American Society of Hirudotherapy

Effectiveness of leech therapy in chronic lateral epicondylitis: a randomized controlled trial

RCT published in The Clinical Journal of Pain (2011)

Last Updated: June 18, 2026Reviewed by: ASH Editorial Board
Research article — evidence reviewArticle reference
Evidence: Randomized controlled trialClinical TrialsBäcker M, Lüdtke R, Afra D et al. · The Clinical journal of pain, 2011

Abstract

OBJECTIVES: Leech therapy has been found to be effective in osteoarthritis of the knee and hand in previous trials. Chronic epicondylitis is a prevalent pain syndrome with limited treatment options. In this study, we tested whether leech therapy would be beneficial in the symptomatic treatment of chronic lateral epicondylitis. METHODS: Forty patients with manifestation of epicondylitis of at least 1-month duration were randomized to a single treatment with 2 to 4 locally applied leeches or a 30-day course with topical diclofenac. The primary outcome was change of pain sum score on day 7 calculated from 3 visual analog scales for pain during motion, grip, and rest. Secondary outcomes included disability (Disability of the Arm, Shoulder, Hand questionnaire), physical quality of life (Short Form-36), and grip strength. Outcomes and safety were assessed on days -3, 0, 7, and 45. RESULTS: Leeches induced a significantly stronger decrease of the pain score (143.7±36.9 to 95.3±45.1) compared with topical diclofenac (131.6±29.6 to 134.7±70.7; mean difference -49.0; 95% confidence interval,-82.9--15.1; P=0.0075) after 7 days. On day 45, this group difference was reduced (-27.5; confidence interval, -60.8-5.8; P=0.110) due to delayed pain relief with diclofenac. Functional disability showed a stronger decrease in the leech group, which was most prominent after 45 days (P=0.0007). Quality of life increased nonsignificantly in the leech group. Results were not affected by outcome expectation. DISCUSSION: A single course of leech therapy was effective in relieving pain in the short-term and improved disability in intermediate-term. Leeches might be considered as an additional option in the therapeutic approach to lateral epicondylitis.

Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.

Publication typeJournal ArticleRandomized Controlled TrialResearch Support, Non-U.S. Gov't
Indexed MeSH termsChronic DiseaseFemaleHumansLeechingMaleMiddle AgedPain MeasurementTennis ElbowTreatment Outcome

Summary

Forty patients with chronic lateral epicondylitis randomized to single leech application versus 30-day topical diclofenac; leech therapy produced significantly stronger short-term pain relief and improved disability at day 45.

Why This Matters for Hirudotherapy

This randomized controlled trial compared a single leech therapy session (2-4 locally applied leeches) with a 30-day course of topical diclofenac in 40 patients with chronic lateral epicondylitis. Leech therapy produced a significantly greater reduction in pain scores at day 7, and functional disability showed a stronger decrease in the leech group, most prominent at day 45. This trial is directly relevant to ASH's domain as it provides RCT-level evidence for leech therapy in a musculoskeletal pain condition beyond the previously studied knee and hand osteoarthritis. The authors suggest leeches as an additional option for lateral epicondylitis. However, the sample size is modest at 40 patients, the long-term pain difference diminished by day 45, and the study does not clarify the underlying mechanisms of action or durability of benefit beyond the study period.

Citation

Effectiveness of leech therapy in chronic lateral epicondylitis: a randomized controlled trial.

Bäcker M, Lüdtke R, Afra D et al. · The Clinical journal of pain, 2011

Added to ASH library: May 26, 2026 · Site last updated: June 18, 2026

This website provides educational information and does not constitute medical advice, diagnosis, or treatment recommendations. Medicinal leech therapy carries clinically meaningful risks and should be performed only by qualified clinicians under institutionally approved protocols. FDA 510(k) clearance for medicinal leeches is limited to specific indications; investigational and off-label discussions are labeled accordingly. For patient-specific guidance, consult a qualified healthcare provider.