Sham surgery: reconsidering the ethical debate
S.L. Niemansburg, J.J.M. van Delden, and A.L. Bredenoord
Department of Medical Humanities, Julius Center, University Medical Center Utrecht
The ethical acceptability of using placebo is a long-standing debate. The use of placebo for
invasive interventions, also known as sham surgery, is particularly considered to be
challenging to justify. Sham differs from oral placebo as a sham procedure will always
involve harm, mainly due to anesthesia and the creation of a wound. Clarifying and
reconsidering the ethical and scientific debate about sham surgery is important for several
reasons. First, due to the call for evidence-based practice in surgery, the need for placebo
controlled trials for new and existing treatments is rising. In addition, the need of using a
sham surgery will increasingly be considered due to emerging innovative approaches, such
as stem cell-based interventions and tissue engineering, that require minimal invasive
surgery or injection.
We performed a systematic search on PubMed to collect the literature discussing the ethical
aspects of sham surgery. First, we identified the central positions and underlying arguments
as they appear in the literature. After clarifying the debate we will reconsider the ethical
acceptability of a sham surgery, particularly in light of new technological developments.
One of the main arguments that support the use of a sham intervention is that it increases
the scientific validity of trials as it prevents several types of bias. Furthermore, it is argued
that the invasive placebo increases societal benefits as it could prevent and reduce
ineffective treatments in health care. It is claimed that the benefits of research could
outweigh the individual risks related to the sham surgery. In addition, some also refer to the
occurrence of other types of clinical studies, such as phase I studies with volunteers, that
include risks without benefits. In addition, the physical risks of injection or surgery can
properly be minimized in different ways, especially since increasingly minimal invasive
procedures are being developed. Some authors mention that the individual benefit of sham
should be taken into account. The primary arguments against a surgical placebo are that the
(physical and psychological) risks are not compensated by the benefits, that it is ethically
wrong to actively mislead a participant, and the risk that the aim of the research is
misunderstood, i.e. therapeutic misconception arises.
While sham interventions do show some specific characteristics, such as the inherent risks
and the fact that a surgical team is actively involved in the placebo procedure, one could
question whether a sham intervention should be treated as an exceptional form of placebo.
There are good reasons to not make sham surgery categorically different from placebo.
However, the sham intervention characteristics do make a sham surgery morally salient.
Although a surgical placebo is not fundamentally unethical a priori, we formulate conditions
under which sham is ethically and scientifically acceptable. These aspect will concentrate on
obtaining an adequate risk-benefit ratio and an appropriate informed consent for these type
of clinical studies.
This research forms part of the Project P2.01 IDiDAS of the research program of the BioMedical Materials
institute, co-funded by the Dutch Ministry of Economic Affairs, Agriculture and Innovation.
Biographical Sketch Sophie Niemansburg
Sophie Niemansburg (1985) studied Medicine at the University Medical Center of Utrecht. She took
courses in Philosophy, such as 'philosophical ethics', 'normative ethics' and 'philosophy of science'. She
did an 12 week internship at the Medical Ethics department of the Julius Center. After receiving her
medical degree in 2010 she worked as a resident at the Neurology department of the Diakonessenhuis
(Utrecht). In October 2011 she started her PhD project at the department of Medical Humanities, under
guidance of dr. A.L. Bredenoord, prof. dr. W.J.A. Dhert and prof. dr. J.J.M. van Delden. The PhD project
aims to address the ethical issues in translating Regenerative Medicine techniques for orthopaedic
disorders into clinical studies and society. Furthermore, she participates in teaching in courses for
medical students concerning both Medical Humanities and Regenerative Medicine.