Leech therapy in chronic myofascial temporomandibular disorder: a randomized pilot trial
Cesur Ö, Stange R, Michalsen A, Lüdtke R (2019) · Journal of Oral Rehabilitation · n=38
Detalle de evidencia de RCTReferencia del ensayo
GRADE bajaCohorte / serie de casos
Perfil del estudio
- Diseño
- single-center, open-label, randomized pilot trial (Berlin)
- Tamaño de la muestra (n)
- 38
- Intervención
- Single session of 2-4 Hirudo medicinalis leeches at periauricular trigger points
- Comparador
- Standard care: occlusal splint plus self-management education
- Punto final primario
- Characteristic Pain Intensity (CPI) at week 4
- Resultado primario
- CPI reduction 21.8 points in leech vs 9.2 in splint at week 4 (between-group difference 12.6, 95% CI 4.1-21.0, p=0.006)
- Effect size (Cohen's d)
- 0.71
- Duración del seguimiento
- 12 weeks
Hallazgos clave
- First RCT for hirudotherapy in TMD
- Effect observed in a notoriously placebo-responsive condition
- Maximum mouth opening (mm) improved by 6.4mm in leech vs 2.1mm in splint
- Patients reported improved sleep quality and chewing function
- No leech-related adverse events near sensitive facial structures
Limitaciones
- Small sample (n=38)
- Open-label
- Single center
- Comparator (occlusal splint + education) of debated efficacy itself
- Periauricular leech placement requires careful trigger-point mapping — operator-dependent
Implicaciones clínicas
Cesur 2019 is the only RCT data for hirudotherapy in myofascial TMD. The condition is highly placebo-responsive, so the result must be interpreted cautiously. For clinicians, the trial supports cautious consideration in patients refractory to occlusal splint therapy. Operator skill in periauricular leech placement is essential and limits widespread adoption.