Study of the effect of leeching on plasma endothelin and soluble interleukin-2 receptor in patients with systemic lupus erythematosus
Cheng SP, Liu JL, Yuan J (2005) · Chinese Journal of Integrative Medicine · n=44
Study Profile
- Design
- single-center, open-label, randomized controlled clinical trial of leeching as an add-on to conventional corticosteroid therapy in systemic lupus erythematosus (People's Hospital of Guizhou Province, China)
- Sample size (n)
- 44
- Intervention
- Conventional corticosteroid treatment plus leeching intervention (n=24); plasma endothelin and soluble interleukin-2 receptor measured before and after treatment
- Comparator
- Conventional corticosteroid treatment alone (n=20)
- Primary endpoint
- Plasma endothelin (ET) and soluble interleukin-2 receptor (sIL-2R) concentrations before and after treatment
- Primary result
- Both groups showed significant improvement in plasma ET and sIL-2R after treatment (p<0.05); the leeching group demonstrated a significantly greater improvement than the conventional-only group (between-group p<0.05); authors concluded that adjunctive leeching improves the level of these biomarkers and may ameliorate renal tissue impairment in SLE
- Follow-up duration
- treatment course duration (specific weeks not reported in abstract)
- PMID
- 15975313
Key Findings
- Rare RCT-level evidence for leeching in a systemic autoimmune disease (SLE) context
- Adjunctive leeching plus conventional corticosteroids produced significantly greater reduction in plasma endothelin and sIL-2R than corticosteroids alone
- First trial-level data suggesting a biomarker-based anti-inflammatory mechanism for leech therapy in SLE
- Chinese integrative-medicine context - leeching is part of the recognized traditional therapeutic toolkit
- Mechanistic relevance to broader autoimmune indications, though the clinical relevance to organ outcomes remains uncertain
Limitations
- Small sample (n=44) limits subgroup and sensitivity analyses
- Single Chinese center with no Western replication of biomarker findings
- Surrogate biomarker endpoints (ET, sIL-2R) rather than hard clinical outcomes (renal failure, mortality, flare frequency)
- Open-label design with no sham control
- Limited methodological detail on randomization, allocation concealment, and outcome assessment blinding
Clinical Implications
Cheng 2005 is the only PubMed-indexed RCT to test leeching in systemic lupus erythematosus. The biomarker improvements (plasma endothelin and sIL-2R) are mechanistically interesting and consistent with anti-inflammatory and vasodilatory properties of leech saliva. However, the trial does not address hard clinical outcomes (renal failure, mortality, lupus flare frequency) and should be cited only as a hypothesis-generating mechanistic signal rather than as evidence for routine clinical use. For US clinicians, leech therapy in SLE is not a recommended indication and the FDA 510(k) K040187 clearance does not cover this use. The trial is included in the registry for completeness of the international integrative-medicine evidence base.
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