A systematic qualitative review of ethical issues in open label placebo in published research

Abstract

Open-label placebos (OLPs), which are transparently administered inert treatments, have gained increasing attention in the research community. They have the potential to harness placebo effects without deceiving the patient. The purpose of this study was to examine and synthesize prior research discussing ethical issues in OLPs. A systematic qualitative literature review was conducted (last search on January 2023) across multiple databases (e.g., MEDLINE, Embase, PsycInfo) using keywords related to OLPs. Publications were screened and assessed for eligibility. Seventeen articles explicitly addressing OLP ethics were included. Data were extracted and thematically analyzed following established qualitative content analysis procedures. 37 distinct ethical issues were identified, grouped into five overarching themes: (1) Sociocultural and Contextual Factors, (2) Implementation and Logistics, (3) Informed Consent, (4) Patient Health Behavior and Dynamics, and (5) Therapeutic Relationship. Frequently mentioned concerns focused on uncertainty of OLP efficacy, the need for further research, and complexities of dose-extending OLPs. The effective integration of OLPs into healthcare necessitates thoughtful consideration and responsible communication. This analysis shows that demonstrating the efficacy of OLPs becomes pivotal for their widespread adoption, underscoring the necessity for additional research to validate their effectiveness. This review was pre-registered on January 26th, 2023, in the Open Science Framework Registry under the identifier: DOI https://doi.org/10.17605/OSF.IO/R6NKG .

Keywords: Bioethics; OLP; Open label placebos; Placebo research; Systematic qualitative review.

Fig. 1

PRISMA flowchart overview.