Evidence map›Paper›PMID 20706875›Full record

Trial reportJournal of general internal medicine2010

Placebo adherence and its association with morbidity and mortality in the studies of left ventricular dysfunction.

Andrew L Avins, Alice Pressman, Lynn Ackerson, Peter Rudd, John Neuhaus, Eric Vittinghoff

Abstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of general internal medicine, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 3 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

15 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Healing in a Social Context: The Importance of Clinician and Patient Relationship.Frontiers in pain research (Lausanne, Switzerland) · 2021
    Review
  8. Article
  9. Review
  10. Article
  11. Article
  12. Article
  13. Article
  14. To adhere or not, and what we can do to help.European child & adolescent psychiatry · 2012
    Article
  15. Adherence, placebo effects, and mortality.Journal of general internal medicine · 2010
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors.

Andrew L AvinsNorthern California Kaiser-Permanente Division of Research, Oakland, CA 94612, USA. andrew.avins@ucsf.edu
Alice Pressman
Lynn Ackerson
Peter Rudd
John Neuhaus
Eric Vittinghoff

Funding

The Enigma of Placebo Adherence and Health OutcomesR01HL081195 · NHLBI · KAISER FOUNDATION RESEARCH INSTITUTE · PI AVINS, ANDREW L · 2006 to 2009
$1.5M
NHLBI NIH HHS R01 HL081195
6 · The paper itself

Abstract

backgroundA provocative finding from several double-blind clinical trials has been the association between greater adherence to placebo study medication and better health outcomes. We used data from the Studies of Left Ventricular Dysfunction (SOLVD) Treatment Trial (SOLVD-TT) and the SOLVD Prevention Trial (SOLVD-PT) to examine whether such associations could be validated and to examine several sources of bias and potential confounding.

methodsSurvival analytic methods were used to estimate the association between placebo adherence and several health outcomes, employing a number of modeling techniques to test for the existence of alternative explanations for the association. Higher adherence was defined as having taken ≥75% of prescribed study medication.

resultsHigher placebo adherence was associated with improved overall survival in both SOLVD-TT and SOLVD-PT [hazard ratio (HR) = 0.52, 95% confidence interval (CI): 0.35 to 0.79 and HR = 0.52, 95%CI: 0.38 to 0.71, respectively]. Associations were similar for fatal or non-fatal cardiovascular or coronary heart disease events. Adjustment for both modifiable and non-modifiable cardiac risk factors (including age, gender, diabetes, blood pressure, smoking, weight, alcohol use, and levels of education) had minimal effect on the strength of the association. Little evidence of bias was found as an explanation for this relationship.

conclusionsIn these two trials, better adherence to placebo was associated with markedly superior health outcomes, including total in-study mortality and incident cardiovascular events. No important confounders were identified. These data suggest there may exist strong but unrecognized determinants of health outcomes for which placebo adherence is a marker.

Indexed as

Patient CompliancePlacebo EffectAdultAgedDouble-Blind MethodEnalaprilFemaleFollow-Up StudiesHeart FailureHumansMaleMiddle AgedMorbidityTreatment OutcomeVentricular Dysfunction, LeftEnalapril

Identifiers

PMID20706875
PMCPMC2988150

What OpenQuestion holds

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LicenceCC BY-NC
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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.