Abstract

The use of placebo outside of randomised controlled trials raises ethical and legal issues. So far, patients' perspectives have been considered only in quantitative studies. These studies did not distinguish between pure placebos (no pharmacological effect) and impure placebos (pharmacological ingredient, but no disease-specific effect). The aim of our study was to explore patients' conceptualisation, experiences and attitudes regarding the use of placebos in daily clinical practice. Qualitative study with a convenience sample of 12 patients and semistructured interviews. The interviews were digitally recorded; full transcripts were obtained. The information was analysed in accordance with the qualitative content analysis method. The definition of placebo given by the participants mostly matched the common understanding of a pure placebo. Most participants supposed that placebos were mainly effective in diseases in which psychological influences play an important role. Furthermore, most participants believed that placebos themselves mainly worked via psychological effects. The acceptance of a hypothetical earlier use of a placebo depended on the success of the therapy. Patients were not aware of the differences between pure and impure placebos. Even regarding pure placebos, patients were more open than many physicians would expect. Trust between the patient and the general practitioner is an important element of the acceptance of a placebo. Appropriate communication could further increase the acceptance. Further research is needed to adapt the information given to the patient about possible placebo therapy.

Highlights

  • In randomised pharmaceutical clinical trials, the use of placebos is quite common

  • Further research is needed to adapt the information given to the patient about possible placebo therapy

  • For example, showed that 45% of German general practitioners (GPs) used a pure placebo [6, 7] at least once a year and a much higher rate was revealed for impure placebos, with a median use of 20 times per year [2]

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Summary

Introduction

In randomised pharmaceutical clinical trials, the use of placebos is quite common. placebos are occasionally used in daily practice, in a hospital environment as well as in an outpatient setting [1,2,3,4,5]. Recent studies have focused on the use of placebos outside RCTs, mainly assessing quantitative aspects [1,2,3] or discussing the legal and ethical controversy about the use of a placebo [14,15,16,17,18]. Most physicians agreed that placebos played an important role in daily practice, for example, to calm the patient or as a supplemental therapy [4]. Their use was associated with ethical and legal uncertainties, especially regarding deception and lack of informed consent. In our study we used the term placebo for both pure and impure placebos

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