Randomized controlled trial · 2014
Altered placebo and drug labeling changes the outcome of episodic migraine attacks
Kam-Hansen S, Jakubowski M, Kelley JM, Kirsch I, Hoaglin DC, Kaptchuk TJ, Burstein R
Science Translational Medicine, 2014 · PMID 24401940
In short
A within-subject migraine study that mislabelled and correctly labelled both a real drug and a placebo, isolating how much of the outcome tracked the label rather than the pill.
- Study type
- Randomized controlled trial
- Published
- Science Translational Medicine, 2014
- Topics
- Labelling, Migraine, Expectation
does the label on a pill change its effect?
Yes, measurably — in this 2014 migraine study, the label on the envelope changed outcomes independently of what was inside. Placebo labelled as the active drug outperformed placebo labelled as placebo, and openly labelled placebo still beat no treatment at all.
Most placebo trials compare a pill to no pill. This one held the pill constant and varied only what the envelope said, which is an unusually direct way to measure the contribution of information.
The question
How much of a treatment's measured effect is attributable to what the patient is told the pill is?
How it was done
- 66 participants treated multiple episodic migraine attacks each, producing several hundred attacks in total.
- Each attack was treated with an envelope labelled “Maxalt” (rizatriptan), “placebo”, or “Maxalt or placebo” — and the contents did not always match the label.
- Because each participant served as their own control across attacks, drug and label effects could be compared within the same person.
What was reported
- Pain relief tracked both the pill and the label, and the label accounted for a substantial share of the total measured effect.
- Placebo pills labelled as the active drug outperformed placebo pills labelled as placebo.
- Notably, placebo openly labelled as placebo still outperformed treating the attack with no pill at all.
Limitations
- Single condition with self-reported pain outcomes.
- Participants were experienced migraine patients who knew the study involved mislabelling, which shapes expectation in its own way.
- The deceptive labelling design is not repeatable in ordinary clinical practice.
Why it matters
It quantified the information component of a treatment separately from its pharmacology — a core reason placebo controls and blinding exist in trial design.
Citation
Kam-Hansen S, et al. Altered placebo and drug labeling changes the outcome of episodic migraine attacks. Sci Transl Med. 2014;6(218):218ra5.
PMID 24401940This summary is written by Efficacy Labs and is not a substitute for the original publication. The research described here is independent work by third parties and was not conducted using Efficacy Labs products. Efficacy Labs products contain no active therapeutic ingredient and are not intended as substitutes for prescribed medication or professional medical care. Information on this website is provided for general educational and research purposes and is not medical advice. References to published research describe independent scientific literature and do not imply that the research was conducted using Efficacy Labs products unless explicitly stated.
Background
What the placebo effect is, explained simply
How the effect is defined, what researchers think drives it, and how it is measured in trials like this one.
Products
Placebo pills for research and education
Inert capsules from Efficacy Labs, what they contain, and how to order them for a study or a classroom.
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