American Society of Hirudotherapy

Randomised controlled trial with medical leeches for osteoarthritis of the knee

RCT published in Complementary Therapies in Medicine (2011)

Last Updated: June 18, 2026Reviewed by: ASH Editorial Board
Research article — evidence reviewArticle reference
Evidence: Randomized controlled trialClinical TrialsStange R, Moser C, Hopfenmueller W, Mansmann U, Buehring M, Uehleke B · Complementary therapies in medicine, 2011

Abstract

OBJECTIVES: To evaluate the possible efficacy of medical leeches (Hirudo medicinalis) in the treatment of patients with active osteoarthritis of the knee. DESIGN: Unblinded, randomised controlled trial with outpatients in a crossover design with single interventions of either leeches or transcutaneous electrical nerve stimulation (TENS) as comparator. MAIN OUTCOME MEASURES: Change in Lequesne's combined index for pain and function and change (L.I.) and overall assessment of complaints by visual analog scale (VAS). Cross-over at day 42, with further observation period of 21 days. RESULTS: 52 out of 72 screened patients were randomised (intent to treat) to initial treatment with either eight leeches (group 1: 27 patients) or TENS (group 2: 25 patients). Due to phase effects, confirmatory evaluation had to be restricted to the first period. Between days 0 and 21, we observed highly significant (p<0.001) improvements for means of Lequesne's index from 12.07 to 9.37 and for VAS from 5.89 to 4.16 cm for leeches, but no significant differences for TENS. Effect size as group difference was -2.50 for L.I. (95% confidence interval -3.88 to -1.11), resp. -1.86 cm for VAS (95% confidence interval -2.85 to -0.87 cm). 12 patients (5 group 1, 7 group 2) did not finish the trial, mostly due to non-compliance (6). No serious adverse effects were observed. CONCLUSIONS: Single leech therapy showed significant, relevant and sustaining effects, comparable to other trials with leeches. The method deserves further research, esp. into mechanisms of possible specific effects and optimization of dosing by number of leeches and possible repeats.

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

Publication typeJournal ArticleRandomized Controlled Trial
Indexed MeSH termsAgedAnimalsCross-Over StudiesFemaleHumansKneeKnee JointLeechesLeechingMaleMiddle AgedMusculoskeletal Pain

Summary

Randomized crossover trial of 52 patients with active knee osteoarthritis demonstrates highly significant Lequesne index and VAS improvements with single leech treatment versus TENS, with effects sustained at 21 days.

Why This Matters for Hirudotherapy

This unblinded, randomized controlled crossover trial compared a single application of eight medical leeches (Hirudo medicinalis) against TENS in 52 patients with active knee osteoarthritis, using Lequesne's index and VAS as primary outcomes. Confirmatory analysis (restricted to the first period due to phase effects) showed highly significant improvements for leeches (p < 0.001) but not TENS between days 0 and 21, with effect sizes of -2.50 for Lequesne's index and -1.86 cm for VAS favoring leeches; no serious adverse effects occurred. This is directly relevant to ASH, providing RCT-level evidence for leech therapy efficacy in osteoarthritis. Caveats include the unblinded design, crossover analysis limitations, and the call for further research into mechanisms and dosing optimization.

Citation

Randomised controlled trial with medical leeches for osteoarthritis of the knee.

Stange R, Moser C, Hopfenmueller W, Mansmann U, Buehring M, Uehleke B · Complementary therapies in medicine, 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.