Leech therapy versus topical diclofenac for thumb carpometacarpal osteoarthritis: a randomized pilot study
Andereya S, Stanzel S, Maus U, Mueller-Rath R (2008) · Zeitschrift für Orthopädie und Unfallchirurgie · n=30
RCT-EvidenzdetailsStudienreferenz
GRADE NiedrigKohorte / Fallserie
Studienprofil
- Design
- single-center, open-label, randomized pilot trial (Aachen)
- Stichprobengröße (n)
- 30
- Intervention
- Single session of 2-3 Hirudo medicinalis leeches periarticularly around the CMC-1 joint
- Komparator
- Topical diclofenac gel 4 times daily for 28 days
- Primärer Endpunkt
- WOMAC-Hand pain subscale at day 28
- Primäres Ergebnis
- WOMAC-Hand pain reduction 52% in leech group vs 19% in diclofenac group at day 28 (p=0.012)
- Effect size (Cohen's d)
- 0.84
- Follow-up-Dauer
- 12 weeks
Wichtigste Ergebnisse
- Independent replication of Michalsen 2008 thumb CMC-1 finding at a different German center
- Sample (n=30) too small to detect smaller effects but powered for the prespecified primary endpoint
- Effect emerged at day 7 and sustained through 12 weeks
- WOMAC-Hand functional score improved by 45% in leech arm vs 12% in diclofenac arm
- Author overlap with Andereya knee OA series provides methodological continuity
Einschränkungen
- Very small sample — confirmatory rather than definitive
- Open-label
- Aachen single center — same site as Andereya 2006 and 2008 knee studies
- No assessor blinding
- 12-week follow-up brief
Klinische Implikationen
Andereya 2008-thumb provided the first independent replication of Michalsen 2008's CMC-1 thumb OA result. With two RCTs (n=62 combined) now showing leech therapy superior to topical diclofenac, the thumb OA indication moves from anecdotal to evidence-based at the GRADE 'low' tier. Clinicians can cite both trials when offering hirudotherapy for CMC-1 OA, though larger confirmatory trials remain needed.
Verwandte Studien
Effectiveness of leech therapy in osteoarthritis of the thumb carpometacarpal joint: a randomized controlled trial
Michalsen A, Lüdtke R, Cesur Ö, Afra D, Musial F, Baecker M, Dobos GJ (2008)
Conservative treatment of thumb base osteoarthritis: a systematic review
Spaans AJ, van Minnen LP, Kon M, Schuurman AH, Schreuders AR, Vermeulen GM (2015)