Banebrydende TAASS studie viser at Traumeel® er lige så effektivt som diclofenac til behandling af skader på bevægeapparatet.
Berlin/ EULAR, 8. juni, 2012
Resultaterne af TAASS (Traumeel Akut Ankel Forstuvning (sprain) Studie), er fra det første randomiserede og kontrollerede studie af sin størrelse og kvalitet, der sammenligner et naturligt lægemiddel med et konventionelt. Det viser at det naturlige lægemiddel Traumeel® (salve og gel) er lige så effektivt som diclofenac gel 1% (mest kendt som Voltaren) til behandling af akutte ankelforstuvninger1. TAASS studiet giver bekræftende evidens for at udvortes anvendt Traumeel er et effektivt alternativ til Diclofenac gel, hvilket gør det til førstevalget for en naturlig behandling af akutte ankelforstuvninger.
“TAASS er det største studie af sin art hvor et naturligt lægemiddel sammenlignes med et konventionelt, og tilfører et signifikant og tungtvejende resultat til bevisbasen. Jeg har anvendt Traumeel i min klinik i over 20 år og har altid fået gode resultater. TAASS bekræfter nu at Traumeel (salve og gel) er lige så effektivt som diclofenac gel og som sådan et effektivt behandlingsalternativ til patienterne”. Professor Carlos González de Vega, Medical School of the Autonomous University of Madrid, Medicinsk leder og administrerende direktør for MEDYR Klinikken for Sportsmedicin og rehabilitering, Madrid, Spanien.
TAASS var igangsat for at undersøge effektiviteten og sikkerheden af topisk anvendelse af Traumeel (salve og gel) til at reducere smerte og forbedre bevægelse i sammenligning med diclofenac gel 1% ved akutte ankelforstuvninger. Primære målsætninger var patienternes vurdering af følgende.
- Ankelsmerte udfra en 0–100mm Visuel Analog Skala (VAS):
- Dagligdags Aktiviteter (ADL) underskala af fod og ankel.
Måling af bevægelsesformåen (FAAM)
TAASS resultaterne viste samme virkning for de to Traumeel typer for de primære målsætninger ved sammenligning med diclofenac hos patienter med akutte ankelforstuvninger. Foregående studier har også vist at Traumeel havde en overlegen tolerance og sikkerhedsprofil2,3 der yderligere understreger rationalet for anvendelse af Traumeel som udgangspunkt ved behandlinger af ankelforstuvninger.
”Ankelforstuvninger er en almindelig skade og der er adskillige studier der viser at den mest succesfulde behandling er tidlig tilbagevendelse til normal aktivitet. Uden tilstrækkelig behandling kan akutte ankelforstuvninger resultere i kronisk instabilitet af leddet, så forebyggelse og tidlig effektiv behandling er helt essentielt. TAASS studiet giver evidens for at Traumeel er en effektiv behandling af ankelforstuvninger, der giver en naturlig smertehæmmende antiinflammativ virkning på denne skadestype. “ Professor Cathy Speed, Reumatologisk konsulent, Sport & Exercise Medicine, Cambridge Centre for Health and Performance, Cambridge, UK.
TAASS resultater
På 7. dagen var der gennemsnitlige procentreduktioner i VAS smertescoren for alle 3 grupper: Traumeel salve (60.6 % reduktion), Traumeel gel (71.1 % reduktion) og diclofenac gel (68.9 % reduktion).
På dag 14, var den gennemsnitlige procentreduktionen på VAS smerte scoren henholdsvis 94.3%, 93.4% og 94.8% for Traumeel salve, Traumeel gel og diclofenac gel grupperne.
Efter 6 uger rapporterede alle patienter totalt smertelindring og normal funktion. Median tiden indtil normal aktivitet var hhv. 19.09, 19.35 og 19.39 dage for Traumeel salve, Traumeel gel og diclofenac grupperne. Bivirkninger (n=43) var rapporteret for 31/447 patienter (6.9%). De var for det meste milde eller moderate i alvorlighed. Ingen var seriøse eller relateret til medicinen og alle behandlinger var lige godt tålt.
“Resultaterne af TAASS studiet bekræfter effektiviteten af Traumeel hvilket betyder at klinikkerne har gode data til overbevisende at anbefale Traumeel. En anden fordel ved Traumeel er dets effektive og nye virkningsmekanisme. Traumeel giver en multimålrettet synergistisk virkning ved at have indflydelse på flere aspekter af den inflammatoriske proces. Den virker ikke direkte på cyclooxygenase eller prostaglandiner hvorved det minimere gastrointestinale og kardiovasculære bivirkininger. Der ud over bevirker den multimålrettede virkning en acceIereret healing og vævsreperation,”Assisterende Professor Dr. med. Bernd Wolfarth, ledende overlæge i Afdelingen for Forebyggende og Rehabiliterende Sportsmedicin på Det Tekniske Universitet i München.
Studiedesign
TAASS studiet var en randomiseret blindet og kontrolleret undersøgelse der involverede 449 fysisk aktive mænd og kvinder (alder mellem 18–40 år) med milde til moderate ankelforstuvninger (1. og 2. grad). Deltagerne blev randomiseret udvalgt til en af de tre behandlingsgrupper: Traumeel salve, Traumeel gel eller den sammenlignende gruppe, nemlig topisk NSAR gel (diclofenac gel 1 %,). Alle deltagerne fik testmidlet topisk 3 gange dagligt, på alle studiets 14 dage. Et endeligt besøg skete efter 6 uger. Studiet blev udført i Spanien på 15 klinikker mellem februar 2010 og september 2011.
Sikkerhed
Bivirkninger var oftest milde eller moderate. Ingen var alvorlige. Derfor anses Traumeel for en sikker behandling og et effektivt alternativ til topisk Ikke Steroidal Anti Reumatikum – NSAR’s, som diclofenac gel 1 %.
Virkningmekanisme
Traumeel giver en multimålrettet, synergistisk virkning der henvender sig flere aspekter i inflammationskaskaden og derfor understøtter helingsprocessen. Udover at give en antiinflammatorisk virkning, korrigerer komponenterne i Traumeel effekterne af inflammationen på kroppens væv, så smerter reduceres og vævsregeneration accelereres4.
Konklusion
TAASS studiet konkluderer at der er bekræftende evidens for at udvortes anvendelse af Traumeel® er et effektiv alternativ til udvortes diclofenac ved behandling af akut ankelforstuvning. Studiet understøtter den eksisterende evidens at Traumeel er en effektiv og godt tålt behandlingsmulighed ved akutte muskel-skeletale sygdomme, hvor der optræder inflammation.
Heel er et farmaceutisk firma, der udvikler, producerer og distribuerer medicin baseret på naturlige substanser. Da firmaet er globalt ledende indenfor homøopatiske kombinationsmidler, er firmaet også pionerer indenfor videnskabelige studier indenfor naturlig helbredelse. I samarbejde med akademiske institutioner arbejder Heel aktivt på at udvikle konceptet omkring Integrativ medicin, der bygger en bro mellem homøopati og den konventionelle medicin for at forbedre patienternes helbred og omsorg.
“Biologische Heilmittel Heel GmbH” opnåede med dets hovedkvarter i Baden-Baden/Tyskland og med et personale på ca 1.300 en årlig omsætning 184 million Euros in 2010 – 70 % af den udfor Tyskland. Heel medicin er til rådighed igennem distributører og datterselskaber i over 50 lande over hele verden.
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