Placebo surgeries: Ethical dilemmas and potential in surgical research (NTvG)
In an article for the Dutch Journal of Medicine (Nederlands Tijdschrift voor Geneeskunde; NTvG), Prof. dr. Andrea Evers, Drs. Hans van Lennep, and Dr. Richard ten Broek discuss the ethical dilemmas and potential of sham surgeries in surgical research. These placebo procedures, performed without an actual intervention, provide crucial insights into surgical benefits and risks but also raise significant ethical questions about patient safety.
Sham surgeries can be ethically justified if they meet the criteria of scientific necessity, reasonable risks, and informed consent (Niemansburg et al., 2015). They are vital for validating surgical procedures, but ethical boundaries must be closely monitored, particularly the 'primum-non-nocere' principle (Hetzler et al., 2023). Participants should have access to the actual treatment if it proves more effective, respecting the principle of beneficence.
Sham procedures can benefit collective healthcare by improving future patient care and reducing public spending on ineffective treatments, but individual values must be respected. Obtaining informed consent and ensuring transparent communication about participation implications are crucial, especially for vulnerable groups.
Recent studies have shown that sham surgeries can reduce unnecessary procedures for conditions like gonarthrosis and osteoporosis, decreasing harm and costs (Benedetti, 2015; Firanescu et al., 2018). Advances in diagnosing and treating adhesions also suggest that non-invasive diagnostics can offer similar placebo effects as sham surgeries, raising questions about their necessity.
The placebo effect, underutilized in clinical practice, has significant economic potential in both pharmacological and non-pharmacological treatments. More research is needed to fully understand its potential fully and to consider whether surgical interventions should routinely be compared to placebo conditions.
High-quality studies on the placebo effect are essential to determine the true efficacy of medical interventions while minimizing harm. Ethical considerations, transparency, and risk management are crucial in conducting sham surgeries, highlighting the importance of non-invasive treatments and the untapped potential of the placebo effect.
Read the full article (Dutch) on the NTvG website to discover the benefits and risks of sham surgeries: https://www.ntvg.nl/artikelen/placeboprocedures-de-operatiekamer
References
Benedetti, F. (2015). Placebo effects. Understanding the mechanisms in health and disease (2nd ed.). New York: Oxford University Press.
Firanescu, C. E., De Vries, J., Lodder, P., Venmans, A., Schoemaker, M. C., Smeet, A. J., Donga, E., Juttmann, J. R., Klazen, C. A. H., Elgersma, O. E. H., Jansen, F. H., Tielbeek, A. V., Boukrab, I., Schonenberg, K., Van Rooij, W. J. J., Hirsch, J. A., & Lohle, P. N. M. (2018). Vertebroplasty versus sham procedure for painful acute osteoporotic vertebral compression fractures (VERTOS IV): randomised sham controlled clinical trial. BMJ. British Medical Journal, k1551. https://doi.org/10.1136/bmj.k1551
Niemansburg, S. L., Van Delden, J. J., Dhert, W. J., & Bredenoord, A. L. (2015). Reconsidering the ethics of sham interventions in an era of emerging technologies. Surgery, 157(4), 801–810. https://doi.org/10.1016/j.surg.2014.12.001
Hetzler, P. T., Berger, L. E., Huffman, S. S., Lee, M., Park, R., Song, D. H., & Dugdale, L. S. (2023). The Characteristics and Ethics of Sham Surgeries. Annals Of Surgery, 278(2), 153–158. https://doi.org/10.1097/sla.0000000000005882