More Questions Left Open Than Answered
The authors conducted the mistletoe trial in Belgrade (Serbia), because Serbian physicians and patients have a “complete lack of any expectation of success from mistletoe treatment”, since in Serbia “mistletoe extracts are unknown and unavailable“. Besides that it is unlikely that academic oncologists are not aware of the international literature, including complementary and alternative methods, the sponsors from Freiburg were obliged to inform the Serbian physicians involved in the trial about the mistletoe discussion.
To declare a single-center study with 220 patients—of whom only 168 were analyzable— as a phase III study disregards all requirements of the GCP/ICH guidelines for valid studies. In addition, early termination of a study may result in an overestimation of a drug’s efficacy.
Patients were randomized to receive either mistletoe treatment or no mistletoe treatment. The authors deliberately decided to do without blinding, because local skin reactions and mild increases in temperature are considered to be signs of optimum dosing.
Since the authors chose, in line with the anthroposophical approach, the product Iscador® Qu (where Qu stands for Quercus, i.e. oak mistletoe extract), it would have been appropriate to choose a blinded design and use a less effective or ineffective mistletoe product derived from apple, pine or elm trees to substantiate the preferences for oak mistletoes.
Conclusion: Once again a mistletoe study that leaves more questions open than it answers. However, the manufacturer of Iscador® Qu, Weleda AG (Arlesheim, Switzerland), has reason to be content for in the near future Serbia will become a new market for their products. Since by then, Serbian physicians and patients will have developed certain expectations towards mistletoe treatment, the necessary multi-center blinded treatment trial can no longer be expected to be conducted in this country.
Prof. Dr. med. Frank P. Meyer
Conflict of interest statement
The author declares that no conflict of interest exists.
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