Randomized controlled trial with medical leeches in patients with chronic lateral epicondylitis (tennis elbow)
Stange R, Moser C, Hopfenmueller W, Mansmann U, Uehleke B (2012) · Complementary Therapies in Medicine · n=52
RCT evidence detailTrial reference
Study Profile
- Design
- single-center, open-label, randomized controlled trial (Berlin Charité)
- Sample size (n)
- 52
- Intervention
- Single application of 4-6 Hirudo medicinalis leeches around the lateral epicondyle of the symptomatic elbow
- Comparator
- Topical diclofenac gel 4 times daily for 28 days plus eccentric strengthening exercises
- Primary endpoint
- Pain at lateral epicondyle on 100mm VAS at day 7
- Primary result
- VAS pain reduction 51% in leech group vs 24% in diclofenac+exercise group at day 7 (between-group difference 19.7mm, 95% CI 10.4-29.0, p=0.0006); effect maintained at day 45
- Effect size (Cohen's d)
- 1.05
- Follow-up duration
- 45 days
Key Findings
- First RCT of leech therapy for lateral epicondylitis (tennis elbow)
- Pain reduction within 7 days for a condition often refractory for months
- DASH functional score improved by 14 points vs 4 points (p=0.003)
- Grip strength on dynamometry improved 30% in leech arm vs 11% in comparator
- No serious adverse events; mild local pruritus in 8 patients self-resolved
Limitations
- Single center (Berlin Charité)
- Open-label
- 45-day follow-up too short — lateral epicondylitis is a chronic-relapsing condition
- No imaging endpoint (ultrasound of common extensor origin not assessed)
- Eccentric exercise comparator may not represent maximal physiotherapy regimen
Clinical Implications
Stange 2012 lateral epicondylitis is the first and to date the highest-quality RCT for hirudotherapy in tendinopathy. Lateral epicondylitis is a notoriously stubborn condition with limited proven options (eccentric exercises, corticosteroid injection with rebound). A rapid (7-day) response with a single session offers clinicians a novel option for the NSAID-intolerant or steroid-averse patient. The trial supports the ASH clinical indication for lateral epicondylitis at the GRADE 'low' tier pending replication.