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
Детали доказательств RCTСсылка на исследование
GRADE НизкаяКогортное исследование / серия случаев
Характеристика исследования
- Дизайн
- single-center, open-label, randomized pilot trial (Berlin)
- Размер выборки (n)
- 38
- Вмешательство
- Single session of 2-4 Hirudo medicinalis leeches at periauricular trigger points
- Компаратор
- Standard care: occlusal splint plus self-management education
- Первичная конечная точка
- Characteristic Pain Intensity (CPI) at week 4
- Основной результат
- 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
- Длительность наблюдения
- 12 weeks
Ключевые выводы
- 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
Ограничения
- 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
Клиническое значение
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.