STUDIES ON THE EFFICACY OF UNCONVENTIONAL THERAPIES - PROBLEMS AND DESIGNS

Many unconventional therapies (e.g. dietary, phytotherapy, acupuncture , homeopathy) ae well known and often applied, but their efficacy has hardly been proven. New trial designs and study components must be fou nd to meet the specific demands of the particular unconventional thera py on one hand and keep the high methodological standard of controlled clinical trials on the other hand. Biometricians and unconventional t herapists are challenged to develop such designs. Typical problems in designing studies of unconventional therapies include that placebo is not possible, therapies cannot be masked, outcome variables are not re liable, therapy is highly individualized, and studies on the efficacy of soft therapies require many patients and long treatment periods. St udies with unconventional therapies should be performed by practitione rs (because they use these therapies), but this leads to further probl ems. Some solutions are given in examples: A study is described invest igating the herbal remedy Kava-Kave for patients in the stat of anxiet y, tension and restlessness; a study on classical homeopathy for chron ical headaches is specified; some designs for dietary studies in patie nts with rheumatoid arthritis are compared. A design called ,,cross-al location of patients to two treatments with randomized option'' are de scribed and discussed. the ,, change-to-open-label design'' could be u seful to investigate soft and natural therapies which require studies with many patients and long-term treatment.