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Selected abstract from the Annual European Congress of Rheumatology, Berlin, 6-9 lune 2012 '

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lsAT0423l - A RANDOVTZED, CONTROLLED, MULTTCENTER STUDY ON THEEFFECTIVENESS OFTRAUMEEL (OINTMENTAND GEL) INTERMS OF PAIN

REDUCTION AND FUNCTION IMPROVEMENT COMPARED WITHDICLOFENAC GEL IN ACUTE ANKLE SPRAIN

C. G. De Vegat., f . González2 onbehalf of Traumeel Acute Ankle Sprain Spain (TAASS) Study lnaestigators

I Clínica lt ' l EDYR,'?CIínica DEYRE, lYadrid, Spain

Background: Acute lateral ankle sprain is generally accepted as the most common ligamentous sports and daily exerciseinjury associated with acute inflammation.When l6'ft rrn+rcatcrl ihe<e ini,rrie5 6¿¡ lead to joint instabil ity and a l imited range ofmotion.

Obiectives:To demonstrate thatTraumeel (ointment and gel) is non-inferiorto diclofenac gel l% in the treatment ofacute ankle sprain,

Methods: In rhis mull icenter study 449 physically active patients (18-40 years) with unilatera, ankle sp'ain wererandomized blinded [o receive 2 g oflraumeel ointment (n= 152) orTraumeel gel (n= 150) or diclofenac gel (n= 147) administeredtopically three times a day for l4 days, with 6-week follow-up. Primary endpoints were patients' assessment on a 0 100 mmVisual Analogue Scale (VAS) ankle pain and on theActivit ies of Daily Living (ADL,0-100) subscale of the Foot and AnkleAbil itylYeasurement (FAAIY) on Day 7.

Results: On Day 7, median percentage reduclions inVAS pain score were demonstrated by all groups:Traumeel ointment,60.6% (medan: basel ne 52.6 mm: change -33,0) ;Traumeel gel ,7 l , l% (median: basel ine 53. 1 mm: change -37. 1) : and d ic lofenac68.9% (median: baseline 55.7 mm; change -37. l).Total pain relief was reported by 8.5%,5.0% and 5,9% of patients in each group,respectively. lYann-Whitney (YfVq effect sizes and lower bound of the confldence intervals (t BCI: predefined benchmark 0.4) forTraumeel ointment and gel combined vs. diclofenac (MW=0.49 l0; LBCI=0.432 l),Traumeel ointment vs. diclofenac (MW=0.4682;LBCI=0.4004) and Traumeel gel vs. diclofenac (MW=0.5 l4); LBCI=0.4464) demonstrated non-inferiority of both the Traumeelpreparations vs. diclofenac for reducing pain. On Day 14, median percentage reductions inVAS pain score were 943%,934% and94.8% (median changes -46.4,-50.5 and -50.5 mm) forTraumeel ointment,Traumeel gel and diclofenac groups, respectivel¡r Onday 7, median improvements in FAAM ADL score were 76.2,)6.2 and 25.0 points (median baseline 51.2, 56.0 and 5 1.2 points)forTraumeel ointment,Traumeel gel and diclofenac groups, respectively. MW effect sizes and LBCI forTraumeel ointment and gecombined vs. diclofenac (f '1W=0.5260; LBCI=0.4656),Traumeel ointment vs. diclofenac (MW=0.5 169:LBCI=O.4485) andTraumeelgel vs, diclofenac (MW=0.5352; LBCI=0.4666) demonstrated non-inferiority of both Traumeel preparations vs. diclofenac forfunctional improvement, On Day 14, median improvements in FAAM ADL score were 41.7,405 and 41,7 points forTraumeelointment,Traumeel gel and diclofenac groups, respectivelyAt 6 week, all patients reported total pain relief and normal functioningMedian time to normal lunction was 19.09, 19.35 and 19.39 days lorTraumeel ointment,Traumeel gel and diclofenac groups,respeflively.Adverse evenLs (n=43) were reported by 311447 patienis (6.9%), Events were mostly mrld or moderate in severity.none was serious and all treatments were ecually well tolerated.

Conclusions: In this large scale trial,Traumeel ointment and gel decreased pain and improved joint function to the sameextent as diclofenac gel in acute ankle spraiñ, with a good tolerability profile.Trial lD: NCTO 1066520

Disclosure of Interest: C, G. DeVega Grant / Research support from: Investigato¡TAASS ludy Biologische Her mittel Heei GmbH:TAASS ludysupported by Bioogische Heilmitte Heel GmbH , Consultant for: Advisory board membenTraumeel, Biologische Heilmittel Hee GmbH ,J. González Grant /Research support from: lnvestigato¡TAASS ludy Biologische Heilmittel Heel GmbH:TAASS lcudy supported by Biologische Herlmittel Heel GmbH