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The Di Bella multitherapy trial

BMJ 1999; 318 doi: (Published 17 April 1999) Cite this as: BMJ 1999;318:1073

Randomised controlled trials may not always be absolutely needed

  1. Alessandro Liberati, Professor of biostatistics (,
  2. Nicola Magrini, Unit head,
  3. Lucio Patoi, Unit head,
  4. Luigi Pagliaro, Professor of internal medicine
  1. Università di Modena, Centro per la Valutazione della Efficacia della Assistenza Sanitaria Modena, Italy
  2. Centro per la Valutazione della Efficacia della Assistenza Sanitaria (CeVEAS) Modena, Italy
  3. CeVEAS Modena, Unità di Medicina Interna e Scienze Oncologiche, Perugia, Italy
  4. Divisione di Medicina Interna, Universitàdi Palermo, Palermo, Italy
  5. Istituto Superiore di Sanità, I-00161 Rome, Italy
  6. Istituto Nazionale Ricerca sul Cancro, I-16132 Genova, Italy
  7. BMJ, London WC1H 9JR

    EDITOR—We disagree with Müllner's editorial1 as it took a very narrow perspective on a case in which attention should have been paid to the relations between general methodological principles of cancer trials and the social context in which the Di Bella story took place.2

    The editorial might give the (wrong) impression that the Di Bella trial3 was inadequate and could not show the lack of antitumour activity of Di Bella's multitherapy. In 1982 an editorial in the New England Journal of Medicine accompanied the publication of a phase II study of the US National Cancer Institute on another anticancer “miracle” treatment named laetrile. This said that the study “closed the book on laetrile.”4 Interestingly, that study adopted the same non-randomised design (and the same negative results) as the Italian study.

    Have general methodological principles of clinical research in oncology changed so dramatically since then? We do not think so and suspect that the editorial indicates limited familiarity with phase II trials in oncology. Too much familiarity with a given research field may lead to blindness concerning its limitations,5 and the view is perfectly legitimate that current standards of phase II oncology trials should be abandoned. But why was not this the main theme of Müllner's editorial? Why did all criticism exclusively target the Di Bella trial?

    To illustrate possible approaches to similar cases in the future a more general discussion of pros and cons of randomised versus …

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