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
RCT evidence detailTrial reference
GRADE LowCohort / case series
Study Profile
- Design
- single-center, open-label, randomized pilot trial (Berlin)
- Sample size (n)
- 38
- Intervention
- Single session of 2-4 Hirudo medicinalis leeches at periauricular trigger points
- Comparator
- Standard care: occlusal splint plus self-management education
- Primary endpoint
- Characteristic Pain Intensity (CPI) at week 4
- Primary result
- 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
- Follow-up duration
- 12 weeks
Key Findings
- 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
Limitations
- 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
Clinical Implications
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.