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Discussion in the Lancet on Misteltoe

The Lancet Oncology 2(4), Apr 1 2001

Trial results warn of dangers in the use of mistletoe extract

The feeling among many oncologists regarding unconventional therapies is that, although probably ineffective, they do little actual harm. The main worry is that patients will eschew mainstream treatments, in favour of such alternative therapies, and thereby worsen their prognosis.

However, a group of researchers, under the banner of the European Organisation for Research and Treatment of Cancer (EORTC) and the German Cancer Research Society now has clear evidence that at least one popular alternative therapy may actually be doing the patient harm. Kleeberg and colleagues were carrying out a randomised, phase III trial looking at adjuvant therapy with low-dose interferon-alpha versus interferon-gamma versus no further treatment, following potentially curative surgery in patients with high-risk stage II (node negative, primary >3mm) or stage III (node positive) melanoma.

The German group decided to add a further arm to the trial, involving treatment with a commonly available brand of mistletoe extract (Iscador), which is very popular in Central Europe, where it is taken by patients with a wide variety of cancers, because of its claimed natural immunostimulatory properties.

Preliminary findings from this trial, which have so far only been reported in abstract form (Eur J Cancer 1999; 35: S82, abstr 264), showed no benefit in disease-free survival or overall survival for either interferon or Iscador.

In the stage III patients, in terms of time to distant metastases, patients in the Iscador arm had a significantly higher number of brain metastases than patients in the other groups (logrank p<0.04); this translated into a significantly poorer prognosis in overall survival (logrank p<0.05), as compared to the control arm.

"This trial is truly unique, because alternative medicine has never been evaluated in a phase III trial before", says Alexander Eggermont (EORTC), who presented brief details on this trial at a meeting of the British Oncological Association (11-14 March, 2001, Edinburgh).

"It is generally believed that while alternative medicines may not help, they certainly will not harm the patient, but this may not really be true. This is the first time that such an agent has been evaluated in a properly randomised trial, and it appears that it could actually harm the patient.

That is not to say that mainstream medicines cannot harm patients as well, but if claims about the efficacy or harmlessness of alternative medicines are to have credibility, they must undergo the same evaluation process."

Sue Silver

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