Anerkendelse til forsker i komplementærmedicin
Zürichsk meta-analyse i renommeret tidsskrift
I november udgaven af ”Artherosclerosis”, som er det officielle tidsskrift fra Den Europæiske Arterioskleroseforening [(EAS)], offentliggøres et videnskabeligt studium af et plantemedikament. Medikamentets virkning på dårligt blodomløb i benene er baseret på phytoterapeutikum, som kendes fra tibetansk medicin. Forskere fra Zürich Universitet står bag studiet ”Treating intermittent claudication with Tibetan medicine Padma 28: Does it work?” Det zürichske forskningsarbejde drejer sig om en meta-analyse, der blev gennemført under ledelse af prof. dr. med. Reinhard Saller, Institut for Naturmedicin ved Zürich Universitetshospital. I en meta-analyse sammenfattes data fra allerede udførte studier og evalueres på ny ud fra et sæt fælles kriterier.
Dette forudsætter, at der på forhånd er egnede videnskabelige studier til rådighed, som kan reevalueres. Meta-analyser er et særsyn inden for komplementærmedicin, idet der for mange naturprodukters vedkommende endnu ikke findes tilstrækkeligt med veldokumenterede kliniske studier. En meta-analyse kan vise sig at være mere powerfuld end enkeltstudier ved netop at sammenfatte data fra forskellige kilder og arbejdsgrupper.
Såvel studiets kvalitet som det af anerkendte fagspecialister fra Schweiz og Tyskland bestående forfatterhold har muliggjort Zürich-studiets optagelse i fagtidsskriftet ”Atherosclerosis” (Impact Factor 3.777). Virkningen af naturlægemidlet, der består af forskellige plantedele og mineraler, blev undersøgt i forbindelse med behandlingen af perifer arteriel forsnævringssyge (PAF), også kaldet vindueskiggersyge, på stadium II. PAF skyldes som regel åreforkalkning (arteriosklerose) i arterierne i bækken eller ben og kan føre til stærke smerter i benene. Disse symptomer optræder i begyndelsen under gang, men senere også i hviletilstand. Studiet viste, at behandling med Padma 28 førte til en væsentlig forlængelse af patienternes maksimale gangstrækning.
10 gange så mange patienter i den gruppe der fik Padma 28 kunne forlænge deres gangstrækning med mere end 100 m sammenlignet med dem, der fik placebo, hvilket er et signifikant resultat.
Behandling med Padma 28 vil derfor være et ideelt supplement til gangtræning, der er en af de vigtigste behandlingsmetoder ved PAF.
Foruden virkningen er også sikkerheden ved Padma 28 blevet undersøgt. Padma 28 har været godkendt som lægemiddel i Schweiz siden 1977 og er blevet positivt omtalt af førende forskere. Bivirkninger er på niveau med placebo (virkningsløst medikament). Studiets resultater giver anledning til en diskussion af Padma 28 som forebyggende og/eller supplerende behandling til alle former for åreforkalkning (arteriosklerose)
Litteratur:
Melzer J, Brignoli R, Diehm, Reichling J, Do DD, Saller R. Treating intermittent claudication with Tibetan medicine Padma 28: Does it work? Atherosclerosis. 2006 Nov;189(1):39-46. Epup 2006 Apr 4. Treating intermittent claudication with Tibetan medicine Padma 28: Does it work? Meta-analyse af PADMA 28 Klinisk virkning og sikkerhed ved PAF
Baggrund
Lægemidlet PADMA 28, der er baseret på en formel kendt fra tibetansk medicin, bruges ved behandling af blodgennemstrømningsforstyrrelser og ved symptomer på perifer arteriel forsnævringssyge (PAF). 80% af alle åreforkalkningsbetingede (arteriosklerosebetingede) karændringer, kan føres tilbage til PAF.
Fontaines stadieinddeling fra I til IV har vist sig anvendelig til at klassificere PAF. Stadie II er præget af symptomet Claudicatio intermittens (vindueskiggersyge) – dvs. gangudløste smerter, som i hvile ophører.
Meta-analysens problemformulering
Hvilke resultater foreligger for lægemidlets effekt og uskadelighed til behandling af patienter med perifer arteriel forsnævringssyge?
Dataindsamling og metode
Der blev i forskellige elektroniske databanker søgt på kliniske studier med PADMA 28. I tillæg blev kilderne i de fundne studier analyseret. Til meta-analysen blev der udvalgt placebo-kontrollerede studier som omfattede mindst 30 forsøgspersoner med PAF på Fontaine stadie II. Derudover skulle studieterapien strække sig over en periode på mindst 12 uger og benytte den smertefrie eller maksimale gangstrækning målt på standardiserede løbebåndstests som måleparameter.
Resultater vedrørende den kliniske virkning
De sammenfattede data i meta-analysen omfatter 5 studier med 272 patientdata. Meta-analysen bekræfter en signifikant og klinisk relevant forlængelse af den maksimale gangstrækning med mere end 100m efter fire måneders behandling hos 20 % af patienterne med Padma 28 i modsætning til omkring 2 % af patienterne med placebo.
Resultater vedrørende sikkerhed (bivirkninger)
Hvad angår sikkerheden blev 19 kliniske studier med PADMA 28 analyseret (2084 patienter, 1555 aktivt, 529 placebo). Der var færre bivirkninger i aktiv gruppen end i placebo gruppen (aktivt 12,3%, placebo 15,7%).
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