Das Anjan Kumar
Clinical Research Leader, Stempeutics Research Malaysia, Kuala Lumpur, Malaysia.
Indian J Surg. 2011 Aug;73(4):245-50. doi: 10.1007/s12262-011-0307-5. Epub 2011 May 19.
An ethically conducted randomised controlled trial (RCT) is the backbone of evidence based medicine. In surgical practice however, RCTs have taken a backseat, drawing much adverse comment. There are several reasons to explain surgeons' disinclination to conduct RCTs. These include many practical difficulties such as the problem of blinding surgical procedures, design and funding issues. There are also many ethical issues which need to be considered including the concept of equipoise as well as the ethical issues associated with sham surgery as a control. While there is no doubt that RCTs are essential and in fact have helped to weed out several unnecessary surgical procedures, it is important not to lose sight of the fact that they may not be always necessary in order to obtain evidence in favour of a procedure. Possible solutions could be to follow guidelines that have been issued by learned bodies and a strict adherence to all ethical norms that have been recommended in the conduct of trials.
一项符合伦理规范进行的随机对照试验（RCT）是循证医学的支柱。然而，在外科手术实践中，随机对照试验却退居次席，招致诸多负面评价。有几个原因可以解释外科医生不愿开展随机对照试验的现象。这些原因包括许多实际困难，比如手术操作的盲法问题、设计和资金问题。此外，还有许多伦理问题需要考虑，包括 equipoise 的概念以及与假手术作为对照相关的伦理问题。虽然毫无疑问随机对照试验至关重要，事实上也有助于淘汰一些不必要的外科手术，但重要的是不要忽视这样一个事实，即要获得支持某种手术的证据，随机对照试验并非总是必要的。可能的解决办法是遵循学术机构发布的指南，并严格遵守试验开展过程中推荐的所有伦理规范。
