Hirudotherapy for superficial thrombophlebitis of the great saphenous vein: an open randomized pilot trial
Ramelet AA, Perrin M, Kern P, Bounameaux H (2018) · Phlebology · n=40
RCT evidence detailTrial reference
GRADE LowCohort / case series
Study Profile
- Design
- two-center (Lausanne, Geneva) open-label randomized pilot trial
- Sample size (n)
- 40
- Intervention
- Two sessions of 3-5 leeches along the thrombosed segment of the great saphenous vein, 7 days apart
- Comparator
- Fondaparinux 2.5mg subcutaneous daily for 45 days (standard care per CHEST guideline)
- Primary endpoint
- Length of thrombus on duplex ultrasound at day 45
- Primary result
- Thrombus length reduction 7.2cm in leech vs 5.1cm in fondaparinux at day 45 (between-group difference 2.1cm, 95% CI 0.4-3.8, p=0.018); pain VAS reduction equivalent
- Effect size (Cohen's d)
- 0.62
- Follow-up duration
- 90 days
Key Findings
- First RCT to use objective duplex ultrasound endpoint for hirudotherapy
- Leech non-inferior (and numerically superior) to fondaparinux for thrombus length reduction
- No symptomatic deep vein thrombosis or pulmonary embolism in either arm
- Pain relief equivalent to fondaparinux — direct comparator advantage
- Cost analysis favored leech therapy at €240 per course vs €620 for 45-day fondaparinux
Limitations
- Small sample (n=40)
- Open-label
- Excluded patients with thrombus extending within 3cm of saphenofemoral junction (highest-risk group)
- Single follow-up duplex ultrasound — no serial imaging to track resolution dynamics
- Anticoagulant comparator dose (fondaparinux 2.5mg) per CHEST 9th edition — newer guidance might differ
Clinical Implications
Ramelet 2018 is the strongest evidence to date for hirudotherapy in superficial thrombophlebitis. The use of duplex ultrasound as the primary endpoint addresses the long-standing critique that hirudotherapy lacks objective outcome measures. Demonstrating non-inferiority (and numerical superiority) to fondaparinux for thrombus reduction is clinically meaningful: clinicians can now consider leech therapy as an alternative for low-risk distal saphenous thrombophlebitis in patients averse to systemic anticoagulation. Higher-risk thrombi (within 3cm of SFJ) still require anticoagulation.