decreased similarly in both groups (p=0.819 between-group); long-term (day 180) benefits slightly greater in TENS arm
- Follow-up duration
- 180 days
- PMID
- 27535276
Key Findings
- First RCT directly comparing leech therapy with TENS, a widely used non-pharmacologic modality for knee OA
- Leech therapy produced statistically significant pain and function improvements equivalent to TENS at day 21
- All WOMAC subscores (pain, stiffness, function) decreased significantly with both modalities through 180 days
- Long-term benefits modestly favored TENS over leech therapy at the 6-month timepoint
- Authors conclude leech therapy is a viable alternative or additional non-surgical option for knee OA
Limitations
- Single center (Atatürk University Faculty of Medicine, Erzurum)
- Single-blind only — patients aware of intervention
- TENS comparator parameters not fully described in published methods
- No NSAID arm — cannot triangulate vs. pharmacologic standard of care
- Both groups improved significantly, making between-group inference dependent on equivalence assumptions not formally tested
Clinical Implications
Isik 2017 is the largest single-RCT of leech therapy for knee OA published outside Germany (n=90) and the first to use a non-pharmacologic comparator (TENS). The equivalence-level finding is clinically useful: for clinicians and patients choosing between leech and TENS, the trial suggests broadly similar short-term outcomes with TENS having a small long-term edge. The trial supports leech therapy as a reasonable alternative for patients who decline electrotherapy. Methodologically the lack of a pharmacologic comparator limits placement within the wider OA-treatment hierarchy, but the Turkish cohort adds geographic diversity to the European-dominated evidence base.
Related Trials
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)
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)
Randomised controlled trial with medical leeches for osteoarthritis of the knee
Stange R, Moser C, Hopfenmueller W, Mansmann U, Buehring M, Uehleke B (2012)