eCAM Advance Access originally published online on October 4, 2007
eCAM 2009 6(1):19-30; doi:10.1093/ecam/nem121
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Review |
Mistletoe Preparation Iscador: Are there Methodological Concerns with Respect to Controlled Clinical Trials?*
Institut Hiscia, Verein für Krebsforschung, Arlesheim, Switzerland
In Europe many cancer patients use complementary therapies, particularly mistletoe. Only a few controlled clinical trials have been performed with the mistletoe preparation Iscador as a complementary treatment for cancer, many of them with medium to low quality due to methodological shortcomings. Reasons for some quality concerns, particularly discontinuation of treatment and/or participation and premature termination are analyzed. Analysis is based on controlled clinical trials dealing with Iscador. Data stem from the archive of published and ongoing research of the «Verein für Krebsforschung» (Society for Cancer Research) in Arlesheim, Switzerland. Controlled clinical studies with cancer patients that were started after 01.01.1990 or were not completed by then have been evaluated. Fifty-six controlled studies are documented, 24 of them randomized and 32 non-randomized. Nine of the randomized studies were done by matched-pair design, the others by conventional parallel group design; six of the last were terminated prematurely primarily for slow recruitment due to patient preferences and compliance of physicians. Patient and physician preference seem to be important factors limiting recruitment for randomized trials and hence implementation. This adds to the overall unwillingness of participation by patients with serious diseases. A well-balanced mix of designs using different research methods and outcomes is suggested combined with analyses, in countries where mistletoe therapy in general or Iscador in particular is unknown or not available.
Keywords: cancer – patient recruitment – preference
For reprints and all correspondence: Dr Renatus Ziegler, Verein für Krebsforschung, Institut Hiscia, Kirschweg 9, CH-4144 Arlesheim, Switzerland; Tel: +41 61 706 72 45; Fax: +41 61 706 72 00; E-mail: ziegler{at}hiscia.ch
*Expanded and updated version of a lecture given at the International Workshop on Study Methods in Complementary Medicine, Robert Bosch Stiftung, Stuttgart, April 20–21, 2006.
Received February 16, 2007; accepted June 7, 2007