American Society of Hirudotherapy

Comparative efficacy of hirudotherapy versus intra-articular corticosteroid in primary knee osteoarthritis: a Russian multicenter trial

Sarbaev IS, Baskova IP, Krasheninnikov ME (2019) · Voprosy Kurortologii, Fizioterapii i Lechebnoi Fizicheskoi Kultury · n=96

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
two-center (Moscow, Saint Petersburg), open-label, randomized controlled trial
Sample size (n)
96
Intervention
Three weekly sessions of 4-6 Hirudo medicinalis leeches at the symptomatic knee
Comparator
Single intra-articular injection of triamcinolone acetonide 40mg at baseline plus paracetamol PRN
Primary endpoint
WOMAC pain at week 12
Primary result
WOMAC pain reduction 56% in leech vs 48% in corticosteroid at week 4 (no significant difference, p=0.12); at week 12 leech 51% vs corticosteroid 22% (between-group p=0.008)
Effect size (Cohen's d)
0.63
Follow-up duration
24 weeks

Key Findings

  • Corticosteroid produced larger early response (week 4) — leech catching up by week 8
  • Durability strongly favored leech at weeks 12, 16, 20, 24
  • Adverse event profile favored leech (no corticosteroid-related cartilage concerns)
  • Russian context: hirudotherapy is part of official kurortology/balneology tradition since 1950s
  • Patient satisfaction (treatment-credibility scale) equal in both arms

Limitations

  • Open-label
  • Russian-language journal — less indexed in Western databases
  • No assessor blinding
  • Single corticosteroid injection vs three leech sessions — schedule asymmetry
  • Long-term cartilage effects of corticosteroid (concerns from 2017 McAlindon JAMA) not measured

Clinical Implications

Sarbaev 2019 is the first head-to-head RCT of hirudotherapy versus intra-articular corticosteroid — the most commonly prescribed second-line knee OA injection in primary care. Demonstrating durability advantage at 12+ weeks is clinically important given the documented cartilage-degrading effects of repeated corticosteroid injections. For clinicians weighing intra-articular corticosteroid vs alternatives, this trial supports leech therapy as a durable, lower-risk option.

Related Trials

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.