An open-label placebo spray against cardiac anxiety in Austrian rehabilitation inpatients
- A randomized two-week trial in inpatient cardiac rehabilitation: 122 patients (38% women, aged 40–83) were allocated to treatment as usual, to usual treatment plus self-monitoring, or to both plus an open-label placebo, a water-based spray used in the mouth twice daily.
- Cardiac anxiety, sleep quality and well-being improved over time in all three groups.
- There were no significant differences between groups on any primary outcome.
- Expected treatment efficacy at baseline was significantly higher than perceived efficacy at the end of the study; adherence to self-monitoring was high and comparable between the relevant groups.
An open-label placebo is an inert treatment given with the patient told that it is inert. Evidence for it in inpatient clinical populations remains limited, and a group at the University of Graz tested it on cardiac anxiety, the fear attached to heart sensations and heart disease.
Three arms, two weeks
The 122 inpatients were allocated to treatment as usual, to usual treatment plus self-monitoring, or to both plus the placebo: a water-based pump spray used orally twice daily. Primary outcomes were questionnaires on cardiac anxiety, sleep quality and well-being before and after the intervention. Secondary outcomes included daily symptom ratings, treatment expectancy, perceived efficacy and adherence. Cardiac anxiety, sleep quality and well-being improved over time in every group. Between groups there were no significant differences on any primary outcome. The authors conclude that the placebo added no benefit beyond usual care and self-monitoring in a setting with structured, effective standard treatment.
Expectation before, experience after
Expected efficacy at baseline was significantly higher than perceived efficacy at the end of the study.
What follows is my comment, not a finding of the trial. The paper does not say how the spray was explained to patients, so I cannot tell whether the wording played a part. But the clinician controls exactly that sentence. "There is no active ingredient" can be heard as "so it will not help" or as "so what helps is what you do with it". A person already scanning the body for heart signals may take an expectation that outran the experience as one more sign that the treatment failed.
Before offering any low-key adjunct to a patient with cardiac anxiety, ask what they expect it to do, say plainly what it will and will not do, and agree on one thing to watch over the coming days. At the next contact, ask about the expectation first and the symptom second.
Expected efficacy at baseline exceeded perceived efficacy at the end, and what the clinician says before the first dose shapes that expectation.
The trial lasted two weeks and took place in an inpatient cardiac-rehabilitation setting.