Evidence map›Paper›PMID 26840547›Full record

ArticleBioethics2016

Are open-Label Placebos Ethical? Informed Consent and Ethical Equivocations.

Charlotte Blease, Luana Colloca, Ted J Kaptchuk

3 registry-linked trialsAbstract read
In one paragraph

Article in Bioethics, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 61 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
61citing papers in PubMed, 4 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.

NCT03294148 nacompletednot on this mapstarted 2017, after this paper: background citation

Mind-body Treatments for Chronic Back Pain

TypeinterventionalSponsorUniversity of Colorado, BoulderRan2017 to 2019Enrolled151ConditionsChronic Pain, Back Pain Lower Back Chronic, Back Pain, LowArmsOpen-Label Placebo Treatment for Chronic Back Pain, Psychotherapy Treatment for Chronic Back Pain
NCT06365892 narecruitingnot on this mapstarted 2024, after this paper: background citation

Effectiveness of Conditioning + Open-label Placebo for the Management of Pain in Children Who Undergo Surgical Treatment of Idiopathic Scoliosis

TypeinterventionalSponsorUniversity of California, San FranciscoRan2024 to 2026Enrolled64ConditionsAdolescent Idiopathic Scoliosis (AIS)Armsopen-label placebo, Treatment as usual
NCT07373210 narecruitingnot on this mapstarted 2026, after this paper: background citation

Conditioning, Open-label Placebo for Pain Management in Adolescents and Young Adults Undergoing Bernese Periacetabular Osteotomy (PAO)

TypeinterventionalSponsorUniversity of California, San FranciscoRan2026 to 2028Enrolled64ConditionsPeriacetabular Osteotomy, OpiatesArmsOpen-Label Placebo, Treatment as usual
3 · Its place in the literature

Who cites it

61 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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1 more citing papers are in PubMed but not listed here.

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

3 authors.

Charlotte Blease
Luana Colloca
Ted J Kaptchuk

Funding

Chronic orofacial pain: genetics, cognitive-emotional factors, and endogenous modulatory systemsR01DE025946 · NIDCR · UNIVERSITY OF MARYLAND BALTIMORE · PI COLLOCA, LUANA · 2016 to 2019
$2.1M
Mentoring and Research in Placebo Studies, Asian Medicine, and CAMK24AT004095 · NCCIH · HARVARD MEDICAL SCHOOL · PI KAPTCHUK, TED · 2007 to 2016
$1.4M
Optimization of brain-based mechanisms supporting psychosocial aspects of acupuncture therapy - a hyperscanning fMRI studyR61AT009306 · NCCIH · MASSACHUSETTS GENERAL HOSPITAL · PI KAPTCHUK, TED, NAPADOW, VITALY · 2016 to 2017
$959k
NCCIH NIH HHS K24 AT004095NCCIH NIH HHS R61 AT009306NIDCR NIH HHS R01 DE025946
6 · The paper itself

Abstract

The doctor-patient relationship is built on an implicit covenant of trust, yet it was not until the post-World War Two era that respect for patient autonomy emerged as an article of mainstream medical ethics. Unlike their medical forebears, physicians today are expected to furnish patients with adequate information about diagnoses, prognoses and treatments. Against these dicta there has been ongoing debate over whether placebos pose a threat to patient autonomy. A key premise underlying medical ethics discussion is the notion that the placebo effect necessitates patient deception. Indeed, the American Medical Association guidelines imply that placebo treatment necessary entails a form of deception. As a consequence of this assumption, the fulcrum of debate on the use of placebo treatment has hinged on whether that deception is ever justified. Recently performed experiments with open-label transparently prescribed placebos have begun to challenge the notion that deception is necessary in eliciting the placebo effect and such effects necessarily involve a binary distinction between autonomy and beneficence. In this article we focus on the content of disclosures in distinctive open-label, transparently disclosed placebo studies and inquire whether they might be said to invoke deception in clinical contexts, and if so, whether the deception is unethical. We find that open placebos may be said to involve equivocation over how placebos work. However, drawing on surveys of patient attitudes we suggest that this equivocation appears to be acceptable to patients. We conclude that open placebos fulfil current American Medical Association guidelines for placebo use, and propose future research directions for harnessing the placebo effect ethically.

Indexed as

DeceptionEthics, ClinicalEthics, MedicalInformed ConsentPhysician-Patient RelationsBeneficenceHumansPlacebo EffectPlacebosPlacebosclinical ethicsdeception in medicineInformed consentoaternalismopen-label placebospatient autonomyplacebo effect

Identifiers

PMID26840547
PMCPMC4893896

What OpenQuestion holds

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Read underepoch 390

Registered trials

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.