Reference
Leibowitz KA, Hardebeck EJ, Goyer JP, Crum AJ. Physician assurance reduces patient symptoms in US adults: an experimental study. J Gen Intern Med. 2018;33(12):2051-2052.
Objective
To examine the effect of physician assurance, a simple, single sentence, in the absence of pharmacological treatment on patient allergic reactions.
Design
Blinded, randomized trial
Participants
The study included 76 adults, 54% under 22 years old, with the following demographics: female (61.8%), male (38.2%); White (40.8%), Asian (23.6%), Hispanic/Latino (9.2%), African-American (9.2%), and “other” (15.7%).
Inclusion Criteria
Patients presenting for a histamine skin prick test
Intervention
Participants were randomized into 2 groups: an assurance group (n=36) and a control group (n=41). All participants (n=76) received a histamine skin prick from a Quintip lancet soaked in 10 mg/mL histamine dihydrochloride on the forearm. Each participant rated their itchiness/irritation immediately before and at 3, 9, 12, 15, and 18 minutes post-histamine skin prick. The provider visually examined the participants’ forearms after the 3-minute rating.
At 3 minutes, the assurance group was told, “From this point forward your allergic reaction will start to diminish and your rash and irritation will go away.” The control group (n=41) was told nothing by the provider.
Study Parameters Assessed
A stopwatch was used to time the duration of the reaction, and an allergy ruler and tape was used to measure the size of the skin reaction. The reaction was recorded on a computer or iPad. All measurements were made by the research assistant, and the provider was not present during participant reporting of symptoms.
Analysis
Multilevel longitudinal regression models used time predictors to model differences in itchiness before and after physician assurance. Two-tailed Z scores were calculated and P≤0.05 was considered statistically significant.
Key Findings
Itchiness during the 3 minutes between the skin prick and physician assurance increased in both groups equally. After physician assurance, itchiness decreased significantly faster than in the non-assurance group (P=0.05), such that the assured group felt significantly less itching than the control group at 9 minutes (P=0.19). This differential held for the interim between 9 and 12 minutes (P=0.047), while the decline in itchiness fell at nearly the same rate for each group. By minute 15, there was no statistically significant difference between the 2 groups as the itchiness was reaching more complete resolution in both groups.
Placebo is an inert substance, but words provide meaning that is rich, alive, and powerful; they are far from inert.
In short, a single sentence of assurance from a physician reduced the subjects’ ratings of itchiness/irritation of a histaminic reaction compared to the control group.
Practice Implications
The placebo effect, “I will please,” was established in a 1955 study as clinically important and assumed to result from the role our brain plays in physical health.1 Its use in medicine officially dates to 1811, although some allege Samuel Hahnemann used blank lactose pellets with patients and provers (healthy volunteers) in the 1790s. An 1811 medical dictionary defined placebo as an epithet given to any medicine adapted more to please than benefit the patient.2 The medicine of that era consisted of bleeding, leeches, and purging. George Washington was bled 4 times in 8 hours and died that evening (December 14, 1799), while Wolfgang Amadeus Mozart was bled at least once and died the next day (December 5, 1791).3,4 Arguably, the use of something, or more precisely anything, to forestall “standards of care” in those days may have been the better choice.
Dr Arthur K Shapiro spent much of his career studying the placebo effect. He first became interested while recovering from mononucleosis during his second year of medical school, when double-blind placebo trials were used to study antipsychotic, antidepressant, and antianxiety medications. He defined placebo in part as “any therapeutic procedure which is given 1) deliberately to have an effect, or 2) unknowingly has an effect on a symptom syndrome, disease, or patients but which is objectively without specific activity for the condition being treated.”5,6 Three decades of research later his definition of placebo remains essentially unchanged; placebos do cause the placebo effect.7 Dr Shapiro is also known for his work with Tourette syndrome, proving it to be a neurological rather than a psychological condition.8
The presentation of the physician or the physician’s costume, stethoscope, mannerisms, style, language, examination table, and medical equipment all affect the outcome just as much as the diagnosis and prognosis.9-12 Essentially the message of the doctor is the therapy or becomes a part of the therapy. This has been referred to as the “meaning response.”13 Placebo is an inert substance, but words provide meaning that is rich, alive, and powerful; they are far from inert.
As clinicians we have seen this meaning response in our clinical practice but we underestimate its power. Outside of a research study we do not take the time to formulate the words, inflections, and body language that will deliver the message we want our patients to hear or believe. We simply move from patient visit to patient visit delivering care in the best way we can. Delivering an inert placebo carries certain moral and ethical concerns that are different, though similar, to the statement of words about a treatment or response outcome.
In the background documents not published in the journal article, note is made of the set-up of the research room to look like a physician’s examination room, the dress of the physician, and the exact sentence to be delivered to each member of the treatment group. So while this was called a placebo study, it is actually a study of the “meaning response,” a term coined by Moreman and Jonas in their review of placebo effect.13 In fact, they argue that in simplifying the treatment of pain by relying on salicylates, for example, modern medicine has lost the connectedness to the birches, willows, and wintergreens from which salicylates can be derived.13 Or, to put it in the context of this histamine allergic reaction study, medicine has lost the nuances of language that could give meaning, comfort, and relief to our patients in certain painful circumstances. We spend too much time looking at a computer screen, or lab or study results, and not enough time looking at the patient and offering them sincere words of comfort. I still recall John Bastyr, ND, telling a small group of us at the end of a clinic shift at National College of Naturopathic Medicine in 1990 the importance of touching each patient as part of the therapeutic process. Much of medicine today has lost and ignored the subtle nuances that can make the difference between an outcome and a very positive outcome. We should not stage our patient responses, but we should speak from the heart and offer appropriate, honest hope that can be of benefit to our patients. The delivery of our therapy is just as important as the therapy that we deliver.
Summary
In this study both groups were administered a histamine skin prick allergy test from a Quintip lancet dipped in10 mg/mL histamine dihydrochloride, on the forearm. After 3 minutes the physician examined the forearm and in the assurance group stated, “From this point forward your allergic reaction will start to diminish and your rash and irritation will go away.” The control group was told nothing. The different reaction between the 2 groups based on self-rating was significant by 9 minutes. Physician language appeared to significantly reduce the itchiness and rash in those who received the positive reassurance.
