Evidence map›Paper›PMID 24401940›Full record

Trial reportScience translational medicine2014

Altered placebo and drug labeling changes the outcome of episodic migraine attacks.

Slavenka Kam-Hansen, Moshe Jakubowski, John M Kelley, Irving Kirsch, David C Hoaglin, Ted J Kaptchuk, Rami Burstein

5 registry-linked trialsAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Science translational medicine, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 168 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
168citing papers in PubMed, 5 pooled it
19.1field-weighted citation impact, top 1% of its field
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.

NCT00719134 phase4completednot on this map

The Effects of Expectation and Knowledge on Rizatriptan and Placebo Treatment of Acute Migraine Headache

TypeinterventionalSponsorBeth Israel Deaconess Medical CenterRan2008 to 2013Enrolled76ConditionsEpisodic MigraineArmsMaxalt, placebo pill, placebo pills
NCT02522988 nacompletednot on this mapstarted 2015, after this paper: background citation

The Use of an Open Label Placebo to Treat Cancer Related Fatigue in Cancer Survivors

TypeinterventionalSponsorUniversity of Alabama at BirminghamRan2015 to 2021Enrolled74ConditionsFatigueArmsOpen-label placebo intervention
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
NCT03547661 nacompletednot on this mapstarted 2018, after this paper: background citation

Open-Label Placebo Treatment of Women With Premenstrual Syndrome: A Randomized Controlled Trial

TypeinterventionalSponsorJens GaabRan2018 to 2021Enrolled150ConditionsPremenstrual SyndromeArmsP-Dragees rosa Lichtenstein
NCT04182295 nacompletednot on this mapstarted 2019, after this paper: background citation

Effect of Information on Placebo in the Informed Consent on the Trial Outcomes and Participant Blinding

TypeinterventionalSponsorKyunghee UniversityRan2019 to 2019Enrolled89ConditionsMuscle SorenessArmsacupuncture, Park Sham Needle
3 · Its place in the literature

Who cites it

168 citing papers in PubMed, 5 syntheses or guidelines pooled it, 391 citations in OpenAlex.

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108 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

7 authors at 4 institutions in 2 countries.

Slavenka Kam-HansenDepartment of Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA 02215, USA.
Moshe Jakubowski
John M Kelley
Irving Kirsch
David C Hoaglin
Ted J Kaptchuk
Rami Burstein
Beth Israel Deaconess Medical Center · USHarvard University · USMassachusetts General Hospital · USUniversity of Plymouth · GB

Funding

Photophobia during migraine: sensory, autonomic and emotional responses to lightR37NS079678 · NINDS · BETH ISRAEL DEACONESS MEDICAL CENTER · PI BURSTEIN, RAMI · 2012 to 2018
$3.1M
Migraine pathophysiology: neural basis of photophobiaR01NS069847 · NINDS · BETH ISRAEL DEACONESS MEDICAL CENTER · PI BURSTEIN, RAMI · 2010 to 2014
$1.9M
Mentoring and Research in Placebo Studies, Asian Medicine, and CAMK24AT004095 · NCCIH · HARVARD MEDICAL SCHOOL · PI KAPTCHUK, TED · 2007 to 2016
$1.4M
NCCIH NIH HHS K24 AT004095NINDS NIH HHS R01 NS069847NINDS NIH HHS R37 NS079678
6 · The paper itself

Abstract

Information provided to patients is thought to influence placebo and drug effects. In a prospective, within-subjects, repeated-measures study of 66 subjects with episodic migraine, we investigated how variations in medication labeling modified placebo and drug effects. An initial attack with no treatment served as a control. In six subsequent migraine attacks, each participant received either placebo or Maxalt (10-mg rizatriptan) administered under three information conditions ranging from negative to neutral to positive (told placebo, told Maxalt or placebo, told Maxalt) (N = 459 documented attacks). Treatment order was randomized. Maxalt was superior to placebo for pain relief. When participants were given placebo labeled as (i) placebo, (ii) Maxalt or placebo, and (iii) Maxalt, the placebo effect increased progressively. Maxalt had a similar progressive boost when labeled with these three labels. The efficacies of Maxalt labeled as placebo and placebo labeled as Maxalt were similar. The efficacy of open-label placebo was superior to that of no treatment. Relative to no treatment, the placebo, under each information condition, accounted for more than 50% of the drug effect. Increasing "positive" information incrementally boosted the efficacy of both placebo and medication during migraine attacks. The benefits of placebo persisted even if placebo was honestly described. Whether treatment involves medication or placebo, the information provided to patients and the ritual of pill taking are important components of care.

Indexed as

Drug LabelingEndpoint DeterminationHumansMigraine DisordersPain MeasurementPlacebosTreatment OutcomeTriazolesTryptaminesPlacebosrizatriptanTriazolesTryptamines

Identifiers

PMID24401940
PMCPMC4005597
OpenAlexW2169836118

What OpenQuestion holds

Textmetadata
LicenceTDM
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.