Why use placebos in clinical trials? A narrative review of the methodological literature

Vickers, A

doi:10.1016/s0895-4356(99)00139-0

Cited by 121Statistical Methods in Clinical TrialsPain Management and Placebo EffectAdvanced Causal Inference Techniques

Why use placebos in clinical trials? A narrative review of the methodological literature

Vickers, A·2000·Journal of Clinical Epidemiology

DOI 10.1016/s0895-4356(99)00139-0

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Abstract

Researchers have a number of different options for their choice of control or comparison intervention in randomized trials. We surveyed the methodological literature looking for reasons why a researcher might choose to administer a placebo (i.e., a mimic intervention) to control subjects. Two implicit assumptions were that the issue of placebo is pertinent only to drug trials and that the nonplacebo effect of a treatment is the "real" or "true" effect. Explicit reasons given in the literature for the use of placebos were facilitating blinding and controlling for the placebo effect. The importance of the latter was often inadequately argued. Reasons to avoid placebos in controlled trials, other than ethics and feasibility, are that placebos do not inform real decisions, and may interfere with accurate estimation of effect size and with nonspecific aspects of treatment. Placebo-controlled trials have high internal validity but may be difficult to apply to clinical practice; the situation is reversed for trials without placebo control.

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Authors: Vickers, A.
Affiliations: Memorial Sloan Kettering Cancer Center (US)
Corresponding author: Vickers, A
ORCID: Vickers, A
Venue: Journal of Clinical Epidemiology
Publisher: Elsevier BV
Published: 2000-02
Volume: 53
Issue: 2
Pages: 157-161
ISSN: 0895-4356 (ISSN-L)
DOI: 10.1016/s0895-4356(99)00139-0
OpenAlex: W1990079090
Cited by: 121
References: 44
Citations by year: 2026: 5 · 2025: 4 · 2024: 4 · 2023: 3 · 2022: 3 · 2021: 4 · 2020: 8 · 2019: 8 · 2018: 2 · 2017: 6 · 2016: 3 · 2015: 4 · 2014: 3 · 2013: 2 · 2012: 6
FWCI: 1.21
Type: journal article
Language: en
Open access: closed
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations: Journal of Clinical Epidemiology (publishedVersion)
PubMed (publishedVersion)
Topics: Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Life Sciences › Neuroscience › Cognitive Neuroscience › Pain Management and Placebo Effect
Physical Sciences › Mathematics › Statistics and Probability › Advanced Causal Inference Techniques
Keywords: placebo effect, blinding, internal validity, effect size estimation, treatment generalizability, randomized controlled trials
MeSH terms: Double-Blind Method, Humans, Placebos, Epidemiologic Research Design, Randomized Controlled Trials as Topic

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Why use placebos in clinical trials? A narrative review of the methodological literature

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