Evidence map›Paper›PMID 22840666›Full record

Trial reportThe American journal of medicine2012

Placebo adherence and mortality in the Heart and Estrogen/Progestin Replacement Study.

Amy M Padula, Alice R Pressman, Eric Vittinghoff, Deborah Grady, John Neuhaus, Lynn Ackerson, Peter Rudd, Andrew L Avins

Open access · greenAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The American journal of medicine, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 22% 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.

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

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.

  1. The effect of placebo adherence on reducing cardiovascular mortality: a meta-analysis.Clinical research in cardiology : official journal of the German Cardiac Society · 2014
    Pooled it
  2. Article
  3. Article
  4. Review
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

8 authors at 5 institutions in 1 country.

Amy M PadulaSchool of Public Health, University of California, Berkeley, CA, USA. ampadula@stanford.edu
Alice R Pressman
Eric Vittinghoff
Deborah Grady
John Neuhaus
Lynn Ackerson
Peter Rudd
Andrew L Avins
Kaiser Permanente · USSan Francisco VA Medical Center · USUniversity of California, San Francisco · USStanford University · USUniversity of California, Berkeley · US

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

backgroundAnalyses from double-blind randomized trials have reported lower mortality among participants who were more adherent to placebo compared with those who were less adherent. We explored this phenomenon by analyzing data from the placebo arm of the Heart and Estrogen/Progestin Replacement Study (HERS), a randomized, double-blind, placebo-controlled trial of estrogen plus progestin for secondary prevention of coronary heart disease in postmenopausal women. Our primary aim was to measure and explain the association between adherence to placebo and total mortality among the placebo-allocated participants in the HERS. Secondary aims included assessment of the association between placebo adherence and cause-specific morbidity and mortality.

methodsParticipants with "higher placebo adherence" were defined as having taken at least 75% of their placebo study medication during each individual's participation in the study, whereas those with "lower placebo adherence" took less than 75%. The primary outcome was in-study all-cause mortality.

resultsMore adherent participants had significantly lower total mortality compared with less adherent participants (hazard ratio, 0.52; 95% confidence interval, 0.29-0.93). Adjusting for available confounders did not change the magnitude or significance of the estimates. Analyses revealed that the association of higher adherence and mortality might be explained, in part, by time-dependent confounding.

conclusionsAnalyses of the HERS data support a strong association between adherence to placebo study medication and mortality. Although probably not due to simple confounding by healthy lifestyle factors, the underlying mechanism for the association remains unclear. Further analyses of this association are necessary to explain this observation.

Indexed as

Cause of DeathPlacebo EffectAgedCoronary DiseaseDouble-Blind MethodDrug MonitoringEstrogen Replacement TherapyFemaleHumansIncidenceMiddle AgedNeoplasmsProportional Hazards ModelsRiskUnited States

Identifiers

PMID22840666
PMCPMC3423204
OpenAlexW1999989208

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.