Use of placebo surgery in surgical research

Professor Andrew Rice, Professor of Pain Research at Imperial College and an Honorary Consultant in Pain Medicine at Chelsea and Westminster Hospital, represented the Faculty of Pain Medicine and the Royal College of Anaesthetists on a round-table discussion on the ethics of placebo surgery in research.  The Royal College of Surgeons position statement is available here.

The publication itself, ‘When should placebo surgery as a control in clinical trials be carried out?’ is available at the links below:
Click here for the text version within website or click here for the PDF version.

The key ethical points for the use of placebo surgery are summarised below:

  • The research question being addressed should be sufficiently important.
  • The researcher should be uncertain about the effectiveness of the treatment.
  • The study design should ensure that patients are not given an ineffective placebo in place of a treatment that is known to be effective.
  • The study design should be appropriate and sufficiently robust to answer the research question.
  • The potential risk and burden to the research participant should be considered and minimised, taking into account the significance of the study, the potential benefit to the participant and the effectiveness of current treatment. (It is unlikely that total substitution of a current effective treatment with placebo would be acceptable).
  • The information given to the potential participant should be honest and clear so that he or she can make an informed decision as to whether to take part.

Some key points of importance for Pain Medicine:

  • The definition of ‘surgery’ includes invasive percutaneous and implantation procedures practised by some anaesthetists engaged in Pain Medicine, for example injection-based interventions, implantation of drug delivery systems and neuromodulation devices.
  • Since pain relief is an outcome that is susceptible to placebo effects then the effectiveness of such interventions, new and those already practiced, should be evaluated by means of placebo controlled trials. Similar standards for judging effectiveness as are currently used for assessing pharmacological interventions should be employed.
  • The ethical case for placebo controlled trials in such cases is well founded.
  • Implantable drug delivery and neuromodulation systems have utility that would allow the devices to be programmed to deliver placebo interventions. Cross over trials are therefore possible using such devices.

 

 

03 February 2016