Evidence map›Paper›PMID 40144035›Full record

ArticleFrontiers in psychology2025

Noble Humbug? Hard and soft laws on clinical placebo use.

Mélina Richard, Manuela Ganz, Lena Dominique Hornstein, Bohdan Stehlik, Mélanie Levy, Charlotte R Blease, Marco Annoni, Bernice S Elger, Jens Gaab

Abstract read
In one paragraph

Article in Frontiers in psychology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Mélina RichardInstitute of Biomedical Ethics, University of Basel, Basel, Switzerland.
Manuela GanzDivision of Clinical Psychology and Psychotherapy, Faculty of Psychology, University of Basel, Basel, Switzerland.
Lena Dominique HornsteinDivision of Clinical Psychology and Psychotherapy, Faculty of Psychology, University of Basel, Basel, Switzerland.
Bohdan StehlikDivision of Clinical Psychology and Psychotherapy, Faculty of Psychology, University of Basel, Basel, Switzerland.
Mélanie LevyHealth Law Institute, Faculty of Law, University of Neuchâtel, Neuchâtel, Switzerland.
Charlotte R BleaseParticipatory eHealth and Health Data Research Group, Uppsala University, Uppsala, Sweden.
Marco AnnoniCentre for Research Ethics and Integrity (CID-Ethics), National Research Council (CNR), Rome, Italy.
Bernice S ElgerInstitute of Biomedical Ethics, University of Basel, Basel, Switzerland.
Jens GaabDivision of Clinical Psychology and Psychotherapy, Faculty of Psychology, University of Basel, Basel, Switzerland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Despite the widespread historical and contemporary use of placebos in medicine, legal regulations addressing their administration remain limited in many countries. This paper examines the legal landscape of clinical placebo use, focusing on key jurisdictions such as France, Germany, Switzerland, the United Kingdom, and the United States. Given the ethical and legal complexities surrounding placebo use, a critical assessment of existing regulatory frameworks is essential. This study employs a multidisciplinary approach, analyzing both binding laws ("hard laws") and non-binding principles ("soft laws") related to placebo administration. Data were collected from legal statutes, health institution guidelines, and professional medical codes to map the regulatory environment governing placebos in different legal systems. The results indicate significant variations in how placebos are addressed legally. For instance in Germany and the UK, no specific laws regulate placebo use, but statutes on informed consent implicitly cover their administration. In the United States, the American Medical Association provides ethical guidelines permitting placebo use under strict conditions emphasizing patient welfare and transparency. Across all examined jurisdictions, unauthorized placebo use may lead to legal consequences such as medical fraud allegations or violations of patient rights. These findings highlight the need for explicit regulatory guidelines to ensure that placebo use adheres to ethical and legal standards. The growing acceptance of open-label placebos (OLPs), which demonstrate efficacy without deception, presents a potential avenue for aligning legal frameworks with evolving medical practices. Future regulatory developments should address the ethical and legal challenges associated with placebos, ensuring patient autonomy and informed consent remain central to their use in clinical practice.

Indexed as

clinical placebo useclinical regulationshard laws and soft lawsinformed consentlegal frameworksopen-label placebos (OLPs)patient rights and autonomyplacebo

Identifiers

PMID40144035
PMCPMC11938247

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.