Sociedad Americana de Hirudoterapia

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

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