Are placebos a legitimate tool in helping patients, or is their use unethical or deceptive? wonders Ben Basger
The word “placebo” is Latin for “I will please”. Pleasing patients seems like a good thing to do. But what if it’s done by deception?
The placebo effect refers to positive clinical outcomes caused by a treatment that is not attributable to its known physical properties or mechanism of action. It is often explained as the result of positive expectation, belief, or hope that patients derive from the clinical encounter.
Placebos have been found to be most effective in the treatment of stress-related conditions, pain, depression, anxiety and nausea (Effects of placebos without deception compared with no treatment: protocol for a systematic review and meta-analysis. BMJ Open 2015;5:e009428. doi:10.1136/bmjopen-2015-009428).
Apparently, the prescription of placebos is common. For example, when practicing internists and rheumatologists in the United State were surveyed about prescribing placebo treatments, about half reported prescribing them on a regular basis, mainly as over the counter analgesics and vitamins, with some using antibiotics and sedatives.
This was done to promote positive psychological effects. Most believed the practice to be ethically permissible, commonly describing them to patients as potentially beneficial medicines or treatments not typically used for their condition. (Prescribing placebo treatments: results of national survey of US internists and rheumatologists. BMJ 2008;337; a1938 doi:10.1136/bmj.a1938).
Do you think they were justified in doing this? Does this mean that an apparently non-indicated medication may actually be indicated ─ as a placebo? How is one supposed to know?
The routine use of placebo treatments raises ethical questions about deception in clinical practice. On the one hand, we are seeking to help patients, but on the other hand we are doing it by deception.
What do you think of intentionally deceiving a patient? Is it ever justified?
Consider the following reasons; to prevent great physical or psychological harm to the patient; to preserve or enhance hope; to deceive temporarily to prevent potential great distress (for example, postponing disclosure); compassionate deception (for example, to reduce great stress or anxiety); the patient is reliably believed or known not to want information; the patient is not emotionally or cognitively equipped to decide or to cope with the truth; deception will enhance autonomy in the long run (for example, by preventing a life-threatening heart attack).
If some of these reasons justify deception, what of the possible consequences:
- violation of the norm of honesty and codes of ethics;
- if discovered, possible loss of trust by the patient and possible loss of public trust;
- possible emotional distress if the lie/deception is discovered;
- failure to respect or enhance the patient’s autonomy;
- violation of the patient’s right to know or right not to be lied to/deceived;
- difficulty of balancing the potential harms and benefits of lying/deception; and/or
- greater tendency to lie/deceive in the future, including possible need to support the present lie/ deception with further lies/deception (Can deceiving patients be morally acceptable? BMJ 2007; 334: 984-6).
In 262 adults with irritable bowel syndrome, the effects of placebo acupuncture were examined in circumstances that involved observation only (that is, improvement due simply to an awareness of being observed), sham acupuncture alone, and an enriched relationship with the treating doctor together with the sham procedure.
The proportion of patients who reported moderate or substantial improvement on the IBD global improvement scale was 3% in the observation group, 20% in the procedure alone group, and 37% in the augmented intervention group.
The group with the greatest relief of symptoms was the one that received sham acupuncture plus 45 minutes of quality contact with a clinician.
This contact involved questions about the patient’s symptoms and beliefs about them, a “warm, friendly manner,” empathy and communication of confidence and positive expectations (Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome. BMJ 2008; 336; 999-1003).
We treat patients in a social and psychophysiological context that can either improve or worsen outcome. The meanings and expectations created by the interactions of health care professionals with patients matter physically, not just subjectively.
Is it possible that many people are drawn to alternative practitioners because of the holistic concern for their wellbeing they are likely to experience, in addition to appreciable placebo responses, which are assumed by sceptics to account for most if not all of the benefit of “alternative” or integrative medicine? (What is the placebo worth? BMJ 2008; 336; 967-968. Placebo Effects in Medicine. N Engl J Med 2015; 373; 8-9).
It should be realised that placebo effects rely on complex neurobiologic mechanisms involving neurotransmitters such as endorphins, cannabinoids, and dopamine, as well as activation of certain areas of the brain.
Some medications depend on these very same mechanisms for their therapeutic (and toxic) effects.
So what do we know about placebo effects? Though placebos may provide relief, they rarely cure. Their therapeutic benefits do not alter the pathophysiology of diseases beyond their symptomatic manifestations.
They primarily address subjective symptoms—that is, there is no evidence that placebos can shrink tumours.
Placebo effects are not just about dummy pills. The effects of non-placebos—that is, real pharmaceuticals—can be intensified or diminished by the way patients feels about them due to health care professional interaction.
Thirdly, the psychosocial factors that promote therapeutic placebo effects also have the potential to cause adverse consequences known as nocebo effects.
Not infrequently, patients perceive side effects of medications that are actually caused by anticipation of negative effects.
It has been estimated that up to one quarter of patients who are randomly assigned to placebos in trials discontinue their use because of perceived adverse effects. It thus seems likely that some patients are treated for adverse medication effects that are actually anticipatory nocebo effects (What is the placebo worth? BMJ 2008; 336; 967-968. Placebo Effects in Medicine. N Engl J Med 2015; 373; 8-9)).
Placebo effects are often considered the effects of an “inert substance,” but that characterisation is misleading. Placebo effects are improvements in patients’ symptoms that are attributable to their participation in the therapeutic encounter, with its rituals, symbols, and interactions.
These effects are distinct from those of treatments such as pharmacotherapy for diabetes or surgical correction of something and are precipitated by the contextual or environmental cues that surround medical interventions, both those that are fake and lacking in inherent therapeutic power and those with demonstrated efficacy.
This diverse collection of signs and behaviours includes identifiable health care paraphernalia and settings, emotional and cognitive engagement with HCPs, empathic and intimate witnessing, and the laying on of hands.
Ben Basger is a lecturer and tutor in pharmacy practice, Faculty of Pharmacy, The University of Sydney.