Antal János
Parexel Magyarország Kft. 1146 Budapest Hermina út 17.
Magy Seb. 2007 Oct;60(5):233-8. doi: 10.1556/MaSeb.60.2007.5.1.
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.
从专业和伦理角度来看，在临床试验中绝对拒绝将假手术作为对照是不合理的。任何新的外科治疗方法的引入都应以充分的科学认可形式作为证据，以支持这种新方法。必须决定假手术或任何其他对照方式是否可以作为临床试验的最佳基线参考。假手术对照临床试验的可行性和伦理可接受性应分别得到批准。在评估任何（假）手术对照临床试验的风险时，我们也应考虑相反情况的结果；也就是说，不开展一个“按照技术规范”的对照临床项目以评估侵入性手术的疗效和安全性所带来的后果。协调两个基本的医学目标是可能且必要的：治疗个体患者以及社会对经过验证的、安全有效的治疗方法的需求。
