Sociedad Americana de Hirudoterapia

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

Detalle de evidencia de RCTReferencia del ensayo
GRADE bajaCohorte / serie de casosCondición: Knee Osteoarthritis →
Tamaño de muestra de este ensayo en comparación con otros ensayos de Knee OsteoarthritisWang H 2018264Lauche R 2025240Lauche R 2014237Lauche R 2014237Farzali S 2025181Cui Y 2024144Andereya S 2008113Andereya S 2008113Isik M 201790Khoshnevisan A 202280
Este ensayo (destacado) por tamaño de muestra junto a otros ensayos indexados de Knee Osteoarthritis. Los ensayos más grandes generalmente tienen mayor peso estadístico.

Perfil del estudio

Diseño
single-center, prospective, randomized, single-blind, parallel-group RCT (Atatürk University, Erzurum, Turkey)
Tamaño de la muestra (n)
90
Intervención
Five Hirudo medicinalis leeches applied to the affected knee once weekly for 3 weeks (leech group, n=46)
Comparador
Transcutaneous electrical nerve stimulation (TENS) therapy following a standardized regimen (TENS group, n=44)
Punto final primario
Change in pain on VAS and WOMAC scores at days 0, 21, and 180
Resultado primario
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
Duración del seguimiento
180 days

Hallazgos clave

  • 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

Limitaciones

  • 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

Implicaciones clínicas

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.

Estudios relacionados

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