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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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