Q: A neurologist suspects non-epileptic seizures in a 24-year-old woman referred with the diagnosis of a seizure disorder because of their atypical features and repeatedly normal EEGs. He plans to administer a saline infusion during an EEG recording after telling the patient that he is administering a medication that can induce a seizure. He hopes to provoke one of her typical seizures and, if he finds no contemporaneous EEG evidence of an epileptic seizure, thereby confirm its non-epileptic etiology. Is performing this provocative placebo test an ethically acceptable practice?
JAMES L. BERNAT, MD, RESPONDS: The ethical issue in this case is whether deceiving the patient by performing a provocative test using a placebo infusion can be justified. Since it was first described in 1982, some epileptologists have advocated performing the saline -provocative test claiming that it was safe and reliable, and prevented harm to patients by correcting their misdiagnosis of epilepsy and permitting the discontinuation of their ineffective treatment with anticonvulsant drugs. They acknowledged that the test was inherently deceptive but claimed that its deception was justified because it yielded the patient a net health benefit. However, most ethical analyses of this practice reached the conclusion that the deception implicit in the test was not ethically justified and that the test should be abandoned.
Purposely deceiving a patient “for her own good” is an example of medical paternalism, a medical practice arising from the hallowed tradition of beneficence that requires physicians to identify and act in the patient's best medical interest. Despite its beneficent intent however, paternalism becomes unethical and harmful when, through purposeful deception, it disenfranchises patients who wish to be aware of and participate in their diagnosis and treatment. A physician's purposeful act of omitting informed consent in a patient capable of providing it, within a situation in which consent is ordinarily required, is an example of medical paternalism.
Medical paternalism is unethical unless it can be justified by showing that the harms avoided by the physician's act are great, the harms imposed by the physician's act are comparatively small, the patient's behavior is irrational, and rational persons would routinely and publicly advocate physician deception in this circumstance. These criteria are not satisfied in the use of the saline infusion provocative test.
BENEFITS: DECEPTIVE SALINE INFUSION
Let us first examine the benefits of the deceptive saline provocative infusion. Its primary benefit is to confirm that a clinical seizure-like episode is a non-epileptic seizure. In one study, 10 percent of patients with true epilepsy had an epileptic seizure provoked by the placebo infusion procedure, so it is a non-specific test. Further, some patients with non-epileptic seizures also have epilepsy, thus even determining that a particular episode was a non-epileptic event does not exclude concomitant epilepsy.
Deception is not required to prove the diagnosis of non-epileptic seizures. Usually, such patients are admitted to epilepsy EEG-video-monitoring units where their anticonvulsant drugs are discontinued and non-deceptive provocative measures are conducted, such as falling asleep and awakening, suggestion, photic stimulation, and hyperventilation. In the one study in which these routine non-deceptive measures were compared to those of the provocative saline infusion test, they were found to be equally effective in diagnosing non-epileptic seizures.
HARMS: DECEPTIVE SALINE INFUSION
What are the harms of the deceptive saline provocative infusion? The principal harm to patients results from the test's required deception. Lying purposefully to a patient damages the integrity of the patient-physician relationship, which is founded on mutual trust and respect. When the patient discovers the deception, she may lose confidence in the physician and, possibly, in the honesty and integrity of the medical profession. This loss of confidence could impair future patient-physician relationships and thereby cause future harm to her medical care. It is known that a disproportionate percentage of patients with non-epileptic seizures experienced childhood sexual and physical abuse that often was perpetrated by a trusted family member or friend. These patients have resulting lifelong difficulties establishing trusting relationships and therefore are at particular risk to harm from deception by physicians.
A subtle harm induced by deception is that it damages medical professionalism. When physicians lie to patients, even for their own good, it can degrade the physician's integrity and image as an ethical professional. When the deceptive test is performed in an academic training program, student, resident, and fellow trainees are required to become partners in the deception. Because it is difficult for disempowered trainees to protest, they are forced to degrade their professionalism.
The American Medical Association Council on Ethical and Judicial Affairs recently issued practice recommendations for physicians who prescribe placebos for therapeutic or diagnostic purposes. They said: “In the clinical setting, the use of a placebo without the patient's knowledge may undermine trust, compromise the patient-physician relationship, and result in medical harm to the patient. Physicians may use placebos for diagnosis or treatment only if the patient is informed of and agrees to its use.”
Most neurologists who have advocated the use of the intravenous saline provocative test assume that notifying the patient that she is being infused with a placebo would counteract the suggestive element of the test and thereby render it useless. But this assumption remains untested. Preliminary studies of the efficacy of placebo use in therapy show the surprising result that its beneficial effect is diminished only very little when patients are told in advance that they are receiving a placebo. Avoiding deception would completely eliminate the ethically troubling aspect of the provocative test.
I recommend that the neurologist in this case refer the patient to an epilepsy center for EEG video-monitoring and not perform the deceptive saline infusion provocative test. Alternatively, the neurologist who wishes to perform the saline infusion test should inform the patient that he is infusing a placebo.
Performing a deceptive saline provocative test is unnecessary to make the diagnosis of non-epileptic seizures, has false-positive and false-negative results, and produces harm to patients and their physicians because of the attendant deception that does not satisfy the criteria for ethically justified paternalism. The deceptive use of placebos has been proscribed by American medical practice standards, and the saline infusion test has been abandoned by most epilepsy centers.
Dr. Bernat is the Louis and Ruth Frank Professor of Neuroscience and Professor of Neurology and Medicine at Dartmouth Medical School. He is the former chair of the AAN Ethics Law & Humanities Committee and is the author of Ethical Issues in Neurology, 3rded. (Lippincott Williams & Wilkins, 2008).
Bernat JL. The ethics of diagnosing nonepileptic seizures with placebo infusion. Virtual Mentor: AMA Journal of Ethics
Smith ML, Stagno SJ, Dolske M et al. Induction procedures for psychogenic seizures: ethical and clinical considerations. J Clin Ethics
Burack JH, Back AL, Pearlman RA. Provoking nonepileptic seizures: the ethics of deceptive diagnostic testing. Hastings Cent Rep
Devinsky O, Fisher R. Ethical use of placebos and provocative techniques in diagnosing nonepileptic seizures. Neurology
Alper K, Devinsky O, Perrine K, Vazquez B, Luciano D. Nonepileptic seizures and childhood sexual and physical abuse. Neurology
Gates JR. Provocative testing should not be used for nonepileptic seizures. Arch Neurol
Benbadis SR, Johnson K, Anthony K, et al. Induction of psychogenic -nonepileptic seizures without placebo. Neurology
Bostick NA, Sade R, Levine MA, Stewart DM Jr. Placebo use in clinical -practice: report of the American Medical Association Council on Ethical and -Judicial Affairs. J Clin Ethics