Randomised controlled trial with medical leeches for osteoarthritis of the knee
RCT published in 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.
Zusammenfassung
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.
Warum dies für die Hirudotherapie relevant ist
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.
Zitation
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
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