Farmaci omeopatici: a chi l’onera della prova di efficacia?
I farmaci omeopatici hanno efficacia pari al placebo. E’ quanto emerge da un'analisi pubblicata sulla rivista Lancet.
Gli autori hanno setacciato diversi trial condotti per documentare gli effetti delle terapie omeopatiche e di quelle convenzionali. Di tutti gli studi individuati per entrambe le categorie, sono stati selezionati solo i migliori, cioè quelli ben costruiti dal punto di vista statistico (soprattutto con più partecipanti seguiti per lunghi periodi di tempo). Gli autori hanno constatato che le sostanze convenzionali mostrano di essere efficaci mentre l’effetto delle sostanze omeopatiche evapora fino a somigliare a quello dell’acqua fresca.
Le proteste dal mondo dell’omeopatia (medici e industrie) non si sono fatte attendere: una pioggia di critiche ha investito la pubblicazione di Lancet.
Regolarmente ogni risultato negativo su questo argomento viene criticato evocando una sorta di complotto gestito dalla medicina convenzionale per proteggere gli interessi dell’industria farmaceutica. D’altra parte le maggiori riviste scientifiche sono accusate di non pubblicare i trial positivi su cure omeopatiche perché in conflitto con gli interessi dell’industria farmaceutica che le finanziano.
La polemica sui metodi per mettere alla prova l’omeopatia ha una lunga storia alle spalle. La contrapposizione è radicale.
Da una parte c'è chi sostiene che la cura omeopatica non possa essere sperimentata secondo i canoni della medicina convenzionale, per via del suo approccio olistico e individuale: il medico omeopata stabilisce la cura dopo aver valutato la sfera organica e affettiva del paziente e propone di conseguenza una sostanza in dosi e modalità che possono essere differenti per ciascun paziente.
Gli avversari ribattono che prima di far ingerire una sostanza a qualcuno la si debba provare secondo metodi che diano alcune informazioni: quando il farmaco è indicato, quanto sono probabili gli effetti positivi e negativi. A oggi è possibile ricavare queste informazioni solo da studi costruiti secondo un metodo che prevede gruppi omogenei e controlli.
Attualmente un criterio di scientificità ampiamente condiviso è questo: chi sostiene una teoria ha anche l’onere di indicare il cosiddetto «esperimento cruciale» che ne potrebbe svelare la falsità.
«Questa terapia provoca l’effetto x nelle condizioni y» è una teoria scientifica.
«Questa terapia funziona,e quando ciò non accade significa che non è stata usata nel modo giusto» non lo è.
Perché?
L’affermazione «Questa terapia provoca l’effetto x nelle condizioni y» è resa falsa con un semplice esperimento: si riproducono le condizioni y e si controlla che si produca l’effetto x.
«Questo terapia funziona, purché chi la prescrive usi il metodo giusto» non ha un esperimento cruciale perché chi la sostiene può sempre giustificare in molti modi il fatto che un trial faccia fiasco («Non è stata sperimentata secondo i metodi giusti»).
Molti dopo la pubblicazione di Lancet hanno adottato questa linea di difesa.
Il Comitato permanente di consenso e coordinamento per le medicine non convenzionali in Italia, in un comunicato stampa in riferimento all’articolo pubblicato sul Lancet, afferma: «per valutare l’efficacia dell’omeopatia sono stati arbitrariamente scelti, in modo “metodologicamente corretto”, come nel caso in questione, parametri indicativi di efficacia con una operazione di pulizia scientifica. In altre parole il lavoro è stato costruito da allopati con criteri allopatici. E’ come se un oste facesse un confronto tra il suo vino e l’acqua per concludere che il vino, anzi il suo vino è più buono».
Mentre la ditta di sostanze omeopatiche Boiron ha accusato più apertamente Lancet di essere in malafede. «Che Lancet abbia aderito a sua volta alla lobby anti omeopatica a dispetto di qualsiasi rigore scientifico? Su quest’ultimo punto è lecito interrogarsi dopo che, in occasione del recente caso Rosuvastatina, Lancet è stato costretto ad ammettere il proprio errore e a presentare le proprie scuse».
A onor del vero Lancet, nel 2003, attaccò duramente la campagna pubblicitaria di Astrazeneca perché attribuiva alla rosuvastatina un profilo di efficacia e sicurezza un favore non provato dagli studi e criticò duramente la validità di un trial comparso sull’American Journal of Cardiology oltremodo favorevole al nuovo farmaco: «E’ difficile comprendere come tale ricerca di natura commerciale sia potuta comparire su un rispettato giornale medico peer-reviewed».
Boiron qui solleva la questione di quanto l’industria farmaceutica riesca a condizionare l’informazione scientifica. Cita però un caso esemplare in cui la scienza ha esercitato il diritto di criticare se stessa e tornare sui propri passi.
Queste polemiche in realtà mostrano tutta la differenza tra il metodo tradizionale e quello omeopatico.
Ripetibilità del risultato
Secondo la medicina scientifica devono essere espresse le condizioni in cui il farmaco mostrerà la sua efficacia, in modo che sia possibile metterlo alla prova e stimare in quanti casi attendersi il risultato utile e in quanti casi un effetto collaterale. Solo quando è possibile controllare questi dati si può valutare il profilo rischi benefici della cura.
