Comparison of the effectiveness of medicinal leech and TENS therapy in the treatment of primary osteoarthritis of the knee: a randomized controlled trial
Isik M, Ugur M, Yakisan RS, Sari T, Yilmaz N (2017) · Zeitschrift für Rheumatologie · n=90
Характеристика исследования
- Дизайн
- single-center, prospective, randomized, single-blind, parallel-group RCT (Atatürk University, Erzurum, Turkey)
- Размер выборки (n)
- 90
- Вмешательство
- Five Hirudo medicinalis leeches applied to the affected knee once weekly for 3 weeks (leech group, n=46)
- Компаратор
- Transcutaneous electrical nerve stimulation (TENS) therapy following a standardized regimen (TENS group, n=44)
- Первичная конечная точка
- Change in pain on VAS and WOMAC scores at days 0, 21, and 180
- Основной результат
- VAS pain score decreased similarly in both groups by day 21 (p<0.001 within-group); between-group course of change in pain similar throughout; all WOMAC subscores decreased similarly in both groups (p=0.819 between-group); long-term (day 180) benefits slightly greater in TENS arm
- Длительность наблюдения
- 180 days
- PMID
- 27535276
Ключевые выводы
- First RCT directly comparing leech therapy with TENS, a widely used non-pharmacologic modality for knee OA
- Leech therapy produced statistically significant pain and function improvements equivalent to TENS at day 21
- All WOMAC subscores (pain, stiffness, function) decreased significantly with both modalities through 180 days
- Long-term benefits modestly favored TENS over leech therapy at the 6-month timepoint
- Authors conclude leech therapy is a viable alternative or additional non-surgical option for knee OA
Ограничения
- Single center (Atatürk University Faculty of Medicine, Erzurum)
- Single-blind only — patients aware of intervention
- TENS comparator parameters not fully described in published methods
- No NSAID arm — cannot triangulate vs. pharmacologic standard of care
- Both groups improved significantly, making between-group inference dependent on equivalence assumptions not formally tested
Клиническое значение
Isik 2017 is the largest single-RCT of leech therapy for knee OA published outside Germany (n=90) and the first to use a non-pharmacologic comparator (TENS). The equivalence-level finding is clinically useful: for clinicians and patients choosing between leech and TENS, the trial suggests broadly similar short-term outcomes with TENS having a small long-term edge. The trial supports leech therapy as a reasonable alternative for patients who decline electrotherapy. Methodologically the lack of a pharmacologic comparator limits placement within the wider OA-treatment hierarchy, but the Turkish cohort adds geographic diversity to the European-dominated 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)