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
Характеристика исследования
- Дизайн
- 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)
- Размер выборки (n)
- 44
- Вмешательство
- Conventional corticosteroid treatment plus leeching intervention (n=24); plasma endothelin and soluble interleukin-2 receptor measured before and after treatment
- Компаратор
- Conventional corticosteroid treatment alone (n=20)
- Первичная конечная точка
- Plasma endothelin (ET) and soluble interleukin-2 receptor (sIL-2R) concentrations before and after treatment
- Основной результат
- 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
- Длительность наблюдения
- treatment course duration (specific weeks not reported in abstract)
- PMID
- 15975313
Ключевые выводы
- 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
Ограничения
- 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
Клиническое значение
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.
Связанные исследования
Effectiveness of leech therapy in osteoarthritis of the knee: a randomized, controlled trial
Michalsen A, Klotz S, Lüdtke R, Moebus S, Spahn G, Dobos GJ (2003)
Leech therapy for symptomatic treatment of knee osteoarthritis: results and implications of a pilot study
Andereya S, Stanzel S, Maus U, Mueller-Rath R, Mumme T, Miltner O (2006)
Comparison of modern leech therapy with intra-articular hyaluronic acid injections for symptomatic relief of knee osteoarthritis
Andereya S, Stanzel S, Maus U, Mueller-Rath R, Mumme T, Miltner O, Andereya S (2008)
A systematic review and meta-analysis of medical leech therapy for osteoarthritis of the knee
Lauche R, Cramer H, Langhorst J, Dobos G (2014)