La ripetibilità del risultato non è invece garantita quando, come nel caso della medicina omeopatica, il risultato positivo è lasciato alla particolare capacità che il medico possiede di intuire quale cura si attaglia al paziente.
Confutabilità del risultato
La possibilità di smentire uno studio con un altro è una garanzia offerta da quel metodo scientifico che gli omeopati rifiutano: si può anche mentire o sbagliarsi sull’efficacia e la sicurezza di una sostanza, ma uno studio che indichi quando, come e perché un farmaco ha buone proprietà terapeutiche, si espone contemporaneamente a critiche che possono verificarne l’attendibilità.
Queste differenze impediscono di stabilire criteri unici per provare l’efficacia di tutti i farmaci, omeopatici e tradizionali. Un decreto in preparazione al Ministero della salute tenta di uniformare i due settori. Il decreto prevede la vendita libera dei farmaci ad alta diluizione (la cui innocuità, al contrario dell’efficacia, è stata provata), mentre la preparazione in cui il principio attivo è più concentrato dovrà avere le stesse caratteristiche di sperimentazione, il foglio illustrativo e l’indicazione terapeutica come i farmaci allopatici. Se il decreto non sarà modificato, nel 2008, anno in cui la legge entrerà in vigore, la gran parte dei rimedi omeopatici oggi in uso sarà fuori legge.
Agli omeopati l’onere della prova che l’acqua sia meglio del vino.
Sergio Cima, Roberto Satolli
Qui non c'entra l'onere
Inserito da Paolo Bellavite (not verified) il Lun, 2007-02-19 15:55
Qui non c'entra l'onere della prova. La meta-analisi del Lancet ha analizzato (a modo suo) prove che ci sono già in letteratura, cercando di smontarle. L'errore metodologico del lavoro di Shang e C. sta nell'avere arbitrariamente selezionato 8 lavori da una messe di 110 e basato su questi soltanto le conclusioni. Questi 8 lavori sono stati scelti sulla base della assunzione che i lavori con numero maggiore di casi sono quelli più attendibili e, guarda caso, proprio questi sono quelli che danno minore risultato terapeutico. Ma gli autori dimenticano di dire che questo fatto (cioè che gli studi con maggior numerosità sono quelli meno discriminanti tra verum e placebo) è del tutto ovvio: infatti prima di fare uno studio normalmente si valuta il numero di casi da reclutare sulla base del risultato atteso. Se il risultato è piccolo, sono necessari molti casi, se il risultato è grande, bastano pochi casi per avere una prova di efficacia. Pertanto, è del tutto scorretto scartare dall'analisi gli studi con pochi casi (che sono quelli che danno risultati più eclatanti), cosa che invece hanno fatto gli autori del tanto pubblicizzato studio del Lancet.
Paolo Bellavite, medico
rispondi
complimenti per l'articolo,
Inserito da Antonella Sagone (not verified) il Lun, 2007-02-19 15:55
complimenti per l'articolo, di chiarezza esemplare. Sento però il bisogno di considerarlo solamente un punto di partenza, sul quale costruire un'ipotesi di verificabilità delle terapie omeopatiche. Infatti, aver constatato che l'approccio omeopatico rende difficile creare le condizioni di riproducibilità che permetterebbero di valutare la sua efficacia secondo il metodo scientifico, non equivale ad aver dimostrato che questo approccio sia inefficace. Questo è un punto molto importante che bisognerebbe enfatizzare di più, per rispetto di chi cura e viene curato con questo tipo di terapia. Il problema ha delle analogie notevoli con un altro ramo della terapia, quella psicologica. Anche qui è estremamente difficile dimostrare l'efficacia di un approccio psicoterapico, perché inevitabilmente la terapia è un processo che si svolge tutto entro l'interazione fra due individui unici e irriproducibili; questo anche nel caso delle terapie più oggettivamente descrivibili come quella cognitiva o quella sistemica. Eppure, non si può certo affermare che tutte le terapie psicologiche siano una chimera (anche se qualcuno molto demagogicamente a volte ci prova). Ma come è possibile, anche se con difficoltà, sistematizzare un approccio psicoterapeutico e fare rispettabilissimi studi per valutarne l'efficacia, così dev'essere per l'approccio omeopatico. Occorre solo analizzare meglio quegli elementi, finora relegati sullo sfondo, che fanno da guida alla valutazione del medico e alla scelta della terapia individualizzata. Deve essere possibile crearsi degli strumenti descrittivi che permettano di discriminare e quindi di ridurre agli elementi chiave essenziali il rapporto terapeutico, la tipologia patologica, la scelta della cura. la chiave di valutazione del Lancet (o meglio degli studi effettuati) è carente perché troppo grossolana: troppe variabili interferenti non sono state prese in considerazione. Bisogna considerare che le variabili normalmente prese in esame dagli studi allopatici (sesso, età, status sociale ecc) sono semplicemente una scelta fra migliaia di aspetti, e l'approccio omeopatico, come altri approcci olistici, semplicemente ne seleziona come significativi degli altri. Si tratta solo di sistematizzare queste conoscenze, spesso affidate all'esperienza e all'intuizione del terapeuta, e poi fare un trial del tutto degno di attenzione. Le polemiche basate su elementi grossolani, o su questioni di principio, o su accuse di malafede, invece, non giovano al progresso di nessuna conoscenza. Antonella Sagone, psicologa
fonte: www.partecipasalute.it
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