A working party looking into the inclusion of placebos in surgical trials has led to a recommendation for greater use of the controversial method by the Royal College of Surgeons of England.
Although placebo control groups are used in drug trials across the world, placebo-controlled surgical trials are extremely rare, with only 75 such trials published up to October last year.
Often labelled with the misleading term ‘sham surgery’, it has long been argued that because placebo surgery is more invasive than placebo drugs it is difficult to justify its use.
However a new paper resulting from the working party, ‘When should placebo surgery as a control in clinical trials be carried out?’, supports evidence to show they should be increasingly considered as part of surgical studies to produce the very best research evidence and be of the greatest benefit to patients.
The research found that in half of the placebo-controlled surgical trials carried out up to 2013, surgery was no more effective than the placebo, calling into question the surgical procedure for the conditions treated.
Lead author and Deputy Vice-Chancellor (Education and International) at Brunel University London, Professor Andrew George, said: “This is a controversial issue, but the benefit to clinical research of placebo-controlled surgery is just as great as in drug treatment, as long as it follows correct surgical practice.
“The misconception is that this method would replace treatment in a control arm that is known to be effective, but that would not be the case. Placebo surgery should only ever be used when there is uncertainty about the relative benefits of an experimental intervention and placebo, and when any potential harm is minimised and reasonable.
“Most importantly, controlled trials could potentially avoid future harm to patients if they demonstrate that a particular treatment is ineffective and should not be adopted into clinical practice.”
Placebo surgery varies from minor procedures such as making an incision in the skin so that the patient doesn’t know whether they have been treated, to a full surgical procedure.
In all cases ethical guidelines must be followed with patients being made aware of, and giving consent to, being part of a randomised trial.