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S E L E C T E DA B S T R A C T F R O M SUPPLEMENT III YOL 71 JUNE 2012

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Annual EuroPean Congress of

RFIETIMATOLOGY eL&&ze+z
Berlin6-9June2012
Diseases; of the Rheumatic Annals 2012; Vol 71: Supp III ISAT0423f from Reprinted
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-i abstract Congress of Rheumatology, Selected Berlin, 6-9lune 2012 from theAnnual European '1--_- ,-

- A RANDOVTZED, CONTROLLED, MULTTCENTER STUDY ON THE lsAT0423l (OINTMENTAND EFFECTIVENESS OFTRAUMEEL INTERMS GEL) OF PAIN REDUCTION AND FUNCTION IMPROVEMENT COMPARED WITH DICLOFENAC GELIN ACUTE ANKLE SPRAIN
C. G. De Vegat., f . Gonzlez2onbehalf of TraumeelAcute Ankle Sprain Spain (TAASS)Study lnaestigators
IClnicalt'l EDYR,'?CInica lYadrid, DEYRE, Spain

Background: Acute lateral ankle sprain isgenerally accepted asthe mostcommonligamentous sportsand dailyexercise ihe<eini,rrie5 with acuteinflammation.When injuryassociated l6'ftrrn+rcatcrl 6 leadto joint instability and a limited range of motion. Obiectives:To demonstrate (ointmentand gel) is non-inferiortodiclofenac thatTraumeel gel l% in the treatmentof acuteanklesprain, (18-40 years)with unilatera, Methods: In rhis mullicenter study449 physically activepatients anklesp'ainwere blinded [o receive 2 g oflraumeel randomized ointment (n= 152) gel(n= 150) gel(n= 147) orTraumeel or diclofenac administered topically three times a day for l4 days, with 6-week follow-up. Primaryendpoints were patients' assessment on a 0 100 mm (VAS) painandon theActivities Visual Analogue Scale ankle (ADL,0-100) of DailyLiving subscale of the FootandAnkleAbility (FAAIY) lYeasurement on Day7. percentage Results: On Day7, median reduclions inVASpainscorewere demonstrated by allgroups:Traumeel ointment, ee e ll , 7 l , l %( m e d i a n . ): ( m e d a nb : ase n l e 5 2 . 6m m :c h a n g e3 3 , 0 ) ; T r a u m g 60.6% b:a s e l i n5 e3 .1 m m :c h a n g e3 7 1 a n dd i c l o f e n a c -37. (median: baseline 55.7mm;change l).Total painrelief 68.9% wasreported group, by 8.5%,5.0% and5,9%of patients in each (YfVq effectsizes lYann-Whitney respectively. (t BCI: predefined and lower boundof the confldence intervals benchmark 0.4)for ointment andgelcombined vs.diclofenac (MW=0.49 (MW=0.4682; Traumeel l0; LBCI=0.432 l),Traumeel ointment vs.diclofenac gel vs.diclofenac (MW=0.5l4); LBCI=0.4464) andTraumeel LBCI=0.4004) demonstrated non-inferiority of both the Traumeel preparations vs.diclofenac for reducing pain. On Day 14, median percentage inVASpainscorewere 943%,934%and reductions -46.4,-50.5 94.8%(median changes and -50.5mm) forTraumeel gel and diclofenac groups, ointment,Traumeel respectivelr On improvements in FAAMADL scorewere 76.2,)6.2and25.0points(median day7, median baseline 51.2, 56.0and5 1.2points) ointment,Traumeel gel and diclofenac groups, forTraumeel respectively. MW effectsizes and LBCIforTraumeel ointmentand ge vs. diclofenac (f'1W=0.5260; combined LBCI=0.4656),Traumeel (MW=0.5 ointment vs. diclofenac 169:LBCI=O.4485) andTraumeel (MW=0.5352; gel vs,diclofenac LBCI=0.4666) demonstrated preparations non-inferiority of both Traumeel vs.diclofenac for functional improvement, On Day 14,median improvements in FAAMADL scorewere 41.7,405and 41,7points forTraumeel gelanddiclofenac groups, ointment,Traumeel respectivelyAt 6 week, all patients reportedtotal painreliefand normalfunctioning time to normallunction was 19.09, Median 19.35 and 19.39 gel and diclofenac groups, dayslorTraumeel ointment,Traumeel (n=43)were reported (6.9%), respeflively.Adverse evenLs by 311447 patienis Events were mostly mrldor moderate in severity. and alltreatments were ecually nonewasserious welltolerated. jointfunction Conclusions:Inthislarge scale painandimproved trial,Traumeel ointment andgeldecreased to the same gel in acuteanklesprai, extentasdiclofenac with a goodtolerability profile.Trial lD: NCTO1066520
Disclosure of Interest: C, G. DeVega Grant / Research supportfrom: InvestigatoTAASS ludy Biologische Hermittel Heei GmbH:TAASS ludy Heilmitte Heel GmbH , Consultant for: Advisoryboard membenTraumeel, supportedby Bioogische Biologische Heilmittel Hee GmbH ,J. Gonzlez Grant / supportfrom:lnvestigatoTAASS ludy Biologische Heilmittel HeelGmbH:TAASS Research lcudysupported by Biologische Herlmittel HeelGmbH

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