[Medical and ethical considerations of sham operation].

The absolute refusal of sham surgery as control in clinical trials can not be justified from professional, ethical point of view. Introduction of any new surgical treatment should be evidence based in the form of sufficient scientific approval to support a novel method. It has to be decided whether sham surgery or any other control modality could be an optimal baseline reference for a clinical trial. The feasibility and the ethical acceptability of sham surgery controlled clinical trials should be approved individually. At the risk evaluation of any (sham) surgery controlled clinical trial, we should contemplate the outcome of the opposite scenario as well; that is, the consequences of not pursuing a "lege artis" controlled clinical project to estimate the efficacy and safety of the invasive procedure. It is possible and obligatory to reconcile two basic medical goals: the treatment of the individual patient and the need of the society for proven, safe and effective treatments.