Amerikanische Gesellschaft für Hirudotherapie

The efficacy and safety of medical leech therapy for osteoarthritis of the knee: A meta-analysis of randomized controlled trials

Wang H, Zhang J, Chen L (2018) · International Journal of Surgery · n=264

RCT evidence detailTrial reference
Sample size of this trial compared with other Knee Osteoarthritis trialsWang H 2018264Lauche R 2025240Lauche R 2014237Farzali S 2025181Cui Y 2024144Andereya S 2008113Andereya S 2008113Sarbaev IS 201996Isik M 201790Khoshnevisan A 202280
This trial (highlighted) by sample size alongside other indexed Knee Osteoarthritis trials. Larger trials generally carry more statistical weight.

Study Profile

Design
systematic review and meta-analysis of randomized controlled trials of medicinal leech therapy in knee osteoarthritis (Chinese investigators, Shandong)
Sample size (n)
264
Intervention
Pooled analysis of 4 RCTs (n=264 total) of medicinal leech therapy in knee OA, updating the Lauche 2014 meta-analysis with additional trials
Comparator
Pooled control conditions across included RCTs: topical diclofenac, conventional NSAIDs, TENS, or hyaluronic acid
Primary endpoint
Visual analog scale (VAS) pain scores and WOMAC scores at 1 week, 4 weeks, and 7 weeks; adverse-event incidence
Primary result
Significant differences favoring leech therapy in VAS and WOMAC scores at 1, 4, and 7 weeks vs control conditions; significantly higher incidence of (predominantly mild) adverse events in leech arms; overall evidence quality rated 'moderate' per GRADE assessment
Follow-up duration
up to 7 weeks pooled

Key Findings

  • Updated meta-analysis of 4 RCTs (n=264) confirms Lauche 2014 finding of significant leech-vs-control benefit for knee OA pain and function
  • Significant improvements in both VAS pain and composite WOMAC scores at 1, 4, and 7 weeks vs control
  • Adverse events significantly more common in leech arms - predominantly mild local reactions (pruritus, bruising)
  • GRADE rating of overall evidence quality: moderate (consistent with ASH editorial-board independent rating)
  • Authors caution that the conclusion should be interpreted cautiously given inherent limitations of included studies

Limitations

  • Only 4 RCTs included - same general evidence base as Lauche 2014 with limited expansion
  • Most included trials open-label with potential for performance and detection bias
  • Adverse-event reporting heterogeneous across included trials
  • Short follow-up windows (up to 7 weeks) preclude long-term durability assessment
  • No subgroup analysis by leech protocol (single vs repeated application) or comparator type

Clinical Implications

Wang 2018 meta-analysis is the most recent quantitative synthesis of the leech-knee-OA RCT literature and confirms the Lauche 2014 conclusion. For US clinicians and guideline writers, the two meta-analyses combined (Lauche 2014 + Wang 2018, both GRADE 'moderate') represent the best available pooled evidence supporting symptomatic leech therapy for knee OA. The slightly higher adverse-event rate is expected and reflects predominantly mild local reactions; serious adverse events remain rare. The conclusions remain conditional on the open-label design of underlying RCTs - the forthcoming ELECT trial sham-controlled result will be the next critical update.

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