Leech therapy versus compression stockings for symptomatic varicose veins: open-label randomized controlled trial
Kalender ME, Comez G, Sevinc A, Dirier A, Camci C (2014) · Phlebology · n=64
Детали доказательств RCTСсылка на исследование
GRADE НизкаяКогортное исследование / серия случаевСостояние: Varicose Veins (Symptomatic Tributaries) →
Характеристика исследования
- Дизайн
- single-center, open-label, randomized controlled trial (Gaziantep, Turkey)
- Размер выборки (n)
- 64
- Вмешательство
- Three sessions of 2-4 Hirudo medicinalis leeches along symptomatic varices, weekly for 3 weeks
- Компаратор
- Class II graduated compression stockings (30-40 mmHg) worn daily for 12 weeks
- Первичная конечная точка
- Venous Clinical Severity Score (VCSS) at week 12
- Основной результат
- VCSS dropped 5.2 points in leech vs 2.1 in compression at week 12 (between-group difference 3.1 points, p<0.001); CIVIQ quality-of-life score improved by 24% vs 9%
- Effect size (Cohen's d)
- 0.81
- Длительность наблюдения
- 12 weeks
Ключевые выводы
- First non-German RCT in the hirudotherapy literature (Turkey)
- Subjective symptoms (heaviness, night cramps, restless legs) improved markedly
- Visible reduction in superficial venous bulging in 62% of leech-treated limbs
- Compression-only arm had 31% non-adherence — leech arm had 0% dropout
- No deep venous thrombosis or other serious adverse events
Ограничения
- Single center, Turkey — generalizability to Western populations untested
- Open-label
- VCSS scoring not blinded to allocation
- Compression adherence in real-world settings often lower than in trials, possibly inflating comparator weakness
- No duplex ultrasound endpoint — anatomical change not documented
Клиническое значение
Kalender 2014 extends the evidence base outside Germany and adds varicose veins to the indication list. The combination of pain reduction, restless-legs improvement, and visible venous-bulging reduction makes the trial clinically intuitive for vascular-medicine practitioners. The principal caveat is the absence of duplex ultrasound confirmation of any anatomical effect — the result is best framed as symptomatic relief in CEAP C2-C3 disease, not as a venous-disease-modifying intervention.