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  Mistletoe in Oncology
  

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By: G. S. Kienle and H. Kiene
Mistletoe in Oncology :
Antitumor Activity,

Question of Demonstrating Efficacy,
and the Hypothesis of Cytokine-mediated Tumor Promotion
Facts, Arguments, Conceptual Bases*

G. S. Kienle and H. Kiene

*Original title: Die Mistel in der Onkologie--antitumorale Wirksamheit, Fragen des Wirksamkeitsnachweises and die Hypothese einer zytokinvermittelten Tumorforderung. Der Merkur-stab 1997; 50: 303-4. English by A. R. Meuss, FIL, MTA.

G. S. Kienle and H. Kiene at the Institute of Applied Epistemology and Medical Methodology have written a paper on the issues of antitumor activity, questions of demonstrating efficacy, and the occasionally-voiced hypothesis of cytokine-mediated tumor promotion. These are important issues, and we are therefore giving the abstract of this extensive paper below. (M. Girke for the Editorial Board).

The starting point for the paper was the statement that mistletoe treatment - mediated by cytokine induction - might occasionally promote tumor growth or metastazation. The argument was based on theoretical analogies to in vitro and animal experiments with exogenic cytokines (or cytokine antibodies) and determinations of treatment-independent changes in cytokine levels of cancer patients treated with mistletoe.

To establish to what extent such findings allow one to draw conclusions relating to mistletoe treatment for cancer patients, cytokine research is presented below, using TNF and IL-6 as examples. It is shown that the results of cytokine research are highly contradictory and go in opposite directions. Data obtained in a specific in vitro experiment with TNF or IL-6 cannot be said to apply to actions in another in vitro, nor the actions of a single cytokine to its action in the presence of another, nor in vitro findings to in vivo findings, nor the exhibition of exogenic cytokines to endogenous cytokine induction. The actions of cytokines are context-dependent in the widest sense; they are like letters that make up a sentence and only have significance or effect in the total context of the given sentence. Therefore, it is not possible to draw conclusions based on clinical situations of mistletoe treatment - from cytokine research data, for example - because, among other things, cytokines are also induced.

Relative to the situation pertaining in cytokine research, comparing situations where actions are still reasonably coherent - metastazation promoted by TNF and IL-6 stimulation of transformed B lymphocytes (B cell lymphoma, B cell leukemia) - corresponding mistletoe experiments do not show such effects but show a reduction in metastases and cytotoxic actions. Moreover, patients with B cell lymphoma, leukemia or plasmacytoma have been known (and documented) to go into remission for many years with mistletoe treatment.

No indication of increased tumor growth or metastazation could be found in empirical material on mistletoe treatment. On the other hand, there are many confirmed data on the antitumor action of mistletoe preparations and mistletoe constituents in in vitro experiments, animal experiments and clinical research. in vitro experiments have shown distinct growth-inhibiting and cytotoxic effects of mistletoe extracts and single substances isolated from then on many tumor cell lines.

Animal experiments have shown a reduction in tumor growth, tumor necrosis, long-term remission, extended survival times, reduced metastazation, inhibition of tumor neoangiogenesis (Korean mistletoe), prevention of chemical carcinogenesis, fewer recurrences, enhanced effect of antitumor radiotherapy, reduced duration and extent of leukopenia induced by chemotherapy or radiotherapy.

Clinical treatment using mistletoe preparations has given many positive results. The paper lists efficacy proofs in single cases. Comparative clinical trials also have given good results, with different percentages of efficacy established in 9 of 11 trials. 33 of 36 controlled trials showed efficacy or superior results for the mistletoe-treated and mistletoe-treated group of patients compared to the control group. One trial showed superiority only with reference to quality of life but not to median survival. Only two trials did not yield positive results. 14 trials with positive results can be said to be meaningful; in 9 of them, the result was statistically significant.

If individual case assessments, collective reports and comparative clinical trials are taken together, the efficacy of mistletoe treatment is, in principle, established.

It should be noted that efficacy evaluation on many occasions is subject to methodological monism, with recognition given only to randomized double blind trials. The ethics or practice of this cannot be justified in terms of epistemology nor of methodology. There are other, more wide-ranging methods of obtaining valid proof of efficacy; in the paper, this is shown with reference to mistletoe treatment.

Summing up, it maybe stated that in vitro, in vivo and clinical data confirm the antitumor activity of mistletoe preparations. No indication was found in any of these three areas concerning increased tumor growth or metastazation. The statement that mistletoe treatment might, on occasion, promote tumor growth or metastazation through cytokine induction is pure speculation. No foundation for this can be found in cytokine research data nor in the extensive empirical material on mistletoe research and treatment

Gunver Sophia Kienle, MD
Helmut Kiene, MD
Institute of Applied Epistemology and Medical Methodology
Muselgasse 10
D-79112 Freiburg
Germany




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