The Medicolegal Implications of Placebo Use in Pain Medicine
A placebo is any medication or procedure with no known therapeutic effect. Placebos are often given for the psychological, rather than physiological, benefit of the patient and are also used as a control measure in the testing of new drugs. Common placebos include sugar pills, saline injections or drugs given in such miniscule doses that there is no beneficial effect. The placebo effect is defined as the positive response experienced by some patients after receiving a placebo, which is thought to be brought about by a combination of patient expectations and beliefs, genetic factors, and the context in which the placebo is given. Common placebo effects include a reduction in pain intensity or blood pressure. However, some patients experience a negative response after placebo administration, and this is known as the nocebo effect. This may range from minor symptoms, such as nausea or headaches, to life-threatening complications, including cardiac arrest.
Although ostensibly of little therapeutic benefit, in terms of pain relief, placebos can be very powerful. Indeed, under certain circumstances, the effects can be indistinguishable from conventional treatments such as medication or surgery. The neurobiological and psychological mechanisms underlying this response have been clearly identified, and the use of placebos in the relief of pain is one of the most well-understood of their applications. In particular, placebos can be useful when all other existing treatment options have been exhausted and the patient’s pain has not been reduced to an acceptable level. Placebos also play a role as an adjunctive treatment to more established therapies. Thus, placebo use in pain treatment is relatively common, with a high proportion of clinicians reporting having prescribed one. Around half of all nurses also report that at some point during their career they have been asked to administer a placebo as part of a patient’s treatment. There may be several motivations for the prescribing of placebos, including a desire to appease the patient and to provide some form of treatment. Deliberate deception is rarely a driving factor but the use of placebos remains controversial.
When patients seek health care, they are afforded basic rights, among which are the right to receive appropriate pain assessment and treatment. Some healthcare regulatory bodies therefore believe that any use of placebos outside the setting of a clinical trial cannot be defended. Nevertheless, various arguments in favour of the use of placebos have been put forward. The commonest of these centres around the benefit to the patient in terms of pain relief, which ordinarily has to be balanced against potential harm arising from treatment. However, a sham treatment may not be the most effective treatment available and it may also not be entirely safe. Aside from the more obvious effects such as uncontrolled pain and nocebo effects, the use of placebos without the patient’s knowledge is morally wrong, and undermines the trust between patient and practitioner which is the foundation of healthcare.
Furthermore, such usage violates informed consent requirements and risks legal action for fraud or malpractice. Litigation against doctors for the use of placebos is rare and medical boards tend to view such acts as poor judgement rather than negligence. However, there have been several successful cases against nurses who have administered placebos when ordered to by a doctor. This appears to be because the court’s view is that a nurse who gives a placebo to a patient deceptively is more directly involved in harming the patient than the doctor who actually prescribed the treatment.
While some regulatory bodies may frown upon the use of placebos, there is evidence that patients may find them acceptable in some contexts. A recent study examined attitudes among non-clinical populations towards the use of placebos in various different scenarios and found that the description of the placebo intervention is important to patients, as well as its effectiveness. If given placebos without their consent, many patients understandably feel misled, even if the treatment is effective. If their level of pain remains unchanged, patients report even higher levels of distress. Nevertheless, many patients report that they are prepared to tolerate this type of deception as long as their pain is reduced. Furthermore, patients are also more likely to accept placebo treatment when there are no other effective treatments available, or when the placebo is used as an additional treatment to a more established therapy. Interestingly, many patients feel that placebo use to diagnose pain is relatively acceptable, a practice that is widely considered unethical and unacceptable amongst medical professionals.
Although few medical associations have produced guidelines restricting the use of placebos, some believe that their use in the assessment or treatment of pain represents substandard care. If this is done without the patient’s knowledge, it is deceptive and may even constitute fraud. However, patients may be prepared to accept such deception if it means that their pain is relieved, although the likelihood of this depends on the context in which any placebo treatment is administered. This needs to be taken into account when deciding on whether to prescribe a placebo, so that the risk of litigation is minimised.
About Dr Jenner
Dr Chris Jenner is a Consultant in Pain Medicine and highly experienced expert witness. Dr Jenner has been providing medico legal reports in a wide range of cases involving pain for over 15 years for personal injury and medical negligence cases. His instructions are broadly divided as claimant (55%), defendant (40%) and Single Joint Expert (5%).
Arnstein, P., Broglio, K., Wuhrman, E., & Kean, M. B. (2011). Use of placebos in pain management. Pain management nursing: official journal of the American Society of Pain Management Nurses, 12(4), 225–229. https://doi.org/10.1016/j.pmn.2010.10.033
Kisaalita, N., Staud, R., Hurley, R., & Robinson, M. (2014). Placebo use in pain management: The role of medical context, treatment efficacy, and deception in determining placebo acceptability. Pain, 155(12), 2638–2645. https://doi.org/10.1016/j.pain.2014.09.029